Loyola Consumer Law Review

Volume 3 | Issue 1 Article 3

1990

The Changing Food Label: The Nutrition Labelingand Education Act of 1990Eric F. GreenbergPartner, Bullwinkel Partners, LTD, Chicago, IL.

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Recommended CitationEric F. Greenberg The Changing Food Label: The Nutrition Labeling and Education Act of 1990, 3 Loy. Consumer L. Rev. 10 (1990).Available at: http://lawecommons.luc.edu/lclr/vol3/iss1/3

Loyola Consumer Law Reporter

THE CHANGING FOOD LABEL:THE NUTRITION LABELING AND EDUCATION ACT OF 1990

By Eric F. Greenberg*

I. INTRODUCTIONFood labels have been called

informative, straightforward andcrucial to consumers. At the sametime, critics argue that food labelsare confusing, overly complex andirrelevant. As a result, federal andstate legislators and regulatorshave struggled for several years toupdate food labeling standards.

The debate surrounding newfood labeling involves a variety ofimportant concerns, such as hu-man nutrition and health, mislead-ing advertising and consumer per-ceptions. The debate is furthercomplicated by the question ofwhether federal or state standardsshould dominate. Those affectedby the debate range from the legis-lators and regulators who attemptto set the appropriate standards, tothe food industry, which pro-pounds the virtue of uniform fed-eral laws, to consumers who areincreasingly conscious of the rela-tionship between diet and health.

Twenty years ago, when theUnited States Food and Drug Ad-ministration ("FDA") establishedthe current regulatory framework,diet and health issues revolvedaround the need for vitamins andminerals.' Today, scientific evi-dence makes it clear that diet andhealth are even more closely relat-ed than previously understood byexperts. Consequently, the biggestareas of concern now are not ribo-flavin and niacin, but fat, fiber,cholesterol and sodium.

In 1989, FDA began working inearnest on a variety of regulationsto update the food label. 2 Congress,ostensibly impatient with FDA'sprogress, began to address foodlabeling legislation, thus creating a"race to regulate."' 3 Congress wonthe race by passing the NutritionLabeling and Education Act 4 ("La-beling Act") which PresidentGeorge Bush signed into law on

November 8, 1990. The LabelingAct calls for the first major changesto food labels in approximatelytwo decades. However, not all ofthe consequences of that victoryare yet clear.

The debate surrounding newfood labeling involves a

variety of important concerns,such as human nutrition and

health, misleading advertisingand consumer perceptions.

This article analyzes the newfederal law in historical contextand explores the interplay betweenrecent legislative and administra-tive activities. After a review of thehistory of food labeling law, thecurrent regulatory scheme is ex-plained. A discussion follows ofrecent efforts at change, includingFDA's proposed new regulationsand the recently enacted LabelingAct. Finally, the article concludeswith an explanation of the mostknotty legal issue in this area, thedebate over national uniformity.

II. THE HISTORY OF FOODLABELING

In the early part of this century,widespread abuses in the food anddrug industries inspired a combi-nation of activists, most notablyDr. Harvey W. Wiley, to press forgovernment controls. The resulting1906 Pure Food and Drugs Act(" 1906 Act") prohibited misbrand-ed and adulterated foods and drugsfrom interstate commerce, andprovided for seizure of violativeproduct and criminal sanctions.The 1906 Act required the govern-ment to prove a violation wascommitted with fraudulent intent.It also provided for the formationof the Bureau of Chemistry, theprecursor to today's FDA.'

Efforts to strengthen the 1906Act were underway in the 1930swhen tragedy struck. Over onehundred people, mostly children,died after ingesting Elixir of Sulfa-nilamide. The tragedy gave newimpetus to efforts to write a tough-er law. That law, the Federal Food,Drug & Cosmetic Act of 1938("FD&C Act"),6 is the centerpieceof FDA enablement today. TheFD&C Act added cosmetics7 andmedical devices" to the agency'sjurisdiction, and removed the in-tent requirements for misbrandingviolations. Under the FD&C Act,FDA was granted authority to pro-vide pre-approval of drugs for safe-ty,9 conduct factory inspections, 0

and to enjoin violations of theAct. I

Significant amendments havebeen made to the 1938 law. Forexample, the 1954 PesticideAmendment gave FDA the powerto set and enforce pesticide resi-dues. 12 The Environmental Protec-tion Agency currently sets toler-ance levels but FDA enforcesthem. Also, the 1958 Food Addi-tives Amendment 3 set up the pre-approval system for food addi-tives, in which sponsors bear theburden of proving safety. Twoyears later, a pre-approval systemfor colors was established. Since1938 FDA has promulgated a raftof regulations to implement itsvarious programs. These regula-tions now comprise about 3,700pages. 14

