FDA WARNING_LETTER - Smarter Nutrition, Inc. - December 28, 2020

The FDA issued a Warning Letter to Smarter Nutrition on December 28, 2020, following a review of their websites (smarternutrition.com and facebook.com/smarternutrition1) in December 2020. The FDA determined that Smarter Nutrition sells products, specifically Smarter Curcumin, Smarter Ubiquinol, and Smarter Vitamin D3, with claims that establish them as unapproved new drugs under the Federal Food, Drug, and Cosmetic Act (the Act).

The violations stem from numerous claims on their website and social media, suggesting the products are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease. Examples include claims that Smarter Curcumin "Helps to Fight Free Radical Damage and Inflammation," "may even fight cancer," and "knock out unhealthy inflammation." Smarter Ubiquinol claims to "Targets free radicals that can damage ovaries and contribute to infertility." Most critically, Smarter Vitamin D3 is marketed with claims related to mitigating, preventing, treating, or curing COVID-19, such as "help your body fight off a respiratory illness" and "decrease your risk of respiratory infection."

These products are considered "new drugs" because they are not generally recognized as safe and effective for their intended uses and lack prior FDA approval, violating sections 301(d) and 505(a) of the Act. Furthermore, Smarter Curcumin and Smarter