FDA Cracks Down on Company Falsely Promoting COVID-19-Curing Teas

The US Food and Drug Administration (FDA) has sent a warning letter to Coco’s Holistic Specialties & Apothecary, an online holistic and Eastern medicine company, for falsely advertising its products’ ability to prevent, treat, cure and even diagnose people with COVID-19.

The letter, which was sent on January 4, 2021, stated that several of the company’s products violated section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a) which prohibits the introduction and delivery of new drugs without the Secretary of Health of Human Service’s approval.

Between November and December of 2020, the FDA observed that the company’s website offered two products that falsely claimed to prevent, treat, cure and diagnose COVID-19 in people: 4-Thieves Florida Tea Concentrate and 4-Thieves Florida Tea Powder. In the letter, the FDA requested that Coco’s Holistic Specialties & Apothecary address its violations for selling unapproved products to protect consumers from fraudulent claims and cease the sale of such products.

The warning letter also states that the products were misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352 for false or misleading labeling. The letter lists several instances of claims on the company’s website that cite the intended use of its products and deceitfully portray them as safe and/or effective for treating or preventing COVID-19. Some examples include:

• “[A]ntiviral, ongoing clinical research on effectiveness against COVID-19”
• “4-Thieves Florida Tea Concentrate is an anti-COVID herbal inoculation, that is 100% plant-based”
• “[W]anted to share my COVID story . . . [t]here were 8 women that allowed me to treat them for covid-19(-like symptoms) as well as using on myself as a preventative . . . [t]he only thing I’ve been using this whole time, since I finished my 1st batch the 2nd week of February, my 4-Thieves Florida Tea Concentrate . . . The herbal prophylactic inoculation I made against Coronavirus is safe & effective for people of all ages & health conditions.”
• “I had formulated in January of this year from my binge-researching pandemics of the past & found that 4-Thieves was the only thing effective against the Black Plague of the dark ages(14-1700s)…”

In a Facebook post from June of 2020, the founder of Coco’s Holistic Specialties & Apothecary, Janine Havins stated that she ran her own clinical trials resulting in proof of the efficacy of her anti-viral herbal concentrate. A few months later in September, she tweeted that her herbal inoculation kept her “healthy as a horse” after being exposed to COVID-19 ten days prior. None of these claims have been substantiated by any regulatory agency.

http://twitter.com/CocoEtsy/status/1308242821317615616

In addition to the FDA’s demand to cease the sale of falsely advertised products, the agency gave the company 48 hours to respond to its warning letter detailing the specific steps it has taken to address the violations. The FDA also advised consumers against purchasing and using any products that have not received its approval for treating or preventing COVID-19.

Unfortunately, this is not the first instance of a company misleading consumers with COVID-19-curing claims — it is one of nearly 100. On December 21, 2020, the FDA sent a similar warning letter to Alabama-based Sparrow Health & Performance LLC for advertising multiple liquid vitamins as well as “Virus Be Gone” products as COVID-19 prevention and/or treatment methods. On the same day, Riverstone LLC received a warning letter for promoting supplements that “may slow viruses and boost the immune system.”

A full list of FDA warning letters for unapproved or misbranded products related to COVID-19 can be viewed here.