FDA Issues Warnings On Mislabeled Supplements Following Senators' Call To Action
Durbin and Blumenthal called for an investigation into companies that manufacture products containing synthetic stimulant routinely advertised as a “natural botanical”
[WASHINGTON, D.C.] – U.S. Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT) welcomed action taken by the Food and Drug Administration (FDA) today in response to their letter calling for increased scrutiny of dietary supplements containing “acacia rigidula” which is often used on dietary supplement labels to mask the inclusion of BMPEA – a potentially dangerous synthetic stimulant. Earlier today, the FDA issued warning letters to five companies regarding eight products which list BMPEA as a dietary ingredient, and some of which identify the source of this stimulant as “acacia rigidula.” The FDA announcement is available here.
“For far too long, dietary supplement manufacturers have either failed to list BMPEA on their product labels or have deceptively mislabeled the stimulant as a “natural botanical.” There is nothing natural about this synthetic stimulant, which researchers describe as an alternative to amphetamine,” said Durbin and Blumenthal. “Last week, we told the FDA: do not wait for tragedy to strike before warning consumers and removing this mislabeled product from store shelves. We are pleased to see that the FDA has heeded our call and finally taken action against the manufacturers of these potentially dangerous products.”
The Senators’ call to action followed the release of a study earlier this month in which researchers found BMPEA in 11 of 21 over-the-counter dietary supplements. The Senators also criticized the FDA for remaining silent on this issue while the percentage of brands of “acacia rigidula” labelled supplements that contain BMPEA have increased from 42.9% in 2012 to 52.4% in 2014.
The European Food Standards Agency and the Danish Veterinary and Food Administration have both cautioned against the consumption of A. rigidula products, while Canadian health authorities have called BMPEA “a serious health risk” and pulled supplements that contain it from store shelves. Furthermore, the chemical is classified as a doping agent by the World Anti-Doping Agency.
The full text of the Senators’ letter is available below.
April 14, 2015
Dr. Stephen Ostroff
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Dear Acting Commissioner Ostroff:
We call on the Food and Drug Administration (FDA) to launch an investigation into manufacturers of dietary supplements containing Acacia rigidula plant extracts and to take swift, appropriate, regulatory action against these mislabeled and deceptive dietary supplements. Last week, the journal Drug Testing and Analysis published an alarming study in which researchers found a deceptively labeled synthetic stimulant, known as β-methylphenylethylamine (BMPEA), in 11 of 21 over-the-counter dietary supplements included in the analysis. Yet, the FDA has not taken any action to protect consumers from these potentially dangerous products.
For too long, dietary supplement manufacturers have either failed to list BMPEA on product labels or have listed the stimulant as a "natural botanical,” which the Food and Drug Administration’s own scientists have disproved. In their own 2013 study published in Journal of Pharmaceutical and Biomedical Analysis, FDA scientists concluded that it is nearly impossible for the amounts of BMPEA present in dietary supplements to be derived from A. rigidula plant extracts. Thus, BMPEA cannot be considered synonymous with A. rigidula, and dietary supplement manufacturers that list A. rigidula, but not BMPEA, on their product label are in violation of the Dietary Supplement Health and Education Act of 1994. Accordingly, we urge the FDA to use its authority to remove these products from the market. While FDA has remained silent on this issue, the percentage of brands of A. rigidula supplements that contain BMPEA have increased from 42.9% in 2012 to 52.4% in 2014.
BMPEA has been described by researchers as an alternative to amphetamine, a potent central nervous system stimulant. Amphetamines themselves have been attributed to a wide range of side effects, including increased blood pressure, heart rate and body temperature; serious cardiovascular complications, including stroke at high doses; suppressed sleep and appetite; and the potential to be addictive. While the direct effects of BMPEA in the human body are not known, FDA should not wait for tragedy to strike before taking action to warn consumers and to remove this mislabeled product.
Other countries and entities have already taken note of A. rigidula and BMPEA’s potential danger. The European Food Standards Agency and the Danish Veterinary and Food Administration have both cautioned against the consumption of A. rigidula products, while Canadian health authorities have called BMPEA “a serious health risk” and pulled supplements that contain it from store shelves. Furthermore, the chemical is classified as a doping agent by the World Anti-Doping Agency.
We are very troubled by FDA’s inaction on this issue and appreciate your cooperation in answering the following questions regarding FDA’s process for regulating dietary supplements and making sure consumers are safe:
- When did it first come to the FDA’s attention that products labeled as A. rigidula may contain BMPEA?
- Does the FDA consider a New Dietary Ingredient (NDI) Notification necessary for A. rigidula or BMPEA? Please explain FDA’s reasoning.
- Has FDA ever received a NDI Notification for A. rigidula or BMPEA? If yes, please provide NDI Notification submission(s) and FDA’s response(s).
- What communications, if any, did FDA have with manufacturers of A. rigidula supplements before and after its 2013 study? Please describe.
- What kind of follow-up did FDA conduct or plan to conduct, in the wake of its 2013 study on A. rigidula?
- Please describe any adverse event cases the FDA has received regarding A. rigidula supplements or products containing BMPEA through MedWatch or other channels.
- How many staff does the FDA have overseeing the regulation of dietary supplements?
FDA should move quickly to conduct a thorough inspection of all dietary supplements containing A. rigidula plant extracts and other BMPEA amphetamine-like substances. By calling your attention to studies like the one released last week, we hope your agency will take action to protect consumers from the deceptive practices of these dietary supplement manufacturers. We also hope this gives your agency an opportunity to reevaluate internal procedures to ensure there is robust oversight of dietary supplements.
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