Dietary supplement marketers turning to DMBA as a replacement for DMAA in weight loss and strength training products will be looking for another substance as FDA swings its enforcement toward DMBA.

FDA continued singling out ingredients in products marketed as dietary supplements and identified by researchers as potentially dangerous by warning 14 firms about DMBA – identified on labels by erms including 1,3-dimethylbutylamine, 2-amino-4-methylpentane and 4-methyl-2-pentanamine.

The Center for Food Safety and Applied Nutrition told the firms, including direct seller 1ViZN LLC, that DMBA renders their products adulterated, according to warning letters published April 28.

CFSAN Office of Compliance Director William Correll explains in the letters submitted April 24 that not only would a new dietary ingredient notification be required before a firm could market products with DMBA, but also that FDA would not allow its use.

Unlike CFSAN’s April 21 warnings to eight other firms about products containing another synthetic stimulant, beta-methylphenethylamine, including some that labeled the ingredient as an extract of the botanical Acacia rigidula, the latest warnings question the safety of the products.

Angel Dust, Contraband And More

The firms CFSAN warned about DMBA and the targeted products are:

1ViZN LLC , Lehi, Utah, Velocity
Beta Labs , Newark, Del., Oxyphen XR Amp’d
Blackstone Labs LLC , Boca Raton, Fla., Angel Dust
Core Nutritionals LLC , Arlington, Va., AMP Citrate
Genomyx LLC , Riverside, Calif., EVOL
Iron Forged Nutrition , d/b/a TGB Supplements, Hopwood, Pa., Contraband
Nutrex Research Inc. , Oviedo, Fla., Adipodex
Powder City LLC , York, Pa., AMP Citrate
Prime Nutrition , Boca Raton, Fla., PWO/STIM
RPM Nutrition LLC , Norwalk, Conn., Red Rum SS
Vital Pharmaceuticals , d/b/a VPX Sports, Weston, Fla., VPX Redline White Heat and MD2 Meltdown
Lecheek Nutrition , Harrison, Ark., Ampilean and Ampitropin
Brand New Energy LLC , Burbank, Calif., Yellow Bullet AMP
DSEO LLC , Riverside, Calif., HybriLean and PREAMP

“Given that you have declared DMBA as a dietary ingredient in the labeling of your product, we assume you have a basis to conclude that DMBA is a ‘dietary ingredient’,” however to “the best of FDA’s knowledge, there is no history of use or other evidence of safety establishing that DMBA will reasonably be expected to be safe when used as a dietary ingredient,” Correll states.

“In the absence of a history of use or other evidence of safety establishing that DMBA, when used under the conditions recommended or suggested in the labeling of your product, will reasonably be expected to be safe,” the eight firms’ products are adulterated, according to the letters.

Through April 8, two adverse event reports were submitted for products containing DMBA, though no causal link is established to the ingredient “as these products contained more than one stimulant,” a CFSAN official said.

“The FDA is not aware of any overt safety concerns with the use of this ingredient, but neither is FDA aware of evidence establishing that DMBA is safe for the uses recommended on the product labeling,” the official added in an email.

Studies Urge Enforcement

Earlier in April, researchers published a study warning that they found beta-methylphenethylamine, or BMPEA, in supplement products marketed for weight loss and sports training. They also noted FDA found BMPEA in Acacia rigidula-labeled products in research the agency published in 2013 ([A#05150427010]).

Some of the same researchers previously cautioned FDA about DMBA. In a study published in October 2014, they urged manufacturers to recall products containing DMBA and asked FDA to warn consumers about the substance, determine whether it is appropriate for use in supplements and, if it is found to be unsafe, enforce against firms that continue marketing violative products ([A#05141013007]).

The lead researcher in both studies, Pieter Cohen, of Harvard Medical School Department of Medicine, said the DMBA warnings show what appears to be more active enforcement by FDA.

“Rather than waiting until heart attacks, strokes or deaths are definitely linked to DMBA supplements, 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,” Cohen said in an email.

These warnings and those submitted April 21 about BMPEA are notable as letters from CFSAN advising firms about noncompliance with FDA’s dietary supplement regulations rather than warnings from the agency’s drug center about products marketed as supplements but containing drug ingredients or making claims that render the products drugs.

Several firms FDA warned in the DMBA letters no longer include the product on their websites and two, Genomyx LLC and LeCheek Nutrition, posted similar statements following the October 2014 study by Cohen and his colleagues that the firm no longer would sell products with the ingredient.

“We always strive to provide the highest level of quality and safety in our products,” but “there has been a high degree of adverse publicity pertaining to one ingredient, AMP Citrate” and “out of an abundance of caution, a concern for the well-being of our loyal customers, and in the best interests of our company, we have decided to stop selling products containing AMP Citrate and are working on a new formula for these products,” Genomyx said in an Oct. 16 posting and LeCheek posted on Oct. 17.

A Genomyx product formulated with an ingredient FDA identified as DMBA, EVOL, remains available on the firm’s website. Unlike most other products on the website, the Riverside, Calif., firm does not list ingredients for EVOL.

FDA began its process of banishing DMAA from supplement formulations with April 2012 warning letters similar to CFSAN’s DMBA warnings. Most of the targeted manufacturers began recalling the violative products and, despite some holdouts that in various fashions resisted FDA’s enforcement, DMAA formulations largely have been absent from the U.S. market since late 2013 Also see "Hi-Tech Lawsuit Calls FDA DMAA Enforcement “Bullying Tactics”" - Pink Sheet, 25 November, 2013..

DMBA Was The New DMAA

FDA’s warnings likely are taking out of the supply chain the latest stimulant ingredient for sports training supplement product firms. Several companies that FDA warned about using DMBA have website statements, some in videos, about either removing DMAA – commonly cited as 1,3-dimethylamylamine – from their formulations or introducing DMBA as its replacement.

In a video introducing the DMBA-containing product branded Angel Dust, Blackstone LLC CEO Aaron Singerman said the ingredient is what “a lot of people have been dubbing the new 1, 3-dimethyl.”

Blackstone, of Boca Raton, Fla., had sold a DMAA-formulated Angel Dust, but “not long ago we ran out of it,” Singerman said.

Another firm, Powder City LLC, of York, Pa., lists its product identified in FDA’s letter, AMP Citrate, on its website adjacent to DMBA printed in brackets and describes the ingredient as “a natural compound found in Pouchong, a type of Chinese tea.”

FDA Chases Another Synthetic Stimulant Off Supplement Ingredient Menu

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