Senator Urges FDA to Withdraw Vinpocetine Notice


On Tuesday, Sen. Orrin Hatch, a Republican from Utah, urged Commissioner Robert Califf, M.D. in a letter, to withdraw the federal register notice for Vinpocetine, a dietary ingredient that has five acknowledgements in the U.S. Food and Drug Administration (FDA) New Dietary Ingredients Database.

According to Hatch’s letter, “the Dietary Supplement Health and Education Act of 1994 (DSHEA) provides pathways for withdrawing dietary ingredients based on safety concerns.” However, in the notice, no “risk of illness or hazard to public health” was cited for the ingredient vinpocetine to be excluded from the definition of a dietary supplement in the Federal Food, Drug and Cosmetic Act.

Vinpocetine, which is commonly marketed as a supplement for improvement of brain function, weight loss and an increase in energy, was instead excluded on September 6, 2016 due to FDA’s conclusion that vinpocetine is synthetically produced instead of being a constituent, making it ineligible to be a dietary ingredient because it did not fit the definition.

Hatch’s letter went on to note that in 1997, 1998, and three times in 1999, FDA pulled five New Dietary Ingredient notifications for vinpocetine for 75 days and conducted safety and regulatory checks. For each review FDA saw there were no concerns with the ingredient or data provided and allowed each product to go to market.

Because vinpocetine is present in more than 300 products, Hatch believes a cost-benefit analyses should instead be conducted when FDA considers withdrawing a dietary supplement product “when safety is not the predicating reason for withdrawal.”

Currently, vinpocetine has not been banned from the market. FDA will continue accepting comments from the public regarding the regulatory status of vinpocetine until November 7th, 2016.

Posted on WholeFoods Magazine Online 10/28/2016