Five Supplement Makers Warned Over Use of Picamilon
The FDA has warned five dietary supplement makers nationwide for their use of the substance Picamilon as an ingredient in their products.
Picamilon is not a dietary ingredient, the FDA says, and therefore declaring it as such in product labeling causes the companies’ products to be misbranded.
In nearly identical Nov. 30 warning letters, the FDA tells Applied Nutriceuticals, DBM Nutrition, ICF International LLC, Top Secret and SDC Nutrition to cease distribution of their products in question.
Picamilon is not a vitamin, a mineral, herb or other botanical, amino acid or other dietary substance to supplement the diet by increasing the total dietary intake — the definition of a dietary ingredient under the FD&C Act.
Rather, the warning letters say, it is a unique chemical entity synthesized from the dietary ingredients niacin and gamma-aminobutyric acid. It is absorbed into the body, crosses the blood-brain barrier and accumulates in the brain as a separate chemical entity, and therefore listing products containing it as a supplement makes the labeling false and misleading.
The FDA says that its review of the substance doesn’t identify it as “Generally Recognized as Safe,” but if the companies contend that it is, they should provide data and documentation substantiating those claims.
In the meantime, the companies need to cease distribution of any products containing Picamilon, or possibly face additional enforcement action from the FDA, such as seizure of product.
The warnings are part of the FDA’s continued crackdown on supplement makers, especially those making unfounded claims and selling what the agency deems “unapproved drugs.” The FDA recently completed a year-long sweep that saw charges brought against 89 such supplement makers.
To read the warning letters, go to www.fdanews.com/12-04-15-Applied.pdf, www.fdanews.com/12-04-15-DBMNutrition.pdf, www.fdanews.com/12-04-15-ICF.pdf, www.fdanews.com/12-04-15-SDCNutrition.pdf and www.fdanews.com/12-04-15-TopSecret.pdf.