Last week witnessed the U.S. Food and Drug Administration (FDA) initiate their first injunction against a dietary supplement manufacturer of considerable size. On November 23, 2011, the FDA took legal action against two dietary supplement companies for their neglect to comply with the dietary supplement current Good Manufacturing Practice (cGMP) regulations under the Federal Food, Drug, and Cosmetic Act. Subsequently, the FDA requested a permanent injunction against ATF Fitness Products Inc. (ATF) and Manufacturing ATF Dedicated Excellence, Inc. (MADE) for allegedly substituting ingredients and products without noting changes on the corresponding labels.
In association with the U.S. Department of Health and Human Services, the FDA is responsible for protecting public health by assuring the safety, effectiveness and security of drugs and other biological products. As an important tool in the fight against fraudulent drug manufacturing practices, the cGMP regulations were put in place to assist the FDA in their efforts to eliminate dangerous and illegal manufacturing practices.
According to cGMP regulations, companies are required to include every ingredient on the labels of their products. Doing so provides the public with accurate knowledge to make informative and safe decisions, as they pertain to the dietary supplement industry.
According to a recent FDA News Release, a recent injunction filed against ATF and MADE claims that these dietary supplement manufacturers substituted ingredients and products without noting the changes on the final product labels, a direct violation of the cGMP. The permanent injunction, filed on behalf of the FDA by the U.S. Department of Justice, would stop the defendants from making and distributing more than 400 products for being in violation of the Federal Food, Drug, and Cosmetic Act.
The government’s complaint, filed Nov. 23, 2011, in the U.S. District Court for the Western District of Pennsylvania, alleges that in addition to “adulterating” and “misbranding” their final products, the manufacturer and its owner failed to report serious adverse events associated with their products. In one case an individual who consumed one of the products reported experiencing a spike in blood pressure, hospitalization and a subsequent mild heart attack.
MADE is responsible for the development and distribution of several hundred dietary supplements, including vitamins and minerals, under the brands “Sci-Fit,” “Nature’s Science” and “For Store Only.” ATF purchases dietary supplements exclusively from MADE and distributes them throughout the United States to various retailers. As a result, more than 400 dietary supplements, distributed by MADE and ATF, are believed to be affected by these negligent practices that place consumers at an increased risk of adverse health events.
“Dietary supplements have a significant role in the public’s health,” said Dara Corrigan, associate commissioner for regulatory affairs. The injunction “reinforces our commitment to ensuring that these supplements meet the cGMP requirements the law establishes.”
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Again, if you or a loved one have been injured by a dietary supplement, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.