FTC Evaluation Process for Advertising Dietary Supplements

Posted on by admin

The FDA and FTC work together under a long-standing liaison agreement governing the division of responsibilities between the two agencies. The FDA has primary responsibility for claims on product labelling, including packaging, inserts, and other promotional material. The FTC has primary responsibility for claims in advertising, in print and broadcast ads, informercials, catalogues, and digital advertising.

The simple definition of following advertisement guidelines can be

A ) Advertising must be truthful and not misleading; and

B ) Before disseminating an ad, advertisers must have adequate substantiation for all objective product claims. (including: Non-GMO, Natural, Dairy Free, etc.)

FTC’s Procedure for evaluating Advertising

FTC evaluates an advertising based on following parameters

  1. Identify “express” and “implied” claims
  2. When to disclose qualifying information
  3. Clear and prominent disclosures
  4. Claims are properly substantiated:
    1. Product claims a specific level of support
    2. Amount and type of evidence:
      • Depends on the nature of the claim
      • What experts in the relevant area of study would generally consider to be adequate
      • General rule – FTC considers well-controlled human clinical studies as the most reliable form of evidence
      • Pre-clinical (animal) or in vitro studies can be considered when they are widely considered to be acceptable substitutes for human research or where human research is infeasible
    3. The quality of the evidence:
      • Design, implementation, and results of each study.
      • Research that conducted in a competent and reliable manner
      • While not required, FTC gives favor to studies published in peer-reviewed journals
    4. The totality of evidence
      • Consider all relevant research. No random picking
      • How relevant each study is to a specific claim (strengths and weaknesses)
    5. How relevant is the science to the product’s claimed benefit?
      • How does the dosage and formulation compare to what was used in the study?
      • Does the product contain additional ingredients that might alter the effect of the ingredient in the study?
      • Is the product administered in the same manner as the ingredient in the study (e.g. time of day, with food, empty stomach, before meals, etc.)
      • Does the study population reflect the characteristics of the population targeted by the ad?