April 7, 2008

2 Min Read
Feds Seize $1.3 Million in Supplements

BRIGHTON, Mich.—FDA announced April 4 that U.S. Marshalls on April 2 had seized more than $1.3 million of dietary supplements from LG Sciences LLC, alleging the products were adulterated. According to the agency, the dietary supplements—Methyl 1-D, Methyl 1-D XL and Formadrol Extreme XL—contained at least one unapproved food additive and/or new dietary ingredient (NDI) for which there was inadequate information regarding safety.

“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, in a statement. “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 noted it has not yet received scientific information on the safety of the seized products and could not determine whether they represent a hazard to consumers. It recommended consumers discuss use of the products, and any possible adverse events related to the products, with a health care professional. Consumers and health care professionals can report adverse events to FDA’s MedWatch program at (800) FDA-1088 or online at FDA.gov/medwatch/report.htm.

In a statement released to INSIDER, Ronald T. Berry, Esq., a lawyer for LG Sciences, said the company’s products are legal and the ingredients safe for consumers, and that the seizure was “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 added the substances are not NDIs because “these ingredients are naturally occurring, with confirmed studies over 25 years ago, and have been on the market in competitors’ products for several years.”

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