Vitamin B6

In a bizarre response to a citizen petition, the FDA has ruled that “pyridoxamine dihydrochloride or any other compound containing pyridoxamine” are not dietary supplements within the meaning as indicated by DSHEA, specifically Federal Food, Drug, and Cosmetic (FFDC) Act § 201(ff)  and “may not be marketed as such.”

This FDA pronouncement implicates DSHEA directly because it appears that the agency has determined that there is no “independent, verifiable evidence” of marketing of pyridoxamine as a food or dietary supplement prior to 1994 when DSHEA went into effect.

The Natural Products Association has put a call out to all members of industry for copies of sales records, shipping orders, labels and/or other relevant documentation that clearly demonstrates that pyridoxamine was in commerce prior to DSHEA.  If you can help NPA, please contact Daniel Fabricant, Ph.D., NPA vice president, scientific and regulatory affairs, via e-mail to dfabricant [at] naturalproductsassoc.org directly.

About 

Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.