| U.S. Food and Drug Administration |
FDA Press Release, Feb 25, 2005
Illegal Dietary Supplements Seized
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.
This advisory was prepared by the FDA Office of Public Affairs.