Lsi - ftc enforcement of health-related claims in advertising

www.duanemorris.com

2

•  FTC sues Reebok under Section 45(a) of Federal Trade Commission Act.

•  FTC alleged claims of laboratory results showing that EasyTone RunTone shoes could “improve muscle tone and strength by 28% in gluteus maximus, 11% in hamstrings, and 11% in calves.”

•  Inadequate proof. –  Single trial. –  Five subjects.

www.duanemorris.com

3

•  Enter into Consent Decree requiring: –  Adequate and well controlled human clinical study:

Ø  Randomized; Ø  Controlled; Ø  Blinded; Ø  At least six weeks; Ø  Proper personnel; Ø  Properly measured.

www.duanemorris.com

4

•  Depictions of results (e.g., models). –  Based on “competent and reliable scientific

evidence.”

www.duanemorris.com

5

•  First Amendment issues. –  Commercial speech.

DM2/3186382.1

+

The National Adverting Division: Advertising Self-Regulation for Drugs, Cosmetics, Food Supplements & Botanicals

Kathleen Dunnigan Senior Staff Attorney [email protected]

+ NAD’s MISSION

n To protect the integrity of advertising by ensuring that claims are truthful and accurate

n Discourage unnecessary government involvement in advertising

7

+ Who Benefits?

n  Consumer confidence increases

n Advertisers can govern themselves n  Quick dispute resolution

n  Level playing field

n  Cost effective alternative to litigation

n Frees up government resources

8

+ National Advertising Division

n Jurisdiction over advertising that is:

n Targeted to adults (over 12)

n “National in scope”

n Objectively provable claim n  Print n  Packaging & labels

n  Broadcast: TV, radio, infomercials n  Direct Mail n  Internet/Twitter/Faceook/Smart phones

9

+ Products Reviewed

n Everything from baldness cures to the Internet

Automobile Accessories Communications

Computers/Electronics Clothing/Accessories

Cosmetics Drugs/Healthcare

Energy Financial Services

Food and Beverage

Hardware/Garden Products Home Furnishings

Household Products Insurance

Leisure/Toys Restaurants/Retail Chains

Sports Products Telecommunications

Travel/Accommodations

10

+ NAD’s Standard

n Advertising must be truthful, accurate and not misleading. The advertiser bears the burden of demonstrating a reasonable basis for its express and implied claims.

n What is the message conveyed?

n What is the support?

n Is there a good fit?

11

+

“The best value on the planet!”

“4 out of 5 Pediatricians Recommend…”

“Clinical Tests Prove...!

“Cleans 80% better* *but still leaves it pretty grimy.”

Issues Reviewed n  NAD examines many issues

and types of substantiation: n  Puffery n  Consumer surveys n  Product testing n  Demonstrations n  Taste tests n  Pricing n  Health Claims n  Disclosures n  Superiority & parity claims

“Tastes even better than the leading brand!”

13

+NAD Case Reports

n  Brilliant legal opinions

n  Detailed summary of the parties positions

n  In depth analysis of claim substantiation

n  Conclusion: Substantiated, Modify or Discontinue

n  Available online, by subscription at www.nadreview.org

14

+ “5 nutrients equal to 2 servings of fruit” Advertisers making claims of nutritional benefits must avoid exaggerating the health or nutritional benefits of their products. Sunny Delight Beverages, Inc., Fruit2O Essentials, # 5182 (2010):

15

+ COASTAL CONTACTS, Inc., Contact Lenses, Case No. 5387 (October 2011): The display of “likes” on Facebook and other social platforms may reasonably be understood by consumers as conveying a message of general social endorsement.

16

+ NAD was concerned specifically about the aspect of the claim “across 100%” because “100%” is a quantified term of absolute completeness of protection, where, in fact, the coverage was not 100% complete across all points on the spectrum.

MSD CONSUMER CARE, INC., A/K/A MERCK CONSUMER CARE (Coppertone Sunscreens 15+ SPF), Case No. 5403 (Dec. 2011).

