MPH Nutrition LLC produces “Mind Recover,” a supplement recommended for athletes to take after every practice or game in order to support healthy brain function. The supplement beverage contains 3,000 mg of Omega-3, which the company promotes as being “important for neurological recovery.” Because MPH is making therapeutic claims related to its product it qualifies as a drug subject to FDA approval, which it has not obtained.
As a result, the company received a warning letter dated October 1 from the FDA stating that a new drug may not be “legally introduced or delivered for introduction into interstate commerce without prior approval by the FDA.” The letter also warns that Mind Recover is not a product amenable to use following self-diagnosis nor can adequate directions be written so that a layperson can use this drug safely for its intended purposes.”
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