FDA Warns Women Of Childbearing Age About Risks of Vinpocetine Supplement

The U.S. Food and Drug Administration (FDA) is warning consumers about an ingredient called vinpocetine that is found in dietary supplements, and the organization is specifically concerned about the use of this ingredient by women of childbearing age.

In a press release on Monday, the FDA said it has reason to believe that consumption of vinpocetine may cause a miscarriage or harm to fetal development. Their findings are based on data that includes a 2019 report by the National Institute of Health's (NIH) National Toxicology Program (NTP).

Vinpocetine—also known as Ethyl Apovincaminate, Common Periwinkle Vinpocetine, Lesser Periwinkle extract or Vinca minor extract—is a synthetic compound derived from vincamine, a substance found naturally in the leaves of the periwinkle plant called Vinca minor.

Vinpocetine is mainly marketed as a dietary supplement for cognitive enhancement, Alzheimer's, dementia and ischemic stroke. However, some products with vinpocetine are marketed towards students as supplements for increased cognitive performance, or brain function. The ingredient is also known to be used by bodybuilders to enhance visual acuity, memory and focus—and to rapidly reduce body fat, the NIH report said.

The findings are disconcerting to the FDA because products containing vinpocetine are marketed towards, and widely available for use by, women of childbearing age.

Vinca minor
Vinca Periwinkle, Vinca minor, the common periwinkle evergreen shrub in springtime in Swinbrook in the Cotswolds, Oxfordshire, UK. Getty/Tim Graham

In 2016, the FDA reportedly proposed to ban vinpocetine, as it argued the product was synthesized in a laboratory and thus failed to meet the legal definition of a dietary supplement that consisted exclusively of natural ingredients.

The Dietary Supplement Health and Education Act (DSHEA) of 1994 defines dietary supplements as a type of food, which put them under different regulations than drugs. The Act says that dietary supplements cannot contain anything that may have "a significant or unreasonable risk of illness or injury" when the supplement is used as directed on the label, or with normal use if there are no directions on the label. If they do, they're considered unsafe. Supplements are, however, considered safe until proven otherwise.

Federal law doesn't require dietary supplements to be proven safe, to the FDA's satisfaction, before they are marketed and available for use. However, it's illegal to market a dietary supplement product as a treatment or cure for a specific disease or to alleviate symptoms of a disease.

The FDA's website tells consumers to be wary of a product that is advertised as "natural," as such a description doesn't ensure that the product is beneficial or safe.