Health Claims and FTC Advertising Law

Transcription

1 Health Claims and FTC Advertising Law Institute of Medicine Food Forum Workshop The Human Microbiome, Diet, and Health Michelle Rusk, Attorney* Division of Advertising Practices *Staff presentation does not necessarily represent views of FTC or any Commissioner. February 23, 2012

2 Overview Coordination with FDA FTC advertising law basics What constitutes adequate substantiation for health claims Recent case examples

3 FTC/FDA Coordination FTC authority overlaps with FDA for foods, supplements, drugs, other health and medical products Two agencies coordinate closely Liaison Agreement FDA Primary authority over labeling FTC Primaryauthority authority over advertising (except Rx drugs)

4 FTC/FDA Coordination FTC legal framework differs from FDA: Primarily a law enforcement agency No pre market approval of claims No regulatory distinction between product categories (drug, supplement, food) No regulatory distinction between types of claims li (health, disease, structure/function) t ti

5 FTC Advertising Law FTC Act, Sections 5 and 12 Advertising must be truthful and not misleading. Objective claims must be substantiated before they are made. All advertising investigations begin with two basic questions

6 1. What claims are conveyed?

7 2. Are the claims substantiated?

8 FTC Substantiation Policy General Doctrine: TheFTC typically requires claims about the efficacy or safety of dietary supplements to be supported with competent and reliable scientific evidence, defined as tests, analyses, research, studies or other evidence based on the expertise of professionals in the relevant area, 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. (Sec II.B)

9 FTC Substantiation Policy In other words: Rigorous but flexible approach (look to experts in the field) No fixed formula for number, length, size of studies (quality over quantity) Generally expect double blind placebo controlled controlled human clinicals FDA substantiation guidance for supplements closely mirrors FTC substantiation policy

10 FTC Substantiation Policy Internal Validity of Studies Control and blinding Duration (does effect persist?) Dose/response relationship Recognized biological mechanism Peer review/publication in reputable journal is a plus Statistically significant AND clinically meaningful

11 FTC Substantiation Policy Context Don t evaluate studies in isolation Consider all relevant evidence Reconcile inconsistent/conflicting results Claim i may need to be qualified Don t make claim if weight of evidence contradicts t

12 FTC Substantiation Policy

13 FTC Substantiation Policy Relevance to Product/Claim: Product and claims should match the science Amount/form of ingredient Population studied Degree/nature of effect Strength of the science

14 Recent Actions The Dannon Company, Inc. (Consent 2009)

15 Recent Actions Danactive children s dairy drink helps prevent colds and flu ( L. CaseiImmunitatas ) t Activia yogurt relieves irregularity ( Bifidus Regularis ) Results in test group were not statistically significant ifi compared to placebo group; 8 out of 10 studies on Activia showed no significant effect The Dannon Company, Inc. (Consent 2009)

16 Recent Actions Nestlé Healthcare Nutrition (consent 2010)

17 Recent Actions Probiotic straw and drink for children 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 Some good evidence but claims went beyond science Nestlé Healthcare Nutrition (Consent 2010)

18 Final Thoughts New FTC order language more concrete and specific about the science required to substantiate claims Not more burdensome; just more transparent Order may require prior FDA approval under a drug monograph or pursuant to NLEA for disease prevention/risk reduction Order may specify two studies, on the product or essentially equivalent product, conducted by different and independent researchers New language applies ONLY to the claims and products covered by the order.

19 More guidance at business.ftc.gov