Phoenix Nutritionals, Inc. – FDA Warning Letter, Jul 1, 2021

The FDA issued a Warning Letter to Phoenix Nutritionals Inc. on July 1, 2021, after reviewing their websites (phoenixvitamins.com, healthyinformation.com) and social media (facebook.com/phoenixnutritionalsinc/) in June 2021. The FDA determined that the company's products, including High Vitality Full Spectrum Liquid Multi-Vitamin, High Vitality Caps, Best Cholesterol Support, Blood Sugar Support, Maximum Stress Support, Complete Joint Support, Natural Anti-Inflammatory Support, and Best Immune Support, are unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act (the Act).

The violations stem from numerous therapeutic claims made on their websites and social media, which establish the products' intent for use in the cure, mitigation, treatment, or prevention of diseases. Specific claims cited include those related to cancer prevention, cholesterol reduction, blood sugar stabilization for diabetes, anxiety and depression treatment, arthritis reversal, inflammation reduction, and COVID-19 mitigation.

These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. 321(p)] because they are not generally recognized as safe and effective for their claimed uses and lack prior FDA approval. Introducing or delivering these products into interstate commerce without approval violates sections 301(d) and 505(a) of the Act [