U.S. Marshalls acting upon authority of the Food and Drug Administration (FDA) seized the following supplements from the LG Sciences warehouse in Brighton, Michigan: Methyl 1-D, Methyl 1-D XL and Formadrol Extreme XL The FDA alleges that the products are adulterated under the Federal Food, Drug, and Cosmetic Act with “one or more unapproved food additives and/or dietary ingredients.” (“FDA seizes $1.3 million in supplements marketed for bodybuilders from Brighton warehouse,” March 4)
According to LG Sciences, the specific ingredients in question by the FDA are 1,4,6 etiocholan-dione (ATD) and 4-etioallocholen-3,6,17-trione (6-OXO-4-androstenedione).
The U.S. Attorney’s office released the following statement:
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.
LG Sciences (formerly Legal Gear) is trying to minimize the FDA seizure.
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.
LG Sciences released the following public statement:
In response to recent action taken by the FDA, LG Sciences wishes to clarify that we contend that all of its products are completely legal and safe. The FDA’s detainment is merely a preliminary step in determining compliance with food regulations. LG Sciences wishes to specifically note that no court has made any determination as to the correctness of FDA’s allegations. Although LG Sciences feels that the temporary restraint of its product by the FDA is inappropriate, the company appreciates that the FDA wishes to protect the public and will cooperate in every possible way.
Unfortunately, the Dietary Supplement Health Education Act (DSHEA) of 1994 is ambiguous and unclear in determining what substances are considered new dietary ingredients (NDI). An NDI requires data be submitted to the FDA regarding safety for human consumption prior to its introduction into the market. Due to a lack of a definitive list of approved dietary ingredients, the FDA mistakenly asserts that the products seized contain substances that are either not dietary ingredients, as defined in the Federal Food, Drug, and Cosmetic Act or that the substances are NDI. However, the substances are not NDI 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. Thus, the ingredients have empirically been shown to be safe to consumers.
Items deemed unapproved food additives by the FDA 1,4,6 etiocholan-dione or commonly known as ATD or 1,4,6 Androstatriene3,17-dione. Additionally items alleged to require a new dietary ingredient status 4-etioallocholen-3,6,17-trione or better known by the trade name 6-OXO-4-androstenedione. LG Sciences looks forward to assisting the FDA in clarifying this matter and the prompt return of its inventory.
About the author
Millard writes about anabolic steroids and performance enhancing drugs and their use and impact in sport and society. He discusses the medical and non-medical uses of anabolic-androgenic steroids while advocating a harm reduction approach to steroid education.
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