FDA Toughens Up on New Dietary Ingredients?

May 12, 2009

By Ricardo Carvajal –      

On May 11, FDA announced the condemnation and forfeiture of $1.3 million worth of dietary supplements marketed to body builders because the supplements contain “one or more unapproved food additives and/or new dietary ingredients for which there is inadequate information to assure that they do not present a significant or unreasonable risk of illness or injury.”  The former would constitute a violation of FDC Act § 402(a)(2)(C)(i) and the latter a violation of section 402(f)(1)(B).  Laboratory tests revealed that the products contained one or more of the steroids 1,4,6-androstatriene-3,17-dione (or “ATD” or 1,4,6-etioallocholan-dione) and 3,6,17-androstenetrione (or “6-OXO”), which are promoted as testosterone boosters.  FDA does not contend that the products present a hazard; the agency contends only that it “has no scientific information concerning the safety of the condemned products or their ingredients.”  FDA recommends that consumers discuss their use of the supplements and any related adverse events with health care professionals.

With the exception of a flurry of warning letters issued to marketers of androstenedione supplements in 2004, FDA has made little use of its authority under FDC Act § 402(f)(1)(B).  We’ll soon know whether this latest action is part of a similarly targeted effort, or is the first sign of a broader intent to get tough on new dietary ingredients that the agency considers unsafe within the meaning of the FDC Act.