A Golden

Anni\ersary of

Consumer Protection

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FDA

ONS e VOL. 22 NO. 5 JUNE 1988 e

• t h e o f f i c i a l m a g a z I N E O F T H E U . S . F O O D A N D D R U G A D MI N I S T R A T I O N

Ot is R. Bowen, M.D.

Secretary, U.S. Department olHealth and Human Service.s

V O L . 2 2 N O . 5 JUNE 1988Frank E. Young, M.D., Ph.D.Commi.s.sioner of Food and Drue

A Golden Anniversary of Consumer ProtectionFDA Commissioner Frank Young looks back 50 years to see howour lives have been changed by a landmark of consumer protection, the Federal Food, Drug, and Cosmetic Act of1938.

TM Disorders: Aches and Pains from Flaws in the JawsAs many as one in four Americans may suffer the headaches, facialpain, and other symptoms of a group of jaw problems known as TMdisorders. While most cases clear up on their own, some may needprofessional help and treatment.

A Summertime Hot Line for Food Safety QuestionsThis summer, residents of Florida, Illinois and Massachusetts candial a toll-free hot line for advice on food safety. If the FDA - USDApilot program is a success, it could be expanded.

Juiceless Baby Juice Leads to Full-Strength JusticeThe Beech-Nut baby food company took a gamble when it decidedto sell artificially flavored sugar water as 100 percent apple juice.It came up a big loser, paying more than $2.5 million in fines whileits officials face possible jail terms.

Should You Take Aspirin to Help Prevent a Heart Attack?After II ,000 doctors in a recent study cut their risk of heart attackby taking an aspirin every other day, many people began wonderingif they should do the same. For some, that could cause more harmthan good.

Fewer Months 'R' Safe for Fating Raw Gulf OystersIt used to be considered safe to eat raw oysters in any month with any'in it. But reports of illness and death after eating bacteria-contaminated Gulf Coast oysters have prompted health officials toshorten the safe season.

Keeping Your Dog Worm-FreeHookworms, heartworms, roundworms, whipworms. . . How didmans best friend ever get so many enemies ? With the help of yourvet, there's a lot you can do to keep your pooch pest-free.

John A. Norris, J.D., M.B.A.Deputy Commissioner of Foodand Drugs

J a c k W. M a r t i nAssoeiate Commissioner forP u b l i c A f f a i r s

Wi l l iam M. Rados Edi tor

Je.sse R. Nichols/Art Directoi

Updates Investigators' Reports

FDA Consumer (ISSN 00362-1332) is publishedby the Food and Drug Administration, U.S.Public Health Service, Department of Healthand Human Services. It is published monthly,except for combined issues for July-August andDecember-January. Use of funds for printingFDA Consumer has been approved by the Officeof Management and Budget.

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T h e N o t e b o o k 3 0 S u m m a r i e s o f C o u r t A c t i o n s T h i s M o n t h ' s C o v e r

Inside Front Cover Photo:

A painful jaw can be caused by many problems-from arthritis to misalignedteeth. In the picture on the facing page, a patient is being fitted with a dentalappliance to help hold her teeth apart properly, in hopes of relieving hercondition. For more about painful jaw problems, turn to page 6.

Cover Design: Paul Salmon

At the center of the montage on thismonth's cover is a sketch of JoanNidiffer, one of the victims of the ElixirSulfanilamide tragedy of1937. Hergrieving mother's letter to PresidentFranklin Roosevelt helped to securepassage, 50 years ago this month, of theFederal Food, Drug, and Cosmetic Act.For more about this consumer protection landmark, turn to page 4.

FDA Consumer /June 1988 i I

updates

Pregnant Women Warned About Acne DrugUnder no circumstances should pregnant women take

isotretinoin (Accutane), a drug prescribed for severe cystic acne. A recent report from the Centers for DiseaseControl describes four cases of multiple, serious birthdefects involving the brain, cardiovascular system, andface in infants born to mothers who had taken isotretinoin

during the first trimester of pregnancy.Since Accutane was first marketed in 1982, FDA has

warned against its use in pregnant women because thedrug was known to produce birth defects in animals. In1983, the agency began receiving reports of human birthdefects associated with use of the drug, and a total of 62birth defects and miscarriages have so far been recordedby the agency. FDA scientists believe that this figure maygreatly understate the true number of incidents sincealmost all types of adverse drug reactions areunder-reported.

FDA and the drug's manufacturer have started an extensive campaign to educate physicians and the public aboutthe risk of birth defects associated with the drug. Theseefforts include letters to physicians detailing risks andproper prescribing information, press releases to thegeneral media about the dangers of Accutane, and the distribution to pharmacists of red warning stickers to beplaced on each prescription bottle.

FDA was to hold an open meeting of its dermatologicadvisory committee to discuss the Accutane problem onApril 26.

Muscle Stimulators Stimulate Fraud

FDA has warned consumers that prescription-onlyelectrical muscle stimulators, which should be usedsolely for certain medical problems, are being used byhealth spas and figure salons for unproven and deceptiveu s e s .

Stimulators sold by two Texas firms. Body Trimmer ofAmarillo and Total Control of Dalhart, were cited by FDAin its March 9 Enforcement Report. Health spas arepromoting these devices for weight control, spot reducing, "cellulite" removal, bust development, wrinkleremoval, and non-surgical "face lifts." FDA has seen noscientific data that the devices are safe and effective forthese uses and considers them to be misbranded andfraudulent if so used.

FDA regulates electrical muscle stimulators asprescription medical devices to be used only by or on theorder of a licensed practitioner. Unlike simple massagedevices, electrical muscle stimulators contract muscles bypassing electric current through electrodes applied to the

skin. They are used legitimately in physical therapy totreat specific medical problems, such as increasing bloodcirculation to a part of the body, preventing blood clots inthe leg muscles of bedridden patients after surgery, andincreasing or monitoring the range of motion of an arm orleg.

Although FDA has received no recent reports of injuries, potential hazards include electrical shocks andburns. The devices should not be used by pregnant womenor people with heart problems, nor should they be usedover the brain or heart.

For more about the hazards of improperly used electrical muscle stimulators, see "EMS: Fraudulent FlabRemover" in the May 1983 FDA Consumer.

Sulfamethazine Undergoes Safety ReviewA widely used swine and cattle drug called sulfametha

zine is undergoing FDA reevaluation for safety. FDAcalled for this review because a study by the agency'sNational Center for Toxicological Research (NCTR) suggests that moderate to high doses of the drug may causethyroid cancer in mice - a concern heightened by the factthat the U.S. Department of Agriculture found illegallyhigh residues of sulfamethazine in some pork products.

Seventy percent to 80 percent of all hogs on the U.S.market receive sulfa. Sulfamethazine, the leading sulfadrug, has been used for 30 years to treat respiratory diseases and promote faster weight gain in food animals. Toensure the meat contains no illegal residues, animals mustbe taken off the drug 15 days before slaughter. This maynot get rid of all traces, however, if the animals have continued exposure in the environment (for example, in theirfeed troughs) or in their feed.

FDA sent a letter on March 10 to sulfamethazinemanufacturers to explain the situation and inform themthat the agency is reviewing all safety information on sulfamethazine while NCTR's data undergoes peer review.

Commissioner Frank E. Young, M.D., Ph.D., discussed the issues and possible solutions during a March17 meeting with manufacturers and representatives ofanimal drug associations. He said he would convene apublic hearing "so that all parties can have an opportunityto present the scientific facts, the studies conducted byNCTR, and other pertinent information." The hearing wasset for May 25 and 26 at the National Institutes of Health,Bethesda, Md.

After studying the information presented at the hearing,FDA may take one of several steps: lower the legal limitfor sulfamethazine residues in pork; decide the drug's usein food-producing animals is an imminent health hazard.

2 /June 1988/FDA Consumer

which would call for FDA's recommending to the Secretary of Health and Human Services that the drug immediately be taken off the market; or announce anotherhearing, which could lead to the drug's removal or othercorrection later on.

Copies of the NCTR study are available from theDockets Management Branch, Room 4-62, 5600 FishersLane, Rockville, Md. 20857. (See also "Keeping OurFood Safe from Animal Drugs" in the July-August 1986FDA Consumer.)

Skin Cream Makers May Face Legal Action

Makers of skin creams who claim that their productscan reverse aging, "renew" skin, "control" the agingprocess, or otherwise make basic functional or structuralchanges in the skin have been warned they face regulatoryaction by FDA.

Letters sent April 14 to 22 cosmetic firms put the industry on notice that FDA in effect has ended year-long discussions with some manufacturers about unproven"anti-aging" claims for their skin creams. (See "ErasingWrinkles: Easier Said Than Done" in the July-August,1987 FDA Consumer.)

FDA Commissioner Frank E. Young, M.D., Ph.D.,explained that cosmetics - products intended to cleanseor superficially beautify - can be sold without pre-marketapproval from FDA. Products marketed with drug claims,however, require agency approval, based on data demonstrating safety and effectiveness. When a product is said tocounteract, retard or "control" the aging process or torejuvenate, repair or "renew" the skin, the statements aredrug claims because they indicate that a "function of thebody, or that the structure of the body, will be affected bythe product."

In a series of letters to major cosmetic firms last year,FDA warned it was "unaware of any substantial scientificevidence that demonstrates the safety and effectiveness"of the purported anti-aging skin care products. LastNovember, FDA again said it could not accept the labeling claims that continued to appear on some products.

FDA said in its April 4 letters that it would soon takeone more look at the labeling and promotions. A productfound to be in "substantial violation" of FDA regulationscan be subject to seizure or may lead to injunction againstthe manufacturer.

OTC Eye Products Safe, Effective

FDA has announced that nonprescription products nowon the market for the temporary relief of dry, red eyes aresafe and effective. However, the agency will require these

drugs to carry a warning that they should not be used on along-term basis except under a doctor's supervision.

The agency's standards for these over-the-counter eyeproducts were published in the March 4 Federal Register.Ingredients approved by FDA to relieve redness are ephe-drine hydrochloride, naphazoline hydrochloride,phenylephrine hydrochloride, and tetrahydrozolinehydrochloride. In addition, the agency approved over 20ingredients to relieve dryness and to lubricate and protectthe eye and eyelid from minor irritation.

All of these eye-care products will have to display thewarning, "If you experience eye pain, changes in vision,continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor." Eyewash products wouldcarry the same warning but without the 72-hour limit onuse. In addition, any eye-care products containingmercury compounds must carry a warning stating thecompounds are present. Mercury compounds, which areused as preservatives, can cause allergic reactions insome people.

The requirements become effective March 4, 1989.Today's standardization of acceptable ingredients and

labeling for a line of nonprescription drugs is the 20thsince FDA's massive review of all nonprescription drugingredients began in 1972. Nonprescription drugs forminor eye infections are still under review.

Correction: Caffeine in Diet Cola

A chart on the caffeine content of soft drinks in the article "Caffeine Jitters: Some Safety Questions Remain" inthe December 1987-January 1988 FDA Consumerhadanincorrect entry for the caffeine content of pepper-type dietcolas. The correct amount is between zero and 30 milligrams per 6-ounce serving.

FDA Consumer /June 1988 / 3

Health Talk With Dr. Frank Young

A Golden Anniversary of Consumer Protectionby Frank E. Young, M.D., Ph.D.,Commissioner of Food and Drugs

Fifty years ago this month, President Franklin Rooseveltsigned into law the Federal Food, Drug, and Cosmetic Act of1938. Why commemorate the passage of a bill enacted half a century ago? Because I can think of no law with more practicalbenefits in our daily lives than the "FD&C Act." This law gaveFDA the responsibility for ensuring the safety of products commanding a quarter of every dollar we consumers spend. So this is,indeed, an appropriate occasion to reflect on how important theFD&C Act is to all of us.

Today, we take for granted the protections that law provides.Consider how vulnerable consumers were before 1938. Before theFD&C Act, FDA's main legal weapon was the Food and DrugsAct of 1906, also known as the Wiley Act, in honor of the manwho was so instrumental in its passage. Dr. Harvey W. Wiley, the"father of FDA." Unfortunately, it had been watered down bycompromises, amendments and adverse court rulings, and itcould only be weakly enforced by an inadequate staff. Public una-wareness of the law's weakness made matters worse. In 1929, Dr.Wiley himself lamented that "no one takes much interest in theFood and Drugs Act.. . . it is regarded as established and in perfect operation. This is a great mistake."

Despite such warnings, consumers in the 1930s, who assumedthat they were well protected, were eating apples sprayed with apesticide that contained high levels of arsenic. They sought to loseweight with Marmola, a product containing enough desiccatedthyroid to create serious health problems, but which couldn't beregulated as a medicine; because obesity wasn't considered an illness in the 1930s, the 1906 law didn't apply. They brushed onuntested cosmetics, including an eyelash dye that caused onedeath and at least 18 cases of permanent blindness by corrodingusers' eyeballs. And they drank radium waters in the futile hope ofcuring their cancers.

Time had shown the need for consumer protection that reallylived up to popular assumptions. Yet to bring forth a law suited tomodern conditions it took the Elixir Sulfanilamide tragedy of1937 - in which a new liquid form of the drug sulfanilamide thathad been tested for flavor, appearance and color, but not forsafety, killed over 100 people.

The Food, Drug, and Cosmetic Act had remarkable effects.New drugs could not be marketed until testing had establishedtheir safety. False or misleading statements on drug labels werenow illegal, and the government no longer had to prove theirfraudulent intent to take legal action. Warnings of the potentialhazards of drugs were required, while drugs that were dangerous(even when taken according to directions) could be banned outright. The common names of all active ingredients were put onthe labels of over-the-counter drugs, as well as the amount of

potent, addictive or hypnotic ingredients. Antiseptics had to bestrong enough to actually kill germs. And, for the first time, medical devices were included in FDA's authority, as were cosmetics.

Foods, drugs and cosmetics were outlawed if made or stored inunsanitary facilities. To enforce these measures, FDA could seekcourt injunctions for more timely and efficient responses to public health threats. In addition to seizure of their products,violators risked greater likelihood of criminal penalties.

Yet the most critical advantage in the 1938 law may have beenits more positive emphasis, which shifted from mainly punitivemeasures to hazard prevention. By providing for pre-marketapproval of new products and other safety measures, the new lawsought to prevent injury and deception rather than just punishingpurveyors of unsafe products after the damage had been done.

