On Jun 26, 9:53 am, "ironjust...@aol.com" <ironjust...@aol.com> wrote:
> Health Freedom Warning: Drug Company Seeks to Outlaw Vitamin B6 to
> Protect Pharma Profits
> www.naturalnews.com/023514.html
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
Ron Peterson
Paul T. Holland
