An online “eastern & holistic herbal medicine” company is on notice from the FDA for claims made about their products’ ability to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.
In a Jan. 4 warning letter, the U.S. Food and Drug Administration described a Nov. 19, and Dec. 17, 2020, review of Coco’s Holistic Specialties & Apothecary’s website at the internet address https://cocosholisticspecialties.org/.
The FDA observed that the company’s website offers 4-Thieves Florida Tea Concentrate and 4-Thieves Florida Tea Powder for sale in the United States and that this product is marketed as being intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.
Based on the FDA’s review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act. This product is also a misbranded drug under section 502 of the FD&C Act. The introduction or delivery for introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act…