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Speakers:
Gregory W. Fortsch, Senior Attorney, Division of Advertising Practices, Bureau of Consumer Protection, FTCJonathan Cohn, Partner, Sidley AustinIvan Wasserman, Partner, Manatt, Phelps & Phillips, LLP
Moderated by David Vladeck, Professor of Law, Georgetown University Law Center
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Updates from FTC on Regulation of OTC Product Promotion
Federal Trade Commission Update --Over-the-Counter (OTC) Product Promotion
The Food and Drug Law InstituteAdvertising & Promotion Conference
Breakout SessionWashington, D.C,October 2, 2014
Gregory W. Fortsch Attorney
Division of Advertising PracticesBureau of Consumer ProtectionU.S. Federal Trade Commission
My comments today reflect my own views. They do not necessarily reflect the views of the Federal Trade Commission, any individual Commissioner, or any other person.
The FTC Act(15 U.S.C. § 41 et seq.)
• The statute that governs advertising and marketing of most products and services in the U.S. is the Federal Trade Commission Act (“FTC Act”).
The FTC Act(15 U.S.C. § 41 et seq.)
• Section 5 of FTC Act: prohibits unfair or deceptive acts or practices
• Section 12: prohibits any “false advertisement” likely to induce the purchase of foods, drugs, devices, services, or cosmetics that is “misleading in a material respect”
FTC/FDA Coordination on OTC Drugs• Overlapping statutory authority
• Memorandum of Understanding (1971)- FDA → prescription drug advertising - FTC → OTC drug advertising, excluding labeling
• Agencies coordinate closely on food and dietary supplement policy issues
FTC/FDA Coordination on OTC Drugs
• FTC legal framework/approach differs from FDA:- Primarily a law enforcement agency, not a health
agency- No pre-market approval process, unlike FDA’s pre-
dissemination clearance - No regulatory distinction between product categories - No regulatory distinction between health, disease, and
structure/function claims
FTC/FDA Coordination on OTC Drugs
• Complementary, consistent actions
• Avoid duplication
• Defer to FDA on content, purity, safety, and efficacy
FTC Substantiation Doctrine• Under Pfizer (1972), advertiser needs a “reasonable basis” for express
and implied objective claims before ad runs
• Two types of advertising claims:
1) Efficacy claims, such as “This pill makes you lose 10 pounds in 2 weeks.
2) Establishment claims, such as “This pill is clinically proven to make you lose 10 pounds in 2 weeks.”— “Tests Prove . . .”— “Doctors Recommend . . .” — “Studies Show . . .”
Substantiation for “Establishment” Claims
• When an advertisement represents that the claim is supported by a certain amount or level of substantiation, the advertiser must possess at least that level of support for the claim.
• These claims are either true or false.
• The required substantiation is evidence acceptable to the relevant scientific community to demonstrate that claims are true.
Substantiation for “Efficacy” Claims•Under the FTC’s Substantiation Doctrine (Thompson Medical (1984)), the amount and type of required substantiation depends on:
1. Type of product (e.g., does it involve health or safety?)
2. Type of claim (e.g., is it a “credence” good?)
3. Benefits of truthful claim versus the cost/feasibility of developing substantiation
4. Consequences of a false claim
5. What evidence do experts in the field expect?
Substantiation for Health Claims
Claims related to health and safety generally must be supported by
“Competent and reliable scientific evidence”
Competent and Reliable Scientific Evidence
• A rigorous but flexible standard
• Question of fact to be determined in each case. Always claims-driven (net impression)
• Often, experts in the field will say that randomized, well-controlled trials are necessary to substantiate a claim that a product treats or prevents a disease.- Experts also may require a clinical study for non-disease claims
that a product will affect the structure or function of the human body. For example, “Fish oil improves memory.”
- Rely on nutrition and science expertise of FDA
Enforcement Considerations
• Is FTC action in the public interest?
- Is a claim likely to be challenged by a competitor under the Lanham Act?