FDA exercises central authorityover food labels and labeling 5

through the FD&C Act,' 6 whichgives FDA the power to act against"misbranded" food.' 7 However,

* Eric F. Greenberg is a partner in the

Chicago law firm of Bullwinkel Partners,Ltd., where he specializes in food and druglaw. He is a graduate of NorthwesternUniversity and Cornell Law School.

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the United States Department ofAgriculture, through the FederalMeat Inspection Act"8 and thePoultry Products Inspection Act,' 9

and the Federal Trade Commis-sion, through the Fair Packagingand Labeling Act, 20 also participatein food labeling regulation.

III. FOOD LABELING UNDER THECURRENT FDA REGULATIONSIn 1969, the White House Con-

ference on Food, Nutrition andHealth transformed concerns withvitamin deficiency diseases,among other things, into new regu-lations on topics such as nutritionlabeling and ingredient labeling.21Current FDA regulations dictatelabel requirements for packagedfoods. 22 FDA requires that foodlabels include a statement of iden-tity (the name of the food), 23 thenet quantity of the contents, 24 a listof ingredients,2 5 and name andaddress of the manufacturer. 26

Placement and type size specifica-tions are part of the requirementsas well. 2"

In addition, one of the centralfeatures of the current frameworkis to require nutrition informationon labels when the manufacturermakes a nutritional claim or whenvitamins, minerals or protein areadded to the product. 28 Otherwise,nutrition labeling is optional.

Whenever nutrition labeling isused, the label must meet a speci-fied format which provides abreakdown of a food's content ofspecified nutrients.29 There mustbe declarations of the content ofspecified food components in rela-tion to a declared serving size. Thelabel must state: (1) the servingsize, (2) the number of servings percontainer, (3) number of calories(4) protein content, (5) carbohy-drate content, (6) fat content, and(7) the percentage of the Recom-mended Daily Allowance of vita-min A, vitamin C, thiamin, ribofla-vin, niacin, calcium, and iron.30 Arecent FDA survey revealed thatabout 60% of food products nowfeature nutrition labeling. 3'

One of the most common objec-tions to the current food labelingregulations is that nutrition label-ing is not mandatory for mostfoods. In addition, consumer advo-

cates, legislators and others com-plain that the nutritional informa-tion required by the currentregulations is incomplete. For ex-

A recent FDA survey revealedthat about 60% of foodproducts now feature

nutrition labeling.

ample, the current regulations donot require the listing of cholester-ol or fiber content of foods, in spiteof the fact that nutritional andmedical authorities increasinglyadvise consumers to monitor theirintake of these components. 32

Another trend putting pressureon the current system is the foodindustry's continuing innovation.New and innovative productsquickly make descriptions, catego-ries and regulatory schemes anach-ronistic.

Additionally, during the 1980smore manufacturers sought to takeadvantage of claims that consump-tion of certain foods providedhealth benefits. 33

IV. RECENT FDA PROPOSALS TOUPDATE THE FOOD LABEL

FDA made piecemeal efforts,had a few false starts, then finallylaunched into an overhaul in 1989.The agency sought comments onfive primary issues: (1) nutritionlabeling, (2) label format, (3) ingre-dient labeling, (4) food descriptorssuch as "light", and (5) healthmessages on labels.34

The agency held four publichearings in different locationsaround the country before makingits food labeling proposals. Ap-proximately two hundred consum-ers, health professionals, trade as-

FDA characterized the publicresponse as demonstrating"broad public support for athorough modernization of

food labeling."

sociation and food industryrepresentatives, and state and localhealth officials testified at thesehearings.35 In addition, fifty local"consumer exchange meetings" re-

sulted in participation of about1500 more persons3 6 Seven thou-sand written responses to the Au-gust 1989 notice were received. 37

FDA characterized the public re-sponse as demonstrating "broadpublic support for a thorough mod-ernization of food labeling."' 38

