U.S. Senator Writes FDA

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Calls for Suspension of Supplements Containing Unapproved Drugs

After a report determined the presence of vinpocetine and picamilon in U.S. dietary supplements marketed as brain enhancers, sports supplements and weight loss supplements, U.S. Senator Claire McCaskill is taking action. McCaskill, a top-ranking Democrat on the Senate Special Committee on Aging, wrote U.S. Food and Drug Administration Acting Administrator Stephen Ostroff requesting the suspension of sales for any supplement containing the ingredients, pending an investigation.

“Because these ingredients are being sold as dietary supplements and not prescription drugs they have not undergone the same level of scrutiny to understand any potential side effects or drug interactions,” explained McCaskill in her letter. One of the ingredients, vinpocetine, is prescribed in other countries such as Germany, Russia and China, for acute stroke and cognitive impairment, but has never been approved in the U.S.  According to the report, in 1997, as required by FDA, a supplement manufacturer submitted a new dietary ingredient notification for vinpocetine, which the FDA ultimately permitted.

Research conducted by the authors of the report found that, after analyzing 23 supplements labeled as containing vinpocetine, “Thirty-nine percent (9/23) of the vinpocetine supplements were misbranded because they did not contain any vinpocetine.” In addition, “Seventy-four percent (17/23) of the supplement labels did not provide any information on the quantity of vinpocetine. For the 6 supplements that did list the quantity of vinpocetine on the label, the actual amount ranged from 95.6% to 107.4% of labeled content.”

After analyzing 31 supplements labeled as containing picamilon, data showed, “Of 31 dietary supplements tested, 30 contained picamilon.” On their labels, “The amount per serving of picamilon ranged from none to 249.1 mg compared to prescription dosages of 50 mg to 200 mg…The quantity of picamilon consumed by following the label's recommended maximum daily serving ranged from 2.7 mg/day to 721.5 mg/day.”

The misbranding, lack of information and wide range of dosages as well as recommended serving amounts of these supplements, makes it impossible for consumers to know exactly what they are consuming or of the potential adverse side effects, the Senator believes. This is of particular concern to American seniors whom Senator McCaskill represents on her committee.

Published in WholeFoods Magazine Online, 10/9/15