- Has the NAD reviewed the claim? If NAD refers the ad to us, we give it a close look.
Current FTC Law Enforcement Activities
OTC Homeopathic Products OTC Homeopathic Products • Filed a comment with FDA about their regulatory
framework for products• Held a Workshop in September 2015
Solace InternationalSolace International• Topical cream for moles, skin tags, and wart
removal• FDA sent warning letter; FTC got an order with
fencing-in relief and redress
Current FTC Law Enforcement Activities
Gray Hair casesGray Hair cases• Supplements aimed at reversing/preventing the
formation of gray hair - two cases settled and a third is in litigation
• Made unfounded claims that their supplements could prevent or reverse gray hair
Melanoma AppMelanoma App• Deceptively claiming their mobile apps could
detect symptoms of melanoma, even in its early stages
Current FTC Law Enforcement Activities
POM WonderfulPOM Wonderful• D.C. Circuit affirmed the Commission’s decision
finding the company and its past president liable for advertisements promoting POM juice for the treatment or prevention of heart disease, prostate cancer, and erectile dysfunction
• The court also upheld that Commission’s order except to the extent that it required 2 randomized controlled clinical studies for the disease claims in the case
Current FTC Law Enforcement Activities
• L’OccitaneL’Occitane• Settlement prohibited claims for substantial
weight or fat loss or substantial reduction in body size
• Also required 2 randomized controlled trials for weight loss claims, and competent and reliable evidence for cellulite claims
• $450,000 monetary relief
Current FTC Law Enforcement Activities
• L’OrealL’Oreal• Challenged advertising claims about gene
targeting mechanism and about scientific studies
• Settlement required competent and reliable evidence for gene claims and prohibited misrepresentations about tests or studies
Current FTC Law Enforcement Activities
• Derma DoctorDerma Doctor• Challenged advertising claims about gene
targeting mechanism and about scientific studies
• Settlement required competent and reliable evidence for gene claims, and prohibited misrepresentations about tests or studies
Current FTC Law Enforcement Activities
CVS Advanced Eye Health ProductCVS Advanced Eye Health Product• Sent counsel for CVS closing letter in March 2015• Does not mean a violation did not occur, but
decided to close since sales were low and claims voluntarily removed by company
FTC Orders Going Forward
• For companies that are under order:- weight loss cases
- ban facially false claims- for unsubstantiated weight loss claims, at least 2 RCTs of product or
“essentially equivalent” product- cases of fraudulent or unethical scientific conduct may require 2 RCTs of the
product or an “essentially equivalent” product- for all other health cases with causal claims of a health benefit
o generally, “human clinical testing” (randomized, double-blind, placebo controlled) of the product or “essentially equivalent” product
o although no set number of RCTs, experts might expect multiple RCTso will look at the quality of the RCT evidence and how it relates to the entire
body of relevant and reliable scientific evidence - Must preserve documents and data that experts would need to assess the RCT
later
Gregory W. Fortsch, Esq.Division of Advertising PracticesBureau of Consumer ProtectionU.S. Federal Trade Commission(202) [email protected]
BEIJING BOSTON BRUSSELS CHICAGO DALLAS GENEVA HONG KONG HOUSTON LONDON LOS ANGELES NEW YORK PALO ALTO SAN FRANCISCO SHANGHAI SINGAPORE SYDNEY TOKYO WASHINGTON, D.C.
FTC’s Failed Attempt To Raise Standard For Dietary Supplement Advertising
FDLI’s Advertising and Promotion Conference
October 2, 2015
Jonathan F. CohnSidley Austin LLP
Outline
I. Regulatory Background
II. FTC’s Attempt to Raise Standard
III. United States v. Bayer
IV. Lessons Learned
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I. Regulatory Background:
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Dietary Supplement Health & Education Act of 1994 (DSHEA), Pub. L. No. 103-417, sec 8, (codified at 21 U.S.C. § 350(b).
Dietary Supplement Health & Education Act of 1994 (DSHEA), Pub. L. No. 103-417, sec 8, (codified at 21 U.S.C. § 350(b).