No one could have known in 1938 how important these newprotections would turn out to be in dealing with fundamentalchanges in food and medicine following World War II. The lawcame just at the advent of sulfa drugs and penicillin, revolutionaryproducts that could actually cure diseases rather than just easesymptoms. After the war, wider marketing of these medicinesand other breakthroughs made FDA's new responsibilities moredemanding than ever. The two decades after the passage of thelaw were so productive in medicine, in fact, that they are oftencharacterized as a "therapeutic revolution."

The shift in food distribution from the corner grocery to thesupermarket was accompanied by many changes in food processing and a wealth of new products for FDA to oversee: Where thetypical grocery in 1941 stocked 1,500 items, some stores todaycarry up to 39,000. Medicated animal feeds were appearing on thefarm, with clear implications for human health.

The 1938 FD&C Act equipped FDA to meet these challenges.It also served as the basis for later laws and regulations to dealwith emerging public health concerns.

In 1955, a special citizens' advisory commission recommendedto the Secretary of Health, Education, and Welfare a massiveexpansion of FDA resources so it could keep up with its growingresponsibilities in a time of rapid technological development. Inconsequence, between 1955 and 1980 FDA increased its stafffrom under 1,000 to almost 8,000 employees and its budget from$5 million to $320 million. It turned out to be money well spent.

The lasting significance of the 1938 act, however, may be as thebasis of a new national consensus on the federal government's rolein consumer protection. It was not always so. Once, industryinvariably fought any attempt to regulate its practices. Dr. Wileybattled for a quarter of a century to secure passage of the 1906Food and Drugs Act; for years, he recalled, such legislation proposed in Congress had been "killed promptly, usually amid

4/June 1988 / FDA Consumer

Nature's Crystals typified thekinds of problems FDA faced before 1938 due to the weak language of the 1906 Food andDrugs Act. The package itself (inthe center of the photo) bore nostatements about therapeutic effectiveness, while promotionalmaterial, like the display card behind the box, listed several outrageous claims. But because thecards were shipped to dealers separately, they were legally not labeling and therefore not underFDA's jurisdiction under the oldlaw. The Federal Food, Drug,and Cosmetic Act of 1938strengthened FDA's authorityover drug labeling and in manyother areas of consumer protection as well.

The present Food and IriM Act applies only to claimsmade on or in the package of medicine. This displaycard is shipped separately, and therefore is subjectt o t J i e l a w . ■^^I^Mre^s Crystals'^ is essential^Tsait a

l a x a l i w .

T h e p r o p o s e d A d a d v e r t i s l i i g ^laughter and ridicule." It often took a catastrophe, like the deathsof 10 St. Louis children from contaminated vaccine, to sparkneeded consumer protection legislation like the Biologies Act of1902.

Passage of the 1938 FD&C Act took five years of furious conflict and the deaths of over 100 people in the Elixir Sulfanilamidetragedy. A terrible price to pay, but there's no doubt today that the1938 law has dramatically improved the consumer climate in thiscountry. Although later refinements of food and drug law werenot all free from conflict, their passage did reflect a greater spiritof responsibility and cooperation among government, industry,the health professions, and the people. Far from the pitched battles of 1906 and 1938, more recent legislation has demonstratedconstructive bipartisan problem solving. Achievements like the1976 Medical Device Amendments are among the triumphs of thenational consensus to protect the public health that the 1938 lawinspired.

Now we are on the crest of a new wave of changes even morebasic than those the FD&C Act posed for us in the 1940s and1950s. Implantable medical devices like pacemakers and drugpumps, artificial hearts and other man-made organs, magneticresonance imagers - devices few could have dreamed of in

1938 - are just the first generation of increasingly sophisticatedwonders before us. Wholly new antibiotics that minimize the riskof bacterial resistance are also being developed.

Perhaps of greatest significance, however, is the advent ofgenetic engineering - "the new biotechnology" — which hasalready produced such diverse wonders as synthetic humangrowth hormone, test kits to detect antibodies to the virusassociated with AIDS, and a monoclonal antibody to prevent kidney transplant rejection; more are on the way. Biotechnology alsopresents magnificent opportunities for the food supply. An FDAadvisory panel of experts from industry, government and acade-mia foresees no fewer than 1,208 specific applications of biotechnology to food growth, safety and preparation. Over half arealready feasible. FDA must prepare its scientific staff and facilities to evaluate these products as they become ready for them a r k e t .

As in 1938, FDA in 1988 is at another watershed of challengeand opportunity. Fortunately, the consensus formed in earlieryears makes it possible to move forward with confidence, notgoaded by disaster, but beckoned by the great promise of thef u t u r e . ■

F D A C o n s u m e r / J u n e 1 9 8 8 / 5

TMnscmms:Aches and Pains from Flaws in the Jaws

by Dixie Farley

Though an unseemly nickname, "The Great Impostor" aptlydescribes the jaw-motion maladies known as temporomandibular (TM) disorders. Indeed, the clicks, earaches, headaches,facial pain, and restricted Jaw use that point to these disordersmimic symptoms of such other conditions as pinched nerves,sinusitis, mumps, and ear infections.

A decade ago, the Impostor was scarcely heard of. But today,hardly a week passes without a news story on this emerging facetof dentistry as cases are diagnosed and treated in increasing numbers. Also increasing, however, is concern about over- diagnosisand over-treatment, sometimes with unproven therapies. This isnot a small concern: Temporomandibular (named for the bonesthat form the hinges of the jaw) disorders may afflict as many as60 million Americans, says the American Dental Association(ADA).

Women between 15 and 44 appear to be most susceptible,though reported cases include both sexes in all age groups. About5 percent of patients have severe, even disabling, symptoms thatrequire extended care and, infrequently, highly specialized surgery. Fortunately, symptoms are usually mild and oftendisappear - even without therapy. To treat every noisy, achingTM joint would be "clinical overkill," as one researcher put it.

Disagreement over definitions, diagnosis, causes andtreatments — and whom to treat — has prompted several nationalmeetings. ADA, for example, convened a consensus conferenceof experts in 1982 to develop preliminary guidelines for thescreening, diagnosis and treatment of TM disorders.

Unanswered questions still remain. To help sort out the facts,here's what a number of experts have to say. But first, the TMstructures themselves:

T M S T R U C T U R E S

A complex network of bones, ligaments, joints and musclesmake up the specialized system by which we chew, yawn,and otherwise move the jaw.

"Temporomandibular" refers to the temporal bones and themandible, or jawbone, which form the hinges that allow the jaw tomove. The temporal bones join the jawbone at the sides of thehead via fibrous tissue called ligaments, which form a capsulearound the joint. Inside the capsule, firmly attached to the jawbone and the capsule, is a thin, cartilage-like, pliable oval disk.This disk separates the bones and forms compartments betweenitself and the bones: one compartment on its temporal-bone sideand another on its jawbone side. Within each compartment is afluid-filled membrane or sac. The disk and membranes absorbshocks and lubricate the joint.

The TM joints can be felt at the front of the earlobes when the

mouth is opened. Some jaw-moving muscles can be felt at thetemples and cheeks when the teeth are clenched. Other musclesattached to the jawbone can be felt at the back of the roof of themouth when thejaw is moved.

Opening and closing the mouth and moving thejaw forward,backward, and side to side require different types of motions indifferent joint compartments with different sets of muscles.These are essentially hinging and gliding actions.

Anything that interferes with the proper functioning of any partof this complex system of structures could result in a TM disorder.

S Y M P T O M S

ftin is the most frequently reported complaint with a TM disorder. "Usually it is a dull ache and often it is worsened or broughton during or after eating or yawning," writes Joseph Marbach,D.D.S., in Executive Health Report (September 1986). He notes:• About 85 percent of patients feel pain on only one side -usually in the temple, cheek, and front of the ear.• Half have pain in the neck muscles.• More than a quarter have pain in the shoulder muscles.• Nearly half feel the pain constantly or at least once a day.

Theories as to what produces the pain include pressure onnerves from misaligned bones in the TM joint, inflammation ofthejoint capsule, and muscle spasm. The fact that a spasm in onemuscle, Marbach writes, can prompt chain-reaction spasms innearby muscles "helps explain how an initial problem in the TMjoint could spread to the neck, shoulders, and back."

Limited jaw movement, the other dead giveaway of a TM disorder, may result from such defects as disk displacement (nearlyalways forward of the jawbone) or abnormal tissue growth in thejoint. Some experts cite the width of the first three fingers asthe extent to which a normally functioning jaw should be ableto open.

Also commonly reported are various joint noises, which mayor may not be signs of a TM disorder. A click when opening thejaw may indicate a displaced disk, but many people have noiseswithout having a TM disorder. A grating or crackling noise morelikely signifies arthritis. Moreover, not all TM patients have jointnoises. Joint noises without pain or restricted jaw movementwould not be enough evidence for a diagnosis of a TM disorder.

It's unclear yet which symptoms are important as far as the needfor treatment is concerned. "About a third of the general population have clicking," says Glenn Clark, D.D.S., M.S., co-directorof UCLA's Temporomandibular Joint Facial Pain Clinic, "butonly a few of these go on to develop locking or disk problems."

Complicating the difficulty in diagnosing a TM disorder is thatsymptoms may fluctuate: They may worsen, improve, recur or

6/June 1988/FDA Consumer

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Radiological TestsFor TM Disorders

More than one type of radiologicalexamination may be needed to accuratelydiagnose a temporomandibular (TM) disorder. Ordinary X-rays, for instance, outline bones clearly, but they don't show softtissue, such as ligaments. Computedtomography (CT) shows bonds even better,but it isn't used initially because it's muchmore expensive and can expose the patientto considerably more ionizing radiation.Other tests - arthrography and magneticresonance imaging (MRI) — have theirspecial benefits and drawbacks, too.

Views are taken to show the TM joint inseveral positions: with the teeth clenched,with the joint relaxed, and with the mouthfully opened. Estimated cost: $75.• Benefits - Useful for initial screening tohelp detect obvious abnormalities whenthere is reason to believe that organic disease may exist.• Drawftacfo —Not def in i t ive. Doesn' t

show soft tissue. Exposes the patient toionizing radiation.

A dye is injected into the TM jointspaces so that, when a conventional X-raypicture is taken, certain parts of the jointshow up in contrast. Estimated cost: $500.• Benefits - Guidelines from a 1982 consensus conference convened by the American Dental Association advise usingarthrography in two situations: when surgery is being considered because a disturbance to a joint's functioning has notresponded to prolonged conservativetreatment and when a displaced disk is thesuspected cause of painful limited openingof the mouth.• Drawbacks - Requires a high degree ofskill to perform. Uncomfortable for thepatient because it may cause momentarypain and tenderness and swelling afterwards. Allergic reaction to the dye is possible. A surgical procedure. Exposes thepatient to ionizing radiation.

The picture-taking part of a CT machinemoves around the patient to take views ofthe bones and muscles from many different angles. The information is entered intoa computer, which creates an image of across-sectional "slice" of the area. Estimated cost: $500.• Benefits - Shows bone detail better thanX-rays and MRI. Can be manipulated to

show some soft tissue, such as the TM-joint disk. Does not involve surgery.• Drawbacks - May be misinterpreted. Inseveral patients, for example, an increasedjoint space seen with CT and interpreted tobe a displaced disk was shown witharthroscopy to be, in fact, abnormal tissueon the temporal bone due to degenerativejoint disease. Can expose the patient tomore ionizing radiation than conventionalX-ravs.

Using giant magnets and radiowaves,MRI involves taking views of the desiredarea from different angles that are thenentered into a computer to produce a picture "slice" of the area similar to a CTscan. The patient is actually moved via atable inside the machine. Estimated cost:$800.• Benefits — Clearly displays details of thedisk and other soft tissue. Involves neither

surgery nor ionizing radiation.• Drawbacks - Most costly. It may not beavailable locally.

Most insurance companies offer plansthat cover these diagnostic tests for TMdisorders, according to the Health Insurance Association of America, but whetheran individual's plan includes such coverage depends on whether that person'semployer has contracted for it. ■

night. If the aching comes back, I wear it more often until the paingoes away."

The patient may be asked whether the jaw gets "stuck," whetherthe bite feels uncomfortable or unusual, whether arthritis hasbeen a problem, whether the pain seems to follow a pattern, andwhether there was a blow to the jaw or head (joint inflammationfrom injury might not show up right away).

Gently feeling (palpating) the TM joints and muscles helps pinpoint areas with incoordinations or tenderness. Listening at thejoints with a stethoscope during jaw movement helps differentiatenoises. Casts of the teeth show the actual bite.

Radiological tests can provide useful information about thepositions of the bones and other parts of the TM joints. (See theaccompanying article.) The decision to order such tests is a judgment call - thus emphasizing the importance of visiting a professional experienced in treating TM disorders. The 1982 consensusguidelines advise that X-rays are appropriate for initial screeningand that, if additional tests are ordered, they should be "to ruleout or confirm specific diagnoses."

Depending on the findings, further examination by a physician,orthodontist, oral surgeon, or TM specialist may be advised. Abiopsy may be warranted if a tumor is suspected.

Beware of dubious diagnostic tests. One procedure of doubtfulworth that is being promoted for diagnosing TM disorders isapplied kinesiology, or muscle-strength testing. But the 1982guidelines state that no scientific evidence supports the idea that

applied kinesiology is a "reliable indicator of jaw dysfunction" oris useful to establish "proper jaw position or vertical dimension"or to help determine a patient's health status.

T R E A T M E N T S

More than 26 therapies are in use, by one estimate, and treatmentis given not only by dentists, physicians, and oral surgeons butalso by persons outside traditional dentistry and medicine, suchas psychologists and chiropractors. The consensus guidelines callfor "a scientific [emphasis added] basis for establishing a treatment . . . and testing its efficacy." And they state that no scientificevidence supports the effectiveness of osteopathic and chiropractic manipulations for TM disorders.

Whenever possible, state the guidelines, TM-disorder therapies should be conservative and reversible. Such measures bringsymptomatic relief to 80 percent of the patients. Therapy usuallylasts about three months.

