A year ago, FDA issued a warning letter to USPlabs alleging that certain products containing dimethylamylamine ("DMAA") that were marketed as dietary supplements were adulterated because (1) DMAA is a new dietary ingredient ("NDI") for which no notification had been submitted as required under FDCA section 413, and (2) the products contain an NDI for which there is inadequate information to provide reasonable assurance that the NDI does not present a significant or unreasonable risk of illness or injury. FDA further contended that synthetically produced DMAA does not qualify as a dietary ingredient.
USPlabs disagreed with FDA’s allegations, and FDA has now posted a follow-up letter in which FDA elaborates on its position. In that letter, FDA disagrees that DMAA qualifies as a dietary ingredient by virtue of being a constituent of a botanical, namely the geranium P. graveolens. FDA also disagrees that DMAA is a dietary substance, absent evidence of its presence in geraniums or evidence of common use as a food or drink. FDA therefore concludes that DMAA is an unsafe food additive that renders the products in question adulterated. However, perhaps of greatest interest is FDA’s application of 301(ll)’s prohibition against the introduction into interstate commerce of any food to which an approved drug has been added. FDA states:
DMAA was approved as a drug in 1948… and… was not marketed in food prior to such approval, either on its own or based on its alleged presence as a component of P. graveolens. You have not presented any evidence of such marketing. In the absence of such evidence, your. . .products are in violation of section 301(ll) of the Act.
Thus, FDA appears to conclude without explanation that section 301(ll) applies to prohibit the introduction or delivery for introduction into interstate commerce of the products in question because they are “food” to which an approved drug (DMAA) has been added. This implies one of two additional conclusions: (1) the products are not dietary supplements, but are instead conventional foods to which 301(ll) applies, or (2) the products are dietary supplements, but 301(ll) nonetheless applies. The basis for either of these conclusions is not readily apparent. Arguably, the second conclusion would be a more interesting regulatory development than the first, as we are not aware of any prior instance in which FDA has applied section 301(ll) to prohibit the marketing of a dietary supplement.
One of the more significant questions raised by the addition of section 301(ll) to the FDCA is whether that section applies to dietary supplements, given the fact that the language of the provision does not explicitly mention dietary supplements, and that there already exists a similar provision that explicitly applies to dietary supplements – namely section 201(ff)(3)(B). In fact, FDA raised this very question in its request for comment on the implementation of section 301(ll) (see our prior post here). Unfortunately, the cursory reference to section 301(ll) in FDA’s follow-up letter to USPlabs raises more questions than it answers.