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.
Coco’s 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 Coco’s Holistic Specialties & Apothecary’s website at the internet address https://cocosholisticspecialties.org/.
The FDA observed that the company’s 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 FDA’s 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 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.
- “[A]ntiviral, ongoing clinical research on effectiveness against COVID-19”
- “January I decided to put aside her [sic] upwards of 20 different holistic plant-based product lines to focus on binge researching herbs from past pandemics, why they worked, what the similarities there are to CV-19 . . . In January this year when I 1st heard of what later transpired into the Novel Coronavirus Pandemic, had binge-researched pandemics of the past, and what had been used to remedy them at those times . . . there were enough similarities between the transhuman variations . . . that I was so intrinsically inclined to acquire the herbs I researched for the original Marseilles France 4-Thieves recipe . . . I next binge-researched what antiviral herbs I could augment in to make it effective against Covid-19 . . . I had taken out the 2 herbs that made the original for external use only, cause I intended to make tea pills to inoculate CV-19, exchanging those with 6 herbs that specifically kill viruses. . . !”
- ”4-Thieves Florida Tea Concentrate is an anti-COVID herbal inoculation, that is 100% plant-based” — from the company’s Facebook page, https://www.facebook.com/KaliLengua.
- “[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.” From an August 12, 2020 post on the company’s Facebook page, https://www.facebook.com/KaliLengua.
- “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). It was found to be a bacterial infection, & 2 ingredients in the original recipe created in Marseilles England by the mother of one of the 4 thieves, made the recipe for external use only & not effective against viruses. So listening to my intuition & knowledge I further binge-researched what antiviral herb I could replace those 2 with to make it effective against COVID-19. After having run my own clinical trials resulting in proof of the efficacy of my anti-viral variation of this herbal inoculation, I aptly named it 4-Thieves Florida Tea, & I sell it as a concentrate.” From a June 15, 2020 post on the company’s Facebook page, https://www.facebook.com/KaliLengua.
- “This is me singing . . . because it waa [sic] the best way I could think of to show my health 10 days after the beginning of my exposure to COVID-19 that I still [am] healthy as a horse, due to my antiviral herbal inoculation.” From a Sept. 21, 2020, tweet from the company’s Twitter page, https://twitter.com/CocoEtsy.
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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