November 18, 2013
FDA on Monday said authorities seized more than $2 million in dietary supplements from Hi-Tech Pharmaceuticals Inc. after it discovered the products contained a stimulant that has been associated with cardiovascular problems: DMAA.
According to FDA in a news release, an inspection of Hi-Tech Pharmaceuticals that began in October identified 11 products that were labeled as containing DMAA (1, 3-Dimethylamylamine) or its chemical equivalent. FDA investigators also found bulk DMAA raw ingredients at the facility.
A lawsuit filed in Georgia alleged the products are adulterated under the Federal Food, Drug and Cosmetic Act because they contain an unapproved food additive.
But Hi-Tech Pharmaceuticals, whose products include weight loss, muscle and sexual-enhancement supplements, also sued FDA. The company alleged FDA's attempt to eliminate DMAA from the market exceeds its authority and violates the Administrative Procedure Act, according to a Nov. 8 article from Courthouse News Service.
"By its own admission, the FDA has declined to engage in the rule-making process necessary to formally ban DMAA. Thus, there has been no public discussion or comment regarding the scientific evidence regarding DMAA and its safety," Hi-Tech Pharmaceuticals was quoted as stating in the lawsuit.
During a presentation at SupplySide West last week, Daniel Fabricant, Ph.D., FDA's Director of the agency's Division of Dietary Supplement Programs, argued that FDA does not need to follow the rule-making process to remove DMAA products from the market. He said DMAA is not a dietary ingredient, so supplements that contain it are not legal to sell in the United States.
Hi-Tech Pharmaceuticals filed the complaint after FDA administratively detained its products on Nov. 1. Afterward, U.S. Marshals seized roughly 1,500 cases of finished goods and about 1,200 pounds of in-process/raw material goods at the company's facility in Norcross, GA.
The supplements found to contain DMAA or its equivalent included the following: Black Widow, ECA XTREME, FASTIN, FASTIN-XR, Lipodrene, Lipodrene HARDCORE, Lipodrene XR, Lipodrene XTREME, LIPOTHERM, Stimerex-ES and YELLOW SCORPION.
Neither Hi-Tech Pharmaceuticals nor an attorney representing the company was immediately available Monday to comment on FDA's news release.
FDA said it has received several reports of death and illnesses associated with DMAA-containing supplements, including heart problems and nervous system or psychiatric disorders. The agency has warned that the substance can heighten blood pressure and could lead to such cardiovascular problems as shortness of breath, tightening of the chest and heart attack.
This is at least the second seizure of DMAA supplements this year. FDA previously seized products at GNC and USPLabs facilities, including Jack3d and OxyElite Pro. Fabricant noted in a July 30 blog that USPlabs ultimately agreed to destroy the products, which had a retail value of roughly $8.5 million.
The agency has received reports of more than 100 illnesses including six deaths associated with products that contain DMAA, according to Fabricant.
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