We advise our clients to have a thorough legal review of all marketing materials, including:

  • Online Brochures
  • Marketing Literature
  • Website

One of the legal areas that clients frequently overlook is the jurisdiction that the Federal Trade Commission (FTC) has over advertising, both in print and online.

The Federal Trade Commission Act (FTCA) requires that all promotional material be truthful and non-misleading. In addition, the FTC has special regulations on:

  • Consumer Testimonials and Endorsements
  • Disclosure of Material Connection
  • Expert Testimonials and Endorsements
  • Red Flag (Bogus Weight Loss Claims)
  • Substantiation of Claims

Our business and healthcare law attorneys have advised clients concerning nuances in their website content and can draft appropriate, FTC-compliant disclaimers.

For some clients there are additional advertising rules under state law that need to be considered. For example, California strictly regulates physician advertising, as well as advertising by other players in the health care industry. Our legal experience is broad and allows our attorneys to advise in a variety of matters. For example, one client asked us to perform a legal review of a proposed television commercial while for another, we drafted a disclaimer for a video.

Our attorneys will draft a compliant:

  • Online Disclaimer
  • Privacy Policy
  • Terms of Use
  • FTC Substantiation File

In some cases, we will advise clients regarding related issues of:

  • Defamation
  • Licensing laws
  • Trademark Infringement

Substantiation of Claims

The FTC requires that advertisers have a “reasonable basis” for substantiating claims. To determine whether such a reasonable basis exists, the FTC looks to several factors including:

  • Type of product (products related to consumer health or safety require greater substantiation).
  • Type of claim (claims that are harder for consumers to assess require more substantiation; this includes “health claims that may be subject to a placebo effect or technical claims that consumers cannot readily verify for themselves”).
  • Benefits of a truthful claim.
  • Cost/feasibility of developing substantiation for the claim.
  • Consequences of a false claim (including physical injury if the consumer relies on an unsubstantiated claim of therapeutic benefit).
  • Amount of substantiation that experts in the field believe is reasonable (the FTC looks to “accepted norms in the relevant fields of research” including those developed by a government or authoritative body).

The FTC typically requires that claims about the efficacy or safety of dietary supplements be supported with “competent and reliable scientific evidence.” The FTC defines “competent and reliable scientific evidence” as:

tests, analyses, research, studies, or other evidence based on the expertise of professionals in the relevant area, that have been 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.

The FTC notes that this is the same standard the FTC applies to any industry making health-related claims.

According to the FTC, there is no fixed formula for the number or type of studies required or for more specific parameters like sample size and study duration. There are, however, a number of considerations to guide an advertiser in assessing the adequacy of the scientific support for a specific advertising claim.

For example, advertisers must have the level of support that they claim, expressly or by implication, to have. If an ad states, “scientists now agree,” the advertiser must be able to substantiate that scientific consensus exists.

As to the level of evidence, the FTC states that well-controlled clinical studies are the most reliable form of evidence, and that “replication of research results in an independently-conducted study adds to the weight of the evidence.”

The FTC notes that anecdotal experiences are particularly unreliable as forms of substantiation: “The individual experiences are not adequate to substantiate the claim without confirming scientific research.” In assessing the overall quality and quantity of evidence, the FTC examines “the internal validity of each piece of evidence.”

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