Treatment of muscle spasms may include a prescription relaxant drug such as diazepam (trade name: Valium), moist heat,massage, and a soft diet. Over-the-counter aspirin, ibuprofen oracetaminophen may be given for the pain. Aspirin and ibuprofenare also anti-inflammatory drugs and, so, are used for arthritis,too. FDA's Center for Drug Evaluation and Research hasapproved a number of prescription analgesic and antiinflammatory drugs for patients requiring stronger treatment. If

FDA Consumer /June 1988/9

Depicted here, moving clockwise from the upper left drawing,are: a normal temporomandibular joint, a joint that hasbecome inflamed from arthritis, a joint "frozen" from overgrowth of tissue after an injury, and a joint that has beendislocated-perhaps from a blow.

(Illustrations courtesy of the American Dental Association andthe American Association of Oral and Maxillofacial Surgeons.)

inflammation persists, corticosteroids may be injected into thejoint, provided there is no infection.

When grinding causes the spasms, a bite appliance can be usedto help the patient hold the upper and lower teeth apart. The plastic device may be formed from a cast of the person's teeth so it fitsprecisely to reposition the jaw, allowing the muscles and ligaments to rest. Wires on each side fasten the appliance over theteeth and allow it to be attached and removed easily.

If chewing patterns become altered from damage caused by thegrinding, the bite may become skewed. To restore alignment, thedentist may file selective teeth, fill or crown damaged teeth, orreplace missing teeth.

Counseling, relaxation training, or biofeedback may help ifstress is a problem. In biofeedback, electrodes taped to the skintransmit impulses made by the tensing muscles to a computerscreen. The idea is that relaxing the muscles is easier when thepatient can see the impulses diminish with the tension.

S U R G E R Y

When surgery is advised, it's reasonable to seek a second or evena third opinion. A good place to ask about TM specialists,says Clark of UCLA, is the nearest university with a dental ormedical program.

"Surgery is appropriate initial treatment when a tumor must beremoved," he says, "or when there is severe jaw immobility, whichmay mean the joint has fused. But these are uncommono c c u r r e n c e s . "

If nonsurgical therapies have failed to give relief and if thecause of the problem can indeed be corrected or reduced by surgery, other operations are appropriate, says Clark. "A disk thathas caused the jaw to lock may be repaired or repositioned." If thedisk can't possibly be repaired and it's causing severe pain orlocking the jaw, it can be removed," he says, "but this would be alast resort."

An outpatient surgical procedure called arthroscopy is beinginvestigated for use on the TM joint. A specially trained surgeonmakes a tiny incision and inserts a very thin, lighted tube calledan arthroscope. Through this tube, the surgeon can visually examine the area, flush it out, perform a biopsy, remove scar tissuecalled adhesions, or manipulate a locked displaced disk backwhere it belongs. This was already being done in larger joints,says Clark, "but the knee, for instance, is 8 to 10 times larger thanthe TM joint, and we just haven't had the smaller instrumentsuntil now. We need more trained people to do this."

T H E B O T T O M L I N E

Expert after expert calls for long-term, controlled studies towardmore conclusive information about TM disorders, including whymost reported cases are among women 15 to 44.

Meanwhile, how can a person guard against the Great Impostor?Good dental care is a start. Problems related to the teeth and

how they fit together should be identified and treated early on. Anexample is when a missing tooth such as a molar isn't replaced,says FDA's Singleton. "The muscles will ultimately overpower theteeth," he says, "causing the molar behind to tip into the space.Then the tooth above gradually changes the way it meets the lowertooth, which can stress the chewing muscles. This can cause aspasm, or cramp, which causes pain, which can lead to furtherspasms. To regain the original relationship, the tipped-over toothmust be straightened with braces and a bridge made to fill thespace."

Being aware that there are different TM disorders and thatmost cases will improve or go away with little or no treatmenthelps, too. But if symptoms persist more than three or four weeks,says Singleton, "it's a good idea to seek professional advice fromsomeone experienced in the field. Most important is an accuratediagnosis. Minor temporary ailments, like stretched ligaments,must be differentiated from chronic problems, like arthritis ormuscle spasms associated with bruxism. Every possibility mustbe explored to correctly identify contributing fectors and to ruleout others, so that any treatment given is both necessary andspecific to the diagnosis."B

Dixie Farley is a member of FDA's public affairs staff.

10/June 1988/FDA Consumer

A Summertime Hot LineFor Food Safety Questions

by Chris W. Lecos

From June through August, the residents of Florida, Illinois and Massachusetts will be able to dial a toll-freenumber to get quick, expert advice andanswers to most of their questions aboutfood safety.

The program is a pilot for the FoodSafety Hotline, being jointly sponsored bythe Food Safety and Inspection Service ofthe U.S. Department of Agriculture andthe Food and Drug Administration. Consumers in the three states can dial1-800-426-3758 between 10 a.m. and4 p.m. Eastern time Monday through Friday. The phones will be staffed with home

economists trained in food safety issuesthat fall under FDA and USDA jurisdiction.

By law, the Agriculture Department hasjurisdiction over meat and poultryproducts, and FDA regulates all otherfoods. However, with the joint hot line,consumers won't have to concern themselves with which agency to call.

FDA Commissioner Frank E. Young,M. D., Ph. D., said that he believed theservice could make an important contribution toward improving the public'sknowledge and awareness of food safety.In a letter last December to Lester M.

Crawford, D.V.M., Ph.D., administratorof USDA's Eood Safety and InspectionService, Young noted:

"A cooperative project between our twoagencies to pilot test the concept of a FoodSafety Hotline will be a notable step forward in providing consumers with anational focal point for obtaining timelyand accurate information.

"All too often," he continued, "consumers do not make jurisdictional distinctions in seeking needed information aboutmicrobiological contamination, food-borne illnesses, and other food safetyissues. This pilot effort will help us makeessential information about food safetymore readily accessible to consumerswhile, at the same time, providing us withvaluable data for our respective consumereducation programs."

Both agencies said that they would carefully evaluate the pilot effort to see if theprogram should be expanded and madepermanent. Individuals who call after theservice is discontinued will hear a tapedmessage asking them to contact USDA'sMeat and Poultry Hotline, a toll-free service operated by the agency since July 1985.

Typical of the kinds of calls to be handled by the Food Safety Hotline will be:• Microbiological hazflrds in food -Organisms that cause food poisoningoccur naturally and can be brought into thehome. For example. Salmonella has been aproblem with poultry and meat products.Listeria monocytogenes has beenassociated with a number of food poisoning outbreaks involving cheese products inrecent years. Other common concerns

include potential health problemsassociated with some shellfish andother seafood.• Food additives - In recent years, FDAhas received numerous inquiries about thesafety of artificial sweeteners such asaspartame and saccharin, sulfites andother preservatives, color additives, andother substances added during foodprocessing.• Food packaging and processing —Consumers have expressed concern aboutpossible health hazards of chemicals fromfood packages leaching into the food.Processing techniques for canning andfreezing foods, as well as proper ways forhandling foods for cooking in microwaveovens, also prompt numerous inquiries.FDA also receives many inquiries onirradiating food products, a preservationmethod now approved for use on pork,fresh fruits and vegetables, and spices andherbs and other aromatic seasonings.• Contaminants in food—In recent yearsthere has been considerable public interestin chemical contaminants such as urethanein alcoholic beverages, pesticide residuesin foods, and others, some of which occurnaturally (aflatoxins and urethane, forexample).

Other common subjects of interestinclude fruits and vegetables; importedfoods; lead and the safety of earthenwareand cookware; the regulation of filth anddecomposition in foods; nutrition labeling; food animals, including animal drugs,drug residues, and medicated feeds; andpet foods, including their safety and labeling requirements.

Although the Food Safety Hotline staffhas received extensive training and isexpected to handle most of the calls on thespot, some calls may require additionalresearch or may have to be referred. Callsto be referred include reports of injuries orillness, food poisoning reports, fraud-related questions, and diet and healthqueries.

Both FDA and USDA receive thousandsof consumer inquiries each year. Duringfiscal year 1987, which ended last Sept. 30,FDA responded to more than 56,000

(Continued on page 13 )

FDA Consumer /June 1988 /11

{Continued from page 11)inquiries on foods, drugs, cosmetics, medical devices, radiological products, veterinary products, and other matters under itsjurisdiction.

USDA also responds to thousands ofinquiries each year, many of them throughthe agency's Meat and Poultry Hotline(1-800-535-4555). During its more thantwo years of operation, the Meat andPoultry Hotline has served more than105,000 persons.

Typical calls received by USDA concerned safe ways to prepare, store,refrigerate, freeze and thaw foods; howlong to cook meat and poultry; how to tellif foods have spoiled; and how to safelypack foods for lunches, picnics and otheroutings.

FDA surveys in recent years indicatethat many Americans are concerned aboutthe chemical additives and pesticideresidues in foods, even though U.S. safetystandards and safety margins are thehighest in the world. Of greater concern toscientists at FDA and elsewhere is theneed to inform Americans of the potentialhealth hazards from microbiological contamination of food - particularly in thehome. Public health officials note that

mishandling of food in the home, including failure to follow appropriate sanitationand food handling procedures, accountsfor most food-borne illnesses in the UnitedStates. Many of these are preventable, andboth FDA and USDA hope that educationthrough such vehicles as the Food SafetyHotline wil l lower their incidence.

FDA regards microbiological hazardsand food-borne illnesses as a major publichealth problem, one that is often underestimated and misunderstood by the generalpublic. The economic cost alone, it hasbeen estimated, runs into billions of dollars in medical care and lost wages eachyear. FDA is devoting an increasingamount of its resources to food-borne

microbiological hazards.The potential seriousness of food-borne

disease is best illustrated by some recentstudies, including one published in 1985by two FDA scientists, Douglas Archerand John Kvenberg. They estimated that 21million to 81 million cases of diarrheaoccur in the United States each year as aresult of food-borne pathogens. (Diarrheais a major symptom of food poisoning.)Many experts believe that food poisoning

FOOD SAFETY HOTLINE

One call does it all forFood Safety Advice1 - 8 0 0 - 4 2 6 - 3 7 5 8Monday-Friday 10:00 a.m. to 4:00 p.m. EDTJune, July and AugustOne phone call to the Food Safety Hotline can answer your questionsabout all the foods you eat-from apples to zucchini to everything inbetween.

With one call you can find out how to• Buy, store, and prepare all foods.• Tell if canned foods are safe to eat.• Avoid food poisoning.• Better understand food labels.

This toll free Food Safety Hotline will be tested in Illinois, Florida, andMassachusetts. G ive us a call; specially trained home economists arewaiting to help you.

The Food Safety Hotline is a joint effort of the U.S. Department ofAgriculture and the U.S. Food and Drug Administration.

Toll-Free Number: 1-800-426-3758

Hours: 10 a.m.-4 p.m. Eastern time

Eligible Callers: Residents of Florida, Illinois, and Massachusetts

Trial Period: June, July and August, 1988

incidents could be reduced substantially ifbetter fbod sanitation and hygiene werepracticed in the home and at restaurantsand other eating establishments.

Although the types of pathogens that cancause outbreaks of food poisoning numberin the hundreds, public health scientistsare concentrating on the several dozen thatare responsible for most food-borne outbreaks and also with finding ways to readily detect these organisms in the laboratory.

For example, the largest outbreak ofSalmonella food poisoning in U.S. historyoccurred in 1985. Public health officialsconfirmed that 16,284 persons in six statesbecame ill after drinking contaminatedlow-fat milk produced at a suburbanChicago dairy. It was later estimated thatas many as 200,000 persons may havebecome ill and two to 12 people may havedied. When a food-borne outbreak occurs,it is not uncommon that many illnesses arenever reported to public health authorities.

FDA also has been involved in recent

years in several dozen recalls of dairyproducts, especially cheese products, thatwere found to be contaminated withListeria monocytogenes. Once consideredrare. Listeria infections are being reportedwith increasing frequency in the UnitedStates. Pregnant women, cancer patients,alcoholics, and people receivingimmunosuppressive drugs are particularlyprone to this type of infection. Healthyindividuals who are exposed generally donot develop serious infections.

Consumers lack control over outbreakstraced to fbod production, but they canminimize the risk of food-borne disease inthe home, and the Food Safety Hotlinestaff — trained to provide expert guidanceon proper food sanitation andpreparation - can help. ■

Chris W. Lecos is a member of FDA's public affairs staff.

FDA Consumer/June 1988 /13

JuicelessBClJJuice Leads to

Fid-Stren h Justiceby Vern Modeland

Making and selling millions of containers of nothing more than sugar,water and flavoring as "100 percent" applejuice has proven to be an expensive andcostly gamble for an established baby foodmanufacturer and its supplier. More than800 charges of violating federal law werebrought against the company, two of itssuppliers, and the executives involved.Fines to date have exceeded $2.5 million,and sentences still pending could totalhundreds of years in jail for the peopleresponsible.

In 1982, FDA began studying the possibility that one or more manufacturers offruit juice products were misleading consumers. Reports were circulating in theNew York state area and on the West Coastthat a synthetic mixture was beingproduced and sold as apple juice. Thestudy turned into an extensive investigation by FDA's Buffalo and New York district offices. It uncovered economic fraud,and an elaborate effort to cover it up, byBeech-Nut Nutrition Corp., Canajoharie,N.Y, and its suppliers, Food ComplexCo., Inc., Woodside, N.Y., and UniversalJuice, Inc., Riverdale, N.Y. Beech-Nutwas listed in its industry's ranking as thenation's second largest baby food manufacture r a t the t ime.

Based upon evidence uncovered by thegovernment, Beech-Nut, its president,and a vice president were indicted late in1986 by a federal grand jury for marketingas applejuice a product that in reality wasnothing more than sugar water and a blendo f c h e m i c a l s t h a t s i m u l a t e d t h e t a s t e a n d

look of applejuice. The governmentcharged the phony juice was distributedbetween 1978 and 1983 in 19 states and five

foreign countries.

The indictment charged conspiracy tominimize a potential loss of at least $3.5million by "delaying for as long as possible" the withdrawal from the market of

applejuice produced from concentratethat Beech-Nut had purchased fromUniversal Juice and Food Complex Co.Industry sources have been quoted as saying the ultimate cost to Beech-Nut may beas much as $25 million in fines, legalcosts, and losses in sales and consumerc o n fi d e n c e .

