FDA WARNING_LETTER - Canadian Chaga - August 03, 2020

On August 6, 2020, the FDA and FTC issued a Warning Letter to Canadian Chaga regarding unapproved and misbranded products related to COVID-19. The FDA reviewed the company's website, https://canadianchaga.com, on July 25, 2020, and August 3, 2020, and found that "124 Chaga Capsules," "Chaga Tea," and "Canadian Chaga Tincture" were offered for sale in the United States with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.

These products are considered unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. § 355(a), and misbranded drugs under section 502 of the FD&C Act, 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 FDA requested immediate action to cease the sale of these unapproved and unauthorized products for COVID-19 related uses. The company must email COVID-19-Task-Force-CDER@fda.hhs.