FDA WARNING_LETTER - Oxford Medical Instruments USA, Inc. - August 10, 2020

On August 11, 2020, the FDA and FTC issued a Warning Letter to Oxford Medicals regarding their website, oxfordmedicals.com, which offered salt inhaler products for sale in the U.S. claiming to mitigate, prevent, treat, diagnose, or cure COVID-19.

The FDA determined these products are unapproved new drugs, violating section 505(a) of the FD&C Act, and misbranded drugs under section 502. The introduction of these products into interstate commerce is prohibited by sections 301(a) and (d). The letter cites the public health emergency and national emergency declarations related to COVID-19 as context for urgent measures against such products.

Oxford Medicals was ordered to immediately cease selling these unapproved and unauthorized products. They must email [email protected] within 48 hours, detailing corrective actions and preventative measures, with supporting documentation. Failure to comply may result in legal action, including seizure and injunction. The firm will be added to FDA's public list of firms receiving COVID-19 related warning letters.

The FTC also stated that advertising products to prevent, treat, or cure human disease requires competent and reliable scientific evidence, which is lacking for these products regarding COVID-19. Violations of the FTC Act may lead to injunctions and orders to repay consumers. Oxford Medicals