The federal indictment, returned inBrooklyn, N.Y, on Nov. 5, 1986, allegedthat Beech-Nut; Food Complex Co.;Universal Juice, which also operatedunder the names of Interjuice TradingCorp., Nameco Trading, and Zee VeeFoods Corp. (all have since gone out ofbusiness); a shipping company. SouthOrange Express, Clifton, N.J.; and severalindividuals conspired to distribute thephony applejuice. The indictment saidthey had intentionally shipped adulteratedand mislabeled products made from phonyapplejuice concentrate with intent todefraud and mislead, and had engaged inmai l f raud.

Three days before trial was to begin lastfall, Beech-Nut admitted corporate guilton 215 felony counts, each of whichcharged adulteration under the FD&CAct. Beech-Nut has paid a record $2.18million in fines and costs; $2,043,000 tothe U.S. Treasury to cover fines and courtcosts assessed against it and a check toFDA in the amount of $140,000 in reimbursement for investigative expensesi n c u r r e d i n t h e c a s e .

"Beech-Nut's fine represents the largestfine ever paid under the Food, Drug, andCosmetic Act by at least sixfold," said

Assistant Attorney General Richard K.Willard, who is in charge of the Civil Division, Department of Justice, whichprosecuted the case with the U.S. Attorney's Office in Brooklyn.

"We hope that such prosecutions senda strong message that consumer fraudwill not be tolerated by the government,"he said.

The trial for others involved in the

charges against Beech-Nut lasted morethan three months before, in February ofthis year, the jury found Niels L. Hoyvald,former president and chief executiveofficer, guilty of 356 felony violations ofthe FD&C Act. The jury also convictedJohn F. Lavery, on 448 felony counts.Food and drug law violations are punishable by up to three years in jail and/or$10,000 fines on each count. Five years injail and/or $1,000 or $10,000 fines on eachcount are the maximum sentences possibleon the other charges.

Before trial was set, Zeev Kaplansky,former president of Universal Juice and itsseveral other operating companies,pleaded guilty to 40 felony counts, including one of conspiracy, 10 for mail fraud(involving written authorizations todeliver the phony juice concentrate), and29 violations of the FD&C Act. He agreedto pay a fine of up to $290,000 and another$10,000 in costs. He also faces up to a yearand a day in prison.

Raymond H. Wells, a former officer andowner of Food Complex Co., pleadedguilty to 10 felony counts, including criminal conspiracy, mail fraud, and violationsof the FD&C Act. He faces extensive finesand up to 34 years in jail.

South Orange Express, for labeling,storing and shipping the phony applejuice

14/June 1988/FDA Consumer

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concentrate, pleaded guilty to five felonycounts, including criminal conspiracy,mail fraud, and two FD&C Act violations.The firm faces a fine of up to $32,000 onthese counts.

In addition, although he was not namedin the indictment, a former salesman forFood Complex Co., Louis Mayoka,pleaded guilty to one felony violation ofthe FD&C Act and also is awaitingsentencing.

The government's indictment saidBeech-Nut juices labeled as, andrepresented to contain, apple juice andapple juice concentrate "contained little orno apple juice." The government alsocharged that Beech-Nut failed to declarethe addition of artificial color and flavoron the labels of its apple juice.

In the spring of 1982, FDA had collectedsamples of apple juice from grocer warehouses for routine analysis. Juice from twoNew York state producers was found to beadulterated. One of the firms was usingconcentrate supplied by Universal Juice.Subsequently, FDA's Buffalo district officelearned that Beech-Nut also was usingUniversal Juice concentrate.

An inspection of Beech-Nut beganimmediately. When advised of FDA'slaboratory findings, in July 1982, Beech-Nut told an FDA investigator that it hadstopped using the Universal Juice concentrate "earlier in the year." The investigatorcollected four samples of apple juice fromBeech-Nut's inventory stock for furthertests. Analysis showed the liquid was notthe 100 percent pure apple juice its labelsdescribed it as.

An FDA field compliance officer calledcompany officials, informing them of thetest results and asking what they intendedto do about the product then already in distribution channels. Lavery told FDA thatBeech-Nut did not plan any recall of theproduct because it was the company'sbelief the juice posed no health hazard.

A trade association, the ProcessedApples Institute (PAX), had become suspicious of the apple juice concentrate sold by

Universal Juice about the same time. In

early 1982, PAI hired its own investigatorto look into Universal Juice's operation.The investigator testified as a governmentwitness in the Beech-Nut trial. He toldthe jury that during three months in thespring of 1982, he had watched quantitiesof chemicals and beet sugar, but no apples,going into the Food Complex plant atWoodside, N.Y., which manufacturedthe concentrate supplied throughUniversal Juice.

The investigator said he followed a tanktruck from that plant to Beech-Nut'sCanajoharie plant. The PAI investigator,wearing a concealed tape recorder, metwith Lavery, who admitted purchasingconcentrate from Universal Juice at a

price considerably below the prevailingmarket value for real apple juice concentrate. The investigator asked Lavery forsamples of the concentrate, and for Beech-Nut's cooperation in bringing a collectivetrade association action against UniversalJuice. Beech-Nut did not agree to join theinstitute's lawsuit, but it did stop purchasing Universal's concentrate for its applejuice products. However, Beech-Nut continued to sell the products manufacturedfrom the phony concentrate, labeling themas apple juice or mixed fruit juices for infants, for almost another year. Testimonyat the trial showed Hoyvald, when helearned of the PAI investigator's visit, personally began efforts to dispose of theremaining inventory as quickly as possible.

The government's indictment said that,in an attempt to delay market withdrawalof foods produced from Universal Juiceconcentrate for as long as possible, Beech-Nut moved its entire "apple juice" stockfrom its New York state facilities to a warehouse in New Jersey after it learned ofpotential seizure. Nine truckloads wereprepared and moved after normal workinghours, investigation revealed.

The company was accused specificallyof moving 30,000 cases to New Jersey inAugust 1982, after it found out New Yorkstate health officials were about to

embargo its inventory. From New Jersey,Beech-Nut distributed the inventorythroughout the Caribbean at "tremendousdiscounts," according to an FDAinvestigator.

Evidence presented during the trialtraced many shipments of the Beech-Nutapple juice that went on after August 1982.One of the shipments was to Puerto Rico.Hoyvald was said to have offered the juiceto his distributor in San Juan at a very substantial discount and, when the distributorturned down the offer, shipped the juice tohim anyway. More than 2,000 cases weresaid to have been crushed and buried in aSan Juan, Puerto Rico, city dump.

To expeditiously move another load ofthe juice out of the country, Hoyvald wassaid to have had it trucked from a San Josewarehouse to Galveston, Texas, andplaced aboard the first available ship to theDominican Republic. Getting the juiceinto the food distribution system outsidethe United States would make tracking itdown more difficult and time consuming,an FDA agent pointed out.

However, the cost of trucking theproduct to Texas was so great that Beech-Nut eventually agreed to reimburse its customer for part of the freight bill, anamount almost equal to the value of theproduct being shipped.

In October 1982, after a lengthy series ofmeetings with FDA, Beech-Nut ultimatelyagreed to a nationwide recall of all applejuice manufactured by it from concentratesupplied by Universal Juice between Jan.1 and June 22, 1982. Production facilitiesin New York and California both wereinvolved in the recall. Mixed fruit juices orother products containing the concentratew e r e n o t r e c a l l e d .

Beech-Nut and the two corporateofficers directly responsible became subject to the more serious criminal chargeswhen they learned the concentrate theywere receiving from Universal Juice wasnot pure apple juice but continued to allowproduction and shipment of the product asapple juice. Shipping an adulterated

16/June 1988/FDA Consumer

FDA Warns Juice Industry"We think fruit juices should be sold with honest and forthright labeling," FDA

has warned the fruit juice industry.Speaking at the International Fruit Juice Convention, Orlando, Fla., in late

February, L. Robert Lake, director of the office of compliance in FDA's Center forFood Safety and Applied Nutrition, said that FDA is not ignoring economicissues.

He specifically mentioned applications of deionized juices that are stripped ofmost of their content except sugars.

"When such products are used, manufacturers still want to call them juices. Wedo not agree but are not really sure just what they are," he said.

Lake also called the industry's attention to a tendency to use juices with verymild flavors in large amounts and a small amount of a more potent juice (such asraspberry), label the product 100 percent juice, but only identify the raspberry onthe principal label panel.

"It is only in reading the ingredient statement that one finds out the product iscomposed of other components such as apple juice, pear juice, and natural flavor,"Lake said.

"This type of labeling appears to be misleading to consumers."Lake urged the fruit juice industry to review its direction and pointed out that

honest and forthright labeling was in the best interests of both consumers and thejuice industry. ■

product is a misdemeanor. To do so withfull knowledge that the product is adulterated is a felony. And testimony showed thatLavery had been alerted as far back as1979 by his company's research anddevelopment, quality control, and purchasing departments to their suspicionsthat the concentrate was not authentic.

Company memos and correspondenceshowed that Jerome LiCari, Ph. D., thedirector of the company's research anddevelopment department, had frequentlyquestioned the authenticity of the Universal Juice concentrate. Investigators forFDA said Beech-Nut's scientists had an

exceptional degree of ability to test theauthenticity of apple juice concentratesupplied by its vendors. Lavery arguedthat, although he recognized there werequestions about the authenticity of theconcentrate, there was no single test thatcould confirm its composition.

Beech-Nut said it did send two

employees to visit its supplier in 1979. Thetwo were taken on a tour of a New Jerseywarehouse where drums of concentratewere stored, but they were not shown theblending operation. The visit led Beech-Nut's quality control department to recommend an agreement be obtained from thesupplier to absolve Beech-Nut of blameconcerning the content of the apple juiceconcentrate it was purchasing fromUniversal Juice. A written agreement wasobtained, but LiCari continued to makehis concern about what Beech-Nut wasdoing known to his superiors through1981. Getting no satisfactory response, heresigned in January 1982 and became akey government witness in the trial.

As the investigation unfolded, LiCarialso was discovered to have been theauthor of an anonymous letter received byFDA in 1983. It described several people atBeech-Nut as "laughing at" state and federal authorities. The letter accused Beech-Nut of stalling FDA's investigation into theadulterated apple juice baby food product.It was signed "Johnny Appleseed."B

Vern Modeland is a member of FDA's public affairs staff.

FDA Consumer /June 1988 i l l

Should You Take AspirinTo Help Prevent a Hmrt Attack?

by Marian Segal

two aspirins and call me in theX morning." So the oldjoke goes when

patients make fun of their doctors. But itwas no joke when more than 22,000 doctors in the United States began to take oneaspirin or a placebo every other day as partof a controlled study to see if the medication could help prevent heart attacks.

Preliminary results of the Physicians'Health Study, as it was called, were published in the Jan. 28, 1988, issue of theNew England Journal of Medicine. Theresearch team, headed by Dr. CharlesHennekens, associate professor of medicine at Harvard Medical School, reportedthat physicians who took 325 milligramsof aspirin (the regular strength of an aspirin tablet) every other day had nearly 50percent fewer heart attacks than those taking a placebo. (A placebo is an inactivesubstance used for comparison with a testdrug in controlled studies.)

A S P I R I N N O T F O R E V E R Y O N E

The burst of publicity following this goodnews, however, was cause for concern tomany physicians. The study analysis is notyet complete, and it's not clear exactly whomay or may not benefit - or perhapssuffer - from such a regimen. The use ofaspirin for preventing first heart attackshas not been reviewed or approved byFDA. Commissioner Frank E. Young,M.D., Ph.D., has emphasized that whenthe data are submitted, the agency willexpedite the review and, when that is complete, evaluate petitions to change theinformation physicians receive to includediscussion of aspirin's use to prevent firstheart attacks. This same process was followed in 1985 when aspirin was approved

for preventing some second heart attacks,and in 1980 when the drug was approved toprevent second transient ischemic attacks -TIAs, or so-called mini-strokes - insome people.

So before you stock up on aspirin to prevent a heart attack, check with your doctor. Aspirin is a potent drug that, takenover a long period, can cause serious sideeffects in some people, including stomachupset, internal bleeding, and potentiallyfatal stroke.

Hennekens, interviewed by TheWashington Post when the report cameout, warned that "No one should go outand Just start taking aspirin." He cautionedthat a patient's "complete risk profile" mustbe considered in deciding whether or notto take aspirin. Overall, the doctors in thestudy, aged 40 to 84, were a healthy groupthat had been thoroughly screened forinclusion in the trial.

In an editorial accompanying the report.New England Journal of Medicine editorArnold S. Relman, M.D., posed the question of whether the findings justify thewidespread use of aspirin for preventingheart attacks. He pointed out that "Theresults of this study were obtained in ahighly selected population: male physicians with no history of myocardial infarction (heart attack), stroke, or transientischemic attacks and with no contraindications to the use of aspirin. Those with liveror renal (kidney) disease, gout, or pepticulcer were also excluded . . . . The tr ia lresults provide good reason to considerusing aspirin in patients meeting thosecriteria, but they do not demonstrate thevalue and safety of aspirin in the generalpopulation - particularly in those at riskfor hemorrhagic strokes or other hemorrhagic complications of aspirin therapy."

S T U D Y T E R M I N A T E D E A R L Y

The study, begun in 1982 and scheduled tocontinue to 1990, was designed to evaluatethe role of aspirin in preventing death fromcardiovascular disease. Participants wererandomly assigned to receive eitherbuffered aspirin or placebo. The study wasdouble-blind, meaning that neither theparticipants nor the investigators hadaccess to information identifying whichdoctors were receiving a placebo andwhich were receiving aspirin.

The study was cut short, however. InJanuary 1988, an independent group thatmet to monitor the data twice yearlyrecommended terminating the trial earlybecause the preliminary results showed"extreme beneficial effects on nonfatal andfatal myocardial infarction." The originalgoal of the study had not been achieved; infact, at that point the total number ofcardiovascular deaths in the treated anduntreated groups was identical - 44 ineach. The risk of heart attack, however,was 47 percent lower in the aspirin-treatedgroup. There were 104 heart attacks (fivefatal and 99 nonfatal) in the treated groupand 189 heart attacks (18 fatal and 171 nonfatal) among those receiving a placebo.

