FDA WARNING_LETTER - Project 1600 Inc. - June 15, 2020

On June 18, 2020, the FDA and FTC issued a Warning Letter to Project 1600 Inc. (Dennis Lynch, 501 Pantigo Road, East Hampton, NY 11937) regarding unapproved and misbranded CBD products related to COVID-19, sold via dmlcbd.com. The agencies reviewed the website on May 29, 2020, and June 15, 2020, respectively.

The FDA observed that the website offered various CBD products for sale in the United States, with claims indicating they are intended to mitigate, prevent, treat, diagnose, or cure COVID-19. These products are deemed unapproved new drugs, violating section 505(a) of the FD&C Act (21 U.S.C. § 355(a)), and misbranded drugs under section 502 of the FD&C Act (21 U.S.C. § 352). The introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act (21 U.S.C. § 331(a) and (d)).

The letter cites the public health emergency declared by HHS on January 31, 2020, and the national emergency declared by the President on