The Alliance For Natural Health

Vitamin B6 (P5P)

The US Food and Drug Administration (FDA) is considering a petition filed by Medicure Pharma, a pharmaceutical company based in New Jersey, requesting a ban on dietary supplements containing pyridoxal 5’-phosphate (P5P), a bio-active and natural form of vitamin B6. Medicure is claiming all dietary supplements containing P5P are adulterated and should be removed from the marketplace.

The escalating public concern over the pending petition stems from a ruling made by FDA in January of 2008, which banned the sale of pyridoxamine—another of the three forms of vitamin B6 found in nature—and declared pyridoxamine a “new drug.” The ruling was in response to a petition filed by Biostratum, a pharmaceutical company that manufactures a drug based on pyridoxamine. By receiving a favorable ruling from FDA, Biostratum now has a solid monopoly on the sale of pyridoxamine.

Our concern is that FDA’s January ruling is setting a precedent that draws into question the future of other vitamins and natural ingredients. Our members have submitted thousands of letters to FDA expressing their distress over the ruling that banned pyridoxamine. We have also launched a campaign for FDA to deny the pending petition based on the fact that P5P has been available without a prescription for decades and should remain so.

The pending petition filed in November 2007 by Medicure admits that P5P is a naturally occurring molecule in the vitamin B6 family that qualifies as a dietary supplement. Medicure’s point of contention is that P5P in dietary supplements will infringe on their profits from a drug they are currently developing, which includes P5P as an active ingredient!

With surprising candidness, Medicure states in their petition, “Pharmaceutical companies developing new drugs must be protected from companies that may seek to market the ingredients in those drugs as dietary supplements. The marketing of such products has the potential to undermine the incentive for the development of new drugs, because many people may choose to purchase the supplements rather than the drugs” [italics ours].

Medicure also believes, according to the petition, that FDA’s role is to “balance, on a case-by-case basis if necessary, the competing interests of dietary supplement and pharmaceutical companies.”

Last we checked, FDA’s mission was to protect and advance the public health. So if P5P already exists in nature, has known health benefits, and is readily available for all consumers, then how does banning P5P further either of those goals? Vitamin B6 is an essential nutrient for healthy blood cell function, and is especially important for expectant mothers and growing children.

Medicure makes no consumer safety claims regarding P5P. Medicure simply wants the ban of a natural product in order to secure a monopoly, and says so quite nakedly. Medicure wants to protect their market and eliminate the availability of P5P to the general public except via their drug! A pharmaceutical company’s drug development should not restrict consumers’ access to natural forms of vitamins, which are essential to good health.

The US Food and Drug Administration is not a branch of pharma’s marketing arm—yet the actions (and inactions) of FDA would have one believe otherwise. FDA’s self-serving interests are compromising consumers’ right to access natural forms of vitamins, which creates another roadblock for individuals to be proactive in their healthcare choices.