FDA WARNING_LETTER - Nature's Highway - March 07, 2022

On March 28, 2022, the FDA and FTC issued a Warning Letter to Nature's Highway CBD (CMS 627304) regarding unapproved and misbranded CBD products marketed for COVID-19. The agencies reviewed the company's websites, natureshighwaycbd.com and facebook.com/natureshighwaysc/, on February 17 and March 7, 2022, respectively.

The FDA determined that the CBD products are 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) due to claims they mitigate, prevent, treat, diagnose, or cure COVID-19. Examples of such claims include statements about CBD combating coronavirus effects, denying viral entry, fighting lung inflammation, or preventing "cytokine storms." 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 FTC cited violations of the FTC Act (15 U.S.C. § 41 et seq.) for advertising products to prevent, treat, or cure human disease without competent and reliable