1. Direct-to-Consumer Advertising of Genetic Tests
Sarah Botha
Division of Advertising Practices
Federal Trade Commission
The opinions expressed are my own and not necessarily those of the FTC

2. DTC Advertising of Genetic Tests and the FTC
FTC’s jurisdiction over DTC advertising of genetic tests
FTC’s method for evaluating promotional claims for health-related products
Tools the FTC uses to prevent consumer deception
FTC’s role with respect to genetic testing

3. FTC Legal Framework and Approach to Regulation
Primarily a law enforcement agency
No pre-market approval process
No regulatory distinction between product categories
No regulatory distinction between health/disease/structure function claims

4. Advertising and the FTC
“The dissemination or the causing to be disseminated of any false advertisement shall be an unfair or deceptive act or practice under section 5 [of the FTC Act, 15 U.S.C. § 45].”
15 U.S.C. § 52(b)

5. Health Products and the FTC
“It shall be unlawful for any person, partnership, or corporation to disseminate, or cause to be disseminated, any false advertisement by any means for the purpose of inducing directly or indirectly, the purchase of food, drugs, devices, services, or cosmetics.”
15 U.S.C. § 52(a)

6. Advertiser’s Responsibilities
An advertiser is responsible for all objective claims – express and implied – that are conveyed to reasonable consumers
“[A]n otherwise false advertisement is not rendered acceptable merely because one possible interpretation of it is not untrue.” (In re National Commission on Egg Nutrition et al., 1976)
Ads must be truthful and not misleading
An ad may be literally truthful and yet still be deceptive to consumers
An ad may be deceptive by omission

7. Advertiser’s Responsibilities
All objective claims must be substantiated at the time they are made
Any disclaimer that is necessary to prevent an ad from being deceptive must be “clear and conspicuous” and must effectively convey the correct net impression to consumers

8. Substantiation Must have a reasonable basis for any objective claim
At least the level claimed in the ad
Depends on a variety of factors, including nature of the claim - “soft, radiant skin” vs. “proven protection against skin cancer”

9. Substantiation for Scientific Claims
Health- or safety-related claims must be substantiated with competent and reliable scientific evidence at the time that the claims are made.

10. Not all clinical studies are the same – the best studies:
Test the relevant clinical endpoints
Are tested on a representative human population
Test the finished product itself, not individual ingredients
Test the same dosages and delivery method
Are double-blinded, randomized, and placebo-controlled
Are statistically significant and have clinically meaningful results
Are published in peer-reviewed journals

11. Clinical studies must be examined in context
Can’t evaluate studies in isolation
Consider all relevant evidence
Reconcile inconsistent/conflicting results
Claim may need to be qualified
Don’t make claim if weight of evidence contradicts

12. What Are Our Priorities?
Products that claim to treat or cure serious diseases
Products that potentially pose significant safety concerns to consumers
Products that are deceptively marketed to or for children and adolescents
Claims with the potential to cause widespread or severe consumer injury
Referrals from the NAD and other self-regulatory programs

13. FTC Tools for Combating Deception
Monitoring of DTC advertising claims for genetic testing and enforcement actions where appropriate
Consumer education
July 2006: FTC-FDA-CDC joint consumer fact sheet titled, “At-Home Genetic Tests: A Healthy Dose of Skepticism May Be the Best Prescription”

14. FTC Participation on SACGHS
Serve as an Ex Officio member on the Secretary’s Advisory Committee on Genetics, Health, and Society (SACGHS)

15.
Sarah Botha