The risk of stroke, on the other hand,increased 15 percent in the treated group(there were 80 strokes in the aspirin-treated group and 70 in the placebogroup). In subdividing the cause of strokeinto ischemic (narrowed or blocked arteries obstructing blood flow to the brain)and hemorrhagic (bleeding from the vessel), however, the only significant increasein risk among the aspirin-treated groupwas for serious hemorrhagic stroke.

(Continued on page 21 )

F D A C o n s u m e r / J u n e 1 9 8 8 / 1 9

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20/June 1988/FDA Consumer

(Continued from page 19)(There were three mild and 10 moderate,severe or fatal hemorrhagic strokes in thetreated group, compared with four mildand two moderate, severe or fatal hemorrhagic strokes in the untreated group.)

This could be expected, consideringhow aspirin works. Aspirin interferes withthe process by which blood plateletsclump together to form clots. If a tinybreak in a brain blood vessel begins toleak, normal clotting would repair thedamage and stop the bleeding. But if bloodclotting were impaired, continued bleeding could cause a hemorrhagic stroke.

It is this same anti-clotting mechanism,however, that appears to help prevent heartattacks and ischemic strokes in somesituations. A blood clot that forms in a

coronary artery may block the vessel completely, cutting off blood flow to part of theheart muscle (in the case of a heart attack)or part of the brain (in the case of a stroke).Aspirin's role in anti-clotting activitycould, therefore, reduce the risk of heartattacks and ischemic strokes by inhibitingf o r m a t i o n o f c l o t s i n t h e a r t e r i e s .

S E L F - M E D I C A T I O N R I S K Y

All of this sounds very good and may seemto provide convincing evidence for consumers to view the original "wonder drug"as even more wonderful. But there is adownside to the story that should be carefully heeded. Patients who self-medicatewith a drug - readily available over thecounter - for a use, such as heart disease,that requires professional direction areengaging in risky business.

Perhaps of greatest concern are the pitfalls of human nature. Risks are alwaysinherent when consumers latch onto

promising news without being aware of thefine print. One ever-present hazard is the

indiscriminate assumption that "more isbetter" - in this case, some might believethat if an aspirin every other day is good,then two aspirin a day must be four timesas good. Frequent or large doses of aspirincan be very harmful for people with certain health problems such as risk of bleeding or stomach, liver or kidney disorders.Consultation with a physician beforeembarking on any kind of regular aspirintherapy is a must.

Another danger is the expectation thataspirin will prove a cure-all for heart disease. Taking aspirin is not a substitute forany of the other risk reduction steps,including stopping smoking, exercising,lowering blood cholesterol levels, andcontrolling high blood pressure. Hen-nekens stressed that a smoker couldreduce the risk of heart attack by 80 percent by quitting — a much greater reduction than that seen from taking aspirin.

Robert Temple, M.D., director of theOffice of Drug Evaluation I in FDA's Center for Drug Evaluation and Research,emphasizes the difficulty of weighing therisks and benefits of aspirin therapy to prevent heart attacks in certain groups of people. "Although the preliminary report isencouraging," says Temple, "complete dataneed to be reported and examined. It isalready apparent that proper selection ofpatients will be critical to its safe use.Depending on a patient's risk of a heartattack, he or she may benefit from thereduction in heart attacks or be adverselyaffected by the increased risk of stroke."He points out, for example, that peoplewith uncontrolled high blood pressurewould be at higher risk of hemorrhagicstroke from regular use of aspirin, and thatthe physicians in the study might have hadbetter control of their blood pressure thanwould be expected in another group.

A D V E R T I S I N G P R E M A T U R E

In a Feb. 24 letter to aspirin manufacturers, FDA Commissioner Youngexpressed both his and Hennekens' concern that "the widespread use of aspirin,without careful physician selection ofappropriate patients, could do more harmthan good."

Concerned as well about the wide publicity aspirin manufacturers have given theNew England Journal of Medicine report.Young also noted that the "disseminationof certain types of information is clearlypremature until appropriate labeling isavailable." The same concerns were voiced

by Rep. Henry Waxman, D-Calif., chairman of the House Subcommittee onHealth and the Environment, at an FDA-sponsored symposium on self-medication.F-D-CReports, a drug industry newsletter,quoted Waxman as saying that the recentaspirin/heart disease-related ads are a"disservice to consumers and a publichealth hazard" because they fail to "fullyand fairly inform the public who shouldnot take aspirin" or warn of the increasedrisk of stroke.

Commissioner Young and representatives from the Federal Trade Commission

(which regulates advertising of over-the-counter drugs) met with all U.S. aspirinm a n u f a c t u r e r s o n M a r c h 2 . A t t h a t m e e t

ing, Young said FDA believes the Physicians' Health Study was well designed andwell conducted, but asked the manufacturers not to promote aspirin for prevention of first heart attacks until the data are

fully reviewed. The aspirin manufacturersagreed to the commissioner's request. ■

Marian Segal is a member of FDA's publicaffairs staff.

FDA Consumer /June 1988 HI

J a n u a r yS M T W T F S

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FewerMonths

Safe for EatingRaw Gulf Oystersby Roger W. Miller

'traditionally, raw oysters have beenX considered safe to eat in any monthwith an "r" in it, but public health officialswould like to amend that bit of folk wisdom.

Any month with an "r" in it translates toSeptember through April. However, anincreasing problem in Gulf of Mexicowaters has brought a recommendation tocook Gulf oysters from April throughOctober, and that includes three monthswith r's.

In addition, health officials have forsome time urged certain high-riskindividuals to avoid raw or partiallycooked seafood of all kinds at any time.

The problem with the Gulf Coast oystersis a bacterium called Vibrio vulnificus. Itis a relatively new bacterium, first recognized in 1975. V. vulnificus can cause illness in normally healthy individuals andposes the mortal threat of septicemia, orblood poisoning, to high-risk people.

High-risk individuals include those withliver diseases or other liver problems(such as from alcohol abuse), people withiron imbalances, and people withweakened immune systems, such as AIDSvictims. And the risks are high. Septicemia is fatal in more than 50 percent of thecases. Further, death usually occurswithin two days.

Since V. vulnificus was identified in1975, there have been 60 reported cases ofillness caused by the bacterium, resultingin 36 deaths. However, the disease isbelieved to be significantly under-reported. Nevertheless, the current total(which included seven deaths in nine casesin 1987) represents "an acute public healthproblem ... for at-risk consumers . . . ."That's what David M. Dressel, chief ofFDA's shellfish sanitation branch, told aworkshop on V. vulnificus last March.Dressel also said he expects the number ofdeaths to increase, at least in part becauseof better reporting.

The treatment of choice for the septicemia caused by V. vulnificus is the antibiotictetracycline. Symptoms include abruptonset of chills, fever, nausea, vomiting andabdominal pain. People who work withshellfish or expose open cuts to seawater

may also get V. vulnificus poisoningthrough wound infections and can lose afinger or more to amputation.

Oysters taken from Gulf of Mexicowaters account for about a third of allthe oysters taken in U.S. waters based ondollar volume, according to the latestfigures from the National Marine Fisheries Service. In 1986, Gulf oysters werevalued at $37,642,000. Oysters taken fromthe Atlantic Ocean were put at $72,178,000,while Pacific Coast oysters weighed inat $5,721,000.

Most of the septicemia victims reportedthrough 1987 in the United States weremen (70 percent to 90 percent) over 40 (90percent) who ate raw or undercooked oysters (80 percent to 90 percent) from Aprilto October (90 percent) and had liver disease (about 75 percent), or were heavyalcohol consumers, had blood or iron disorders, or whose immune systems weresuppressed by illness.

The concern about the Gulf Coast situation was evidenced in the March workshopattended by federal, state and local officials as well as industry representatives.FDA also used its April 1988 Drug Bulletin to alert doctors and others to the

problem. It was the second time in threeyears that V. vulnificus was highlighted inthe Drug Bulletin, which is distributed tothe nation's 440,000 physicians as well as600,000 other health professionals.

Despite all the concern about V. vulnificus, there are a lot of unanswered questions about the "bug," such as;• How many "bugs" does it take to make aperson sick?• Why are most of the cases caused by oysters taken from the Gulf of Mexico,although the bacterium is also found onthe Atlantic and Pacific coasts as far northa s B r i t i s h C o l u m b i a a n d M a i n e ?• What effect do time, temperature andtravel have on the growth of the organism?• Why are the infections caused only byoysters taken from warm water and whyisn't polluted water involved?

Pathogenic vibrios (types of comma- orS-shaped bacteria) are found in 5 percent

(Continued on page 25)

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Gulf Coast oysters are harvested by amethod called tonging. Wielding thetonging rake is Tony Previto ofFDA's Fishery Research Branch atDauphin Island, Ala. The unit isconducting research on Vibrio vulnificus, a pathogen that thrives in theGulf during warm water months.

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Mark Tamplin, a microbiologist atDauphin Island, checks over the facility's depuration tank where oystersare kept in sea water that is passedthrough an ultraviolet filter to killliving organisms, including V. vulnificus. A parallel tank contains oysters in unfiltered water. The aim is tosee if depuration is a feasible way ofridding oysters of the pathogen.

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The test tube above glows by fluorescence, indicatingthe possible presence of V. vulnificus. The tube containsoyster meat and water. The fluorescence is released byan enzyme common to vibrio-like pathogens. Testing isdone before and after depuration to determine if theprocess clears oysters of vibrios.

(Continuedfrom page 22)

to 10 percent of the raw shellfish on themarket, Dressel reported. But 40 percentor more of the Gulf Coast oysters maycarry V. vulnificus during the months ofApril through October, according to KarlC. Klontz, M.D., a Centers for DiseaseControl official assigned to the Floridastate health department. Water temperature, organic enrichment of the water, andsalinity may all affect vibrio survival.

although V. vulnificus seems to breed in awide range of salinity.

Pathogenic (harmful) vibrios usuallydon't grow at cooler temperatures (below40 degrees Fahrenheit), but V. vulnificusmay multiply despite refrigeration.However, it's interesting to note that amajority of the 1987 V. vulnificus casesoccurred when the oysters had crossedstate lines, leading to the suspicion thattime and temperature abuses wereinvolved. Thus, FDA and other health

agencies are stressing good manufacturingpractices to the Gulf Coast oyster industry.Good manufacturing practices, or GMPs,is a bureaucratic term that, in this case,means keeping the oysters clean and cooland getting them from the water to the consumer's stomach as fast as possible.

One possibility that warrants researchand testing is the use of depuration on oysters destined for raw consumption. Depuration is a cleaning method that involvespurging shellfish by holding them in tanksand disinfecting the water they pump. It isbeing used by some clam harvesters, but atpresent is considered too expensive for theoyster industry.

The states have primary responsibilityfor the safety of food taken from theirwaters. Various federal agencies provideservices such as collecting informationand researching, as well as offering GMPregulations and other guidelines.

The March workshop resulted ingeneral agreement that the No. 1 priorityis to improve consumer and health professional education efforts about the possibledangers associated with eating raw Gulfoysters from April through October. Better data collection, research, and information sharing were other needs cited.

V. vulnificus also carries a legal threatfor the states and the oyster industry.Already suits have been filed by victims.In what was believed to be the first casetried, a Louisiana state court ruled inMarch in favor of a Mississippi man whocontracted septicemia after eating Louisiana oysters. Judge Bob Downing of the19th Judicial District Court said the statewas liable because it has the power andresponsibility to warn, and should havewarned, the man and the public about thedangers of eating raw oysters. The judgesaid if a warning notice had been requiredby the state on oyster shipments, the statewould not have been liable. If JudgeDowning's thinking prevails, oyster shipments may have to be tagged with a hazardnotice and warnings posted in placeswhere oysters are sold or served raw. ■

Roger W. Miller is director of FDA's communications staff.

FDA Consumer/June 1988/25

K E E P I N G Y O U R D O G

by Dori Stehlin

Parasitic worms are a problem that mostdog owners have to face at some pointin their dogs' lives. While they all areequally repulsive, they are not all thesame. There are actually many differentworms that can infect dogs, and they cancause a wide variety of symptoms. Whatthey are, what they do, and how to get ridof them and then prevent reinfection areimportant things for every dog owner tok n o w .

Heartworm (Dirofilaria immitis)Adult heartworms, which can grow as

long as 12 inches, can cause severe heart,lung and liver damage in dogs. Signs ofinfection include weight loss (despite ahealthy appetite), coughing, difficult orpainful breathing, a swollen abdomen andlegs, and lethargy. Unfortunately, symptoms do not develop until the disease iswell advanced.

Mosquitoes transmit heartworm disease. They pick up the larvae when theybite an infected dog and then deposit thelarvae on the next dog they bite. The larvaepenetrate the dog's skin through themosquito bite. In infected dogs, heart-worms are usually found in the right ventricle of the heart and pulmonary artery,and adjacent blood vessels.

To prevent infections with heartworm,veterinarians will do a blood test to detectthe presence of the heartworm larvae. Inareas where mosquitoes are only aproblem in the summer, this test is usuallydone right before the warm weather starts.

For dogs that are not infected, preventive medicine can keep them that way. Theprescription drug diethylcarbamazine(DEC), which is given orally, kills the larvae before they can reach the heart andmature. DEC must be given daily beginning before and continuing for two monthsafter the mosquito season. It may have tobe given all year long in areas where the

climate is always warm and mosquitoesare always active.

Another drug, ivermectin, also effectively kills the larvae. However, unlikeDEC, treatment with ivermectin is onlyneeded once a month during the mosquitos e a s o n .

FDA approved ivermectin in 1987 foruse in dogs to prevent heartworms. FDAregulates veterinary drugs to ensure safetyand effectiveness.

Neither of these drugs should be givento dogs with established populations ofadult worms and large numbers of larvae.The death of all the heartworms in a badlyinfected dog could cause shock and evendeath.

To kill adult worms, treatment with thedrug arsenamide is effective. The drug ishighly toxic, however, and pneumonia mayoccur within the first two weeks as theadults die and their fragments lodge in theterminal branches of the pulmonaryartery. Because of these adverse effects,dogs treated with arsenamide must beclosely observed during their recovery.

In addition to arsenamide, surgery toremove the adult worms is also possible.Of course, any treatment to kill the adultworms should be followed by preventivedrugs to prevent reinfection.

