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>>
>> On Jun 26, 9:53 am, "ironjust...@aol.com" <ironjust...@aol.com> wrote:
>>
>>
>> FDALawBlog gives the following less biased take:
>> 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.
>>
>> --
>> Ron