Based on its August 1989 advancenotice and the comments and hear-ings, FDA proposed four sets ofregulations in July 1990.39 Thesedealt with nutrition labeling,40 cho-lesterol labeling, 4' nutrient contentlabeling (a system to replace theRecommended Daily Allowancesystem), 42 and serving sizes. 43 Inaddition, the July 1990 proposalsincluded notices that FDA plannedfuture proposals on fat descriptors,ingredient labeling, food descrip-tors such as "light", and finaliza-tion on health claims. The nutri-tion labeling format proposalswere expected in late 1991; thetime-consuming chore of conduct-ing consumer preference surveysmay have inspired this delay.

V. CONGRESS PASSES AFEDERAL LABELING LAW

Paralleling FDA's efforts, sever-al legislative proposals were intro-duced in Congress to update foodlabeling standards. 44 During July1990, at about the same time FDAissued its advance notice, a billpassed the House of Representa-tives to address food labeling.45

Then, in late October, the Senatepassed the House bill with minoramendments and the House ap-proved the amendments by voice-vote. President Bush signed theLabeling Act into law on Novem-ber 8, 1990.46

This unusual two-track state ofaffairs may have been the result ofcongressional impatience withFDA efforts to update food labels.FDA, however, had attempted toadhere to a strict schedule in itsfood labeling overhaul. The race toregulate may have been the resultof the popularity of the food label-ing issue and a desire by bothregulators and legislators to takecredit for helping the Americanconsumer.

The Labeling Act mandates that

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Nutrition Labeling(continued from page 11)

FDA promulgate a variety of foodlabeling regulations. The majortopics covered by the Labeling Actare nutrition labeling, food de-scription claims, disease-relatedclaims and preemption of non-identical state laws in these andother areas.

The race to regulate may havebeen the result of the

popularity of the food labelingissue and a desire by both

regulators and legislators totake credit for helping the

American consumer.

Under the new law, most foodsmust be labeled with statements oftheir serving size, number of serv-ings, number of calories per serv-ing, number of calories from fatper serving, total fat, saturated fat,cholesterol, sodium, total carbohy-drates, complex carbohydrates,sugars, dietary fiber, total protein,and any vitamins or mineralswhich were required label informa-tion before October 1, 1990.47 Incontrast, current FDA regulationsonly call for labeling of servingsize, servings per container, calo-ries, protein, carbohydrates, fat,sodium, and a list of vitamins andminerals. 48 The Act also includes aprovision for FDA to designateadditional nutrients. 49

One of the significant changes inthe new law is the requirement thatmost foods, including bulk con-tainers of many fruits, vegetablesand raw fish, be labeled with nutri-tion information. ° Current regula-tions only require nutrition label-ing when a food label makes anutritional claim or when the foodis fortified with vitamins, mineralsor proteins.5' Restaurants or placeswhere food is intended for imme-diate consumption or for take-outare exempted,52 as are small busi-nesses. 53 In addition, the Act pro-vides FDA with discretion to ex-empt foods that have no significantamounts of any required nutri-ents.54

The Labeling Act combines intoa single section provisions govern-ing both description-type claimssuch as "light" and health-relatedclaims. 5 Under the law, food mak-ers will be required to follow regu-lations FDA will promulgate whentheir label characterizes the level ofany required nutrient or describesthe relationship between a nutrientand a disease or a health-relatedcondition.5 6 Other limitations ontypes of claims made, such as whenthe absence of a nutrient can bestated, are also specified.57 The Actalso requires a statement on thelabel directing the consumer's at-tention to additional nutrition in-formation.

8

The Labeling Act exemptsclaims made in the brand name ofa product used before October 25,1989. In particular, the exemptionapplies to the use of the word"diet" in soft drink brand names.5 9

At a minimum, FDA must makerules to govern use of the wordsfree, low, light or lite, reduced, lessand high. These descriptors arelargely unregulated now. Current-ly, light or lite is used on a varietyof products, to refer to a reductionin calories, fat, sugar, alcohol, coloror sodium. FDA presumes "light"refers to a reduction in calories;therefore, the agency in the pasthas tried to require manufacturersto make explicit label statementswhen the word refers to anythingelse.

60

The legislators hope this newset of requirements will finallyresult in a clear program for

management ofdisease-related claims for

foods.

