FDA WARNING_LETTER - TeaTaze, LLC - April 30, 2021

The FDA issued a Warning Letter to Nicholas P. Gerstner of TeaTaze.com on July 23, 2021, following a review of their websites in March-April 2021. The FDA determined that TeaTaze.com sells products, including Organic Blueberry White & Green, Clean Green Energy Detox, and Ignited Oolong Slimming teas, with claims that establish them as unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

The violations stem from various claims on www.teataze.com and www.facebook.com/teatazetea, suggesting the teas are intended for disease cure, mitigation, treatment, or prevention. Examples include claims that Organic Blueberry White & Green tea has "cancer-fighting antioxidants," "treat[s] anxiety," and "fight[s] infections"; Ignited Oolong Slimming tea helps "relieve symptoms and prevent disease," "lower cholesterol," and "prevent diabetes"; and Clean Green Energy Detox tea is an "immunity booster" against "COVID-19," "cancer," and "viruses."

These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their claimed uses. Introducing or delivering these products into interstate commerce without prior FDA approval violates sections 301(d