Enacted to ensure that supplements can be marketed without meeting the stringent requirements imposed on drugs:
•No pre-approval required
•Randomized, placebo-controlled, double-blind clinical trials not required
Enacted to ensure that supplements can be marketed without meeting the stringent requirements imposed on drugs:
•No pre-approval required
•Randomized, placebo-controlled, double-blind clinical trials not required
Substantiation Standard:
•“truthful and not misleading” 21 U.S.C. § 343(r)(6)(B)
Substantiation Standard:
•“truthful and not misleading” 21 U.S.C. § 343(r)(6)(B)
Regulatory Background:Structure-Function v. Disease Claims
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“describe[] the role of a nutrient or dietary ingredient intended to affect the structure or function in humans,” 21 U.S.C. § 343(r)(6)(A)
“not claim[ed] to diagnose, mitigate, treat, cure, or prevent a specific disease or class of
diseases,” 21 U.S.C. § 343(r)(6)
“describe[] the role of a nutrient or dietary ingredient intended to affect the structure or function in humans,” 21 U.S.C. § 343(r)(6)(A)
“not claim[ed] to diagnose, mitigate, treat, cure, or prevent a specific disease or class of
diseases,” 21 U.S.C. § 343(r)(6)
Regulatory Background: FTC Guidance
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“‘Competent and reliable scientific evidence’ means tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”
“CARSE”
Regulatory Background: FTC Guidance
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“There is no fixed formula for the number or type of studies required . . .” (p. 9).
“There is no fixed formula for the number or type of studies required . . .” (p. 9).
“There is no set protocol for how to conduct research that will be acceptable under the FTC substantiation doctrine.”
(p. 12).
“There is no set protocol for how to conduct research that will be acceptable under the FTC substantiation doctrine.”
(p. 12).
“The FTC’s standard for evaluating substantiation is sufficiently flexible to ensure that consumers have access to information about emerging areas of
science” (p. 8).
“The FTC’s standard for evaluating substantiation is sufficiently flexible to ensure that consumers have access to information about emerging areas of
science” (p. 8).
II. FTC Attempt To Raise Standard
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1
2
3
FTC Strong-Arms Higher Standard Through Consent Decrees
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• “[T]wo adequate and well-controlled human clinical studies. . .”
• “Such study shall be randomized, and, unless it can be demonstrated that blinding or placebo control cannot be effectively or ethically implemented given the nature of the intervention, shall be doubleblind and placebo-controlled.”
Two Failed Attempts To Raise Standard Through Litigation
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FTC v. Garden of Life, 845 F. Supp. 2d 1328, 1335 (S.D.
Fla. 2012), aff’d in part and vacated in part, 516 F. App’x 852
(11th Cir. 2013)
FTC v. Garden of Life, 845 F. Supp. 2d 1328, 1335 (S.D.
Fla. 2012), aff’d in part and vacated in part, 516 F. App’x 852
(11th Cir. 2013)
When a consent decree speaks only of “competent and reliable scientific
evidence,” the government cannot redefine it through expert testimony and “require
[the] court to read additional requirements into the Consent Decree.”
When a consent decree speaks only of “competent and reliable scientific
evidence,” the government cannot redefine it through expert testimony and “require
[the] court to read additional requirements into the Consent Decree.”
Basic Research v. FTC,
No. 2:09-cv-0779 at 26-27(D. Utah Nov. 25, 2014)
Basic Research v. FTC,
No. 2:09-cv-0779 at 26-27(D. Utah Nov. 25, 2014)
By demanding “gold standard” clinical trials, which “exceed the requirements
of the [consent decree],” the government failed the “expectation
of reasonableness.”
By demanding “gold standard” clinical trials, which “exceed the requirements
of the [consent decree],” the government failed the “expectation
of reasonableness.”
