Pyridoxamine (vitamin B6) was banned as a supplement—but you can help bring it back. Action Alert!
The FDA has provided a back channel by which nutrients that the human body needs can be turned into drugs, and many natural compounds are at risk. If a drug company files an investigational new drug (IND) application on a nutrient before supplement companies have complied with the FDA’s (as yet unfinished) new supplement policies, the company can ask the FDA to have the supplement version removed from the market—even if the company never ends up producing a drug.
This is exactly what happened to pyridoxamine—and with your help we can bring it back.
Pyridoxamine is one of three bioavailable forms of vitamin B6. It has many health benefits and is essential to human life. It helps the body process carbohydrates, supports the nervous system, and prevents homocysteine, which has been linked to an increased risk of heart disease, from building up in the blood. It was available for years as a dietary supplement…until the FDA banned it in 2009 in response to a Citizen’s Petition from BioStratum Inc., who wanted to use it in a drug. No drug was ever developed—meaning that the public lost access to this crucial vitamin entirely.
Years later, a new citizen’s petition has been filed by ViGuard Health Inc. to once again allow pyridoxamine to be sold as a supplement.
Ironically, the name on the citizen’s petition is J. Wesley Fox, who is listed as an executive board member of ViGuard Health. His LinkedIn profile lists that he was also Chief Scientific Officer of BioStratum from 1994-2005. It is a curious twist: An executive of the company that wanted pyridoxamine supplements removed from the market is now asking for the FDA to allow pyridoxamine supplements to be sold. Indeed, this seems to be the company’s sole focus.
Whatever the motivations behind ViGuard’s petition, it does point out the illogic behind the FDA’s position. The policies that allow drug companies to turn vitamins into drugs must be changed, but it is especially egregious to ban the supplement form of a nutrient even after a company is no longer investigating it as a drug. Nevertheless, this is what the FDA is proposing in their new dietary ingredient (NDI) guidance—one of the many reasons the NDI guidance must be amended.
Other natural compounds are imperiled by this policy. Medicure Pharma has petitioned the FDA to remove P5P supplements, another form of vitamin B6; l-glutamine could also be removed. Until the FDA finalized its policy on new supplements (referred to in FDA parlance as “new dietary ingredients”), there are likely dozens, if not hundreds of natural ingredients that could suffer a similar fate.
We must support ViGuard’s petition to allow pyridoxamine supplements to be sold once again. Even though this is essentially the same entity at fault for its removal from the market, allowing the sale of pyridoxamine once again would benefit the natural health community. More importantly, we must urge the FDA to change its policy that allows nutrients to become drugs in the first instance. This is a separate policy which we are also working to change, and will keep you updated on our efforts on that front as well.
Action Alert! Write to the FDA in support of ViGuard’s pyridoxamine petition, and also urge the agency to reject Medicure Pharma’s P5P petition. Please send your message immediately.