Another over-the-counter fitness and weight-loss supplement has come under the scrutiny of the US Food and Drug Administration, with some experts calling for an all-out ban on the compound called DMAA.
Last month, the FDA issued warning letters to 10 manufacturers of dietary supplements containing the amphetamine-like substance “for marketing products for which evidence of the safety of the product had not been submitted” to the agency. On Monday, a Harvard Medical School researcher published a research letter in the Archives of Internal Medicine calling on the FDA to pull DMAA-containing supplements from shelves, citing possible health risks from case reports that include panic attacks, seizures, heart attacks, stroke, and deaths in those who took high amounts.
“It’s been one of the replacement products for ephedra,” the herbal product banned by the FDA in 2004 after it was linked to rapid heartbeat and heart attacks, said Dr. Pieter Cohen, an internist at the Cambridge Health Alliance and assistant professor at Harvard who wrote the research letter. “Although, in animal models DMAA has been shown to be more potent than ephedra.”
DMAA is an amphetamine-like compound that purports to boost workouts and weight-loss efforts by increasing energy and metabolism. It was once found in decongestant nasal sprays that were taken off the market in the 1970s because of a lack of efficacy.
“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, director of FDA’s Dietary Supplement Program, said in a statement.
The US Army recently banned DMAA-containing supplements from being sold in commissaries on its military bases and launched a study of DMAA after two soldiers died last year from heart attacks following a workout, according to the New York Times; both soldiers had traces of DMAA in their blood.
Supplement manufacturers claim the substance is natural -- found in the leaves and stem of a rose-scented geranium plant -- but Cohen said that’s based on a single study from decades ago showing that the plant is composed of less than 0.7 percent DMAA.
According to the current federal law regulating supplements, manufacturers can include any compounds in their products if they can demonstrate they’ve been in the food supply for years with no safety hazards. Rose-scented geranium (Pelargonium graveolens) has been used to flavor cakes, jams, and ice cream.
Given the minute amount of DMAA found in geranium plants, Cohen said, “it would be virtually impossible to produce even a small fraction of DMAA” from the plants themselves.
Instead, manufacturers must make it synthetically in a lab, which the FDA said requires them to demonstrate that the chemical is safe for human consumption.
GNC Holdings Inc. -- which operates GNC stores that sell DMAA supplements like Jack3D and Oxy Elite Pro -- issued a statement last week disputing concerns over the safety of some of its best-selling supplements. The company asserted that the FDA failed to provide medical or scientific evidence showing that DMAA is unsafe and said, when used as directed, DMAA supplements have “the same effect on the body as drinking two cups of coffee.”
While studies are lacking to determine the exact safety hazards, if any, posed by DMAA, Cohen said he tells his patients to avoid any supplements containing it. “I saw a patient just today who was taking this supplement to improve her workouts,” he said. “She bought it in a health-food store and assumed it must be safe.”
It was hard, Cohen added, to convince his patient to throw the product away since she wasn’t having side effects. He told me he didn’t know whether she was ultimately swayed by his admonitions.Deborah Kotz can be reached at firstname.lastname@example.org. Follow her on Twitter @debkotz2.