FDA WARNING_LETTER - Red's Kitchen Sink at Bourbon Street Ice - March 02, 2021

The FDA issued a Warning Letter to Ms. Netus of Red's Kitchen Sink on March 2, 2021, following a review of her website (www.redskitchensink.com) and social media (Facebook, YouTube) in January and February 2021. The FDA determined that products sold, including "Pressure Be Gone," "Cell Defense Shield," "Bony-Barony Detox Tea," and "Cell Fuel 102" (capsules, powder, and gel), are unapproved and misbranded drugs.

The products are deemed drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] due to claims on the websites indicating their intended use for the cure, mitigation, treatment, or prevention of disease. Examples of such claims include "fight and prevent diseases and inflammation" for Cell Defense Shield, "lower blood pressure" for Bony-Barony Detox Tea, and "Joint Pain Relief" for Cell Fuel 102.

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 stated uses and lack prior FDA approval. Introducing or delivering these un