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.
Officials with a company in New York are on notice from the FDA for claims that their Earth Tea Extra Strength product for sale in the United States can mitigate, prevent, treat, diagnose or cure COVID-19 in people.
In a Feb. 18, 2020, warning letter, the FDA described inspections on Jan. 25 and Jan. 29, that reviewed B4B Corp.’s website and social media pages.
The FDA’s review revealed that this product, Earth Tea Extra Strength, is an unapproved new drug sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, this product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. § 352.
“The statements on the company’s website and Twitter feed establish the intended use of the product and misleadingly represent it as safe and/or effective for the treatment or prevention of COVID-19 include, according to the FDA.
Examples of the statements and claims 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.”
- “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 24-48 hours. Loss of taste and smell will resume there after or immediately.”
- “Health Benefits . . . 3. COVID19 . . . So far we have seen other benefits of Earth Tea. Even though it was specifically developed to fight COVID . . . Earth Tea is confirmed to stop coughing from COVID-19 100% . . .”
- “So basically Earth Tea came to life from our manager trying to cure himself back in March when there was (sic) no treatments available, he cured himself successfully then realized if it helped him it can help others. As someone who is considered a patient not a doctor or scientist he had no idea what to expect from the medical world. As he self checked himself ‘min by min’ he tweaked Earth Tea to a set formula that worked against COVID19.”
- “We know Earth Tea loves your #lungs which is why its (SIC) so powerfull against #COVID19 so as this volunteer makes progress we are planning to uplift Earth Tea to be #1 choice to get people off the #ventilator not only for COVID-19 but in general.”
- In a Nov. 27, 2020, post on their Twitter page , the company officials quote Tweeted another user’s post that says: “Covid19 Stopper How it came to Life and lessons learned #COVID19 #coronavirus #naturaltreatment . . .” This post contains an image of the Earth Tea Extra Strength product label, which says, “100% Natural COVID-19 SMOKING COUGH STOPPER.”
- “We would suggest to anyone out there facing #COVID19 issues. #TryEarthTea you do not have to be a #longhaulers Earth Tea can fight for you.”
- In a Nov. 3, 2020, post on their Twitter page, the company posted an image of their Earth Tea Extra Strength product label, which says, “100% Natural COVID-19 SMOKING COUGH STOPPER,” and they state, “Got #Covid19 Call the Stopper Hotline . . .”
- “Well we are sitting on the greatest weapon of all against SARS-Cov-2 waiting and waiting and waiting and waiting for the Gov to say Attack!!!!! The Mr Furious (Earth Tea) can go to work . . .”
- “When it comes to #COVID19 Earth Tea stops the prolong (sic) issues. Loss of taste and smell etc comes back fast.”
- “Earth Tea the #1 #Covid19 fighter!!!!” — From an Oct. 29, 2020, post on their Twitter page .
- “Covid19 . . . Has met its match. Earth Tea. Our official formula now 100% guarantee to get rid of #Covid19. If you would love to try Earth Tea for Free as prevention send us a text . . .”
- “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.”
- “Earth Tea proven natural treatment for COVID-19. by B4B corp. work (sic) in minutes get u feeling normal within 24 hrs. earthtea.us #COVID19 #CORONAVIRUS.”
The full warning letter can be viewed here.
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