Advertisement
Mayo Clinic Proceedings Home

Vinpocetine: An Unapproved Drug Sold as a Dietary Supplement

      To the Editor:
      In the United States, the law governing dietary supplements permits vitamins and minerals, botanical products, amino acids, and protein powders to be sold as supplements. The laws regulating supplements have one safeguard to give the US Food and Drug Administration (FDA) the opportunity to intervene before manufacturers introduce an unapproved drug as a supplement: before introducing a new ingredient into supplements, the manufacturer is required to submit a “new dietary ingredient notification” to the FDA. The FDA assesses the application and responds as to whether the ingredient is appropriate for sale as a dietary supplement.
      If a manufacturer proposes selling an unapproved prescription drug, the FDA would be expected to inform the manufacturer that it is not a legal dietary supplement ingredient. However, the FDA has not always enforced the law. An example is vinpocetine, a pharmaceutical agent prescribed in Germany, Russia, China, and other countries at dosages from 5 mg to 40 mg for acute stroke and cognitive impairment.
      • Bereczki D.
      • Fekete I.
      Vinpocetine for acute ischaemic stroke.
      Vinpocetine has never been approved by the FDA as a prescription drug in the United States. Data regarding vinpocetine’s neuroprotective effects are conflicting, with a recent Cochrane review suggesting no benefit,
      • Bereczki D.
      • Fekete I.
      Vinpocetine for acute ischaemic stroke.
      and vinpocetine can lead to flushing, headaches, and decreased blood pressure.

      National Toxicology Program. Chemical information review document for vinpocetine [CAS No. 42971-09-5]. http://ntp.niehs.nih.gov/ntp/htdocs/chem_background/exsumpdf/vinpocetine091613_508.pdf. Published September 2013. Accessed August 10, 2015.

      In 1997, a supplement manufacturer submitted a new dietary ingredient notification for vinpocetine to the FDA.

      Tanner J. 75-Day Premarket Notification for New Dietary Ingredients [vinpocetine]. US Food and Drug Administration website. http://www.fda.gov/ohrms/dockets/dockets/95s0316/rpt0012_01.pdf. Published August 29, 1997. Accessed August 10, 2015.

      Rather than responding that an unapproved drug may not be sold as a supplement, the FDA permitted the introduction of vinpocetine into supplements. Today, more than 340 brands of supplements contain vinpocetine.

      Natural Medicines Comprehensive Database. http://www.naturaldatabase.com. Accessed August 10, 2015.

      The FDA may have assumed that vinpocetine was a botanical extract, but it is not. Vinpocetine can be synthesized from vincamine, an alkaloid extracted from the leaves of the lesser periwinkle (Vinca minor).
      • Bereczki D.
      • Fekete I.
      Vinpocetine for acute ischaemic stroke.
      However, to my knowledge, vinpocetine itself has never been identified in lesser periwinkle or any other plant.
      Recently, my colleagues and I analyzed all supplements labeled as containing vinpocetine that are available for purchase online from GNC (General Nutrition Centers, Inc) or The Vitamin Shoppe, two of the largest supplement retailers in the United States.

      Avula B, Chittiboyina A, Sagi S, Wang Y-H, Wang M, Khan IA, Cohen PA. Identification and quantification of vinpocetine and picamilon in dietary supplements sold in the United States: drug testing and analysis. Drug Testing Analysis. doi: 10.1002/dta.1853.

      Vinpocetine supplements were most commonly sold as sports supplements, brain enhancers, and weight loss supplements. We found that only 6 of the 23 supplement labels (26%) provided consumers with accurate dosages of vinpocetine.

      Avula B, Chittiboyina A, Sagi S, Wang Y-H, Wang M, Khan IA, Cohen PA. Identification and quantification of vinpocetine and picamilon in dietary supplements sold in the United States: drug testing and analysis. Drug Testing Analysis. doi: 10.1002/dta.1853.

      The FDA has permitted an unapproved new drug with unproven efficacy and known adverse effects to be sold directly to consumers. By permitting the sale of a drug as a dietary supplement, the FDA has created a dangerous precedent by which new drugs can bypass the rigorous drug approval process and be sold directly to consumers without FDA approval. When this happens, consumers are unable to obtain accurate dosing information and are not aware of adverse effects. The FDA should not permit unapproved drugs, even semisynthetic derivatives of natural compounds, to be sold as dietary supplements.

      References

        • Bereczki D.
        • Fekete I.
        Vinpocetine for acute ischaemic stroke.
        Cochrane Database Syst Rev. 2008; : CD000480
      1. National Toxicology Program. Chemical information review document for vinpocetine [CAS No. 42971-09-5]. http://ntp.niehs.nih.gov/ntp/htdocs/chem_background/exsumpdf/vinpocetine091613_508.pdf. Published September 2013. Accessed August 10, 2015.

      2. Tanner J. 75-Day Premarket Notification for New Dietary Ingredients [vinpocetine]. US Food and Drug Administration website. http://www.fda.gov/ohrms/dockets/dockets/95s0316/rpt0012_01.pdf. Published August 29, 1997. Accessed August 10, 2015.

      3. Natural Medicines Comprehensive Database. http://www.naturaldatabase.com. Accessed August 10, 2015.

      4. Avula B, Chittiboyina A, Sagi S, Wang Y-H, Wang M, Khan IA, Cohen PA. Identification and quantification of vinpocetine and picamilon in dietary supplements sold in the United States: drug testing and analysis. Drug Testing Analysis. doi: 10.1002/dta.1853.