‘A bold, aggressive move’: FDA sends warning letters to 14 companies over DMBA

By Stephen Daniells contact

- Last updated on GMT

‘A bold, aggressive move’: FDA sends warning letters to 14 companies over DMBA

Related tags: Dietary supplement, Food and drug administration

Fourteen companies have received warning letters from the FDA regarding products containing DMBA (1,3-Dimethylbutylamine), which the Agency states is not a legal dietary ingredient and products containing it are considered to be adulterated.

The ingredient was the subject of a 2014 study conducted by Dr Pieter Cohen, a physician connected with the Harvard School of Medicine, and published in the journal Drug Testing and Analysis​.  In his study, DMBA was identified in 12 of 14 brands of supplements tested.

DMBA has chemical similarities to DMAA, another stimulant-like ingredient that was once common in pre-workout formulas. Controversial ingredient DMAA was linked to a number of adverse events reports, including being implicated in the deaths of two soldiers, and was mandated to be removed from the market by FDA​.

Dr Cohen welcomed the FDA’s actions, describing them as, “a bold, aggressive move to eliminate DMBA, a new synthetic stimulant, from the marketplace. 

“We were alarmed to find DMBA in supplements and learn that there had only been two very small animals studies ever performed with this stimulant - not a single human study that we are aware of.

“I'm delighted to see the FDA send a very strong message to multiple manufacturers: DMBA is not found in nature, it is synthetic and poses potential health risks to consumers.

“This is extremely 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: there is no justification to sell DMBA in supplements and it poses a potential health risk to consumers.”

'A pattern of new stimulants cropping up under the deceptive guise of botanical extracts'

Dr Cohen's study was a collaboration with NSF International, and John Travis, NSF International Senior Research Scientist and dietary supplement testing expert, said NSF applauds FDA efforts to remove harmful ingredients such as DMBA from dietary supplements.

"Our research last October found DMBA in 12 dietary supplements, which was concerning as DMBA is chemically similar to other harmful stimulants that have been banned by regulatory agencies in the US, UK, The Netherlands, Brazil and elsewhere because DMBA can harm human health. DMBA has been attributed to negative health events such as strokes, heart failure and sudden death. We are seeing a pattern, that has continued with new stimulants such as DEPEA and BMPEA, cropping up under the deceptive guise of botanical extracts.

"This is why retailers and consumers look for dietary supplements that have been tested and certified by a third party such as NSF International, because it provides assurance that the product label is accurate and free of harmful contaminants and adulterants like DMBA. It is also why the number of certified supplements has doubled in the last year as responsible companies demonstrate the safety and quality of their products,"​ said Travis. 

FDA has multiple enforcement options

Steve Mister, President and CEO of the Council for Responsible Nutrition, told us: “Now that FDA has indicated that BMPEA is not a legal dietary ingredient, we are encouraged to see that the agency is moving quickly to identify the same concerns for this ingredient.  

"This demonstrates that FDA has multiple enforcement options under the law, including the use of the new dietary ingredient notification provision as a means to remove a product if no NDI has been filed."

Warning letters

The FDA sent warning letters to 14 companies regarding a total of 17 products for which the product labeling identifies DMBA as a dietary ingredient.

“The FDA considers these products to be adulterated because they are labeled as containing a new dietary ingredient, DMBA, and because they have not satisfied the conditions described above to include DMBA as a dietary ingredient,” ​states the FDA in a release.

“Under existing law, including the Dietary Supplement Health and Education Act passed by Congress in 1994, the FDA can take action to remove products from the market, but the agency must first establish that such products are adulterated or misbranded.”

The companies (listed below) have 15 business days from the date of receipt of the letter to respond to the Agency.

Vital Pharmaceuticals, Inc. d/b/a VPX Sports (Products: VPX Redline White Heat (strawberry, fruit punch, and watermelon) and MD2 Meltdown)
Powder City LLC (Product: AMP Citrate)
Prime Nutrition (Product: PWO/STIM)
Beta Labs (Product: Oxyphen XR Amp’d)
Genomyx LLC (Product: EVOL)
Lecheek Nutrition (Products: Ampilean and Ampitropin)
Iron Forged Nutrition d/b/a TGB Supplements (Product: Contraband)
Nutrex Research, Inc. (Product: Adipodex)
Blackstone Labs LLC (Product: Angel Dust)
1ViZN LLC (Product: Velocity)
Core Nutritionals LLC (Product: AMP Citrate)
RPM Nutrition, LLC (Product: Red Rum SS)
Brand New Energy LLC (Product: Yellow Bullet AMP)
DSEO LLC (Products: HybriLean and PREAMP)

DMBA is also known as 1,3-Dimethylbutylamine; 2-Amino-4-Methylpentane Citrate; 4-Amino-2-Methylpentane Citrate; 4-Amino Methylpentane Citrate; Amperall; AMP; AMP Citrate; 4-AMP Citrate; 4-Methyl-2-Pentanamine.

BMPEA

The warning letters come less than a week after the FDA sent warning letters to five companies over their use of the ingredient BMPEA​, again linked to a study by Dr Cohen (Drug Testing and Analysis​).

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