# FDA WARNING_LETTER - Coco's Holistic Specialties & Apothecary - December 17, 2020

Source: https://www.globalkeysolutions.net/records/warning_letter/cocos-holistic-specialties-apothecary/b11d2413-a3e8-4191-b0f9-630b9bd8ff02

> FDA WARNING_LETTER for Coco's Holistic Specialties & Apothecary on December 17, 2020. Product: Drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: WARNING_LETTER
- Company Name: Coco's Holistic Specialties & Apothecary
- Inspection Date: 2020-12-17
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On January 4, 2021, the FDA and FTC issued a Warning Letter to Coco's Holistic Specialties regarding the sale of unapproved and misbranded products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. The agencies reviewed the company's website (https://cocosholisticspecialties.org/) on November 19 and December 17, 2020, and social media pages (Facebook, Twitter) directing consumers to the site.

The products, specifically "4-Thieves Florida Tea Concentrate" and "4-Thieves Florida Tea Powder," are deemed unapproved new drugs under section 505(a) of the FD&C Act (21 U.S.C. § 355(a)) and misbranded drugs under section 502 (21 U.S.C. § 352). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)).

The letter cites the ongoing COVID-19 public health emergency and national emergency declarations as context for urgent action against such products. The company is required to immediately cease selling these unapproved products for COVID-19 related uses. Within 48 hours, the company must email COVID-1

## Related Officers

- [Director](https://www.globalkeysolutions.net/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
- [Associate Director](https://www.globalkeysolutions.net/people/serena-viswanathan/7d1b292d-1f22-42ff-8452-0bc9673b8326)

Company: https://www.globalkeysolutions.net/companies/cocos-holistic-specialties-apothecary/a7329ee3-2ffc-45d4-92bf-a35bcd82ed92

Office: https://www.globalkeysolutions.net/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c