The U.S. Food and Drug Administration (FDA) issued a warning early in June, 2019 about an ingredient in dietary supplements that can be dangerous for women of childbearing age. The FDA warning concerns the compound vinpocetine. Vinpocetine is an ingredient in supplements that increases cognitive performance, enhances energy, and reduces body fat. Based on a recent study, the FDA is concerned the compound can cause miscarriage or impede fetal development
What is Vinpoctine?
Vinpocetine is synthetically produced compound that may appear on product labels under the names vinca minor, lesser periwinkle, or common periwinkle extracts. The compound is sometimes sold on its own and sometimes in combination with other ingredients. Most consumers take it as a supplement to improve memory and mental sharpness. It is also popular among bodybuilders who use it to rapidly reduce body fat.
Regardless of its labeling or intended use, a recent study from the National Toxicology Program (NTP) of the National Institute of Health (NIH) indicates vinpocetine poses a danger to reproductive health.
An FDA Warning to Women About Miscarriage Risk
The FDA warning about vinpocetine followed a study that found decreased fetal weight and increased rate of miscarriage in animal trials. The rats and rabbits used in the study metabolized vinpocetine at the same rate a pregnant woman would. That means humans may experience the same effects as what the test animals experienced in the study.
The study found the rate of miscarriage and abnormal fetal development among laboratory animals to be much higher than normal. The study also found that the concentration of the compound found in dietary supplements varied greatly from the package label. In practice, consumers may take higher than recommended doses because the commercial concentrations are apparently variable.
The FDA warning focused on the availability of products containing vinpocetine and the lack of a warning for women of childbearing age. The bottom line is that this compound can have serious consequences for women’s reproductive health, and manufacturers have made no mention of the danger.
Dietary Supplements and the Consumer
Dietary supplements are a $40 billion a year industry. Around 170 million Americans take a supplement daily, and there are more than 50,000 dietary supplements on the market. For many, taking a supplement is part of a health-conscious lifestyle. However, to make healthy choices consumers need the facts about the products they put in their body. They need to trust that dietary supplements are safe and correctly labeled.
Companies that manufacture or distribute dietary supplements are responsible for assessing the benefits and dangers of their products prior to marketing. The companies are also responsible for meeting all other federal requirements including:
- The accuracy of their labeling
- The purity of their products
- The accuracy of their product’s description
Failure to follow federal requirements is negligence, and can pose serious risks for consumers. When problems or concerns escalate to the point of an FDA warning, manufacturers should already be working to resolve the issues.
Dietary Supplements and the FDA
The FDA oversees the sale of dietary supplements and stands behind the majority of manufacturers. Primarily, the FDA supports manufacturers who consistently comply with the agency’s safety and labeling standards. However, the agency acknowledges there are other companies who market and distribute dangerous products.
For dietary supplements, the FDA is only responsible for taking action for any dangerous or inaccurately labeled products after it reaches the market. Unlike pharmaceutical drugs, the FDA’s role in the regulation of vitamins and supplements can only be reactionary, not proactive.
With regard to vinpocetine specifically, this means that the agency has not reviewed individual products or manufacturers. Consequently, there is a blanket FDA warning about the potential danger the compound poses to women of childbearing age. This warning may include many manufacturers of many different products.
In addition to its warning to consumers, the FDA has advised vinpocetine manufacturers to revise their product labels to include the safety warning addressed to pregnant women or women who might become pregnant.
FDA Launches New Tools for Consumers
In order to reduce the risks of taking adulterated or mislabeled dietary supplements, the FDA introduced a new tool for consumers called the Dietary Supplement Ingredient Advisory List (DSIAL). Similar to the FDA’s medical device reporting database, the DSIAL is designed to quickly spread the news of products that fail to adhere to FDA standards. The FDA advises cross-referencing your dietary supplement routine with the list for your safety.
FDA Warning about Dietary Supplements During Pregnancy
Most pregnant women consider dietary supplements to be a convenient and indispensable part of a healthy pregnancy. When a woman is pregnant, her nutrient needs increase and a prenatal vitamin is a quick and easy way to meet those increased needs. In fact, virtually all doctors recommend pregnant women to take a prenatal vitamin.
For pregnant women and women who may become pregnant, it can seem like their condition comes with a lot of restrictions. There is a lot of contradictory information in books and online about foods, activities, and supplements to avoid during pregnancy.
From avoiding deli meat for fear of listeria to avoiding alcohol and cigarettes, some taboos are personal choices and some have the benefit of scientific studies. For dietary supplements, choosing a safe product is somewhat trickier because of the lack of proactive FDA supervision.
Vitamins and Supplements to Avoid During Pregnancy
In addition to avoiding any supplement that is the subject of an FDA warning, pregnant women should also consider avoiding:
- Vitamin A: Too much vitamin A can be harmful. Prenatal multivitamins should have all the vitamin A pregnant women need. The body stores excess vitamin A in the liver, which can have toxic effects including birth defects.
- Vitamin E: A fat-soluble vitamin, excess vitamin E can increase the risk of premature rupture of membranes, or water breaking too early.
- Black Cohosh: An herbal supplement that is sometimes marketed for female reproductive health, this product should only be used by women who are not pregnant because it can cause contractions and induce preterm labor.
- Goldenseal: Goldenseal is an herbal supplement that has been linked to increased jaundice in newborns. Complications from severe jaundice can be quite serious.
- Dong quai: A very popular herb used in traditional Chinese medicine, pregnant women should avoid it because it can cause uterine contractions resulting in miscarriage or death.
- Yohimbe: This herb that is native to Africa has been associated with high blood pressure and other cardiac health problems, and should never be used during pregnancy.
A lack of FDA oversight means there is no regulation of the ingredients on supplement labels. Even small amounts of the supplements above can be dangerous during pregnancy.
Have you Experienced Pregnancy Loss After Taking a Supplement?
Manufacturers of dietary supplements containing vinpocetine have a responsibility to perform tests to evaluate the safety of the product. Instead, it was an independent study that showed the danger this compound poses to women of childbearing age.
Hopefully, the FDA warning will be enough to prevent miscarriages, birth defects, of infant deaths. Women who have taken products containing Vinpocetine, who have also experienced miscarriage or birth defects, should contact Drug and Device Watch. In such cases, the mother and family may be eligible to pursue compensation for their losses.
To find out more about the FDA warning, dangerous drugs, and your legal rights, contact Drug and Device Watch. We can help you determine the best course of action for your potential claim. Schedule a free consultation by calling 1-888-458-6825 or reach out online.