FDA WARNING_LETTER - Trinity Sports Group, Inc. - June 30, 2012

The FDA issued a Warning Letter to Trinity Sports Group, Inc. after reviewing their websites (www.neuroimpact.net, www.trinitysportsgroupinc.com), Facebook, and Twitter accounts in June 2012. The "Neuro Impact Concussion Response Formula" product is promoted with claims that cause it to be an unapproved new drug and a misbranded drug under the Federal Food, Drug, and Cosmetic Act.

The product is deemed a drug because it is intended for the cure, mitigation, treatment, or prevention of disease, as evidenced by claims like "FORMULATED SPECIFICALLY FOR CONCUSSION RECOVERY," "help those who suffer a concussion recover more rapidly," and celebrity/health professional endorsements. Specific ingredient claims also suggest therapeutic effects (e.g., "Anti-inflammatory," "decreases ... brain cell damage").

As a "new drug," it lacks FDA approval, violating section 505(a) of the Act. Furthermore, it is misbranded under section 502(f)(1) because concussions are not amenable to self-diagnosis and treatment, meaning adequate directions for layperson use cannot be provided. The introduction of this misbranded drug into interstate commerce violates section 301(a).

Trinity Sports Group, Inc. must promptly correct these violations, investigate their causes, and prevent recurrence. They are required to respond in writing within fifteen working days, detailing corrective actions and providing documentation, or explain