FDA Warns 14 Sports Supplement Companies Of Illegal DMBA (AMP Citrate)

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A week after warning five dietary supplement companies that their products contained BMPEA, an unapproved and poorly-studied amphetamine relative, the FDA is acting on other sports and nutrition products that contain DMBA, a drug from the 1940s that raises blood pressure. However, DMBA has never been formally tested in humans for either safety or effectiveness. The current action is more broad-reaching in that 14 companies have been cited for a total of 17 products that list DMBA on their labels.

In FDA parlance, these products are deemed adulterated with a new dietary ingredient that has neither been previously present in the food supply or any history or evidence for its safe use as recommended. These food-related qualifications reflect the fact that dietary supplements are regulated in the U.S. as foods, not drugs.

These warnings carry to implicit understanding that the companies will cease sales of the supplements and respond to the agency within 15 days as to what actions will be taken to prevent the unlawful addition of this chemical to their products. Failure to do so would result seizure of products and injunction against manufacturers and distributors.

DMBA stands for 1,3-dimethylbutylamine but the substance goes by other names on supplement labels such as AMP citrate (4-amino-2-methylpentane citrate). For clarity, this compound is completely unrelated to another chemical called DMBA that has been used since 1949 to cause skin and breast cancers in rodents (7,12-dimethylbenz[a]anthracene) to study how cancers develop and can be prevented and treated.

Genomyx LLC is one company cited by the FDA for continuing to sell a supplement containing DMBA as AMP citrate. The company has issued a press release on October 16, 2014 following the appearance of the paper by Cohen et al., indicated that sales would cease and the product reformulated. The company has not responded to a request for comment.

A major player in raising awareness to these dietary supplement additions is Pieter A. Cohen, MD, an internist at Cambridge Health Alliance and assistant professor of medicine at Harvard Medical School. Last month, Cohen sounded the alarm on BMPEA-containing products almost two years after FDA researchers found that the relative of amphetamine was in products but not found in nature, as claimed on supplement labels.

Together with colleagues at NSF International testing laboratories on Ann Arbor, Michigan, and the National Institute of Public Health and the Environment of The Netherlands, Cohen found that 12 of 14 supplements that listed DMBA or a related name on the label did indeed contain the chemical. The study, supported by Cohen’s funds and a pro bono contract with NSF International, were published on October 8, 2014 in a Drug Testing and Analysis paper. NSF International offers product testing and regulatory compliance services to dietary supplement makers.

Some manufacturers have claimed that DMBA is a natural ingredient found in Pouchung tea, albeit at 12 parts per billion, a fact that Cohen argues is irrelevant to the context in which synthetic DMBA is being added to supplements.

In their paper, Cohen wrote, “Even if DMBA were found at these very low levels, manufacture[r]s would require at least 1000 kg of Pouchung tea to extract 12 mg of DMBA, and humans would not have previously been exposed to the high levels of DMBA that we found in dietary supplements.”

Cohen tells us that the impetus for the study was his team’s 2013 identification in other sports supplements of a methamphetamine analogue called DEPEA. “We were interested to see what was replacing DEPEA in formulations after DEPEA was removed.  What we found was DMBA,” said Cohen, via email.

Cohen was sharply critical of the FDA for their slow response to BMPEA in dietary supplements, a claim that was amplified in a New York Times article by Anahad O’Connor and a statement from the paper’s editorial board. The Times specifically argued that the agency’s dietary supplement division’s hiring of two former trade organization leaders was a cause of the delayed response.

But Cohen seems pleased with the pace of FDA’s response to DMBA adulteration of supplements.

“I am delighted to see the FDA move to remove DMBA from the marketplace – especially that the FDA is making it clear of the potential risks to consumers,” said Cohen. “This is important to do before heart attacks and strokes are definitely linked to this new stimulant – as there’s no reason this drug should be in supplements in the first place.”

The following list are the names of companies and products cited by the FDA. The hyperlinks go to the warning letters issued to each company.

For more health and pharmaceutical news and commentary, follow me on Twitter @DavidKroll, or here at Forbes.com.

Source: Forbes