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FDA Charged With Not Pulling Potentially Unsafe Supplement

Safety Vs Risk Choice ConceptA US senator recently accused the Food and Drug Administration (FDA) of dragging feet in pulling potentially unsafe dietary supplements. Sen. Claire McCaskill, D-Mo., accused the FDA of ignoring her calls to pull supplements containing the soviet-made picamilon.

Picamilon is a synthetically made drug, formed by a combination of niacin (vitamin B3) and GABA (gamma-Aminobutyric acid).[1] It was first developed in 1969 and is not approved for sale in the United States although it is reportedly been prescribe in Europe for decades. GABA has been used orally for relieving anxiety and improving mood.[2]

It is not hard to see why the drug seems to have piqued the interest of the supplements industry. It contains naturally available compounds. Niacin is a vitamin and GABA is made naturally in the body. However, this does not make it less of a drug.

Sen. McCaskill is calling on the ten major retailers to pull all supplements containing picamilon as an ingredient. She had reportedly written twice to the FDA requesting the agency “take appropriate steps to determine whether picamilon is appropriate for sale, and to remove it from store shelves if it is not.”

Interestingly, though considered a drug and not a supplement, picamilon is available for sale over the Internet. Of course, those selling it are calling it a supplement while touting its “benefits” for stress reduction and cognitive support among other things.

In a separate development, Oregon Attorney General recently filed a complaint against GNC for, allegedly, knowingly selling products containing the substance.

While we hail the senator and Oregon AG in their attempts to keep the public safe from questionable supplements, we also do hope that they have reasonable understanding of dietary supplements. You would be surprised at how little many doctors out there know about these.

But, give credit where it’s due, if the Senator and AG know about this hitherto virtually unknown drug, chances are that they (hopefully) know quite a bit about the health industry.

Also, we hope personal biases as well as big-pharma dollars do not influence further regulation of the supplements industry. Over-regulation is as bad as under-regulation.

There have been a number of supplement recalls. These are often for quick-result interests such as sexual enhancement, muscle building, and weight loss. Sometimes the potentially high-risk substances are undisclosed. Contrary to what some keep saying out there, the FDA does regulate dietary supplements, but not the same way as drugs.

You can read the full Senator McCaskill report at RAPS website.


[1] Wikipedia: Picamilon

[2] WebMD: GABA

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