Tell Decision-Makers that Picamilon is NOT a Synthetic Drug!

Ellen Rosenblum, the attorney general of Oregon, has filed a lawsuit alleging that “GNC, one of the world’s largest retailers of supposedly all-natural dietary supplements, has knowingly sold products spiked with two synthetic drugs.” Sen. Claire McCaskill has called for the removal of one of those same supplements, and the FDA may be involved in it because they want to remove helpful supplements before a new Alzheimer’s drug is approved.

One of the two substances involved, BMPEA, is a powerful synthetic stimulant. The other, however, isn't synthetic at all, but is a combination of GABA (a completely natural substance made from the amino acid glutamine) with niacin (vitamin B3).

GABA is produced by our own bodies and is the natural way we calm ourselves.

Tell the FDA, the Oregon AG, and Sen. McCaskill that picamilon is not a synthetic drug but a combination of natural ingredients that must continue to be freely available to consumers.

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Picamilon is NOT a Synthetic Drug

Dear [Decision Maker],

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I was distressed to learn that Oregon Attorney General has filed a lawsuit alleging that "GNC, one of the world's largest retailers of supposedly all-natural dietary supplements, has knowingly sold products spiked with two synthetic drugs."

One of the two substances involved is a powerful synthetic stimulant. The other, however, isn't synthetic at all, but is a combination of GABA (a completely natural substance made from the amino acid glutamine) with niacin (vitamin B3). GABA is produced by our own bodies and is the natural way we calm ourselves.

The AG's  ill-informed lawsuit follows a recent call from Sen. Claire McCaskill (D-MO) to pull both picamilon and vinpocetine (an extract of a natural substance useful for the brain) from store shelves pending an investigation into whether they should be sold as prescription drugs rather than as dietary supplements.

I am also extremely concerned by the broader implications of this lawsuit -- specifically, the absence of an updated FDA guidance on new dietary ingredients (NDIs). Thousands of "new supplements" (that is, placed on the market after 1994) whose producers have not filed NDI notifications could potentially be considered illegal "drugs" or "unlawful dietary ingredients" despite the fact that the FDA won't say how this can be prevented. If picamilon is declared an illegal drug and driven off the market, it could leave thousands of other products -- products that consumers rely on -- vulnerable to similar assaults.

Both AG Blumfeld's lawsuit and Sen. McCaskill's call to remove picamilon are setting bad precedents, especially since the FDA has not yet released its updated NDI guidance.

Picamilon is natural, and it has no serious side effects, so it clearly isn't a safety issue. I do know that a potential blockbuster drug for Alzheimer's is in phase three of FDA trials. Is  the FDA thinking of removing  natural substances that help the brain before this new drug is approved? After all, the FDA submitted an affidavit to the Oregon AG saying that picamilon is not a dietary ingredient. This is a puzzling position, given the fact that if the FDA thought there was a safety issue, or any other concern with picamilon, it could take its own action to remove it from the market. If there was an issue with the ingredient in question, why should it be removed only in Oregon and not everywhere else?

At any rate, picamilon is not a synthetic drug but a combination of completely natural ingredients, both essential for the body. It must continue to be freely available to consumers.

Sincerely,
[Your Name]
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