CBD Social – FDA Warning Letter, Mar 15, 2022

On March 28, 2022, the FDA and FTC issued a Warning Letter to the company operating cbdsocial.com after reviewing their website on February 17 and March 15, 2022. The letter states that the company is offering cannabidiol (CBD) products for sale in the United States with claims that they 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 of the FD&C Act. The introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act. Examples of claims cited include CBD preventing SARS-CoV-2 replication, inhibiting gene expression, reversing COVID-19 effects, promoting immunity, and preventing the virus from entering cells.

The letter demands immediate action to cease the sale of these unapproved and unauthorized products. The company must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective steps and providing supporting documentation. Failure to comply may result in legal action, including seizure and injunction. The company will be added to FDA’s public list of firms receiving warning letters for COVID-19 related product violations.

Additionally, the FTC states