Harmful to fetal development? FDA warns of adverse reproductive effects of vinpocetine
The warning is part of the US agency’s continued efforts to provide guidance and clarity in the expanding dietary supplement market
04 Jun 2019 --- The US Food and Drug Administration (FDA) has issued a warning to consumers about concerns regarding the safety of vinpocetine, an ingredient often marketed for cognitive sharpness. Specifically, the agency is voicing concerns about the use of this ingredient by women of childbearing age, following reports stating that vinpocetine may cause a miscarriage or harm fetal development. The move is a further step in the agency’s strengthened efforts to adapt to the realities of the growing US market for dietary supplements.
Vinpocetine is a synthetically produced compound often referred to on product labels as Vinca minor extract, lesser periwinkle extract, or common periwinkle extract. Dietary supplements containing vinpocetine are often marketed for uses that include enhanced memory, focus, or mental acuity; increased energy; and weight loss.
According to data reviewed by the FDA, including a recent report by the National Institute of Health’s (NIH) National Toxicology Program (NTP), consumption of vinpocetine is associated with adverse reproductive effects. According to the FDA’s statement, these findings are particularly concerning because products containing vinpocetine are widely available for use by women of childbearing age.
“That’s why today we’re advising pregnant women and women who could become pregnant not to take vinpocetine. We are also advising firms marketing dietary supplements containing vinpocetine to evaluate their product labeling to ensure that it provides safety warnings against use by pregnant women and women who could become pregnant,” reads the statement, joint-issued by Amy Abernethy, Principal Deputy Commissioner, Office of the Commissioner, and Frank Yiannas, Deputy Commissioner for Food Policy and Response, Food and Drug Administration.
Studies on the effects of vinpocetine on pregnant animals found that vinpocetine decreased fetal weight and increased the chances of a miscarriage. The blood levels of vinpocetine measured in the pregnant animals were similar to those reported in people after taking a single dose of vinpocetine, indicating that pregnant women may experience adverse effects from vinpocetine similar to those seen in the pregnant animals.
Although in some countries outside of the US, vinpocetine is regulated as a prescription drug, vinpocetine products sold as dietary supplements in the US have not been reviewed by the FDA under the safety and effectiveness standards that apply to drug products.
Vinpocetine was flagged as an ingredient of concern some years ago. In the 1990s, the FDA received several premarket safety submissions (known as new dietary ingredient notifications) for vinpocetine as an ingredient in dietary supplements. In 2016, the agency requested comment from stakeholders as part of an administrative proceeding to evaluate whether vinpocetine is legal for sale as a dietary supplement.
In September 2016, the agency announced its tentative decision to reverse its position that vinpocetine is a legal dietary ingredient. At the time, lobby groups such as the Council for Responsible Nutrition (CRN) spoke out against this viewpoint, highlighting five successful new dietary ingredient (NDI) notifications and 20 years of availability on the market. Innova Market Insights data show that there was a sharp drop in dietary supplement product launches in 2017 when compared to 2016 launch numbers, but these numbers picked up again in 2018.
With the results in NTP’s report, the FDA notes that it will expedite completion of the administrative proceeding that it began in September 2016, since “the availability of dietary supplement products containing vinpocetine has grown and the labels of vinpocetine products often have no warnings about the dangers of miscarriage and harm to fetal development.”
Growing concerns in a growing market?
The dietary supplement market is a growing industry, with consumers from varying demographics seeking to augment their health and suppliers responding to this demand with gusto. One clear example is of course the growing market for hemp and CBD products.
In February, the FDA announced it was seeking to significantly “modernize” dietary supplement regulations, in an attempt to root out “bad actors” that distribute and sell dangerous products. Promised to be the most “significant modernizations” in 25 years, announced steps will seek to ensure that the US regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation, developing new enforcement strategies and engaging in a dialogue with dietary supplement stakeholders.
Industry groups responded positively to the announcement, but urge the agency to work towards more clarity on the legal path to market for hemp-derived cannabidiol (CBD) as a food and as a dietary supplement, as well as issue final New Dietary Ingredient (NDI) Guidance.
In April, the agency launched a reference tool for consumers and manufacturers. The new Dietary Supplement Ingredient Advisory List contains warnings about unlawful ingredients in dietary supplements.
As the FDA continues to seek ways to adapt to the realities of the evolving dietary supplement industry, more stringent warning such as this one regarding vinpocetine are sure to follow.
By Lucy Gunn
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