FDA WARNING_LETTER - Coco's Holistic Specialties & Apothecary - December 17, 2020

On January 4, 2021, the FDA and FTC issued a Warning Letter to Coco's Holistic Specialties regarding the sale of unapproved and misbranded products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. The agencies reviewed the company's website (https://cocosholisticspecialties.org/) on November 19 and December 17, 2020, and social media pages (Facebook, Twitter) directing consumers to the site.

The products, specifically "4-Thieves Florida Tea Concentrate" and "4-Thieves Florida Tea Powder," are deemed unapproved new drugs under section 505(a) of the FD&C Act (21 U.S.C. § 355(a)) and misbranded drugs under section 502 (21 U.S.C. § 352). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)).

The letter cites the ongoing COVID-19 public health emergency and national emergency declarations as context for urgent action against such products. The company is required to immediately cease selling these unapproved products for COVID-19 related uses. Within 48 hours, the company must email COVID-1