The American Herbal Products Association (AHPA) recommends the Secretary of Health and Human Services (HHS) consider initiating rulemaking to declare vinpocetine to be 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).
AHPA's comments contend that vinpocetine's use as food was possibly overlooked or that it could come into use as a food in the future.
"A food manufacturer may establish vinpocetine as generally recognized as safe and add the ingredient to a food, at which time vinpocetine would qualify as a dietary ingredient," AHPA states.
AHPA also notes that Congress provided the Secretary of HHS with authority to create exceptions to normal exclusions from the definition of a dietary supplement.
"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.