FDA WARNING_LETTER - 21st Century LaserMed Pain Institute d/b/a Create Wellness Clinics - July 21, 2020

The FDA and FTC issued a Warning Letter to 21st Century LaserSTEM Pain & Regenerative Medicine Institute on July 21, 2020, for illegally marketing unapproved, misbranded, and adulterated products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. The agencies reviewed the firm's websites and YouTube channel, identifying several violations. An umbilical cord derived stem cell product was found to be an unapproved new drug (21 U.S.C. § 355), a misbranded drug (21 U.S.C. § 352), and an unlicensed biological product (42 U.S.C. § 262(a)). The "Deluxe Immune Support Bundle" and "Emergency II COR-1:9 CV-19 Deluxe Immune Boost Protection Kit" were deemed unapproved new drugs (21 U.S.C. § 355(a)) and misbranded drugs (21 U.S.C. § 352). The "COVID-19 Coronavirus SARS-CoV-2 Antibody At Home Rapid Telemedicine Test Kit" was cited as an adulterated device (21 U.S.C. § 351(f)(1)(B)) and a misbranded device (21 U.S.C. § 352(o)) for lack of premarket approval/IDE and failure to notify the agency. The introduction of these products into interstate commerce is prohibited. The letter mandates immediate cessation of sales for these unauthorized products. The firm must respond within 48 hours to relevant FDA task forces, detailing corrective actions and preventative measures. Failure to comply may result in legal action, including seizure and injunction, and inclusion on FDA's public list of fraudulent COVID-19 products. The FTC also cited the firm for unlawful advertising under 15 U.S.C. 41 et seq., requiring immediate cessation of unsubstantiated claims and warning of potential injunctions and consumer refunds.