Purecraft LLC

Warning LetterOpen

Jason Navarrete Purecraft LLC 237 A St., PMB 70555 San Diego , CA 92101-4003 United States Info@purecraftcbd.comIssued Jan 10, 2023Center for Drug Evaluation and Research | CDER

View Letter

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

Letter Details

Firm: Purecraft LLC
Location: Jason Navarrete Purecraft LLC 237 A St., PMB 70555 San Diego , CA 92101-4003 United States Info@purecraftcbd.com
FEI Number: N/A
Country: United States
Issue Date: January 10, 2023
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

Purecraft LLC was cited for selling unapproved CBD products with claims to mitigate, prevent, treat, diagnose, or cure COVID-19, violating section 505(a) of the Federal Food, Drug, and Cosmetic Act by marketing unapproved new drugs. The products were also found to be misbranded drugs under section 502 of the FD&C Act, with marketing conducted through the company's website and social media platforms (Facebook and Instagram). This enforcement action occurred during the COVID-19 public health emergency, when the FDA was taking urgent measures to protect consumers from unauthorized products making disease claims without FDA approval.