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Shops Remove Possibly Dangerous Diet Supplements After Study Faults FDA

Following a report this week that the U.S. Food and Drug Administration kept silent about synthetic stimulant contamination in some popular diet supplements, a major vitamin seller announced it will pull products that may be tainted with the chemical BMPEA.

Here’s The Vitamin Shoppe announcement via PR Newswire:

Mike Mozart/flickr

Mike Mozart/flickr

Because the health and safety of our customers is our number one priority, and out of an abundance of caution, we are immediately removing all acacia rigidula containing products, due to the concern that some of them may contain BMPEA, from our stores and website. BMPEA is a synthetic drug-like substance that should not be used in dietary supplements.

We are concerned by the findings outlined in the study published yesterday in Drug Testing and Analysis, which state that some acacia rigidula containing products may also contain BMPEA. If these findings are confirmed by the FDA, these products should not be sold as dietary supplements.

The Vitamin Shoppe requires that all manufacturers of the products we carry comply with all applicable laws. The Vitamin Shoppe decided to remove these products because the safety of these products is now in question and may not be in compliance with FDA regulations. In addition, the Vitamin Shoppe continues to encourage the FDA to use its authority to remove any dietary supplements from the market which it deems unsafe.

On Wednesday, The New York Times offered a detailed account of the tainted supplement study, which was published in the journal Drug Testing and Analysis:

Popular weight-loss and workout supplements on sale in hundreds of vitamin shops across the nation contain a chemical nearly identical to amphetamine, the powerful stimulant, and pose dangers to the health of those who take them, according to a new study. The Canadian health authorities in December called the chemical, BMPEA, “a serious health risk,” and pulled supplements that contain it from store shelves.

The Food and Drug Administration documented two years ago that nine such supplements contained the same chemical, but never made public the names of the products or the companies that made them. Neither has it recalled the products nor issued a health alert to consumers as it has done with other tainted supplements. The F.D.A. said in a statement that its review of supplements containing the stimulant “does not identify a specific safety concern at this time.”

But public health experts contend that the F.D.A.’s reluctance to act in this case is symptomatic of a broader problem. The agency is not effectively policing the $33 billion-a-year supplements industry in part because top agency regulators themselves come from the industry and have conflicts of interest, they say.

Dr. Pieter Cohen, an assistant professor at Harvard Medical School, and the lead author of the study, said in an email that he has some short-and long-term hopes for what happens next in the tainted supplement saga. Cohen, also a primary care doctor at Cambridge Health Alliance wrote:

I would hope the FDA stops hiding their head in the sand and immediately warns consumers that they have found a synthetic stimulant in many supplements. The FDA should use it’s full enforcement capabilities to remove BMPEA from all supplements. The FDA should also clarify that the plant being used as cover for this stimulant, a shrub called Acacia rigidula, has no legitimate place in supplements and all supplements labeled as containing Acacia rigidula should be immediately withdrawn from the market. Continue reading

Diet Pill Dilemma: Why Is FDA Approving Drugs When Europe Isn’t?

By Karen Weintraub
Guest Contributor

We’ve all dreamt of popping a pill to help us safely lose weight, or at least eat that chocolate cake without guilt. But alas, even though the Food and Drug Administration has approved two new diet drugs in recent months, that dream probably isn’t any closer to reality.

2day929/flickr

2day929/flickr

In the current issue of the BMJ (formerly the British Medical Journal), Sidney Wolfe, founder of the advocacy group Public Citizen, slams the FDA for approving the drugs – lorcaserin (US brand name Belviq) and topiramate (called Qsymia). The FDA’s European counterpart rejected both of them because of heart risks that turned up during preliminary trials.

The FDA decided that the risks were relatively small and ordered the manufacturers to look for problems once they are on the market – basically, approving the drugs now and worrying later if they prove dangerous. Buyer beware.

The problem, Wolfe explained in a phone interview from Washington where he is preparing to testify at a National Institutes of Health meeting tomorrow, is that the reasons for hunger are complex and connected to many biological systems.

“When you give a drug powerful enough to effect hunger it is also going to affect other systems of the body,” most often the heart, he said. Continue reading