Red's Kitchen Sink at Bourbon Street Ice Warning Letter Details

Summary

Red's Kitchen Sink at Bourbon Street Ice was warned for marketing four products—Pressure Be Gone, Cell Defense Shield, Bony-Barony Detox Tea, and Cell Fuel—as unapproved new drugs through their website and social media platforms. The FDA determined these products violated the Federal Food, Drug, and Cosmetic Act because their marketing claims (such as "help fight and prevent diseases," "anti-viral, antimicrobial and anti fungal properties," and relief of respiratory conditions) established them as drugs intended to cure, mitigate, treat, or prevent disease. The company lacked the required FDA approval to market these products as drugs and had introduced them into interstate commerce in violation of the Act.