Products alleged to be adulterated under the Federal Food, Drug, and Cosmetic Act
At the request of the U.S. Food and Drug Administration, on Wednesday U.S. 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.
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.