Federal Agents Seize Nearly $1.3 Million of Illegal Dietary Supplements
Products alleged to be adulterated under the Federal Food, Drug, and Cosmetic Act
On March 2006, the FDA warned Legal Gear (the
predecessor of LG Sciences) to cease distribution of a different
product that was marketed as a dietary supplement but was actually an
unapproved new drug containing synthetic steroids.
At the request of the U.S. Food and Drug Administration, Marshals seized more than $1,301,712 of dietary supplements from LG Sciences, LLC, of Brighton, Mich., because the products contain unapproved food additives and/or new dietary ingredients that cause the products to violate the law. Labeled as dietary supplements, the products are marketed for use by body builders.
The dietary supplements seized were marketed
and distributed on-line and in retail stores under the names "Methyl
1-D," "Methyl 1-D XL," and "Formadrol Extreme XL."
The seized products previously were tested and
found to contain one or more unapproved food additives and/or new
dietary ingredients for which there is inadequate information to
provide reasonable assurance that the ingredients do not present a
significant or unreasonable risk of illness or injury.
"The FDA takes seriously its responsibility to
protect Americans from unsafe dietary supplements," said Margaret
Glavin, FDA's Associate Commissioner of the Office of Regulatory
Affairs. "Wednesday's action shows FDA's commitment to protecting
consumers from potentially harmful products."
"Working with the FDA, we are taking prompt
civil action to protect the public health by seizing these illegal
products and forestalling their shipment into the stream of commerce in
any manner that could create harm to the public," said U.S. Attorney
Stephen J. Murphy. "I commend the professionalism and swift action of
the FDA investigators who discovered and investigated this serious
problem, and I am glad our lawyers could provide the legal muscle
needed to support the seizure."
FDA has not received scientific information on
the safety of the seized products and cannot determine, at this time,
whether they represent a hazard to consumers. Therefore, consumers who
still have the products should strongly consider discussing the use of
these products with their health care professionals. FDA also
recommends that consumers consult their health care professionals if
they have experienced any adverse events that they suspect are related
to the products' use.
Consumers and health care professionals can
report adverse events to the FDA's MedWatch program at 800-FDA-1088 or
online at www.FDA.gov/medwatch/report.htm.