Tuesday, November 29, 2005

Pyridoxamine- The Saga Continues!

The FDA is allowing a period of public comment, until Dec 19, regarding BioStratum's petition to have pyridoxamine declared "an adulterated substance' and by extension, illegal to be sold by retailers.

Here is the FDA link.

At the present moment, the FDA has stated pyridoxamine as illegal to be sold as a supplement:

"Based on the facts set forth in the petition, the agency
tentatively concludes that pyridoxamine, the active moiety\1\ of
pyridoxamine dihydrochloride, is excluded from the dietary supplement
definition under the exclusion clause in 21 U.S.C. 321(ff)(3)(B)(ii)
and therefore may not be marketed as or in a dietary supplement. "

My interpretation is that if you can prove that you sold pyridoxamine, as a supplement previous to BioStratums patent application, the FDA might be inclined to reverse their position. But I am certainly not a lawyer.

The is a link to make your comment included at the link above.