FDA WARNING_LETTER - Living Senior, LLC - August 17, 2020

On August 19, 2020, the FDA and FTC issued a Warning Letter to Blue Ribbon Hemp and CBD Seniors regarding the sale of unapproved and misbranded CBD products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. The agencies reviewed www.blueribbonhemp.com and www.cbdseniors.com on August 7 and August 17, 2020, respectively.

The FDA determined these 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). 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.

The company must immediately cease selling these unapproved and unauthorized products. Within 48 hours, an email must be sent to COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective actions, including steps to prevent recurrence and supporting documentation. Failure to comply may result in legal action, including seizure and injunction. The firm will be added to FDA