Hookworm (Ancylostoma caninum)Hookworms are small — between one-

quarter and three-quarters of an inch long.Adult worms live in the intestines and suckblood from the intestinal wall.

Infection with hookworms can occur if a

dog ingests larvae - which infected dogsshed in their stool. Infected mothers canalso pass the worms to their unborn puppies across the placenta and to newbornsthrough their milk. In addition, hookworms can penetrate a dog's skin.

The most serious cases of hookwormdisease occur in puppies younger than 4

months. As few as 50 to 100 hookwormscan consume a puppy's blood faster thanthe bone marrow can make it, leading tosevere anemia and death within a month.

Hookworms are not as serious a

problem in adult dogs, and a mature, well-nourished dog can be infected withoutshowing any signs. However, these dogsneed to be treated; otherwise they can be asource of infection for puppies.

Bloody diarrhea usually accompaniessevere infections. Dermatit is can occurwhen the worms penetrate the skin.

There are several oral drugs that willeffectively kill adult worms. Treatmentmust be repeated in 10 to 14 days to removeany worms that were still larvae when thefirst dose was given. Besides drug treatment, the dog may require blood transfusions to replace lost blood and a specialdiet - high in protein, iron and vitamins -to help the animal regain its strength.

Controlling hookworm should begin byinsuring that females are free of the parasites before breeding and kept out of contaminated areas during pregnancy.Infection can be prevented with dailydoses of both diethylcarbamazine (used toprevent heartworm disease) and styryl-pyridinium.

Good sanitation is also essential to prevent infection in both dogs and people.Although canine hookworms can't maturein people, the larvae can migrate throughthe skin and subcutaneous tissue, causingserious skin lesions. Paved kennel runscan be sanitized with a solution that contains one cup detergent, one cup sodiumborate, one gallon bleach, and approximately four gallons of water.

Roundworms {Toxascaris leonina andToxocara canis)

Roundworms are tough creatures.Roundworm eggs can withstand freezing

(Continued on page 28)

26/June 1988/FDA Consumer

Mosquitoes transmit heartworm disease.They pick up the larvae when they bite aninfected dog and then deposit the larvaeon to the next dog they bite.

The Spread ofH e a r t w o r m

D i s e a s e

From its original area inthe eastern half of theUnited States, heartwormdisease has spreadthroughout the UnitedStates and in to Canada.

Experts say reasons forthe spread include: increased mobility of dogs,carrying the infectioninto areas where it previously was not found;increase in stray dogs,serving as reservoirs ofinfection; decrease ofmosquito control measures; and the parasite'sadaptability to colder clim a t e s .

1960S

1 9 8 0 s

(Maps courtesy of Merck & Co., Inc.)

F D A C o n s u m e r / J u n e 1 9 8 8 / 2 7

K E E P I N G Y O U R D O G W O R M - E R E E

Adult heartworms live in the heart and pulmonary arteries, causing inflammation,roughening of the artery walls, reducing or blocking blood flow. They alsocause damage to the lungs, liver and kidneys, as well as the heart.

(Continued from page 26)

and are resistant to most common disinfectants. The eggs are also sticky. They tendto adhere to paws and hair and becomem i x e d w i t h s o i l .

In some cases, they are also tough to getrid of once a dog is infected. While the larvae of one of the two common roundworm

species — Toxocara canis — may notmature or cause any symptoms in puppiesover 6 months and adults, in newborn pupsthese worms can cause bronchitis, pneumonia and death. In adults, T. canis larvaecan migrate throughout the body wherethey lie dormant in the muscles, connective tissue, kidneys, and many other tis

sues. These dormant larvae, which arealmost impossible to get rid of, become aproblem if a dog has puppies. Duringpregnancy, these larvae again becomeactive and migrate into the developingf e t u s .

Because of this problem with dormantlarvae, most puppies are considered to beinfected even if they don't have symptoms.According to the Merck VeterinaryManual, puppies should be treated asearly as 2 weeks of age, and the mothersshould be treated at the same time. Repeattreatments are necessary if eggs appear inthe feces.

The other roundworm species, Toxas-caris leonina does mature in the intestines

of adult dogs. Infected dogs may have dullhair and pot bellies. In puppies, more serious symptoms such as vomiting, diarrhea,bronchitis and pneumonia can occur.

There are several drugs available thatwil l el iminate an active roundworm infection, including an over-the-counterproduct - piperazine salts. Preventingreinfection requires good sanitation. Thisincludes control of rodents and cockroaches because they can be intermediatehosts

In addition, children should be keptaway from lactating mothers and youngpuppies until successful treatment is complete. Although roundworms will notmature in humans, the larvae can migratethrough internal organs and cause tissuedamage. In rare cases serious damage,such as blindness, may occur.

Whipworms (Trichuris vulpis)Whipworms are 2 to 3 inches long and

can live in a dog's large intestine for up to16 months. Eggs, which are passed in aninfected dog's stool, can remain alive forup to five years in a warm, moiste n v i r o n m e n t .

Most dogs infected with whipwormsshow no sign of disease. Symptoms suchas diarrhea and weight loss occur only inthe most severe cases.

While there are several prescriptiondrugs available to treat whipworms, boththe larvae and the adult whipworms arenotoriously resistant to medication,according to Dr. Sandra Woods, aveterinarian with FDA's Center for Veteri

nary Medicine. "Elimination may requireseveral treatments over a period of manym o n t h s a n d r e i n f e c t i o n s f r o m a c o n t a m i

nated environment are common," she said.Because treatment is so difficult,

preventing infection in the first place isimportant. Because the eggs cannot survive without warmth and moisture, cleanliness and eliminating moist areas canconsiderably reduce reinfection.

Tapeworms (Dipylidium caninum)All parasites need a host. But for

tapeworms — like many other parasites —

2 8 / J u n e 1 9 8 8 / F D A C o n s u m e r

K E E P I N G Y O U R D O G W O R M - E R E E

one isn't enough. Before it can infect adog, it has to infect an intermediate host.While small mammals are the intermediate hosts for some tapeworms, Dipylidiiimcaninum makes its temporary home in theflea. This flea-transmitted tapeworm is themost common one to infect urban dogs,who rarely eat anything but preparedfoods.

Tapeworms, which can grow as long as20 inches, rarely cause serious disease.According to the Merck VeterinaryManual, symptoms can vary from failureto thrive, malaise, irritability, erraticappetite, and shaggy coat to colic, milddiarrhea, emaciation, and seizures.

There are several prescription medications used to eliminate tapeworms, butunless the worm is destroyed completely,the remaining segments can regeneratewhole worms in just a few weeks. Becauseof this potential for the worms to growagain, the stool of dogs being treated fortapeworm must be carefully checked foreggs a few weeks after treatment starts. Toprevent reinfection, fleas must beel iminated.

While worms may seem inevitable, theycan be prevented in many cases. All puppies should be treated by a veterinarian forhookworm and roundworm whether or not

they have symptoms.Adult dogs should be seen by a vet two

or three times a year, according to FDAveterinarian Sandra Woods. "A healthydog might not have symptoms, but thatdoesn't mean harm isn't being done," shesaid.

Determining which worm a dog isinfected with requires microscopic examination of blood or fecal samples. For thisreason and the fact that many effectivemedications for worms require a prescription, dog owners should not attempt todiagnose or treat their pets by themselves.

Finally, many of the symptoms causedby worms can also be caused by other diseases. The only way to be sure is to see av e t e r i n a r i a n . M

Dori Stehlin is a member of FDA's publicaffairs staff.

FLIAS ft nCKIWhile worms make themselves at home inside a dog, fleas and ticks enjoy

settling down on the outside. In addition to uncomfortable itching from theirbites and bloodsucking, they can transmit diseases - such as tick paralysis -and other parasites.

Flea control isn't easy. The eggs and pupae (the non-feeding stage ofdevelopment between the last larval stage and the adult flea) are hard toeliminate and can continuously emerge for months. In addition, fleas spendonly a small part of their life cycle on the dog. Only the adults get on the dogto feed, and they can survive off the animal for up to two months. Because ofthese factors, effective control requires treatment of not only the dog, but itssurroundings as well.

The first step in effective flea control is to treat the dog with a direct skinapplication of pesticide in the form of a spray, aerosol, bath, rinse, dust, orfoam application. A flea collar may be used for some additional protection,but it should not be the sole means of control.

The latest development in flea collars — the ultrasonic collar — does noteven seem to provide that additional protection. These collars produce ultrasound emissions that, in theory, will repel fleas from dogs and cats. But,according to an article in FDA Veterinarian,". . . no published reports ofwell-controlled trials in support of such claims have come to FDA's attention." In addition, FDA's Center for Veterinary Medicine found that thesound produced by the collars — inaudible to people — could be heard byanimals. The center said that, at the very least, the sound could be annoyingor disturbing.

In addition to the dog itself, the room where the animal sleeps shouldreceive an insecticide treatment because flea feces, eggs, larvae, and pupaewill definitely accumulate there. Regular washing of the dog's bedding andfrequent vacuuming, which will pick up a lot of eggs, can also help keep theflea population under control. The vacuum cleaner bag should be burnedafter vacuuming to prevent it from serving as a flea incubator.

Any other areas where the dog spends time — such as living rooms,bedrooms, the yard, and the car - should also be sprayed with insecticide.

Tick control is similar to flea control. But, in addition to pesticides,removing ticks by hand can help control a mild infestation. FDA veterinarian Sandra Woods recommends that before someone tries this, however, theyshould have a veterinarian show them how.

After removing the ticks by hand, they should be destroyed either by burning with a match or by dropping them in a jar half filled with turpentine. Thejar should be closed tightly with a metal lid before disposal.

Outdoors, keeping grass cut short can help discourage tick infestation —and reduce the chance a tick will get on the dog — since ticks can't survivetoo much direct sunlight and heat. ■

F D A C o n s u m e r / J u n e 1 9 8 8 / 2 9

T h e N o M > o o k

The Notebook: a potpourri of items of interest gatheredfrom FDA news releases, other news sources, and the Federal Register (designatedFR, with date of publication).The Federal Register is available in many large publicl ib rar ies .

■ FDA has determined that caffeine is the only safe andeffective ingredient for over-the-counter stimulant drugsiFRFeb. 29).

■ Holders of patents on FDA-regulated products now have30 days (up from the previous 10) to respond to petitionscharging that the patent holder did not act with "due diligence" in pursuing prompt FDA approval of a product.FDA's patent extension regulations enable owners ofpatents on certain human drugs, medical devices, and foodor color additives to try to regain some of the patent timelost while awaiting product approval from the agency (FRMarch 7).

■ FDA's 1988 list of critical medical devices includes 182

products. The number of these devices - which areintended to be surgically implanted in the body or to support or sustain life, and whose failure could cause significant injury to a patient — is up from 75 on the original 1978list. The list is "only illustrative" and does not necessarilyinclude all devices that fall under the critical device definition (FT? March 17).

■ The Consumer Product Safety Commission is testingnew designs for child-resistant pill containers that shouldbe easier for adults to use and still protect children fromaccidental poisoning. The new designs include individualpill wrappings, caps that are opened with a key, and a capthat is pulled up instead of pushed down before turning.

■ FDA has denied a request by the Community NutritionInstitute to hold a hearing on the safety of aspartame. Theagency concluded that no issues of material fact were raisedin the request to justify a hearing and confirms that aspartame can still be used in several beverages, frozen confections, and breath mints (FR March 2).

■ The Department of Agriculture's Food Safety andInspection Service has amended the standard of identity forfrankfurters and similar cooked sausages to provideprocessors with more flexibility when producing productsthat have less fat. These products can now contain morethan the previous 10 percent limit on added water as long astotal fat and water content does not exceed 40 percent (FRMarch 15).

■ It looked like a documentary on preventing hair loss, butit was really a 30-minute advertisement for Helsinki Formula Shampoo. In discussions with the National Advertising Division (NAD) of the Council of Better BusinessBureaus, Inc., the advertiser said it was no longer makingclaims that the shampoo could prevent hair loss and promote new hair growth. In fact, the advertiser had agreed toa consent order with the U.S. Postal Service to permanentlydiscontinue those claims.

NAD also recently questioned the advertiser of Viadenttoothpaste and oral rinse about claims that the number onerecommendation of dentists and hygienists to preventplaque buildup was use of Viadent. The advertiser submitted results of a survey of dental professionals to substantiateits claim, but nevertheless informed NAD the claims wouldno longer be used.

■ Because FDA has approved the psychotropic substancede!ta-9-tetrahydrocannabinol (found naturally in marijuana) for use as an antiemetic by patients receiving cancerchemotherapy, the United States has petitioned the UnitedNations to reschedule the drug from Schedule I of the Controlled Substances Act to Schedule II. While drugs in bothschedules have a high potential for abuse. Schedule I drugshave no currently acceptable medical use (FR March 29).

3 0 / J u n e 1 9 8 8 / F D A C o n s u m e r

4Investigators'Reports

A Fast Track

'Ratty' Foodby Maria?} Segal

Shootout at the OK Corral? Not exactly,but picture this: During an FDA inspection of foods stored in a Garfield, N.J.,warehouse, the son of the firm's presidentstarts shooting rats with a pellet gun. Oneof the nasty critters chases an FDA investigator down a narrow aisle. Birds fly inthe door and perch on bags of flour.

The investigator got away unharmed -and armed with photographic evidence ofinfestation so gross that all the food at thewarehouse was seized just two days afterthe inspection was concluded. The quickaction was possible because the evidencewas so clear that a seizure could be supported by photographs and observationsalone, without having to wait for laboratory confirmation of contamination insamples. This streamlined procedure,recently reinstituted by FDA after 10years, is being used more and more frequently to protect the consumer in cases ofgross contamination. In such cases, theagency charges that all the food stored is inviolation of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Actbecause the storage environment is sounsanitary that all of the food is subject tocon tamina t ion .

The firm, Latona's Food ImportingCorp., distributes imported Italianspecialty foods to restaurants and grocerystores in northern New Jersey and parts ofNew York, operating from a one-story,8,500-square-foot cinder block building.

