A week after the Food & Drug Administration heeded calls for action by scientists and health advocates by demanding that dietary supplement makers stop selling products with a speed-like ingredient, the agency sent another warning to 14 manufacturers asking them to cease the sale of several products with another possibly harmful stimulant.
Reuters reports that the FDA’s latest crackdown on potentially dangerous weight-loss and body-building products involves the stimulant DMBA.
The agency sent letters last week to manufacturers of 16 dietary supplements notifying the companies that products that include DMBA or AMP as a dietary ingredient are in violation of FDA rules.
Additionally, the FDA announced that it considers products with DMBA adulturated because there isn’t enough information to provide reasonable assurance that the stimulant is safe.
A study published last year in the journal Drug Testing and Analysis found that at least a dozen readily available supplements – often marketed to improve athletic performance, increase weight loss and enhance brain function – contain the stimulant.
At the time, the study noted that DMBA had never before been detected in supplements and had never been studied in humans.
DMBA, according to the study, is chemically similar to the stimulant DMAA which was banned by the FDA after being linked to heart failure, strokes, and sudden cardiac arrest.
While the study urged the FDA to clarify the legal status of DMBA more than a year ago, Dr. Pieter Cohen, a Harvard Academic and author of the 2014 study, tells Reuters that the FDA’s recent action is welcome news.
“Rather than waiting until heart attacks, strokes or deaths are definitely linked to this new designer stimulant, the FDA has now made it extremely clear to manufacturers that there is no justification to sell DMBA in supplements,” he says.
The FDA’s letter to manufacturers notes that by labeling DMBA as a “dietary supplement” in product labels, the makers must be able to prove they have the basis to conclude that the stimulant is a “dietary ingredient” that has not been adulterated.
However, the agency points out that the Federal Food, Drug, and Cosmetic Act [FFDCA] states that a new dietary ingredient shall be deemed adulterated unless it can meet two requirements:
• The dietary supplement contains only dietary ingredients that have been present in the food supply as an article used for food in a form in which the food has not been chemically altered; or
• There is a history of use or other evidence of safety establishing that the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe and, at least 75 days before being introduced or delivered for introduction into interstate commerce, the manufacturer or distributor of the dietary ingredient or dietary supplement provides FDA with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
The FDA concludes that because there is no basis to support DMBA in either requirement, the manufacturers’ products must be considered adulterated.
“Failure to immediately cease distribution of your product Velocity and any other products you market that contain DMBA could result in enforcement action by FDA without further notice,” the letter states, in this case, when writing to 1ViZN LLC, the owner of Velocity dietary supplements.
Under law, the FDA has the authority to seize products that violate the rules and to enjoin the manufacturers from continuing to make and sell them.
The FDA’s letters to the manufacturers are just the latest in a series of steps the agency has taken to prevent the use of potentially dangerous stimulants in dietary supplements.
Last week, the agency warned five companies to stop selling products that contain the stimulant BMPEA, a chemical that has similarities to amphetamine, that has never been tested for human safety, and which does not naturally occur in the plants used for these supplements.
Like DMBA, BMPEA – which is often found in supplements containing Acacia rigidula – has been found to be similar to previously banned DMAA.
In all, the FDA sent 14 letters covering 16 supplements: VPX Redline White Heat and MD2 Meltdown, Red Rum SS, PWO/STIM, AMP Citrate, Adipodex, AMPilean and AMPitropin, Contraband, EVOL, HybriLean and PREAMP, Yellow Bullet AMP, Angel Dust, Oxyphen XR Amp’d and Velocity.
The FDA has given the supplement makers 15 days to specify steps that have been or will be taken to correct violations.