F.D.A. Sends Warning Letters to 10 Marketers of ‘Workout Boosters’
By NATASHA SINGER and PETER LATTMAN
Published: April 27, 2012
The Food and Drug Administration warned marketers of dietary supplements this week that certain popular “workout boosters” could increase people’s blood pressure, potentially causingshortness of breath or heart attacks.
With names like Jack3d and OxyElite Pro, these products have been popular with athletes because they contain an ingredient, known as dimethylamylamine or DMAA, advertised to increase energy, concentration and metabolism. Marketed as dietary supplements, the products have been best sellers among fitness buffs at stores like GNC and the Vitamin Shoppe, as well as on Web sites likebodybuilding.com.
But in warning letters sent on Tuesday to 10 firms that make or distribute such items, federal health regulators deemed the products adulterated because, the agency said, the firms had failed to demonstrate the safety of the crucial ingredient. DMAA, agency officials wrote in the letters, “narrows the blood vessels and arteries,” frequently leading to elevated blood pressure.
“Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products,” Daniel Fabricant, director of the F.D.A.’s dietary supplement program, said in a statement on Friday afternoon. “They haven’t done that, and that makes the products adulterated.” The firms have 15 business days to tell the F.D.A. what actions they plan to take to address the issues cited in the letters.
Marketers say the ingredient is safe.
Greg Miller, a spokesman for GNC, said the company was “unaware of any scientific or medical evidence which calls the safety of DMAA into question” and disagreed with the F.D.A.’s action.
Peter B. Hutt, a lawyer at Covington & Burling who represents USPlabs, the marketer of Jack3d and OxyElite Pro, said: “The company is convinced that DMAA is lawfully marketed as a dietary ingredient under federal law and the company will present a full defense of the ingredient.”
Other firms that received the agency’s warning letters include Muscle Warfare, which markets a DMAA product called Napalm; MuscleMeds Performance Technologies, the marketer of Code Red; and Farenheit Nutrition, which markets a product called Lean-Efx.
The agency’s warning follows an announcement earlier this year by the United States Defense Department that it was investigating whether products containing DMAA played a role in the deaths of two soldiers last year.
DMAA was originally developed in the 1940s by Eli Lilly, the pharmaceutical company, as a nasal decongestant called Forthane, but the drug maker stopped making the medicine.
In Canada, the government health agency has classified DMAA as an amphetaminelike drug, prohibiting companies there from selling the ingredient as a dietary supplement.
Steve Mister, the chief executive of the Council for Responsible Nutrition, a dietary supplement trade group, said that DMAA had been the subject of controversy in the industry.
“Some companies have been critical,” Mr. Mister said, “but some companies that make it say that they have the data to show that it is both safe and a legitimate dietary supplement ingredient.”
Still, Mr. Mister added, “I am not defending this ingredient because none of my member companies make it.”