17

Enhanced FTC Enforcement of Health-Related Claims

Mary K. Engle Associate Director for Advertising Practices

U.S. Federal Trade Commission

Law Seminars International Teleconference January 19, 2012

18

FTC/FDA Coordination

Ø  Overlapping authority Ø  Liaison agreement:

§  FDA: labeling §  FTC: advertising

Ø  Agencies coordinate closely on food & dietary supplement policy issues

19

FTC Advertising Law 101 Ø  FTC Act, Sections 5 & 12 Ø  Advertising must be truthful and not

misleading Ø  Advertisers must possess a reasonable

basis for claims they make, and must have at least the level of evidence claimed in the ad

Ø  Health-related claims generally require competent and reliable scientific evidence

20

FTC Substantiation Standard, as Applied

Ø  Rigorous but flexible Ø  Generally, well-controlled human clinical

studies

Ø  High quality (double blind) Ø  Consistent with larger body of evidence

Ø  Matches product and claim (dose, form, route of administration, degree of effect)

21

Ø  Standard FTC injunctive provision prohibits particular kinds of health-related claims unless the defendant: §  “possesses and relies upon competent

and reliable scientific evidence that substantiates the representation”

Ø  Problem: Doesn’t give much guidance to defendant as to what’s adequate in particular situations, hard to enforce, courts have misinterpreted

Traditional Order Provisions

22

Ø  Orders will be tailored to the facts of each case (one size does not fit all)

Ø  FTC is making transparent in orders the analysis it already does to determine whether a claim is substantiated – Pfizer factors, evaluation of entire body of relevant evidence

Ø  For some claims, FTC is using short-cut to determining substantiation by referencing FDA determinations

New Order Provisions

23

Ø  Three tiers (but not every order will have all three): §  Specified Disease Claims §  Other Specified Health-Related Claims §  Residual Fencing-in Provision for any Other

Health-Related Claims

New Order Provisions

24

Illustrative Cases

Ø  Iovate Health Sciences (various weight-loss, allergy supplements)

Ø  Nestle Healthcare Nutrition (Nestle BOOST Essentials Drink)

Ø  POM Wonderful (POM Wonderful pomegranate juice & POMx pills)

Ø  Dannon (Activia and DanActive)

25

Iovate (consent 2010)

Ø  Claims included cold/flu prevention; “lose 32 lbs FAST”

Ø  Mischaracterized AllergyMD product as homeopathic

Ø  $5.5 million settlement for consumer refunds

26

Nestle Healthcare Nutrition (consent 2010)

Ø  Probiotic straw and drink for children Ø  Claims: prevention of upper respiratory

tract infections; protects against cold and flu; reduces absence from school; reduces duration of acute diarrhea in children up to 13

Ø  Some good evidence but claims went beyond science

27

Dannon (consent 2011)

Ø  Dairy drink and yogurt with probiotics Ø  Ads claims:

§  DanActive is clinically proven to reduce the risk of colds and flu

§  Activia is clinically proven to relieve temporary irregularity and help with slow intestinal transit time

Ø  Evidence inadequate to support cold/flu reduction for DanActive

Ø  Evidence on Activia showed 3 servings/day needed to get results

28

POM Wonderful (complaint 2010)

Ø  “Clinically proven” claims about benefits for heart disease, prostate cancer, erectile dysfunction

Ø  No blinding or control in prostate cancer study; no benefit beyond placebo in erectile dysfunction study; many studies for heart disease showed no benefit

Ø  FTC in litigation with company and 3 principals; settlement with science/regulatory officer

29

Ø  Specified Disease Claims: Where defendant made claims that product could treat, cure, prevent, or reduce the risk of disease, order will require such claims to be approved by FDA:

•  through OTC drug monograph or approved new drug application (in the case of diet supps, and food, if company made treatment/cure claims for food), or

•  By regs under Nutrition Labeling and Education Act (in case of foods)

Ø  So: if claim would not be permitted in labeling, the order won’t permit it in advertising

New Order Provisions – First Tier

30

How “new” is this?

