December 20, 2022
The Federal Trade Commission on Tuesday announced publication of a guidance that supplants a document issued in 1998, “Dietary Supplements: An Advertising Guide for Industry.”
The new document, “Health Products Compliance Guidance,” is 40 pages, including footnotes.
Since the 1998 guidance was published, FTC has filed more than 200 cases challenging false or misleading advertising claims for dietary supplements, foods, over-the-counter drugs and other health-related products, according to an FTC news release announcing the new document.
The revised guidance draws on those cases with 23 new examples, and among the major revisions, the guidance covering dietary supplements is extended to all health-related products, FTC said.
The related products include foods, over-the-counter drugs, homeopathic products, health equipment, diagnostic tests and health-related apps.
“Among other things, the new guide includes a much more detailed discussion of the amount and type of evidence needed to substantiate health-related claims, with more emphasis on the fact that the FTC, as a general rule, expects high quality randomized, controlled human clinical trials,” the agency added in the news release.
The new guidance also “aims to correct misunderstandings and ‘urban myths’ that have circulated about FTC substantiation standards,” FTC attorney Lesley Fair wrote in a blog.
She highlighted “some revisions and expansions worthy of special mention” in the updated guidance, including the breadth of products discussed, the “clear and conspicuous” standard and qualified claims, the “competent and reliable scientific evidence” standard, and testing methodology.
Ivan Wasserman, an attorney in Washington, D.C., who advises clients in the dietary supplement industry on advertising compliance matters, said the guidance “appears to be a welcome holiday gift from the FTC,” though he cautioned his law firm is “still carefully digesting” the document.
“The law itself hasn’t changed in the last 25 years, but how supplements and other health products are advertised, and how the FTC views things like disclaimers, endorsements, homeopathy and the relationship between certain types of science and claims, has evolved considerably,” Wasserman said in an email to Natural Products Insider. “Updated guidance, with more specific, current examples, will hopefully be a tremendous tool for the industry to build marketing campaigns and substantiation dossiers that meet FTC’s current expectations.”
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