FTC ADVERTISING LAW. FDA Public Meeting on Non-Invasive Neurostimulation Devices & Cognitive Function

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1 FTC ADVERTISING LAW FDA Public Meeting on Non-Invasive Neurostimulation Devices & Cognitive Function Michelle Rusk, Attorney* FTC Division of Advertising Practices November 20, 2015 *Staff presentation: Does not necessarily represent views of FTC or any Individual Commissioner.

2 Overview FTC Jurisdiction Coordination with FDA FTC advertising law basics Recent case examples

3 FTC Jurisdiction Broad mandate: stop deceptive and unfair practices in commerce (including false and unsubstantiated marketing claims) All types of products and services All forms of advertising and marketing

4 FTC/FDA Coordination FTC authority overlaps with FDA for marketing of foods, drugs, cosmetics, devices Liaison Agreement: FDA has primary authority over claims made in labeling; FTC has primary authority over advertising (defined broadly)

5 FTC/FDA Key Differences FTC legal framework differs from FDA: Primarily a law enforcement agency No pre-market approval of products/claims No regulatory distinction between types of claims (health, structure/function) No regulatory distinction between product categories (device, drug, food)

6 FTC Advertising Law FTC Act, Sections 5 and 12 5 prohibits any unfair or deceptive act or practice in commerce (all products and services). 12 prohibits false ads (ads that are misleading in a material respect) for foods, supplements, drugs, devices, cosmetics.

7 FTC Advertising Law In other words: Advertising must be truthful and not misleading. Objective claims must be substantiated before they are made.

8 FTC Advertising Law All FTC advertising investigations begin with the same two basic questions 1. What claims are conveyed? 2. Are those claims substantiated?

9 Ad Meaning 1. What claims are conveyed? Consumer driven Express and implied claims ( FDA Approved ) Net impression of the ad Testimonials convey efficacy Omissions/half truths Disclosure of material information* *Mouseprint footnotes are not effective disclosures

10 Substantiation 2. Are the claims substantiated? For any health-related claim, including brain function/cognition: The FTC typically requires claims about benefits and safety to be supported by competent and reliable scientific evidence.

11 Competent and Reliable Scientific Evidence Rigorous but flexible (look to experts in the relevant field) No fixed number, length, size of studies Generally expect double blind, placebo-controlled human clinical testing; not in vitro, animal studies Is study internally valid, consistent with larger body of science, relevant to product and claims?

12 $214 computer game sold by infomercials; scientifically proven to permanently improve focus, memory, behavior, school performance in children, including with ADHD 1 pilot study, not randomized, blinded, or controlled; no measure of focus/memory/behavior; no showing of lasting effect Co. and 2 officers prohibited from making cognitive/ academic/behavior claims without substantiation Focus Federal Education Trade Commission (2015)

13 Speak $70 bottle supplement with omega-3,- 6, vit E, K clinically proven to support healthy speech/language in children with autism/verbal apraxia. Fake apraxia website; testimonials No scientific evidence $175,000 in consumer refunds as part of $3.68 million settlement; disclosure of paid endorsers Nourish Life (2015)

14 2002 ab belt device enforcement sweep Washboard abs without exercise; lose 4 inches in 30 days;10 mins = 600 sit-ups; safe for all users FDA and local California D.A. assisted Efficacy claims false EMS not safe for pregnant, those with pacemakers, others. Electronic Products Dist; Hudson Berkley; United Federal Fitness Trade Commission of America (2002)