FDA WARNING_LETTER - MPH Nutrition LLC

The FDA issued a Warning Letter to MPH Nutrition, LLC, regarding their product "Re:Mind Recover," sold on www.remindrecover.com. The FDA reviewed the website in August 2015 and determined the product is promoted for conditions that classify it as a drug under Section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

The therapeutic claims on the website, including videos and a "White Paper," suggest the product is intended for the cure, mitigation, treatment, or prevention of disease, specifically neurological recovery, concussion recovery, and addressing symptoms following a concussion. Examples include claims about Omega-3s supporting neurological recovery, decreasing future injury risk, and being part of concussion protocols. The website also promotes an "Omega-3 Protocol for Brain Injury" using "Re:Mind Recover" for recovery after contact and mentions potential benefits for stroke, ADHD, and depression. Additionally, the firm's Facebook page contained endorsed testimonials claiming the product helps with lasting effects of concussions and brain healing.

Because "Re:Mind Recover" is not generally recognized as safe and effective for these uses, it is considered a "new drug" under Section 201(p) of the Act. Introducing a new drug into interstate commerce without prior FDA approval violates Section 505(a) and 301(d) of the Act. Furthermore, the product is misbranded under Section