As for disease-related claims,the law requires that FDA makeregulations allowing such claimswhen it finds there is "significantscientific agreement" on a particu-lar diet-to-disease relationship. 6'At a minimum, the agency mustevaluate claims for the relationshipbetween calcium and osteoporosis,dietary fiber and cancer, lipids andcardiovascular disease, lipids andcancer, sodium and hypertension,

and dietary fiber and cardiovascu-lar disease. 62

FDA has announced that it willnot reopen or extend commentperiods on existing proposals. Itwill issue instead a series of an-nouncements seeking commentson limited aspects of the existingproposals and on supplementaryproposals to assure that the regula-tions it makes comport with thelaw's requirements. 63

The legislators hope this new setof requirements will finally resultin a clear program for managementof disease-related claims for foods.The saga of FDA's recent efforts inthis area is long and tortured.

... advances in medicine andincreasing knowledge aboutthe effect of diet on health

have led to a number of widelyaccepted links between food

components and diseaseprevention.

If a food's label or advertisingreveal that the food is intended tocure, mitigate, treat or preventdisease, or affect the structure or afunction of the body64, it therebymakes a drug claim, and legally theproduct becomes a drug. FDA'straditional approach to healthclaims associated with foods was astrict prohibition, largely becausemost such claims were little morethan quackery. 6

However, advances in medicineand increasing knowledge aboutthe effect of diet on health have ledto a number of widely acceptedlinks between food componentsand disease prevention. For exam-ple, lowering cholesterol has beenconnected to reducing the risk ofheart disease, and high calciumintake is associated with prevent-ing osteoporosis. As a result, FDAhas struggled for several years withformulating an appropriate regula-tory scheme for permitting healthclaims.

66

Most recently, in February of1990, FDA issued a proposalwhich established six criteria forpermissible health messages; 67

health claims must be (1) truthful

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and not misleading, (2) limited todescribing the value of ingestion orreduction "of a dietary compo-nent, as a part of a total dietarypattern," based on all publiclyavailable scientific evidence, (3)consistent with generally recog-nized medical and nutritional prin-ciples for a total dietary pattern, (4)consistent with an FDA-acceptedscientific summary and consumerhealth message summary, (5) ac-companied by a reference to theapplicable consumer health mes-sage summary which providesmore complete information, and(6) accompanied by complete nu-trition labeling.68

In the proposal, FDA said man-ufacturers could continue to in-clude health messages on products,but the agency would, as an interimenforcement policy, evaluate themon a case-by-case basis, with fourconsiderations for guidance.Among the considerations was alist of six topic areas for healthmessages that were "least likely torun the risk of regulatory action,"because they were those "aboutwhich significant evidence andgeneral scientific agreement ex-ists. ' '69 These topics areas are thosewhich the Labeling Act now re-quires FDA to explore: calciumand osteoporosis, dietary fiber andcancer, lipids and cardiovasculardisease, lipids and cancer, sodiumand hypertension, and dietary fi-ber and heart disease.70 Carryingout its enforcement policy, FDA inSeptember 1990 warned six foodcompanies about health claims oncereals, baked goods and otherfoods.

7'

VI. THE ROLE OF STATEGOVERNMENT IN REGULATING

THE FOOD LABELA. Preemption of State And LocalRegulations

Interestingly, food industryleaders sometimes seem less con-cerned with the specifics of anynew labeling rules and more con-cerned with whether those ruleswill be uniform throughout thenation. Indeed, there has long beena good deal of agreement thatFDA's food labeling regulatoryscheme is outdated and needs im-provement. However, the food in-

dustry, like all national industries,prefers not to battle fifty differentstate requirements, and possiblyeven more local requirements, be-cause differing requirements ne-cessitate much more complexpackaging, marketing and distribu-tion systems, and raise costs. Anychanges, they argue, should be ac-companied by preemption of stateand local laws on the same topics.State officials prefer the flexibilitythat comes without preemption.

