The American Herbal Products Association (AHPA) recommended the Secretary of Health and Human Services (HHS) consider initiating rulemaking to declare vinpocetine to be a lawful dietary ingredient in comments submitted to the Food and Drug Administration (FDA).
AHPA also strongly encouraged FDA to clarify that if vinpocetine is either found to be currently in the market as a food ingredient or comes to be included as a food ingredient in the future, the ingredient would therefore qualify as a dietary ingredient.
On September 7, FDA issued a Federal Register notice that requested comments on the Agency's tentative conclusion that vinpocetine is not a dietary ingredient and is excluded from the definition of dietary supplement in the Federal Food, Drug, and Cosmetic Act (FD&C Act).
"Although this authority has not been used in the 22 years since this statutory provision was established, it should be assumed that the Congress foresaw that there might be circumstances in which it would be appropriate for the Secretary HHS to undertake the described regulatory steps to create such an exception," AHPA's letter to FDA states.
For more information, visit www.ahpa.org.