DirecttoConsumer Advertising of Genetic Tests

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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
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DTC Advertising of Genetic Tests and the FTC

• FTCs jurisdiction over DTC advertising of
  genetic tests
• FTCs method for evaluating promotional claims
  for health-related products
• Tools the FTC uses to prevent consumer deception
• FTCs role with respect to genetic testing

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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

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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)

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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)

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Advertisers Responsibilities

• An advertiser is responsible for all objective
  claims express and implied that are conveyed
  to reasonable consumers
• An 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

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Advertisers 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

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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

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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.

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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

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Clinical studies must be examined in context

• Cant evaluate studies in isolation
• Consider all relevant evidence
• Reconcile inconsistent/conflicting results
• Claim may need to be qualified
• Dont make claim if weight of evidence contradicts

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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

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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

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FTC Participation on SACGHS

• Serve as an Ex Officio member on the Secretarys
  Advisory Committee on Genetics, Health, and
  Society (SACGHS)

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WWW.FTC.GOV
Sarah Botha sbotha_at_ftc.gov 202-326-2036