Coco's Holistic Specialties & Apothecary

Warning LetterOpen

Janine Havins Coco's Holistic Specialties & Apothecary United States cocosholisticspecialties.etsy@gmail.comIssued Jan 4, 2021Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations0

Issue DateJan 4, 2021

Product TypeDrugs

StatusOpen

Letter Details

Firm: Coco's Holistic Specialties & Apothecary
Location: Janine Havins Coco's Holistic Specialties & Apothecary United States cocosholisticspecialties.etsy@gmail.com
FEI Number: N/A
Country: United States
Issue Date: January 04, 2021
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Coco's Holistic Specialties & Apothecary was cited for selling unapproved new drugs—specifically 4-Thieves Florida Tea Concentrate and Powder—that were marketed to mitigate, prevent, treat, diagnose, or cure COVID-19, in violation of section 505(a) of the FD&C Act. The products were also found to be misbranded drugs under section 502 of the FD&C Act. The FDA identified these violations through reviews of the company's website and social media platforms (Facebook and Twitter) conducted in November and December 2020, during the height of the COVID-19 public health emergency declared by HHS and the President.

Coco's Holistic Specialties & Apothecary FDA Warning Letter, January 4, 2021