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.


AusarHerbs
Madera, CA

An online company that sells “mixtures and teas” is on notice from the FDA for claims made about their products’ ability to mitigate, prevent, treat, diagnose or cure COVID-19.

In a Jan. 12 warning letter, the U.S. Food and Drug Administration described a Dec. 17, and Dec. 21, 2020, review of AusarHerbs’s website at the internet address https://ausarherbs.com/.

The FDA observed that the company’s website offers “Corona Destroyer Tea” 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, the tea and other 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.

Listed below are examples of the claims on the company’s 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 name of the product, “Corona Destroyer Tea,” and the two formula options “Prevention” and “Reversal.”
  • “Based upon the notes and files left behind by Dr. Sebi his fellow colleagues and trusted family members have recommended this formula to prevent and destroy what is being called Corona virus/ Covid 19. … This formula will reversed Covid 19 in 7 days, every time. Symptoms gone in 3 days.” 
  • “Based upon the notes and files left behind by Dr. Sebi his fellow colleagues and trusted family members have recommended this formula to prevent and destroy what is being called Corona virus.” 

The company was given 48 hours to send an email to the FDA’s 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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