Inspections of the premises in 1985 and1986 showed that crowded and cluttered

storage made cleaning and inspectiondifficult. During the last inspection (Nov. 2to Nov. 10, 1987), investigators found liverats, a rat nest with baby rats, dead rats,and rat droppings on food containersthroughout the building. The rats had easyaccess to the building — they simplyentered through the large receiving/shipping door, which was routinely kept openduring the day and did not seal tightlywhen closed at night.

Many food containers had been gnawedby rats, and live beetle-like insects werefound in the firm's pasta products, whichaccounted for about 80 percent of the totalfood inventory. Spices, flour, tomatoes,and cheese were also stored in the

building.On Nov. 12, FDA seized all products on

the premises. The Newark district officeoriginally requested seizure only ofproducts in vulnerable packaging, likecardboard, paper, cellophane, and plastic.Flowever, in reviewing the report, theagency's division of regulatory guidance inthe Center for Food Safety and AppliedNutrition expanded the recommendationto include goods packaged in cans and hermetically sealedjars because rats hadgnawed into the cases, nested among thecontainers, and in some instances chewed

off the labels. The division noted that "the

products in glass and metal containers areso heavily rodent defiled that consumers,upon opening these containers, would bevery susceptible to getting rodent filth ontheir hands and the filth may fall into thefood when the containers are opened."

On the first day of last November'sinspection, the firm had agreed to stopshipping any products in containers susceptible to infestation, but the very nextday they attempted to ship flour. So FDA'sNewark office notified the New JerseyDepartment of Health of the apparent violations, and the state then embargoed allthe firm's products. Under state supervision, the firm began to examine its inventory and move salvageable products toother warehouses. On Nov. 25, Latona'sentered into a court-approved consentdecree with FDA. The firm agreed to destroy all products in cartons that showedevidence of rodent defilement. They alsoagreed to examine all macaroni, bag bybag, for contamination and to destroy theentire lot if one bag were found to containinsects. Salvageable products will ber e c o n d i t i o n e d .

Mariari Segal is a member of FDA's publicaffairs staff.

Brand New Bugs

A shipment of curry from India didn'twin any favor with American gourmets,but it did excite the interest of entomolo

gists. The powder, FDA investigators discovered, was contaminated with mites;and not just any mites, but a previouslyunknown genus and species.

During routine monitoring of importsarriving in Los Angeles, FDA inspectors

collected a sample of Indian curry and sentit to the agency's Los Angeles laboratoryfor examination. There, entomologistsRichard W. Potter and Alan R. Olsen

began their work to identify any insectsfound in the product. (Identification of thecontaminant helps pinpoint the origin ofcontamination — for example, at thestorage warehouse, in the field, or in theshipping container.)

When they examined the little mites they

found in the curry. Potter and Olsen discovered they were looking at a whole newgenus and species. Their first clue was theatypical arrangement of tiny bristles on thebodies of the mites. With this and other

indications, they began a thorough andlengthy review of the literature to ascertainthat this was indeed a distinct, previouslyundescribed genus and species of mite.That done, the scientists wrote up theirdescription of the organism, which was

FDA Consumer /June 1988/31

t

subsequently published in the December1987 issue of the InternationalJournal ofArcarology. (Acarology is the study ofticks and mites.)

Rhypoglyphus indicus — the scientificname given to the mite by Potter andOlsen - has since been found in a varietyof food products originating from Taiwan,Thailand, and the Philippines.

The curry, incidentally, was refusedentry into the United States because ofadulteration with mite and insect filth.

Vagabond 'Vinegar'

Surprise awaited an investigator fromFDA's San Juan district office and a U.S.

deputy marshal when they tried to seizesome phony vinegar last October: The 795cases they expected to find were gone.

The U.S. assistant attorney for the district of Puerto Rico promptly threatened toprosecute the firm if the goods weren'treturned right away. Five days later, thecases showed up and were seized.

The Bohio brand of so-called "distilled

vinegar" was distributed by Freiria & Co.,Inc., of San Juan and produced by Henfra-mar Corporation of Bayamon. (The firmsshare the same president and vice president.) The product was actually dilutedacetic acid.

FDA first visited the firms in January1986 as a result of a consumer complaintabout insect fragments in another of theirproducts. The firms weren't yet registeredwith FDA, so the investigator wanted samples of all their items: cooking sauces,spices, and other condiments. But theBohio "vinegar" was out of stock at bothHenframar and Freiria. Then in May,FDA conducted a follow-up inspection togive the firms the necessary filing formsand collect samples of the "vinegar." Analysis by FDA's San Juan district laboratoryshowed the samples to be acetic acid.

FDA wrote Henframar on July 23 thatacetic acid is recognized as safe in foods ifit is of "food grade" (as was the Henframardiluted acetic acid) and is used accordingto FDA regulations - one such rulerequires the ingredient to be declared onthe labeling as "acetic acid" or "dilutedacetic acid." The letter went on to say thatacetic acid is not vinegar, that vinegar ismade only from fermented apple juice,and that the firm's "diluted vinegar" wastherefore misbranded and against the lawand should be relabeled.

Henframar responded in August with arequest to correct the labels it had on handto read "imitation vinegar." FDA wroteback on Nov. 18 that stickers could be usedto correct the labeling, so long as the word"imitation" immediately preceded theword "vinegar" and was the same size andequally prominent. The corrected labelwas also to list all ingredients, such aswater, acetic acid, and natural apple ciderflavor, and to declare any added color.

On March 16, 1987, the firm sent FDAcopies of corrected labels for approval. OnMay 7, FDA answered that one correctedlabel was satisfactory. A follow-up visit inJune, however, showed the firm was stillproducing diluted acetic acid and labelingit "distilled vinegar."

As a result, on Oct. 1, on FDA's behalf,the U.S. District Court for the District ofPuerto Rico ordered that the products beseized. This was attempted on Oct. 16, butwasn't accomplished until Oct. 21, afterthe wandering goods had been returnedfrom their mysterious hiding place.

Freiria filed a claim for the 795 cases onNov. 9. Under a consent decree signed onFeb. 8, 1988, the firm agreed to pay allexpenses, such as court and storage costs,and to correct the labels under FDA's

supervision or forfeit a $20,000 bond.

C o n t a m i n a t e d R a t s

Inspection of the thousands of semi-trailer-size shipping containers stacked ondocks at ports of entry to the United Statescan yield dried black fungus, canned rattlesnake, chocolate-coated ants, and otherexotic food products. But, none as curious,perhaps, as smoked rat.

Meat and meat products from cattle,sheep, swine, goats and horses are regulated by the U.S. Department of Agriculture, but wild game — a term that includesrats - comes under FDA's jurisdiction. Soit was that inspectors from FDA's LosAngeles office reported a close encounterof the inspection kind with smoked canerat {Thryonomys swinderianus), shippedto the United States from Ghana. Cane rats

weigh about three pounds and, while seenas a destructive pest in their native sugarcane fields, their meat is considered adelicacy worth twice the price of beef, mutton or pork to some East African natives.

The importer hasn't gotten to test howwell smoked rat might fare in the U.S.market, however. Samples of the productanalyzed at the L. A. district laboratoryshowed there were 15 ants in 200 grams ofthe meat and hairs from other rodentsthat had apparently infested the productafter processing.

The rat meat was detained by FDA, andthe importer was told it would have to bebrought into compliance with the FederalFood, Drug, and Cosmetic Act or beshipped back to Ghana. The meat wasexpected to be back in Ghana beforem i d s u m m e r .

— 77i A small sample of reports from thefield was prepared by Dixie Farley, VernModeland, Marian Segal, and Irene Caro.

32 /June 1988/FDA Consumer

Summaries of Court Actions

Summaries of Court Actions are given pursuant to section 705 ofthe Federal Food, Drug, and Cosmetic Act. Summaries of CourtActions report cases involving seizure proceedings, criminalproceedings, and injunction proceedings. Seizure proceedings arecivil actions taken against goods alleged to be in violation, andcriminal and injunction proceedings are againstor individualscharged to be responsible for violations. The cases generally involvefoods, drugs, devices or cosmetics which were alleged to be adulterated or misbranded or otherwise violative of the law whenintroduced into and while in interstate commerce or while held forsale after shipment in interstate commerce.

Summaries of Court Actions are prepared by Food and DrugDivision, Office of the General Counsel, HFIS.

Published by direction of the Secretary of Health and HumanServices.

S E I Z U R E A C T I O N S

Foods/Contamination, Spoilage, Insanitary HandlingPRODUCT: Flour, and sugar, at Puerto Nuevo, Dist. Puerto Rico,Civil No. 87-00841(HL).CHARGED 7-1-87: While held by Wah-Mey Enterprises, Inc.,Puerto Nuevo, Puerto Rico, the articles contained rodent filth andhad been held under insanitary conditions - 402(a)(3), 402(a)(4).DISPOSITION: Default - ordered destroyed. (E.D.C. No. 65219; S.Nos. 87-513-242/3; S.J. No. 1)

PRODUCT: Pecan pieces, at Nashville, M. Dist. Tenn.; Civil No.3-87-0246.CHARGED 3-30-87: When shipped by Orchard Pecan Co., Inc.,Albany, Ga., the article had been prepared, packed or held underinsanitary conditions - 402(a)(4).DISPOSITION: Default-ordered destroyed. (E.D.C. No. 65152; S.No. 87-333-413; S.J. No. 2)

PRODUCT: Rice flour, at Rio Piedras, Dist. Puerto Rico; CivilNo. 87-177 H.L.CHARGED 2-6-87: While held by M. Cuebas, Rio Piedras, PuertoRico, the article contained insect filth — 402(a)(3).DISPOSITION: Default-ordered destroyed. (E.D.C. No. 65116; S.No. 87-513-041; S.J. No. 3)

PRODUCT: Shrimp, peeled, frozen, frozen pizza, frozenFrench fried potatoes, frozen cheesecake, and other food stocks,at St. Paul Park, Dist. Minn.; Civil No. 3-84-324.

CHARGED 3-29-84: While held by Quade & Sons Refrigeration,Inc., St. Paul Park, Minn., the articles had been held under insanitary conditions; and the articles named above were unfit for fooddue to a foreign chemical odor - 402(a)(3), 402(a)(4).DISPOSITION: A number of the articles were claimed by thedealer; and specified articles were claimed by Flower ValleySpecialty Pies, Inc., Red Wing, Minn, (frozen pies), C.W. Corp.,Richfield, Minn, (frozen seafood), and Greater Lake County EoodBank, Minneapolis, Minn, (pizza, French fries, etc.). Subsequently, the dealer abandoned any claims to the specified articlesclaimed by Flower Valley Specialty Pies, Inc. The latter claimantagreed that its specified articles could be destroyed after samplingby it and the dealer. The claims of the dealer for the specified articles claimed by Greater Lake County Eood Bank and C. W. Corpwere similarly relinquished pursuant to stipulation of the parties,and Greater Lake County Food Bank abandoned its claim.

A default decree of condemnation ordered the destruction of theunclaimed goods; a consent decree of condemnation authorized therelease for salvaging of those articles still claimed by the dealer.(E.D.C. No. 64247; S. No. 84-397-563 etal.; S.J. No. 4)

Dietary Supplement/VitaminsPRODUCT: Multi-component packets containing II dietary-supplement tablets and capsules at New Brunswick, Dist. N.J.;Civ i l No. 86-1777-HLS.CHARGED 5-19-86: While held by Universal Laboratories, Inc.,New Brunswick, N.J., who packaged the packets using interstatecomponents, the article (labeled "Animal Pak . . . Formulated andManufactured By Universal Laboratories, Inc., New Brunswick,NJ . . . Contents per 2 packets . . . Calcium Pangamate 100 mg. . . Vitamin A 50000 I.U. . . . Vitamin D 2800 I.U.") containedvitamin A, vitamin D, and vitamin Bg (pyridoxine), which might beinjurious to health when used at the specified daily intake forextended periods -402(a)(1); the article contained the nonconforming food additive calcium pangamate (no regulation was in effectwith respect to it and its intended use)-402(a)(2)(C); the articlecontained the nonconforming food additives folic acid and iodine(derived from kelp), since the daily intake recommended for bothfood additives was in excess of that permitted by regulation —402(a)(2)(C); the article contained the nonconforming food additives l-arginine, 1-phenylalanine, and d-methionine, which were notsafely used in accordance with regulation-402(a)(2)(C); and themulti-component package lacked a complete quantity of contentsstatement, appropriately descriptive names, and complete ingredient listings —403(e)(2), 403(i)(l), 403(i)(2); and the substancesargentine liver, inositol, dl-methionine, betaine HCl, and para-

FDA Consumer /June 1988 / 33

aminobenzoic acids should not have been listed as nutrients, but aspart of a list of all ingredients, and the label should not have givenprominence to, or emphasized in milligram amounts, the ingredients that were not vitamins, minerals, or represented as a sourceof vitamins or minerals - 411(b)(2)(A) and (B).DISPOSITION; The article was claimed by the dealer, who deniedthe charges, asserted the complaint to be defective for failure toidentify the goods by lot number, and demanded trial by jury. Thegovernment served requests of admissions on the claimant. Subsequently, a consent decree authorized release of the articles to theclaimant for destruction. (F.D.C. No. 64889; S. No. 86-427-324;S.J. No. 5)

Drugs/Human UsePRODUCT: Aspirin combination capsule-shaped tablets, at Wil-sonville, Dist. Ore.; Civil No. 87-381-FR.CHARGED 4-13-87: When shipped by A & M Drug Brokerage,Inc., Carrollton, Texas, the article, which contained no naproxenalthough it was labeled (bottle) "Naprosyn . . . (naproxen) tablets. . . Exp. Date: 6-90 . . . Syntex Puerto Rico, Inc.," was a new drugwithout an effective approved New Drug Application - 505(a); andthe article was a counterfeit drug, in that the tablets of the article,and the containers and labeling, without authorization, bore thetrademark, trade name, imprint, or likeness of a drug manufacturedby other than the actual manufacturer — 201(g)(2).DISPOSITION: Default - ordered constructively destroyed byturning over to FDA. (F.D.C. No. 65171; S. No. 87-416-730; S.J.No. 6)

