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At the request of the United States Food and Drug Administration (FDA), the U.S. Attorney's Office for the Western District of Pennsylvania filed a Complaint for Forfeiture against $13,500 worth of adulterated and misbranded dietary supplement containing ephedrine alkaloids that were located at ATF Fitness Products, Inc. (ATF) in Oakmont, PA. The U.S. Marshals seized the products in response to a warrant issued by the court.
The products seized include SciFit Procut lots 18822, 16312, 16918, 16834, and 19023 and Thermogen II lot 18981 in an assortment of cases and bottles valued at $13,500.
The seizure follows an FDA investigation that determined the products either contained prohibited ephedrine alkaloids or claimed to contain ephedrine or ephedrine alkaloids but did not.
Under the Food, Drug and Cosmetic Act, FDA may remove a dietary supplement from the market if it presents a significant or unreasonable risk of illness or injury when used according to its labeling or under ordinary conditions of use, if no conditions of use are suggested or recommended in the labeling. On February 11, 2004, FDA made such a finding for dietary supplements containing ephedrine alkaloids. On April 12, 2004, FDA's final rule prohibiting the sale of dietary supplements containing ephedrine alkaloids went into effect. Prior to the final rule, the agency notified firms manufacturing and marketing dietary supplements containing ephedrine alkaloids of its intent to issue a final rule prohibiting their sale.
The Act also prohibits firms from marketing dietary supplements that contain label information that is false or misleading such as claiming to contain ingredients that are not actually present. Under the Act, FDA may remove such products from the market because they are misbranded.
FDA is committed to promoting and protecting the public health by taking action against unsafe products and products that make false and misleading claims.
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