[WASHINGTON, D.C.] - U.S. Senators Dick Durbin (D-IL) and Richard Blumenthal (D-CT) today called on the Food and Drug Administration (FDA) to inspect products containing the designer, unapproved and untested stimulant, known as 1,3-Dimethylbutylamine (DMBA) which has been found to be chemically similar to DMAA, a harmful pharmaceutical stimulant banned by the Food and Drug Administration.

In a study released today and reported by USA Today, researchers found DMBA in 12 of 14 supplements that claimed to improve athletic performance, increase weight loss, or enhance brain function. The authors concluded that the “concentrations [of DMBA] found in the supplements strongly suggest that DMBA is synthetically mass-produced to create pharmaceutical effects.”

“Evidence of potential consumer risk associated with DMBA and other designer stimulants is mounting and we commend your agency on its recent report on the emergence of these potentially harmful stimulants,” wrote the Senators.  “Given FDA’s existing authority, your agency should immediately launch an investigation of products containing these untested stimulants and issue warning letters to manufacturers demanding that they provide the necessary safety information. If necessary, we urge you to exercise the full range of your authority to rein in adulterated and misbranded products, which includes warning letters to facility inspections, product seizures, injunctions, and criminal prosecutions.”

The finding of the study published in the journal, Drug Testing and Analysis, are particularly concerning given that DMBA has never been tested in humans and the two studies testing its effect on animals with severed spinal cords provided some evidence that DMBA can increase blood pressure and have other effects similar to DMAA, although less potent. Three cases of adverse effects reported to the Netherlands Anti-Doping Authority, all related to a supplement containing DMBA, also found that patients experienced “rushing, difficulty sitting still, a sense of motion and increased focus.”

In August 2013, Durbin and Blumenthal introduced the Dietary Supplement Labeling Act which would improve the information available to consumers by requiring more information on product labels, give more authority to the FDA to require manufacturers to register their products and ingredients and provide proof of any health benefit claims, and curb the prevalence of drinks and foods that are masquerading as dietary supplements as a means of avoiding reviews and regulation by the FDA.

In 2012, FDA warned 11 companies that the stimulant, dimethylamylamine (DMAA), was an illegal and dangerous ingredient that should be removed from supplements.  Of the warned companies, only USPLabs continued to use DMAA in its products – Jack3D and OxyElite.  After the FDA issued another warning and seized products with a retail value of roughly $8.5 million in early 2013, USPLabs agreed to destroy supplements containing DMAA. In the warning, FDA cited receiving 86 adverse event reports of psychiatric disorders, heart problems, and even death involving products containing DMAA. 

In October 2013, Durbin raised safety concerns about OxyElite Pro, a diet supplement produced by USPLabs that may have been linked to 48 cases of liver injury including death.  The product contained aegeline – a new ingredient in possible violation of federal law which requires a company to report new dietary ingredients and evidence of their safety to the FDA.  Durbin called on USPLabs to provide information showing it has complied with federal law requiring dietary supplement manufacturers to report new dietary ingredients and evidence of their safety to the FDA.

Text of the letter is below.

October 8, 2014

The Honorable Margaret A. Hamburg, M.D.

Commissioner of Food and Drugs

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

Dear Commissioner Hamburg:

            In light of today’s Drug Testing and Analysis publication of a disturbing study finding an unapproved synthetic stimulant, known as 1,3-Dimethylbutylamine (DMBA), in 12 of 14 over-the-counter dietary supplements, we call on FDA to take action against products containing DMBA. We believe products containing DMBA are adulterated and/or misbranded, and the FDA has a responsibility, under the Dietary Supplement Health and Education Act of 1994 to take action against the manufacturers of such products.

DMBA is chemically similar to DMAA, a harmful pharmaceutical stimulant already banned by the Food and Drug Administration (FDA) and linked to 86 reports of illnesses and death. The study published today is the third analysis in recent months in which scientists have identified designer stimulants in dietary supplements that claim to be “natural.” The FDA has yet to take any effective action against companies manufacturing these products despite indications that the chemical may be mass-produced, has not been safety tested, and may be deceptively labeled. FDA should investigate dietary supplements containing DMBA and other designer stimulants and take swift, appropriate regulatory action to immediately warn consumers against tainted products.

Since the removal of DMAA from dietary supplements, researchers have identified a series of new synthetic stimulants that have taken its place. The study released today, conducted by scientists based at Harvard Medical School, NSF International, and the National Institute for Public Health and the Environment in the Netherlands, focused on 14 supplements suspected of containing DMBA, one of these new synthetic stimulants and close cousin of DMAA. Researchers identified DMBA in 12 supplements claiming to improve athletic performance, increase weight loss, or enhance brain function. The researchers report that if the 12 products containing DMBA were taken as recommended, consumers would consume as much as 26 to 320 mg of DMBA each day.

The FDA has the authority to require information from dietary supplements that contain New Dietary Ingredients (NDI) or take action against products that have undeclared or deceptively labeled ingredients. The evidence presented in the analysis released today provides clear justification for FDA to exercise this authority.

Two of the supplements tested suggest on the label that DMBA was extracted from Pouchong tea; however, there is no scientific evidence that DMBA has ever been extracted from Pouchong tea, much less at the large doses found in the supplements. Supplement manufacturers are required to notify the FDA if their dietary supplements contain an NDI, and provide data showing there is a history of safe use of the dietary ingredient when used as suggested in the product’s label. There is no indication that the supplement manufacturers of DMBA filed an NDI notification with the FDA.

Moreover, the authors conclude that the “concentrations [of DMBA] found in the supplements strongly suggest that DMBA is synthetically mass-produced to create pharmaceutical effects.” This is particularly concerning given that DMBA has never been tested in humans and the only two studies on DMBA, both published in the 1940s, only tested its effect on animals with severed spinal cords. However, those animal studies already provide some evidence that DMBA can increase blood pressure and have other effects similar to DMAA, although to a lesser degree. Also, three cases of adverse effects reported to the Netherlands Anti-Doping Authority, all related to a supplement containing DMBA, found that patients experienced “rushing, difficulty sitting still, a sense of motion and increased focus.” Clearly, more information is needed to understand the full health effects of this stimulant.

Lastly, a sample of the supplements analyzed contained ingredients that were mislabeled or deceptively labeled. For example, one supplement listed AMP citrate on the supplement label, rather than listing the chemical name for DMBA, and two of the fourteen supplements studied listed DMBA as an ingredient, but, when tested, did not even contain one mg of the ingredient.

Evidence of potential consumer risk associated with DMBA and other designer stimulants is mounting and we commend your agency on its recent report on the emergence of these potentially harmful stimulants. We ask that you continue your leadership in providing vigorous oversight of dietary supplements in the market. Given FDA’s existing authority, your agency should immediately launch an investigation of products containing these untested stimulants and issue warning letters to manufacturers demanding that they provide the necessary safety information. If merited, we urge you to exercise the full range of your authority to rein in adulterated and misbranded products, which includes warning letters to facility inspections, product seizures, injunctions, and criminal prosecutions.

Our hope is that by calling your attention to studies like the one released today, your agency will take the appropriate steps necessary to remove harmful supplements and protect consumers from any unnecessary health dangers.

Sincerely,