NDI draft guidance continues to inform FDA's enforcement thinking, latest DMBA warning letter shows

By Hank Schultz

- Last updated on GMT

NDI draft guidance continues to inform FDA's enforcement thinking, latest DMBA warning letter shows

Related tags Dietary ingredient Food and drug administration

The Food and Drug Administration is continuing enforcement actions based on the precepts laid out in the draft guidance on New Dietary Ingredients with a warning letter sent to a company marketing a product that contains the stimulant-like ingredient DMBA.

The warning letter dated August 7 was sent to Dawn Nutrition​, a company based in Omaha, NE.    There were a number of issues cited in the warning letter, most prominent of which was the presence in several products of DMBA, otherwise known as dimethylbutylamine.  FDA noted that Dawn Nutrition was using the term “1,3 Dimethylamulamine” for the ingredient on its label, and also noted that within the industry the ingredient goes by many other names, such as 1,3 -Dimethylbutylamine, 2-amino-4-methylpentane, AMP citrate, and 4-methyl-2-pentanamine. To the agency, it’s all DBMA, and it’s all problematical for several reasons.

First off, the agency stated that there is no evidence that DMBA was in the food supply as an article of food prior to Oct. 15, 1994, meaning that is a New Dietary Ingredient and should have a notification on file.  In concord with that observation, the agency said that there is no safety information on the ingredient.  And thirdly, the agency said that the ingredient may have been produced synthetically, and if so, would not qualify as a dietary ingredient, a reasoning that rests on language contained in the New Dietary Ingredients Draft Guidance which was first issued in 2010 and has been the subject of fierce debate since.

“FDA is saying that in order to be in a dietary supplement, it has to be a dietary ingredient. It has to be a vitamin, mineral or amino acid . . . the definition in the statute.  It goes back to the whole debate with the NDI draft guidance that we are still waiting for the final version.  According to that, a synthetic version of a botanical is not a permissible dietary ingredient. It is essentially the same argument that was made with DMAA,”​ Justin Prochnow, a shareholder in the law firm Greenberg Traurig, told NutraIngredients-USA.

Shady botanical origin

DMBA first made a splash last year with the publication of a study headed by industry critic Dr Pieter Cohen of Harvard.  Cohen and his collaborators found DMBA in 12 of 14 pre workout supplements that they studied​. 

In a story reminiscent of the issues surrounding first DMAA and later dendrobium, an orchid species from which another stimulant-like ingredient popular in sports nutrition products was purportedly extracted, two of the labels in the Cohen study implied that DMBA is a derivative of tea.  Even if that might be true, it raises the same issues as were raised with dendrobium, namely that the ingredient is present in the botanical source in such tiny concentrations as to be commercially unviable and that it could never be said to have been present in the past in the food supply as an article of food and therefore at the very least should have a New Dietary Ingredient Notification on file.

In another installment in the DMBA story, in April of this year, FDA sent warning letters to 14 companies over DMBA in their products​.

Murky botanical origins

“One study in Chinese by Chen and Ou purports to have found DMBA at levels of 0.012 ppm in Pouchung tea as a degradant upon storage; however, an authentic chemical reference standard was not used to confirm the identity or quantity of DMBA in this study,” ​wrote Cohen and his co authors.

"Even if DMBA were found at these very low levels, manufacturers would require at least 1000 kg of Pouchung tea to extract 12 mg of DMBA, and humans would not have previously been ex- posed to the high levels of DMBA that we found in dietary supplements,”​ the authors wrote.

“We are unaware of any scientific evidence that DMBA has ever been extracted from any plant, while synthetic DMBA is easy to synthesize and widely available,”​ the paper said.

False labeling, GMP miscues

In addition to the DMBA question, FDA took Dawn Nutrition to task for failing to do any testing on incoming material that the company rebranded for distribution. The company lacked anything in the way of specifications and quality control procedures according to the agency. The company had no written procedures for labeling operations and had no way to track lot numbers, according to warning letter.

In addition, the agency found a number of products were not even close to matching the composition stated on the label. One product had as little as 16% of the stated protein content, while another contained a sugar overage that exceeded 1,800% of the sugar content stated on the label.

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