FDA WARNING_LETTER - NeuroXPF - March 27, 2020

On March 31, 2020, the FDA and FTC issued a Warning Letter to NeuroXPF regarding the sale of unapproved and misbranded CBD products claiming to mitigate, prevent, treat, diagnose, or cure COVID-19. The agencies reviewed NeuroXPF's websites (neuroxpf.com, facebook.com/NeuroXPF/, twitter.com/NeuroXPF) on March 23 and 27, 2020.

The FDA determined these CBD 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 emphasizes the public health emergency declared for COVID-19.

NeuroXPF is required to immediately cease selling these unapproved products. Within 48 hours, the company must email COVID-19-Task-Force-CDER@fda.hhs.gov detailing corrective actions, including documentation and steps to prevent recurrence. Failure to comply may result in legal action, including seizure and injunction. NeuroXPF will be added to FDA's public list of firms selling fraudulent COVID-19 products.

The FTC also cited violations of the FTC Act, stating that claims of preventing, treating, or curing human disease require competent and reliable scientific evidence, which is