FDA WARNING_LETTER - nova botanix ltd - April 14, 2020

On April 16, 2020, the FDA and FTC issued a Warning Letter to International House (canabd.com) for selling unapproved and misbranded CBD products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. The agencies reviewed the company's website and social media on April 10 and 14, 2020.

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). The letter highlights the ongoing COVID-19 public health emergency and national emergency declarations.

International House is required to immediately cease selling these unapproved products for COVID-19 related uses. Within 48 hours, the company must email COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective actions, including steps to prevent recurrence, and provide 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 companies selling fraudulent COVID-19 products.

The FTC also stated that advertising products to prevent, treat, or cure human disease without competent and reliable scientific evidence, such as well-controlled human clinical studies, violates the FTC Act. No such studies exist for the identified product regarding COVID-19.