Washington, D.C. – On Tuesday, the U.S. Food and Drug Administration (FDA) announced vinpocetine did not meet the definition of a dietary ingredient and would be excluded from the definition of a dietary supplement in the Federal Food, Drug and Cosmetic Act.
According to the FDA, vinpocetine is synthetically produced instead of being a constituent of vincamine, an alkaloid found in the Vinca mino L. plant, and of tabersonine, an alkaloid found in Voacanga seeds.
To be considered, a dietary ingredient may be one or any combination of the following substances:
- a vitamin
- a mineral
- an herb or other botanical
- an amino acid
- a dietary substance for use by people to supplement the diet by increasing the total dietary intake
- a concentrate, metabolite, constituent, or extract
While FDA states that vinpocetine does not fall under the definition of a dietary ingredient, vinpocetine currently has five listings in the FDA New Dietary Ingredients (NDI) Database, with the first dating back to July 8, 1997, and has had a response letter, for each acknowledgment, stating there were no concerns with the ingredient or data provided.
“This is a form of double jeopardy,” said Daniel Fabricant, Ph.D., executive director and CEO of NPA. “To go through the regulatory gate a 2nd time is akin to finishing a round of golf and winning but then having to play a 2nd round while someone charges at you while you hit each golf shot. This sets a very bad precedent and is no environment to conduct business in.”
Fabricant also went on to note, “The FR notice was also absent [of] any economic impact analysis. There is an economic impact here as firms have been lawfully marketing this ingredient since it was successfully notified in the 90’s. Consistent with the statute, is the agency planning to conduct an economic impact analysis? The original economic impact analysis on 21 CFR 190.6 never presented a situation where a properly notified ingredient, considered lawful for a period of time, could be removed instantaneously approximately 20- years ex post facto. It would appear that removal of this ingredient would bear little incremental public health effect (per the notice) but a significant incremental cost associated with the change in regulatory status, which is, by law, generally considered in such actions and how to provide more or other cost-effective alternatives or enforcement discretion. No discussion on enforcement discretion is present either. Why? Is this what responsible industry can expect in the future with other new dietary ingredients?”
FDA will be accepting comments from the public regarding the regulatory status of vinpocetine until November 7th.
Posted on WholeFoods Magazine Online 9/7/2016