In a May 2015 warning letter to Texas Superfoods president Dennis Black, the U.S. Food and Drug Administration identifies multiple violations of federal new drug regulations. Based on 2014 facility inspections and reviews of the company's website, the FDA cites the unregulated manufacture and sale of unapproved new drugs.
The chief FDA complaint targets the company's claims that its products cure, treat or prevent disease, in direct violation of the Federal Food, Drug and Cosmetic Act. The absence of FDA-approved, medically prescribed doses means that customers cannot use the products safely. The warning letter also addresses the company's inability to ensure FDA approval of manufacturing standards, resulting in contaminated products.