ProHealth Inc. – FDA Warning Letter, Feb 19, 2021

The FDA issued a Warning Letter to Prohealth.com after reviewing their website in December 2020, identifying that their "Full Spectrum™ St. John's Wort Extract" product is marketed with claims establishing it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). The product is intended for the cure, mitigation, treatment, or prevention of disease.

The FDA determined the product is a "new drug" under section 201(p) of the Act because it is not generally recognized as safe and effective for its claimed uses. Introducing or delivering a new drug into interstate commerce without prior FDA approval violates sections 301(d) and 505(a) of the Act.

Furthermore, the product is deemed misbranded under section 502(f)(1) of the Act because it fails to bear adequate directions for its intended use. As a prescription drug, it requires supervision by a licensed practitioner, making it impossible to provide adequate directions for layperson use. The introduction of misbranded drugs into interstate commerce violates section 301(a) of the Act.

Prohealth.com is required to take prompt action to address these violations and notify the FDA in writing within fifteen working days of receipt of the letter, detailing the specific steps taken to prevent recurrence. Failure to comply may result in legal action, including seizure and injunction