TeaTaze, LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

The claims on your websites establish that the products are 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)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease.

Passage 2

Your Organic Blueberry White & Green, Clean Green Energy Detox, Tokusen Hinshucha Fuji Midori Green, Vibrant Green, Caffeine-Free Herbal Energy, Ignited Oolong Slimming, Power Puer Aged, and Silver Tranquility White tea products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are "new drugs" under section 201(p) of the Act [21 U.S.C. 321(p)].

Passage 3

Your Organic Blueberry White & Green, Clean Green Energy Detox, Tokusen Hinshucha Fuji Midori Green, Vibrant Green, Caffeine-Free Herbal Energy, Ignited Oolong Slimming, Power Puer Aged, and Silver Tranquility White tea products are intended for treatment or prevention of one or more diseases that are not amenable to self-diagnosis, treatment, or prevention without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, your Organic Blueberry White & Green, Clean Green Energy Detox, Tokusen Hinshucha Fuji Midori Green, Vibrant Green, Caffeine-Free Herbal Energy, Ignited Oolong Slimming, Power Puer Aged, and Silver Tranquility White teas fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)].