The Labeling Act's preemptionand state enforcement sections arethe result of extensive lobbyingand compromise. Under these pro-visions, states are prohibited frommaking any non-identical require-ments for foods subject to federalstandards of identity, nutrition la-beling or claims requirements, orfor a variety of basic labeling re-quirements not specifically cov-ered by the new law, but already inplace.72

The law also specifically saysthat it is intended to be expresslypreemptive only, and that it is notintended to change the express orimplied preemptive effect of anyother sections of FD&C Act. 73

Food industry members, belea-guered by California's chemicalwarning initiative, Proposition65, 7 4 would have preferred thatnew food labeling laws or regula-tions explicitly preempted suchhealth warnings by states. Proposi-tion 65 requires that products, in-cluding foods, that contain eventrace amounts of chemicals thatCalifornia has determined causecancer or birth defects, includewarnings to that effect. 75 The newlaw does not preempt regulationssuch as Proposition 65 that involvewarnings "concerning the safety ofthe food or component of thefood."

76

Interestingly, FDA's four July1990 announcements stoppedshort of deciding whether to makethe rules explicitly preemptive. In-stead, each of the four documentsdescribed the preemption issue as"complex and divisive", and askedfor public comment on the issue. 77

It was widely reported that FDAhad originally called for some mea-sure of preemption of state laws onthe same topics, and had even

prepared the draft proposals withsuch provisions.

However, the White House Of-fice of Management and Budgetapparently objected to the preemp-tion language. The Bush Adminis-tration has reaffirmed an approachto federalism, outlined during theReagan years, by which federalpreemption was to be avoided asmuch as possible.7 8 Apparently,OMB and FDA began to debate themerits of preemption, but FDA,possibly pressured by the ongoingcongressional efforts on food label-ing, decided to publish the propos-als without a specific recommen-dation on preemption.

Advocates of state involvementin food labeling lament that in the1980s federal authorities abdicatedtheir responsibilities in this area.Thus, they argue, the states muststep in to protect consumers. Na-tional companies, on the other

Because a lack of uniformitycan result in higher prices toconsumers, state officialsostensibly trying to protectconsumers may defeat their

own purposes.

hand, point to the severe addedcosts and complications that non-uniform state laws will foster. Ifburdensome enough, an unusualstate requirement might even leadto the disappearance of productsfrom the state.

Because a lack of uniformity canresult in higher prices to consum-ers, state officials ostensibly tryingto protect consumers may defeattheir own purposes. Nonetheless,advocates of state regulation presson. Many who agree with the stateswould concede that uniform na-tional food labeling is a good idea,but still would prefer to let statesdecide about safety warnings likethose called for by Proposition 65.

B. State Enforcement of FederalLaw

The Labeling Act permits stateenforcement of select portions offederal law. 7 9 States are given au-

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Nutrition Labeling(continued from page 13)

thority to bring actions in theirown name, within their own juris-diction, for violations of a long listof FD&C Act provisions, as well asprovisions created by the LabelingAct governing nutrition labelingand claims.8 0 A state must first givenotice to FDA of its intent topursue such an action and waitthirty days for informal or formalaction to be started by the federalgovernment.8 ' The state must re-frain from acting if FDA diligentlypursues or settles a court actionagainst the violator, or has settledanother formal or informal pro-ceeding.8 2 Precisely how this willwork in practice is unclear. Forexample, there may be disputesover what constitutes an informalor formal regulatory action.

A special provision appears tohave been added to keep FDAfrom beginning an enforcementaction within the first thirty daysand then dropping it; the state maycommence its own action afterninety days if FDA begins actionwithin the first thirty days afternotice,8 3 but then does too little toactivate the "diligently prosecut-ing" clause.84

It remains to be seen whetherFDA will have the resources torespond to state prodding. More-over, conflicts in enforcement ap-proaches may result, as state ac-tions, guided only by federallegislation, begin to conflict withFDA action, which is guided byboth law and enforcement policy.The state enforcement clauses mayprove the undoing of the apparentprotection against non-uniformityafforded by the preemption provi-sions.

VII. CONCLUSION

The dictates of the new law,combined with FDA regulations,will result in new and differentfood labels. Nutrition labeling,which has been largely optionaluntil now, will be required for mostfoods. Further, the new nutritionlabel will include information onmore food components, such ascholesterol, dietary fiber and satu-rated fats.

