FDA WARNING_LETTER - Dr. Thomas Polucki Upper Cervical Chiropractic, Inc. - June 09, 2021

On July 28, 2021, the FDA and FTC issued a Warning Letter to the company operating getbetterxshop.com and santaclaritachiropractor.com, following website reviews on June 2 and June 9, 2021. The letter addresses the sale of unapproved and misbranded products, Nitric Oxide Support and Melatonin, marketed with claims to mitigate, prevent, treat, diagnose, or cure COVID-19.

The FDA determined these products are unapproved new drugs under section 505(a) and misbranded drugs under section 502 of the FD&C Act, violating sections 301(a) and (d). Examples of violative claims include Nitric Oxide inhibiting coronavirus replication and Melatonin boosting immunity against COVID-19. The FTC also cited unsubstantiated claims on santaclaritachiropractor.com regarding chiropractic care and supplements providing an "immune boost" against COVID-19, violating the FTC Act.

The company must immediately cease selling unapproved COVID-19 products and making unsubstantiated claims. Within 48 hours, they must email COVID-19-Task-Force-CFSAN@fda.hhs.gov detailing corrective actions and documentation, and email rcleland@ftc.gov certifying cessation of unsubstantiated claims. Failure to comply may result in legal action, including seizure, injunction, civil penalties