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FTC Rejects FDA Defense in Dietary Supplement Marketing Action

In a recent administrative opinion, the Federal Trade Commission (FTC) rejected a defense that the marketing of dietary supplement products within FDA so-called structure and function claims, precluded enforcement by the FTC of deceptive health claims.

In a recent administrative opinion, the Federal Trade Commission (FTC) rejected a defense that the marketing of dietary supplement products within FDA so-called structure and function claims, precluded enforcement by the FTC of deceptive health claims.

In In the Matter of Daniel Chapter One and James Feijo, No.9329 (Dec. 18, 2009), the FTC alleged that advertisements for the dietary supplement products represented, expressly or by implication, that:

  • BioShark inhibits tumor growth and is effective in the treatment of cancer;
  • Herb Formula inhibits tumor growth and is effective in the treatment or cure of cancer;
  • GDU eliminates tumors and is effective in the treatment of cancer; and
  • BioMixx heals the destructive effects of radiation and chemotherapy and is effective in the treatment of cancer.

The FTC also alleged that those representations were deceptive in because defendants represented, directly or by implication, that they possessed and relied upon a reasonable basis that substantiated the representations when in fact Respondents lacked a reasonable basis to substantiate them.

In its Opinion ruling on the defendants' appeal, the Commission upheld charges that the respondents' advertising for their cancer treatment product was false as unsubstantiated, even if it could be claimed that it was a dietary supplement permissible under the FDA Act, because the differences in the two laws would not be binding on the FTC. The Commission also found that even if the claims were structure and function representations under the FDA Act and thus permissible under the Dietary Supplement Health and Education Act ("DSHEA")(which the Commission urged they were not), the claims were still required to be truthful and not misleading and supported by adequate substantiation in the form of clinical studies on humans using the actual product in question.

In its ruling, the Commission also upheld the requirement that respondents send a specific letter to all customers stating that the FTC found the advertising claims false and misleading and unsubstantiated, prohibited the claims and required that truthful scientific evidence about the product be set forth. It rejected the argument that this violated constitutional rights because it not only prohibited free speech, but compelled government mandated speech.

This case is a reminder to marketers of dietary supplement products who may rely on published literature to support structure and function claims that they must also adhere to the more stringent FTC requirement of obtaining competent and reliable evidence to support the claims, and not just FDA standards which may also apply.

To learn more about Food, Drug, Cosmetic & Dietary Supplement Law, click here.

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