The new law also requires FDAto make rules governing the use ofthe descriptive terms like free, low,lite or light, reduced and high. Newrules in this area should help elimi-nate confusion about what theseterms mean when they are used todescribe food. The agency mustalso formulate rules that will allowmanufacturers to make healthclaims for their products whenthere is significant scientific agree-ment about a relationship betweena dietary component and disease.Finally, although the new law willsurely create some national unifor-mity, it will not be complete, andthe unknown effect of the stateenforcement provisions may lessenindustry enthusiasm and makeuniformity, in practice, illusory.

Unless manufacturers begin tochange their labels before the newregulations are effective, and un-less FDA acts more quickly thanexpected in making these regula-tions, consumers will probably notsee widespread changes in theirfood labels for at least two years.The major portions of the new lawrequire new regulations to be effec-tive thirty months after passage, byMay of 1993. With the fast pace ofchange in medical and nutritionalscience, let us hope the new re-quirements are not obsolete assoon as they appear.

ENDNOTES1 54 Fed. Reg. 32610,32612 (1989).2 52 Fed. Reg. 28843 (1987).3 See e.g., H.R. 3562, 101st Cong., 2d

Sess. (1990); S. 1453, 101st Cong., 2dSess. (1990).

4 The Nutrition Labeling and EducationAct of 1990, Pub. L. No. 101 -535 (Nov.8, 1990) (hereinafter, "Labeling Act").

5 Act of June 30, 1906, ch. 3915, 34 Stat.768 (repealed).

6 21 U.S.C. §§ 301-392 (1938).7 21 U.S.C. §§ 361-364 (1988).8 Id. at §§ 351-353.9 Id. at§ 355.

10 Id. at § 372.11 Id. at § 332.12 Id. at §§ 321 (q,r), 342(a)(2), 346a, 346b.13 21 U.S.C. §§ 321, 331, 342, 346, 348,

458 (1958).14 21 C.F.R. Parts 1 - 1299(1990).15 The terms "label" and "labeling" differ.

"Label" means "a display of written,printed, or graphic matter upon theimmediate container of any article." 21U.S.C. § 321(k) (1988); By contrast,"labeling" means all "labels and otherwritten, printed, or graphic matter (1)upon any article or any of its containers

or wrappers or (2) accompanying sucharticle." 21 U.S.C. § 321(m) (1988). The"accompanying" clause has been re-lied on to prevent clever attempts tocircumvent restrictions on labeling,such as by mailing product and label-ing, in the form of pamphlets, underseparate cover. See, Kordel v. U.S.,335 U.S. 345, 350 (1948)

16 21 U.S.C. 8§ 301-393 (1988).17 See 21 U.S.C. § 343 (1988) for the

various reasons a food can be consid-ered "misbranded."

18 21 U.S.C. §§601-695(1988).19 21 U.S.C. §§ 451- 470 (1988).20 15 U.S.C. §§ 1451, et seq. By a 1980

Memorandum of Understanding, FTCand FDA agreed that FTC would haveprimary responsibility over the truth orfalsity of food advertising, while FDAwould have primary responsibility overall matters concerning the regulation offood labeling. FDA CPG 7155m.01(10/1/80).

21 55 Fed. Reg. 29487,29488 (1990).22 21 C.F.R. §§ 101.1-101.108(1990).23 21 C.F.R.§ 101.3(1990).24 Id. at § 101.105.25 Id. at§ 101.4.26 Id. at § 101.5.27 Id.at§§ 101.2, 101.15.28 Id. at § 101.9(a).29 Id. at § 101.9(c).30 Id.31 55 Fed Reg. 29487 (1990).32 55 Fed. Reg. 29490.33 52 Fed. Reg. 28843 (1987).34 54 Fed. Reg. 32610 (1989). FDA, like

any regulatory agency, must follow thestrictures of the Administrative Proce-dure Act, 5 U.S.C. § 551 et. seq. (1982),21 U.S.C. § 371 (1988), in making rules.When FDA makes rules, it plays alegislative role. Typically, "informal"rulemaking such as this begins with apetition from an outsider; it may alsobegin at the agency's own instance. Aproposal is prepared and published inthe Federal Register, and public com-ments on it are sought. Sometimes, aswith the food labeling overhaul, an"advance notice" precedes the pro-posal to obtain input to help the agencyformulate the proposal.

Once public comments are received,the proposal is altered as the agencydeems appropriate based on the com-ments, and a final rule is published inthe Federal Register. Typically, the finalrule becomes effective after a specifiedperiod of time. Adversely affected par-ties may petition for FDA reconsidera-tion of a final rule or for a stay of itseffectiveness. 21 C.F.R. § 10.33 (1990).

