Medicure Pharma submitted a citizen petition to FDA that asserts that all dietary supplements containing pyridoxal 5’-phosphate (“P5P supplements”) are adulterated under FDC Act § 402(f). The petition asserts that P5P (a form of vitamin B6) is a new dietary ingredient which has neither been present in the food supply as an article used for food in a form in which the food has not been chemically altered, nor has it been the subject of a new dietary ingredient notification. The petition further asserts that those supplements were therefore not lawfully marketed prior to the date on which the investigation of P5P as a drug triggered the dietary supplement exclusionary clause in FDC Act § 201(ff)(3)(B)(ii). The petition asks FDA to remove all P5P supplements from the market, or in the alternative, to initiate rulemaking under FDC Act § 201(ff)(3)(A) to exclude them from the statutory definition of a dietary supplement. Medicure Pharma is investigating a drug product under an Investigational New Drug Application that contains P5P as its active ingredient, and the company contends that marketing of P5P supplements undermines the company’s incentive to continue developing its drug product.
The success or failure of the petition will turn on a few issues. First, the petition contends that P5P is a new dietary ingredient because it was not marketed before October 15, 1994. This is certain to prompt a thorough search on the part of P5P supplement manufacturers for evidence of marketing prior to that date. Second, the petition contends that P5P has not been “present in the food supply as an article used for food” within the meaning of FDC Act § 413(a)(1) because the presence of P5P in foods is “incidental.” However, the Institute of Medicine recognizes that P5P is one of the major forms of vitamin B6 in animal tissues, and that animal tissues are a source of vitamin B6. Third, the petition contends that even extensive marketing of a dietary supplement does not forestall application of the dietary supplement exclusionary clause if the supplement was marketed unlawfully. Although the petition acknowledges that a plain reading of the exclusionary clause does not support this view, the petition asks FDA to read the term “lawfully” (as in “lawfully marketed”) into the exclusionary clause on the ground that not doing so would yield absurd results. Finally, the petition contends that, even if P5P is lawfully marketed as a dietary supplement, FDA can prohibit any further marketing under section 201(ff)(3)(A) to help preserve incentives for new drug development. In doing so, the petition fails to acknowledge that FDA’s rulemaking authority under FDC Act § 201(ff)(3)(A) is tied to a finding of adulteration under § 402(f), a finding that could be difficult to support in the case of a form of vitamin B6.
To view the petition and file comments, click here.