The FDA has sent a warning letter to B4B Corporation, makers of Earth Tea, against false statements regarding the treatment and cure of COVID-19. The FDA says that the company is offering the product for sale and that it is intended to “mitigate, prevent, treat, diagnose, or cure COVID-19 in people.” That makes the product and unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act and also makes the product a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. § 352.
Some examples of claims on the company’s website that misleading represent the product as safe and/or effective for the treatment and prevention of the viral illness include, “Earth Tea works fast so it can eliminate quarantine time. With those simple steps we can move to end the Pandemic fast. While vaccines gets distributed we are clearing the sick and needy.” and “You do not need to take this treatments continuously for Virus Issues . . . Earth Tea Extra Strength natural antibiotics will works on virus . . . You’ll be back to normal within 24-48hrs. Loss of taste and smell will resume there after or immediately.” and ‘To this day.. Earth Tea is the most effective Treatment against#COVID19 as Treatment and Prevention.. All NaturA1.. #TRYEARTHTEA Get well in 24-48 Hours..72 Hours MAX.”
The FDA has instructed the company to take immediate action to address the violations cited in the letter. It is the company’s responsibility to make sure that the products they sell are in compliance with FDA’s regulations and the FD&C Act.
It is unlawful to advertise that a product can prevent, treat, or cure human disease unless a company has competent and reliable scientific evidence, including, when appropriate, well-controlled human studies, substantiating that the claims are true at the time they are made. No study is currently known to exist for the product above in relation to COVID-19.
FDA is advising consumers not to purchase or use products that haven’t been cleared, approved, or authorized by the FDA and that are being misleadingly represented as safe and effective for the treatment and prevention of COVID-19. The company will be added to the list of fraudulent coronavirus disease products on FDA’s website of firms and website that have received warning letters for this issue.
