FDA Seizes $1.3 Million in Supplements Marketed for Bodybuilders

LG Sciences Methyl 1 D

FDA seizes $1.3 million in supplements marketed for bodybuilders from Brighton warehouse
by Geoff Larcom | The Ann Arbor News
Friday April 04, 2008

Federal agents seized more than $1.3 million in illegal dietary supplements from a Brighton business that markets products to bodybuilders, authorities announced Friday.

U.S. Marshals confiscated the items Wednesday at a warehouse of LG Sciences, LLC, located on Whitmore Lake Road, because the products contain unapproved food additives or dietary ingredients that violate the law, according to a statement from the U.S. Food and Drug Administration.

The products are labeled as dietary supplements, but are marketed for use by bodybuilders. Products seized were marketed and distributed online and in retail stores under the names Methyl 1-D, Methyl 1-D XL and Formadrol Extreme XL.

Methyl 1-D XL is pictured on the LG Sciences Web site as a bottle of capsules that increases strength and muscle mass. Comments on the site praise the company for the gains users experienced with the products.

The FDA said the seized products previously were tested and found to contain one or more unapproved food additives and/or dietary ingredients that had not been studied to ensure they wouldn’t cause illness or injury.

People who have used the products should consult their doctor, the FDA said.

“Wednesday’s action shows the FDA’s commitment to protecting consumers from potentially harmful products,” Margaret Glavin, the agency’s associated commissioner of the Office of Regulatory Affairs, said in a prepared statement. Glavin could not be reached for comment Friday evening.

Ronald Berry, an attorney for LG Sciences, said Friday evening that all the company’s products are legal, and the ingredients are safe for consumers. He called the FDA seizure “merely a preliminary step in determining compliance with food regulations.”

“Although LG Sciences feels the temporary restraint of its product by the FDA is inappropriate, the company appreciates that the FDA wishes to protect the public,” Berry said in a statement.

In March 2006, the FDA warned a company called Legal Gear – the predecessor to LG Sciences – to cease distribution of another product that was marketed as a dietary supplement but was actually an unapproved new drug containing synthetic steroids, the government’s statement said.

U.S. Attorney Stephen Murphy, whose Detroit office secured the warrants for the seizure, said the civil case likely won’t involve prosecuting individuals. He said the “FDA wanted to get these things before they went out to stores.”

FDA spokeswoman Stephanie Kwisnek said in an e-mail that the FDA is continuing to investigate LG Sciences.

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FDA News

FOR IMMEDIATE RELEASE
April 4, 2007

Federal Agents Seize Nearly $1.3 Million of Illegal Dietary Supplements
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.

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