FDA WARNING_LETTER - CBD Gaze - May 21, 2020

On May 26, 2020, the FDA and FTC issued a Warning Letter to the operator of www.cbdgaze.com. The agencies reviewed the website on May 7 and May 21, 2020, and found that it participates in the Amazon Associates program, promoting CBD products like Restorative Botanicals Ultra High Strength Hemp Oil Supplement and Serenity Hemp Liquid Dietary Supplement.

The website makes claims implying these products can mitigate, prevent, treat, diagnose, or cure COVID-19. These claims cause the products to be unapproved new drugs under section 505(a) of the FD&C Act and misbranded drugs under section 502. Introducing or delivering these products into interstate commerce is prohibited under sections 301(a) and (d), and misbranding them while held for sale after interstate shipment is prohibited under section 301(k).

The FDA and FTC demand immediate cessation of promoting and selling these unapproved and unauthorized products for COVID-19 related uses. The recipient must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction, and the firm will be added to FDA's public list of non-compliant entities. The FTC also requires an email to rcle