35 55 Fed. Reg. 29487 (1990). Althoughpublic hearings and forums were heldon the food labeling overhaul, theywere only informal information gather-ing hearings. These were not evidentia-ry hearings (witnesses were not sworn)such that the process could be charac-terized as "formal" rulemaking.

36 Id.37 Id.38 Id.39 55 Fed. Reg. 29456-29533 (1989).

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40 Id. at §§ 29487,29491.41 Id.42 Id. at §§ 29476, 29478.43 Id. at §§ 29517, 29524.44 See, e.g., H.R. 3562, 101st Cong., 2d

Sess. (1990); S. 1453, 101st Cong., 2dSess. (1990).

45 H.R. 3562, 101st Cong., 2d Sess.(1990).

46 Labeling Act, Pub. L. No. 101 -535 (Nov.8, 1990).

47 Id. at §§ 2(a)(q)(1).48 See supra notes 22-30 and accompa-

nying text.49 Labeling Act, at § 2(a)(r)(2)(A)(i).50 Id. at § 2(a)(q)(4)(A). In addition, the U.S.

Department of Agriculture announcedin January that it has begun to explorethe best approach to mandatory nutri-tion labeling for meat and poultry prod-ucts. U.S. Department of AgriculturePress Release, Jan. 18, 1991.

51 21 C.F.R.§101.9(a)(1990).52 Labeling Act, at § 2(a)(q)(5)(A)(i).

53 Id. at § 2(aXq)(5XD).54 Id. at § 2(a(q)(5)(C).55 Id. at § 3.56 Id. at § 3(a)(r)(2)(A)(i).57 Id. at § 3(a)(r)(2)(A)(ii).58 Id. at § 3(a)(r)(2)(B).59 Id. at § 3(aXr)(2)(C),(D).60 Personal communication, F. Edward

Scarbrough, Acting Director, Office ofNutrition and Food Sciences, Centerfor Food Safety and Applied Nutrition,U.S. Food and Drug Administration,October 2, 1989.

61 Labeling Act, at § 3(a)(r)(3)(B)(i).62 Id. at § 3(b)(1)(A)(vi).63 56 Fed. Reg. 1161.64 See, definitions of "drug" in FD&C Act,

21 U.S.C. § 321 (g); and "food" 21U.S.C. § 321().

65 See, U.S. v. 25 Jars, etc. of U.S. FancyPure Honey, 218 F.Supp. 208 (D. Mich.1963), aff'd, 344 F.2d 288 (6th Cir. 1965)(honey was claimed to be a cure for avariety of ailments).

66 52 Fed. Reg. 28843 (1987); 54 Fed.Reg. 32615 (1989); 55 Fed. Reg. 29487(1990).

67 55 Fed. Reg. at 5180 (1990).68 Id. at §§ 5179-5180.69 Id. at §§ 5184.70 Labeling Act, at § 3(b)(1)(A)(vi).71 HHS News Release, Sept. 6, 1990.72 Labeling Act, at § 6(a).73 Id. at § 6(c)(3).74 The Safe Drinking Water and Toxic

Enforcement Act of 1986, CAL. HEALTH& SAFETY CODE §§ 25249.5-25249.13(Deering 1986).

75 Id. at §§ 25249.6, 25249.11(c).76 Labeling Act, at § 6(c)(2).77 See, e.g., 55 Fed. Reg. 29528 (1990).78 Executive Order No. 12612, October

26, 1987.79 Labeling Act, at § 4.80 Id. at § 4(b)(1).81 Id. at § 4(b)(2)(A).82 Id. at § 4(b)(2)(C).83 Id. at § 4(b)(2)(B).84 Id. at § 4(b)(2)(C).

The Section of Antitrrecently created a Consconsumer protection deState and private enfoinvolving consumer fraiwill be the principal intemembership includes stcounsel, and private piconsumer protection m

If you wish to joininformation about its a

imittee or if you want furthercontact the Committee Chair:

Ray V. Hartwell, III Esq.Hunton & Williams

P.O. Box 1535Richmond, Virginia 23212

(804) 788-8510(804) 788-8218 (FAX)

Volume 3 Number l/Fall, 1990 15