FDA WARNING_LETTER - Noetic Nutraceuticals - May 13, 2020

On May 15, 2020, the FDA and FTC issued a Warning Letter to NNLifestyle, following reviews of their website (www.nnlifestyle.com) on April 30, 2020, and May 13, 2020, and associated social media. The letter states that NNLifestyle offers CBD products for sale in the U.S. with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.

These products are cited as unapproved new drugs, violating 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). The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d) (21 U.S.C. § 331(a) and (d)). The letter emphasizes the public health emergency declared for COVID-19 and the FDA's urgent measures to protect consumers from unauthorized products.

NNLifestyle is required to immediately cease selling these unapproved products for COVID-19 related uses. Within 48 hours, the company must email COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective actions, including steps to prevent recurrence