FDA WARNING_LETTER - Panther Sports Nutrition - October 23, 2017

The FDA issued a Warning Letter to Panther Sports Nutrition concerning its products "Ostarine MK2866" and "LGD MAX," marketed as dietary supplements. The FDA expressed significant safety concerns about these products, which contain Selective Androgen Receptor Modulators (SARMs), citing risks such as liver toxicity, heart attack, and stroke. The agency determined that these products do not meet the definition of a dietary supplement under section 201(ff) of the FD&C Act because their active ingredients, Ostarine and LGD-4033, were authorized for investigation as new drugs and were not marketed as supplements or food prior to this authorization (21 U.S.C. § 321(ff)(3)(B)(ii)). Consequently, the FDA classified "Ostarine MK2866" and "LGD MAX" as unapproved new drugs under section 201(p) of the FD&C Act, intended to affect body structure/function (muscle building) and not generally recognized as safe and effective. Furthermore, due to their potential for harmful effects, they are considered prescription drugs under section 503(b)(1)(A), requiring professional supervision. The firm's sale of these unapproved new drugs violates sections 301(d) and 505(a) of the FD&C Act. Additionally, the products are misbranded under section 502(f)(1) because their labeling lacks adequate directions for use, a requirement for prescription drugs. Introducing these misbranded products into interstate commerce violates section 301(a). Panther Sports Nutrition must promptly correct these violations within fifteen working days, providing a written response detailing corrective actions, recurrence prevention, and actions for distributed products, or face potential legal action including seizure and injunction.