FDA: Picamilon is not a dietary ingredient

By Stephen Daniells

- Last updated on GMT

FDA: Picamilon is not a dietary ingredient

Related tags Dietary ingredient Dietary supplement

Dietary supplements containing picamilon are considered adulterated by the US Food and Drug Administration, because picamilon is not a legal dietary ingredient, the Agency has told NutraIngredients-USA.

Picamilon (also known as nicotinoyl-GABA) is a derivative of GABA (gamma-aminobutyric acid) and nicotinic acid. It was reportedly developed by the All-Union Vitamin Research Institute in 1970 as a way of helping GABA cross the blood brain barrier, where it would exhibit anti-anxiety and anti-convulsant effects (orally consumed GABA on its own does not cross the blood brain barrier).

A search on PubMed​ (accessed Oct 2, 2015) for picamilon produces 49 results, with 39 of those being in Russian. A further five papers were published in Ukrainian.

Dietary supplements containing the ingredient were the subject of a recent analysis by researchers from the National Center for Natural Products Research at the University of Mississippi and Cambridge Health Alliance / Harvard Medical School published in Drug Testing and Analysis.

 “In the 30 supplements that contained picamilon, the quantity of picamilon consumed by following the label's recommended maximum daily serving ranged from 2.7 mg/day to 721.5 mg/day,” ​they wrote. “These dosages range from trivial to exceeding prescription dosages.”

Marianna Naum, PhD, strategic communications and public engagement staff in the Office of Foods and Veterinary Medicine at the FDA, told NutraIngredients-USA: “According to the FDA’s review, picamilon does not satisfy the definition of a dietary ingredient. Therefore, FDA does not consider picamilon to be either an old dietary ingredient or a new dietary ingredient.”

Picamilon is not used in many products, and the ones it is used in are mostly positioned as physical and cognitive performance products. About 50 products currently list picamilon (also known as pikatropin) on their labels, according to the National Institutes of Health’s Dietary Supplement Label Database​ (accessed Oct 2, 2015).

So will FDA be taking action on this issue? "FDA has to prioritize our efforts in light of public health concern and agency resources,"​ said Dr Naum. 

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1 comment

Picamilon from natural ingredients

Posted by Jim,

Picamilon is made from a natural amino acid called (Alpha amino butyric acid) that is found in wine, beer and bakers yeast then it is combined with vitamin B3 and FDA calls this a chemical?.

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