Forewarned is Forearmed: FTC and FDA Set Out their Priorities Concerning Dietary SupplementsNovember 23, 2009
By Riëtte van Laack –
In two little noticed speeches delivered at the Council for Responsible Nutrition’s ("CRN’s") Annual Symposium on October 22, 2009, FTC’s Director David Vladeck and FDA’s Principal Deputy Commissioner Joshua Sharfstein set out their agencies’ priorities for regulation of dietary supplements. For FTC, a continuing priority is advertising substantiation. Mr. Vladeck, in his speech, stressed that it is not just the ultimate advertiser that will be held liable for substantiation. In addition, those who are the source for the advertising claims, including ingredient suppliers and contract manufacturers, are responsible for claims that they make to their (trade) customers.
Vladeck also mentioned the new guidelines on the use of endorsements that we addressed in a previous post. FTC intends to aggressively enforce the guidelines. Any advertiser will be held to the same standard of substantiation of competent and reliable scientific evidence, including advertisers who use endorsements or testimonials.
Vladeck acknowledged that the recent court decision in the Lane Labs case has raised questions about what constitutes competent and reliable evidence. Therefore, in future injunctive orders, FTC intends to provide more precise language to describe what type of evidence is required. What is clear from FTC’s perspective is that evidence from one or two studies contradicting or inconsistent with the weight of the evidence is not sufficient to substantiate a claim – even when those studies are performed according to standard, reliable, scientific protocols.
FTC and FDA intend to increase their level of cooperation. This increased cooperation is particularly evident in the area of enforcement activities directed toward dietary supplements that pose a serious health concern because they carry claims for serious diseases such as cancer or the H1N1 flu. As an example, see the recent joint warning letter issued to DrWeil.com and Weil Lifestyle LLC,
FTC and FDA also intend to pursue dietary supplements that present undisclosed health risks because the products have been spiked with pharmaceutical substances. Both FTC and FDA are struggling with the best approach to this problem. In his remarks at the CRN Symposium, Dr. Sharfstein pointed out that FDA is pursuing criminal investigations in this area. He further mentioned the dietary supplement GMP regulation, and adverse event reporting requirements as potential tools to address the problem. In addition, Dr. Sharfstein suggested that stricter enforcement of the requirement to notify FDA of intent to market a new dietary ingredient might be an avenue to address the problem. Such a notification provides FDA with an opportunity to review the safety of a new dietary ingredient and its use.
In his remarks, Dr. Sharfstein suggested that a notification is required for any new dietary ingredient. However, under section 413(a)(1), submission of a notification is not required if “[t]he dietary supplement contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered.” Dr. Sharfstein also suggested that guidance on what constitutes a new dietary ingredient subject to notification may be forthcoming, and that the agency intends to clarify its standards for such notifications. (We note that the agency has been working on guidance in this are for years, and held a public hearing on this subject in November of 2004.)
All of these agency activities notwithstanding, Dr. Sharfstein reminded his audience that every company in the dietary supplement industry is ultimately responsible for the safety of its products.