As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a company has been given months to years to correct problems. The FDA frequently redacts parts of warning letters posted for public view.

Cocos Holistic Specialties & Apothecary Online sales

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 Cocos Holistic Specialties & Apothecarys website at the internet address https://cocosholisticspecialties.org/.

The FDA observed that the companys 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 FDAs 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.

Listed below are examples of the claims on the companys website that establish the intended use of their products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19.

The company was given 48 hours to send an email to the FDAs COVID-19 Task Force describing the specific steps they have taken to address these violations.

The full warning letter can be viewed here.

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FDA sends warning letter to company that is advertising COVID-19 curing tea - Food Safety News