PRODUCT: CFX-19 protein hydrolyzates powder, at Salisbury,Dist. Md.; Civil No. 83-2670.CHARGED 7-21-83: While held by Robertson Resources, Ltd.,Salisbury, Md., the labeling of the article (which included the following: (label) "CFX-19 An Extract Of The Feet Of ImmatureChickens A Folk Food In Powder Form," (letter) "Dear Customer,Revital Medical Device is an amino acid product. A natural healingpowder used as a topical application," (magazine article used aslabeling) "Revital — The Most Powerful Food Known To Man . . .the amazing food powder," and (letter) "Dear Customer, We havechanged the name of our food powder and food tablets. The newname is CFX-19 . . . The product has been changed in name only"failed to bear adequate directions for its intended therapeuticpurposes - 502(f)(1); and the article was dangerous to health whenused as recommended or suggested in its labeling - 502(j).DISPOSITION: The article was claimed by the dealer, who deniedthe charges. Subsequently, a consent decree of condemnationordered the article destroyed, but the consent was not an admissionas to the charges. (F.D.C. No. 64057; S. No. 83-397-075 et al.; S.J.No. 7)

PRODUCT: Hair treatment kits containing hair treatment solution and shampoo, at West Palm Beach, S. Dist. Fla.; Civil No.86-8513.CHARGED 9-9-86: While held by Custom Packaging Service,West Palm Beach, Fla., who manufactured the kits using interstatedrug ingredients, the article, labeled "Rivixil with SKM005* European Hair Treatment Program . . . For a Fuller, Thicker Head ofHair. . . imported from Italy . . . Hair Treatment. . . Shampoo. . . Dist. by Riahom Corporation New York, NY," was a new drugwithout an effective approved New Drug Application for the article's use for hair restoration and growth —505(a); and the article'slabel lacked the established name and quantity of each active ingredient (e.g., minoxidil)-502(e)(l)(A)(ii); and the article's labelinglacked adequate directions for use for the article's recommendedconditions, and the article was an unapproved new drug for whichadequate directions for use could not be written — 5G2(f)(l).DISPOSITION: Default - ordered destroyed. (F.D.C. No. 64965;S. No. 86-374-514 et al; S.J. No. 8)

PRODUCT: Topical analgesic ointment, at Wilsonville, Dist.Ore.; Civil No. 86-1265-FR.CHARGED 10-10-86: When shipped by Chemrich Laboratories,Los Angeles, Calif., the article, which was labeled "ImmuVir . . .specially formulated base, InterVir-A . . . Topical Analgesic Ointment . . . Distributed by BioPharma, Inc. . . . Lake Oswego, OR,"was a new drug without an effective approved New Drug Application for its intended use in the cure, mitigation or treatment of diseases, including herpes-505(a).DISPOSITION: Default - ordered destroyed. (F.D.C. No. 65023;S.No. 86-465-398; S.J. No. 9)

Drugs/VeterinaryPRODUCT: Furazolidone medicated premix, and other drugpremixes and medicated feeds, at Lexington, W. Dist. Tenn.;Civil No. 86-1156.CHARGED 7-18-86: While held by Lexington Feed Mill, Inc., Lexington, Tenn., the articles were medicated animal feeds and drugsintended for use in producing medicated animal feeds, and the circumstances used for the production of medicated feeds lacked conformity with current good manufacturing practices —501(a)(2)(B).DISPOSITION: Consent — authorized release to the possessor forbringing into compliance with the law. (F.D.C. No. 64932; S. No.86-487-371; S.J. No. 10)

PRODUCT: Medicated feed premixes, and medicated feed premix components, at Fort Dodge, N. Dist. Iowa; Civil No. 2 C8 6 - 3 0 3 7 .

CHARGED 5-5-86: While stored to the account of Custom FeedBlenders Corp., Fort Dodge, Iowa, some of the articles had been

34/June 1988/FDA Consumer

prepared in an unregistered establishment, and the circumstancesused for their manufacture, processing and packing failed to conform with current good manufacturing practice —502(o),501(a)(2)(B); and some of the articles failed to bear adequate directions for use - 502(f)(1).DISPOSITION: An ownership interest in the articles was claimedby White Transfer & Storage Co., Fort Dodge, Iowa, who applied tointervene in the action. Subsequently, Custom Feed BlendersCorp., Fort Dodge, Iowa, claimed the articles, sought to intervenein the action, and asked that the prior application to intervene ofWhite Transfer & Storage Co. be stricken since it was erroneouslyfiled. The application of Custom Feed Blenders Corp. was granted,and the application of White Transfer & Storage Co. was deemedwithdrawn. Custom Feed Blenders Corp., the claimant, denied thecharges and asked that the action be dismissed or (if any articleswere illegally within the court's jurisdiction) that certain articles bereleased and re-exported rather than being destroyed. The government served upon the claimant requests for admissions, writteninterrogatories, and requests for the production of documents. Subsequently, a consent decree condemned the articles and ordered theclaimant to submit its motion for re-exportation of the imported articles within 20 days. Ultimately, the articles were ordered destroyed.(F.D.C. No. 64891; S. No. 86-473-201 et al.; S.J. No. II)

PRODUCT: Medicated premixes, and medicated premix components, at Fort Dodge, N. Dist. Iowa; Civil No. 2 C 86-3038.CHARGED 5-5-86: While held by Custom Feed Blenders Corp.,Fort Dodge, Iowa, the circumstances used for the articles' manufacture, processing, and packing failed to conform with current goodmanufacturing practice - 501(a)(2)(B).DISPOSITION: The articles were claimed by the dealer whodenied the charge. The government served written interrogatories,requests for admissions,and requests for the production of documents on the claimant. Subsequently, a consent decree of condemnation ordered the articles destroyed. (F.D.C. No. 64890; S. No.86-473-201 etal.;S.J. No. 12)

C o s m e t i c s

PRODUCT: Grease paint sticks (red), and kits containing redgrease paint sticks, at Freeport, E. Dist. N.Y.; Civil No. 84-1135.CHARGED 3-16-84: While held by Zander Brothers, Inc.,Freeport, N.Y., who manufactured the articles using interstateingredients, the articles (labeled in part "Zander Bros. New York. . . Grease Paint" and "Grease Paints the Carnival make-up set. . .Zander Bros. New York, N.Y.") contained the nonconforming coloradditives FD&C Yellow No. 5, D&C Red No. 7, and D&C Red No.9, which were not permitted to be used in cosmetics intended for usein the area of the eye — 601(e).DISPOSITION: Consent - author ized re lease to the dea ler fo r

bringing into compliance. (F.D.C. No. 64210; S. No. 84-322-509;S.J. No. 13)

C R I M I N A L A C T I O N S

DEFENDANTS: John A. Blackman, vice president of a pharmaceutical firm, and Jay Greenblatt, pharmacist and consultant.South Hackensack, Dist. N.J.; Criminal No. 83-352 (JFG).CHARGED on or about 12-12-83 by grand jury, but subsequentlysuperseded by a second indictment and, in the case of the vice president, by a criminal information: That John A. Blackman's pharmaceutical firm had obtained 1,325,000 capsules of ampicillin froma St. Croix, U.S. Virgin Islands, pharmaceutical manufacturer andthat John A. Blackman had caused such capsules to be labeled withfalse and fictitious lot numbers and expiration dates - 30I(i)(I); thatJohn A. Blackman caused such capsules to be a counterfeit drug,since, without authorization from a specified firm who was a leading New Jersey manufacturer and distributor of ampicillin, hecaused the capsules to be packaged with copies of the labels and thepackage inserts of such specified firm thereby falsely representingthe capsules to be the product of, or to have been packaged or distributed by such specified firm - 201(g)(2); when shipped by JohnA. Blackman to a pharmacist. Jay Greenblatt, employed at QueensVillage, N.Y., a quantity of ampicillin capsules were misbranded,having been packaged and labeled by John A. Blackman with falselot numbers and expiration dates and with false representations as tobeing the product of such specified firm — 502(a); when shipped byJay Greenblatt to the owner of a pharmacy in Queens Village, N.Y.,a quantity of ampicillin capsules were misbranded asabove-502(a); and when shipped by Jay Greenblatt to a retailsalesclerk at a pharmacy in Queens Village, N.Y, a quantity ofampicillin capsules were misbranded as above - 502(a).DISPOSITION: After the defendants litigated the action with extensive motions, the two named defendants entered into plea agreements. John A. Blackman pleaded guilty to two counts ofdistributing misbranded drugs and one count of counterfeitingdrugs; he was fined $3,000, and he was placed on probation for fiveyears with the performance of 500 hours of community service. JayGreenblatt pleaded guilty to two counts of distributing misbrandeddrugs; he was fined $2,000, and he was placed on probation forthree years with performance of 300 hours of community service.(F.D.C. No. 63559; S. No. 8I-25I-58I etal.; S.J. No. 14)

C O N T E M P T A C T I O N S

DEFENDANT: George Kevin Bryant, vice president of BryantFoods, Inc., Bayou La Batre, S. Dist. Ala.; Civil No. 84-I096-H.CHARGED on or about 1-30-85 in a complaint for civil contempt:That the defendant violated the consent decree when he sold the following amounts of crab meat after the entry of the consent decree

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and when he failed to accurately inform the government of suchsales: 1,200 pounds to Bodiford Shrimp Co., Inc.; 1,000 pounds toMetcalf Seafood; 200 pounds to Porter Seafood, Inc.; 80 pounds toMaria's Seafood; and 90 pounds to C&L Seafood; and that thedefendant also violated the consent decree when he moved 24,750pounds of frozen crab meat from the firm's plant to Sea PearlSeafood Co., and failed to inform the government of his actions.DISPOSITION: George Kevin Bryant was ordered to compensateFDA $3,499.62 and was further ordered to pay a $500 fine for eachday in the future that he was in violation of the consent decree. (Inj.No. 1084; S. No. 84-401-552; S.J. No. 15)

INJUNCTION ACT IONS

DEFENDANT: N. Anita Bryant, t/a Bryant Foods, Inc., BayouLaBatre, S. Dist. Ala.; Civil No. 84-1096-H.CHARGED 9-26-84 in a complaint for injunction: That the defendant cooked, processed, packed, labeled, held for sale, and distributed in interstate commerce crab meat (from crabs received ininterstate commerce); that such crab meat contained bacterial filthand had been prepared, packed and held under insanitaryconditions-402(a)(3), 402(a)(4); that FDA inspections had revealed numerous insanitary conditions; that FDA analyses of thedefendant's crab meat revealed contamination with E. coli\ and thatthe defendant had been repeatedly warned of the insanitary conditions and practices at her plant.DISPOSITION: A consent decree of permanent injunctionenjoined the complained-of violations and enjoined plant operationsinvolving interstate foods, unless and until a number of specifiedconditions had been met, including the establishment of methodsand controls to ensure that the foods were not adulterated, the certification by an expert that such methods and controls had beenestablished, and the analysis for bacterial contamination and thedestruction or bringing into compliance of all foods on hand. (Inj.No. 1084; S. No. 84-401-552 et al.; S.J. No. 16)

M I S C E L L A N E O U S A C T I O N S

SUBJECT: Myristalkonium chloride & quaternium 14 blend,and the Over-the-Counter (OTC) Topical AntimicrobialProducts Review, Washington, Dist. Columbia; Civil No. 84-1021.CHARGED 4-2-84 by George Robert P. Farquhar, manager andresearch director of a sanitizing systems firm, Washington, D.C.,against FDA in a complaint for damages and other redress: That,despite evidence of safety and effectiveness already in governmentfiles for an active ingredient in OTC topical antimicrobials for useon intact skin, FDA had withheld and delayed approval of Farqu-har's citizen's petition concerning his myristalkonium chloride &quaternium 14 blend as the active ingredient in topical

antimicrobials for patient pre-operative skin preparation, surgicalhand scrub, etc.; that FDA had delayed or refused to reopen theadministrative record for OTC topical antimicrobial drugs; and that,because of such delay, plaintiff would pass the one year priorityperiod for filing for foreign patents and force losses of potentialprofits abroad. The complaint was also amended several times torevise Farquhar's claims against FDA.DISPOSITION: The government admitted that it had failed torespond to the plaintiffs citizen's petition within the required 180days; but, in general, the government denied the other charges. Ashort time later, FDA denied the plaintiffs petition to reopen therule-making record. After extended litigation, the government andthe plaintiff both moved for summary judgment in their respectivefavor.

The court granted summary judgment to the government. Thecourt said that the rule-making (which plaintiff sought to have reopened) was part of FDA's ongoing retrospective review of approvedOTC drugs and that, unfortunately, it was not the procedure that theplaintiff should have followed in order to have his "new drug"approved. The court found that the plaintiffs product had neverbeen marketed for the plaintiffs proposed uses, and thus (even if itwas in fact safe and effective) the absence of marketing data requiredFDA to treat the plaintiffs product as a "new drug." The attempt toinclude such a new drug in the OTC review was therefore inappropriate, and plaintiff would be required to proceed through a NewDrug Application.

When the plaintiff sought a declaratory judgment (in his fourthamended complaint) that his product was not a "new drug" whenused as a sanitizing agent for food handlers (a use not originallycharged, but a use for which FDA had conceded the product hadbeen marketed), the court ruled that such was not a question for thejudiciary to properly consider in the first instance and that the plaintiff had to exhaust his administrative remedies. On such grounds,the court granted summary judgment for the government.

Because the plaintiff pursued other issues so vigorously, the courtalso set forth its reasonings concerning the plaintiffs charges involving denial of equal protection. Federal Tort Claims, the Tucker Act,and injunctive relief. As part of the court's conclusions, the courtsaid: "Rather than pursuing the proper administrative course, whichmight have fulfilled plaintiffs original goals, plaintiff launched thislengthy and expensive federal litigation. As so often happens, plaintiffs lawsuit has brought him nothing but an extra year's delay."

The plaintiff appealed to the Court of Appeals. The Court ofAppeals on its own motion summarily affirmed the judgment of theDistrict Court, stating that it was "abundantly clear that the law asstated in 21 U.S.C. §§ 321(p), 355 has been properly applied by theDistrict Court." The plaintiff petitioned the United States SupremeCourt for a writ of certiorari. Certiorari was denied. (Misc. No.749; S.J. No. 17)

361 June 1988/FDA Consumer f . r U . S . G O V E R N M E N T P R I N T I N G O F F I C E 1 9 8 8 - 2 0 1 - 8 6 5 / 8 0 0 3 1

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