FDA warns childbearing women against using vinpocetine, NPA takes issue with the tactic

June 5, 2019

FDA issued a warning to consumer about safety concerns of the ingredient vinpocetine for women of childbearing age, based on a recent report from the National Institue of Health’s National Toxicology Program, which states that consumption of the synthetically-produced compound by this population may cause miscarriage or harm fetal development. Dietary supplements containing this ingredient have been marketed for supporting memory, focus, energy, and weight management. This is just the latest controversy over FDA and vinpocetine in recent years. Despite the fact that several new dietary ingredient notifications for vinpocentine had already been filed and accepted by FDA in the 1990s, FDA concluded in 2016 that vinpocetine is not a dietary ingredient and is excluded from the definition of dietary supplements in the Federal Food, Drug, and Cosmetic Act.

That same year, the agency requested comment from stakeholders as part of an administrative proceeding to evaluate whether vinpocetine is legal for sale as a dietary supplement. Since that time, products containing vinpocetine continued to be sold and increased in number. As a result of the National Toxicology Program’s report, FDA said in a statement that it intends to expedite completion of the administrative proceeding that it began in September 2016.

The Natural Products Association (NPA; Washington, DC) has taken issue with this latest move and consumer warning from FDA, which the group says could have major implications for new dietary ingredient notifications and have an adverse impact on consumers and manufacturers of dietary supplements. “This is a red herring for the FDA to ban vinpocetine. This latest report has nothing to do with the FDA’s 2016 notice that it reached a tentative conclusion that vinpocetine is not a dietary ingredient. The FDA is grasping at straws in an attempt to ban this safe and legal product,” said Daniel Fabricant, PhD, president and CEO of NPA, in a press release. The vast majority of vinpocetine products, says NPA, contain less than 10 mg of vinpocetine, and already include warning labels for pregnancy and for children under the age of 18.