FDA WARNING_LETTER - Phytag Labs - September 09, 2021

The FDA issued a Warning Letter to Mr. George Rivera of Phytag Laboratories regarding their "GLUCOTYPE2" product, sold on their website and Amazon storefront. An August 2021 review found claims establishing the product as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), intended for disease cure, mitigation, treatment, or prevention.

Specific claims cited include "CONTROL YOUR BLOOD SUGAR NOW," support against "Type 2 diabetes," "reducing inflammation, lowering cholesterol, reducing nerve pain," and "lowers elevated blood sugar levels and blood pressure in Type 2 Diabetes." These claims render "GLUCOTYPE2" a "new drug" under section 201(p) of the Act, requiring prior FDA approval, which it lacks.

Furthermore, the product is deemed misbranded under section 502(f)(1) of the Act because it lacks adequate directions for use by a layperson, as it addresses conditions requiring supervision by a licensed practitioner. Introducing or delivering this unapproved and misbranded drug into interstate commerce violates sections 301(d), 505(a), and 301(a) of the Act.

The letter requires a written response within 15 working days detailing corrective actions and prevention measures. Failure to comply may result in legal action, including seizure and injunction. The Federal Trade Commission