The U.S. Food & Drug Administration (FDA) has taken a landmark enforcement action against a Pennsylvania dietary supplement manufacturer for substituting ingredients without updating the changes on the final product labels. This first permanent injunction of its kind would stop the defendants from making and selling more than 400 so-called ‘dietary supplements‘ for being in violation of the Federal Food, Drug, and Cosmetic Act. The FDA’s action came as a result of the companies’ failure to comply with the dietary supplement current Good Manufacturing Practice (cGMP) regulations.
Free Dietary Supplement Lawsuit Evaluation: If you or a loved one has been injured by a dietary supplement, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the dietary supplement and we can help.
What’s the problem?
November 23, 2011 – Today, the FDA requested a permanent injunction against the following entities for failure to comply with cGMP regulations:
- ATF Fitness Products Inc. (ATF)
- Manufacturing ATF Dedicated Excellence, Inc. (MADE)
- James G. Vercellotti of Oakmont, Pa., owner and operator of both companies
Under cGMP, drugmakers are required to ensure quality in their dietary supplements by controlling all aspects of their manufacturing processes. MADE currently manufactures over 400 dietary supplements under the brand names ‘Sci-Fit,’ ‘Nature’s Science’ and ‘For Store Only.’ ATF buys these products and subsequently distributes them to retailers around the country.
“Dietary supplements have a significant role in the public’s health,” said Dara Corrigan, associate commissioner for regulatory affairs. “Today’s injunction reinforces our commitment to ensuring that these supplements meet the cGMP requirements the law establishes.”
The groundbreaking injunction, which was filed in the U.S. District Court for the Western District of Pennsylvania, states that ATF, MADE, and Mr. Vercellotti adultered, misbranded, and failed to report serious side effects associated with their dietary supplement products. In one case, a consumer who took the supplements reportedly experienced a drastic spike in blood pressure followed by a mild heart attack.
It is the Food & Drug Administration’s mission to protect the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use. The FDA is also responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, devices that emit electronic radiation, and for the regulation of all tobacco products.
Do You Have a Dietary Supplement Lawsuit?
The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in dietary supplement lawsuits. We are handling individual litigation nationwide and currently accepting new dietary supplement injury cases in all 50 states.
Free Dietary Supplement Lawsuit Evaluation: If you or a loved one has been injured by a dietary supplement, you should contact our law firm immediately. You may be entitled to compensation by filing a dietary supplement injury suit and we can help.