Vitamin B6 in trouble: FDA confused about pyridoxamine

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.

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.

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15 Comments

  1. Jarret Morrow said:

    Joel, thank you for this update! I would presume that either multivitamin or B complex vitamin products that contained Vitamin B6 would constitute evidence for the marketing of Vitamin B6 as a food or dietary supplement?

  2. Pyridoxamine Researcher said:

    The charade of the FDA’s collusion and corruption by pharmaceutical corporate profiteering is revealed here. While funding media reports and bogus made-to-fail clinical studies about the lack of efficacy of vitamins or even their harmfulness, they declare a vitamin, pyridoxamine, a useful drug at the same time. True hypocrisy at its finest. Why? It is of course to fund the money engine of AMA + Pharma + Insurance. On one hand, thank God they use something that actually works without side effect. On the other hand, more of the same lack of vision combined with greed superceding any consideration of human welfare. Next up: your breakfast, lunch, and dinner are banned by the FDA as drugs.

  3. Jeff Brubaker said:

    Unbelievable, to put it mildly. Indeed, all this hoop-la about B6 as a new drug corresponds to and overlaps with verifiable decreases in the sheer number of new “blockbuster” drugs in virtually all therapeutic areas currently, plus the increasing pressure on drug companies to fork over their high profits to investors; to wit, the creation of heretofore unknown “diseases” like male impotence (the big seller), restless leg syndrome, or having to pee frequently after drinking too much coffee (or beer if you are watching the game), all for the purpose of pushing some sort of drug or another to a populace willing to shove pills down their throats at a rate exceeding most other developed countries combined.

    Poor Americans! But now we may watch the SWAT guys from bureau of tobacco, alcohol, and firearms raid vitamin manufacturers for supplements while protecting our right to bear howitzers and assault rifles. Go Team! This is not America after all.

  4. Bharrod said:

    Do you think that it’s a coincidence that this happens right around the same time that Big Pharma is putting out a new drug for Chronic Fatigue Syndrome and for Fibromyalgia? I THINK NOT! – the FDA is corrupt, as was shown on CNN – Lou Dobbs evening news last month, according to it’s own internal documents from it’s own scientists! Big Pharma owns the FDA, that is well known, until we get the corruption out of the FDA, this is going to continue to happen!

  5. Pingback: Magick Dragonfly » Secrets of Natural Healing: Vitamin B-6 declared a “drug” by FDA; to be banned from vitamin supplements

  6. Diane said:

    How about Rx Vitamin D? Talk about stupid!!! I was severly deficient, no measurable D (results begin at 6) put on Rx Vit D (D2) 50,000 units, for 6 months. At the end of 6 months, not 1 point gain in my D level. Four months on OTC Vit D (D3) & I’m up to 35.

  7. David B said:

    Is there no end to the corruption.
    if the FDA isn’t a crime against humanity, then what is.
    the FDA is an abomination. Hopefully, if thers is a God, the the FDA will meet its fate in HELL

  8. Andy said:

    Is anything safe? Or, is that just what we’re led to believe? More political manipulation by fear in the name of regulation and someone is getting rich.

  9. Charles Armes said:

    Not strange situation at all. It’s the FDA up to their old tricks. We the people need to tell them to go back to their drugs and leave vitamins alone, for God’s sake. I cannot believe we let such an organization have the power they do. They have been dancing around trying to sneak into our natural medicines and foods because there is money there, but a wolf is a wolf is a wolf.

  10. ryan @ vitamin d benefits said:

    On the topic of Vitamin D, the importance of vitamin D in the development of cancer was further confirmed by a Sylvia Chistakos, Ph.D., of the UMDNJ-New Jersey Medical School. Her research, published in The Journal of Biological Chemistry, showed that the active form of vitamin D induces the development of a protein that can stop the growth of breast cancer cells.

  11. db said:

    The FDA in its current form aught to be abolished — Has NO place in a free society. I will go where I want to get the vitamins I want — MY VITAMINS FROM MY COLD DEAD FINGERS!

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