A 9th U.S. Circuit Court of Appeals panel handed client Nutrition Distribution LLC a major victory in its ongoing battle to prevent IronMag Labs LLC from its false advertising of its sports supplements containing Ostarine, a substance developed by pharma giant GTx to treat degenerative muscle diseases and cancers, announced Robert Tauler of Tauler Smith LLP in Los Angeles. The lawsuit alleges that IronMag Labs sells Ostarine without a prescription and markets Ostarine as a bodybuilding supplement, even though Ostarine is still in clinical trials. IronMag does not disclose to its customers that Ostarine has well known side effects.
Nutrition Distribution’s position was bolstered by an amicus curiae brief filed by GTx Inc., which said that Ostarine is being investigated as a new drug, is the subject of clinical trials, and, as such, cannot be sold in supplements.
Tauler Smith’s Lisa Zepeda made the successful appeal, arguing in part that “the FDA has made a clear statement that Defendants are selling their products illegally. Thus, even according to the district court’s own reasoning, Nutrition Distribution’s claims are not precluded.”
“We are pleased that the Ninth Circuit acknowledged GTx’s position that since Ostarine is the subject of publicly disclosed clinical trials, it cannot subsequently be marketed as a dietary supplement. It is important that the creators of drugs like Ostarine are able to protect their inventions and the integrity of the clinical trial process to ensure the safety of products,” Tauler said.
The decision was covered by the industry’s leading news source, Natural Products Insider.
- This story spells out the issues involved in the lawsuit: https://tinyurl.com/FDAs-role
- Coverage of the 9th Circuit judges’ decision to dismiss, with prejudice, a lower court’s ruling as “an abuse of discretion … due to a misapplication of the law.” https://tinyurl.com/primary-jurisdiction.
- Watch the arguments made before the court here (Dec. 6, 2017).
- Read the Jan. 24, 2018 ruling here.