III. United States v. Bayer
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Based on “novel and unlawful” standard
Based on “novel and unlawful” standard
US v. Bayer: Background
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Bayer Consent Decree
FTC Guidance
“‘Competent and reliable scientific evidence’ means tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that has been conducted and evaluated in an objective manner by persons qualified to do so, using procedures generally accepted in the profession to yield accurate and reliable results.”
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“To Promote Overall Digestive Health”
“To Promote Overall Digestive Health”
“Helps Defend Against Occasional:
•Constipation•Diarrhea
•Gas and Bloating”
“Helps Defend Against Occasional:
•Constipation•Diarrhea
•Gas and Bloating”
“This product is not intended to diagnose, treat, cure, or
prevent any disease”
“This product is not intended to diagnose, treat, cure, or
prevent any disease”
Government’s Position In Litigation
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DSHEA is irrelevant
FDA regulations and guidance are irrelevant
Structure-function category is irrelevant
Refused to concede that FTC Guidance and consent decree were identical
Single expert can decide standard for industry
Evidence At Trial
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Government Expert Testimony Conflicted With FTC Guidance
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Government Experts
Specific eight-part protocolSpecific eight-part protocol “[N]o set protocol”“[N]o set protocol”
“Highest quality” and “Level 1” RCT
“Highest quality” and “Level 1” RCT
“[S]ufficiently flexible to ensure . . . access to information about emerging areas of science.” “[S]ufficiently flexible to ensure . . . access to
information about emerging areas of science.”
No animal or in vitroNo animal or in vitro “Animal and in vitro will also be examined”
“Animal and in vitro will also be examined”
Same 3-strain productSame 3-strain product May use “similar formulation”May use “similar formulation”
Same populationSame population May “extrapolate”May “extrapolate”
FTC Guidance
Government Failed to Inform Expert of Laws & Regulations
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Law & Regulation Not Informed
FTC Guidance “I actually did not rely on it or look at it when I made my original report.”
Dietary Supplement Law
“[I] had not heard of the statute” at “the time that [I] provided [my] report in September, 2014”
FDA Regulations
“did not review or consider [] FDA regulations in any way to the extent they might have been relevant”
Structure/Function Rules
“I had not been informed by the FTC or DOJ about structure function claims related to this, no.”
Government “Expert” Lacked Necessary Expertise
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Q: You are not an expert in probiotics, we can agree on that, can’t we?
A: Yes.
Q: You do not hold yourself out as an expert on dietary supplements?
A: That is correct.
Does not regularly use probiotics in clinical practice.
Bayer’s Experts
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Bayer’s Expert Testimony
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1. Overwhelming “competent and reliable scientific evidence” for
Bayer’s claims
1. Overwhelming “competent and reliable scientific evidence” for
Bayer’s claims
2. Experts do not expect drug-level randomized controlled-clinical trials
2. Experts do not expect drug-level randomized controlled-clinical trials
Court’s Opinion
• Denied Government’s contempt motion
• No violation of court order
• Rejected attempt to raise the standard
• No damages, penalties, or fines
• Reasoning, currently under seal
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IV. Lessons Learned
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• Put government to its proof: Try more cases
• Discovery against government
• Rely on strong experts (before and during litigation)
• Scientific substantiation
• Industry can win
UPDATE FROM FTC ONREGULATION OF OTC PRODUCT
PROMOTION
FDLI’s Advertising and Promotion Conference
October 2, 2015
Ivan WassermanManatt ,Phelps & Phillips
Gregory W. Fortsch: Attorney, Division
of Advertising Practices
Richard L. Cleland: Assistant Director,
Division of Advertising Practices
Michelle Rusk: Senior Staff Attorney,
Division of Advertising Practices
* Special Rules?
* Many ways to prove “effectiveness”?
* Disclaimers?
* Traditional Use?
* Experts in the field?
UPDATE FROM FTC ONREGULATION OF OTC PRODUCT
PROMOTION
FDLI’s Advertising and Promotion Conference
October 2, 2015
Ivan WassermanManatt , Phelps & Phillips
Questions?
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