FDA WARNING_LETTER - Halosense Inc. - March 30, 2020

On March 30, 2020, the FDA and FTC issued a Warning Letter to Saline Therapy regarding unapproved and misbranded products related to COVID-19. The agencies reviewed www.salinetherapy.com and social media on March 20 and 26, 2020. The FDA determined that Saline Therapy's salt therapy products, offered for sale in the U.S., are intended to mitigate, prevent, treat, diagnose, or cure COVID-19. These products are deemed unapproved new drugs under section 505(a) and misbranded drugs under section 502 of the FD&C Act, violating sections 301(a) and (d).

The letter cites the public health emergency and national emergency declarations for COVID-19. Saline Therapy is requested to immediately cease selling these unapproved and unauthorized products for COVID-19 related uses. The company must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective actions and providing documentation. Failure to comply may result in legal action, including seizure and injunction. Saline Therapy will be added to FDA's public list of firms with COVID-19 related warning letters. The FTC also noted that advertising products to prevent, treat, or cure human disease without competent and reliable scientific evidence violates the FTC Act, potentially leading to injunctions