§  “The absence of an FDA determination that a health claim is scientifically valid will be a significant factor in the Commission’s assessment of the adequacy of substantiation for the claims.”

31

Back to the Future §  “The Commission regards the ‘significant

scientific agreement’ standard, as set forth in the NLEA and FDA’s regulations, to be the principal guide to what experts in the field of diet-disease relationships would consider reasonable substantiation for an unqualified health claim.

§  Thus, it is likely that the Commission will reach the same conclusion as FDA as to whether an unqualified claim about the relationship between a nutrient or substance in a food and a disease or health-related condition is adequately supported by the scientific evidence.”

§  Source: 1994 FTC Food Advertising Enforcement Policy Statement

32

Reasonable Fencing-In

Ø  Well-established that FTC has wide discretion in determining type of order necessary to remedy challenged practices

Ø  Order may go beyond the illegal practices challenged

Ø  Orders need only bear a reasonable relationship to unlawful practices found and be clear and precise

33

Ø Other Specified Health-Related Claims §  Based on the record of the investigation,

where the level of scientific support required by experts in the field has been established, “competent and reliable scientific evidence” will be tailored, depending on the product/claim

§  One or more clinical trials may be required for particular claims/particular products

New Order Provisions – Second Tier

34

§  Iovate: for weight-loss claims §  Nestle HCN: for claims of reduced

absences from school/daycare due to sickness

§  Dannon: for irregularity relief claims -- §  order defines “competent and reliable

scientific evidence” as consisting of at least two adequate and well-controlled human clinical studies of the Covered Product, or of an Essentially Equivalent Product

New Order Provisions – Second Tier

35

How “new” is this? Ø  Novartis Corp., 127 F.T.C. 580 (1999) (final order requiring two

adequate and well-controlled, double-blinded clinical studies to substantiate claims that Doan’s is more effective than any other OTC analgesic drug)

Ø  Thompson Medical Co. Inc., 104 F.T.C. 648 (1984) (final order requiring two adequate and well-controlled, double-blinded studies to substantiate efficacy and comparative claims for OTC analgesic drugs)

Ø  Schering Corp., 118 F.T.C. 1030 at 1120-21 (I.D.) (1994) (discussing appropriateness of order requirement for two clinical studies for weight loss claims, regardless of whether the product at issue is a food or drug, based upon the standard used in Thompson Medical)

Ø  Jerome Milton, Inc., 110 F.T.C. 104 (1987) (consent order requiring one or two clinical studies, depending on the claim, for toothpaste)

Ø  Viral Response Systems Inc., 115 F.T.C. 676 (1982) (consent order requiring two adequate and well-controlled clinical studies) 36

Ø  This provision generally covers broad categories of products and claims beyond those specifically challenged in the complaint

Ø  Claims about the health benefits, performance, or efficacy of foods, drugs, or diet supps: §  Standard “competent and reliable scientific evidence”

language with two clarifications: §  Both quality and quantity of evidence must meet

accepted scientific norms §  Evaluate studies in context of entire body of relevant

evidence

New Order Provisions – Third Tier

37

Ø  This provision would also cover “qualified” health claims, i.e., health claims based on strong emerging science not yet authorized by FDA

Ø  Caveat: how do consumers interpret the claim, i.e., is it really qualified?

New Order Provisions – Third Tier

38

Wrapping Up

Ø  Consider what claims are reasonably implied by ad, as well as what is stated expressly

Ø  Ads should not overstate what the research shows

Ø  Health-related advertising claims must be supported by strong science

39

For More Information

Ø  business.ftc.gov

Ø  [email protected]

40

Lsi - ftc enforcement of health-related claims in advertising

Business

Transcript of Lsi - ftc enforcement of health-related claims in advertising