Retailers have begun to pull some popular weight-loss supplements from the shelves after a study this week found that they contained an amphetamine-like substance, known as BMPEA—a chemical that carries "a serious health risk," the New York Times' "Well" blog reports.
Popular weight-loss supplements sold at various retailers across the country contain an amphetamine-like substance known as BMPEA—a chemical that carries "a serious health risk." But FDA has been reluctant to pull products from shelves or issue a health alert to consumers, a new study in Drug Testing Analysis finds.
The controversy over the substance comes as the $33 billion weight-loss and workout supplement industry faces increasing scrutiny. In February, the New York state attorney general's office accused four large retailers of selling fraudulent herbal supplements with potentially dangerous ingredients and called for the products' removal from store shelves.
Under federal law, the majority of dietary supplements are only permitted to contain ingredients that are part of the food supply or were available on the market before 1994. Supplements also are not subject to federal safety or effectiveness reviews; as a result, they typically are pulled from the shelves only after they have been found to cause consumer harm.
BMPEA was first created in the 1930s as a replacement for amphetamine, but it was not submitted as a pharmaceutical medicine and its side effects on humans were never studied.
According to Bastiaan Venhuis, a scientist at the National Institute for Public Health and Environment in the Netherlands, the effects of BMPEA are similar to those of DMAA, an amphetamine-like supplement. DMAA has been known to cause heart attacks and strokes, and the substance was banned from military bases in 2011 after it was found to have played a role in the death of two soldiers.
A Canadian health alert regarding BMPEA said, "Amphetamine stimulants can increase blood pressure, heart rate and body temperature; lead to serious cardiovascular complications (including stroke) at high doses; suppress sleep and appetite, and be addictive."
FDA scientists over the years have noticed that many popular supplements listed a plant called acacia rigidula as an ingredient, a shrub-like plant found in Mexico and southern Texas. Pieter Cohen, the lead author of the new study and an assistant professor at Harvard Medical School, says the plant's presence in so many supplements was a red flag. He says that it is common for companies to label amphetamine-like chemicals in weight-loss and exercise supplements as an obscure plant.
In 2013, the agency reported in the Journal of Pharmaceutical and Biomedical Analysis that nine of 21 tested products that listed acacia rigidula also contain BMPEA. However, the agency never made public the names of the products containing the compound and did not issue a health alert to consumers about the potentially contaminated supplements. Instead, FDA in a statement said its audit of the supplements containing BMPEA did "not identify a specific safety concern" at the time.
More broadly, public health experts say health authorities have moved too slowly after discovering potentially dangerous chemicals in supplements. For instance, Kenneth Spaeth, the division chief of occupation and environmental medicine at North Shore University Hospital in New York, says he told FDA in 2013 that 20 of his patients developed harmful side effects after using a brand of B vitamins.
He waited weeks for a response, and the agency said in a Freedom of Information Act request that it was "unable to locate" records of Spaeth's communications. Nearly six months after Spaeth first aired his concerns, the agency finally issued a public health alert about the product. Spaeth says, "The bottom line is that I feel the FDA did not do everything they could to protect the health of my patients and anyone else taking these supplements."
Public health experts contend that that FDA's reluctance to ban products containing the substance is because high-level agency regulators come from within the industry and have conflicts of interest. Michael Jacobson, executive director of the Center for Science in the Public Interest, says, "To have former officials in the supplement industry become the chief regulators of that industry is like the fox guarding the hen house."
Ethicist Art Caplan agrees, noting, "There are just too many people who could have that job who don't have these conflicts."
Cohen and his colleagues were unable to uncover the names of the supplements that FDA had found to contain BMPEA, so they began conducting their own supplement examinations.
Their study—published on Tuesday in Drug Testing Analysis—identified the stimulant in 11 of 21 studied products. The products are:
Recalled supplements make their way back on the shelves
Details from the new study have encouraged some major retailers to pull products known to contain BMPEA from their shelves.
For example, the Vitamin Shoppe has said it planned to stop selling the supplements identified as containing BMPEA in the study. Meanwhile, the company says it is urging FDA "to use its authority to remove any dietary supplements from the market that it deems unsafe" (O'Connor, "Well," New York Times, 4/7; O'Connor, "Well," New York Times, 4/9).
The takeaway: Retailers are beginning to pull certain weight-loss supplements after a study this week revealed that they contained an amphetamine-like substance that could cause harm to consumers.
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