Our firm has been warning industry that FDA was likely to begin turning its attention toward the New Dietary Ingredient (NDI) requirements in the near future. The legislation proposed by Senator McCain and the subsequent compromise with Senator Hatch added support for our prediction, as NDI’s were at the forefront of the negotiation, culminating in an agreement to put pressure on FDA to develop a guidance document for NDI Notifications. In June, Robert Moore, Regulations Implementation Team Supervisor with the Office of Nutrition, Labeling and Dietary Supplements in FDA’s Center for Food Safety and Applied Nutrition (CFSAN) indicated that following the release of a guidance document, enforcement of the NDI Notification provision of the federal regulations would be “judicial” and imminent.

Even though the guidance document has yet to be released, FDA’s recent actions with respect to Piracetam and 1,4,6-etioallocholan-dione (also known as 3,17-keto-etiochol-triene and more commonly referred to as ATD), indicate that enforcement actions may have already begun. FDA sent a letter dated August 30, 2010 to one dietary supplement firm concerning several products the agency believed were marketed in violation of the Federal Food, Drug and Cosmetic Act. In the letter, FDA indicated that they do not believe that either Piracetam or ATD are dietary ingredients, and when combined with claims that the products affect the structure or function of the body, these substances are “new drugs,” not supplements. Significantly, in a footnote to the letter, FDA referenced a 2003 NDI Notification filed by the firm for Piracetam and a 2004 reply by CFSAN, stating FDA’s position that Piracetam is “not a dietary ingredient.” So, here, where a company purportedly complied with the 75-day premarket NDI Notification requirement, not only did FDA fail to respond to the company’s notification within the 75-day waiting period, but when the agency did respond it was more than 90-days after the notification had been filed.  Now, more than six years after the initial notification was filed, FDA delivers a warning letter to the company alleging that the sale of Piracetam violates the Food, Drug and Cosmetic Act. Surprise and confusion would be logical reactions.

Subsequently, FDA contacted the manufacturers of the products identified in the agency’s letter as containing ATD and requested that these firms conduct voluntary recalls of those products. In addition to the NDI-related Food, Drug and Cosmetic Act violations, FDA alleged that there are “adverse health risks” associated with ATD, an anti-aromatase that can put consumers at risk of illness or injury. In press releases notifying the public of a voluntary recall, the industry firms indicated that while they did not agree with FDA’s position with respect to the alleged regulatory violations, they agreed to voluntarily recall the products as they had already been discontinued nearly 12 months earlier. The press releases also indicated that the firms had not received any reports nor were they aware of any adverse events related to the ATD-containing products.  FDA’s choice to focus less on whether the substances in question were New Dietary Ingredients and instead to stress the alleged health risks to consumers is particularly curious, given that FDA waited many years during which the products were widely and openly sold – and even until the products were long discontinued – before taking action.

Due to the long-after-the-fact timing of these particular enforcement actions, little substantive debate or review of the NDI regulations were generated.  The FDA actions do, however, reinforce the need for clarification and guidance with respect to NDI Notifications and should serve as notice to the dietary supplement industry as a whole that FDA is shifting its focus toward NDI’s and that we can likely expect more enforcement actions in the near future.