The Food and Drug Administration recently sent warning letters to 10 marketers of diet supplements that tout themselves as “workout boosters.”
The supplements, including Jack3d and OxyElite Pro, contain dimethylamylamine, or DMAA, which the manufacturers claim can increase energy, concentration and metabolism, often referring to it as a “natural” stimulant, the agency said.
But the FDA cautioned that the safety of DMAA has yet to be demonstrated, noting that it can narrow blood vessels and arteries, causing elevated blood pressures which in turn can result in cardiovascular events such as shortness of breath or heart attacks.
DMAA is not a “dietary ingredient” because it is synthetically produced, the letters noted, and therefore cannot be lawfully marketed as a dietary supplement.
“Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that and that makes the products adulterated,” Daniel Fabricant, Ph.D., Director of the FDA’s Dietary Supplement Program, said in a statement.
The letters warn the marketers and manufacturers to cease distribution immediately or face an enforcement action by the agency.
Recipients of the letters questioned the FDA’s action. A lawyer for USP Labs, which markets Jack3d and OxyElite Pro, told The New York Times that DMAA is “lawfully marketed as a dietary ingredient under federal law and the company will present a full defense of the ingredient.”
To read the FDA’s warning letter to USP Labs, click here.
Why it matters: DMAA has caused controversy before. Canada’s government health agency classified the ingredient as an “amphetamine-like” drug that cannot be used as an ingredient in dietary supplements in that country. Manufacturers of dietary supplements are well advised to exercise caution when developing and disseminating claims for their products.