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ProHealth Inc. was warned for marketing Full Spectrum™ St. John's Wort Extract as a drug without FDA approval by making disease claims on their website, including that the product was "effective for mild to moderate depression" and "reduces anxiety." The product violated the Federal Food, Drug, and Cosmetic Act because it lacked the requisite new drug application approval and made therapeutic claims that established its intended use as a drug rather than a dietary supplement. Additionally, the product failed to bear adequate directions for use as required for drugs under section 502(f)(1) of the Act.