Cannafyl

Warning LetterOpen

Mr. Edward Chaney Cannafyl 7595 E. McDonald Dr., Suite 140 Scottsdale , AZ 85250 United States info@cannafyl.comIssued Mar 1, 2021Center for Drug Evaluation and Research

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

Letter Details

Firm: Cannafyl
Location: Mr. Edward Chaney Cannafyl 7595 E. McDonald Dr., Suite 140 Scottsdale , AZ 85250 United States info@cannafyl.com
FEI Number: N/A
Country: United States
Issue Date: March 01, 2021
Issuing Office: Center for Drug Evaluation and Research
Product Type: Drugs
Status: Open

Summary

Cannafyl was warned for marketing unapproved CBD products for humans and animals with therapeutic claims, including unsubstantiated assertions that the products could mitigate, prevent, treat, diagnose, or cure COVID-19. The human CBD products (Balance, Relief, and Relax CBD Drops and Relief CBD Salve) violated sections 505(a) and 301(d) of the FD&C Act as unapproved new drugs and were misbranded under section 502(f)(1), while the Pet CBD Drops product violated section 512(a) as an unapproved new animal drug and section 501(a)(5) as an adulterated product. The violations were identified during an FDA review of the company's website and social media platforms in November 2020, conducted during the COVID-19 public health emergency.