Federal Judge Orders Permanent Injunction for Repeated FDCA Violations
On May 27, 2020, U.S. District Judge Edgardo Ramos in the U.S. District Court for the Southern District of New York entered an order of permanent injunction against two individuals doing business as Sundial Herbal Products to stop distributing unapproved new drugs and misbranded drugs, including their Organic Hemp Seed Oil and Cassava Meal. The complaint was filed by the U.S. Department of Justice on behalf of the FDA. See FDA’s news release regarding the injunction here.
The court concluded that Sundial’s products have no published adequate and well-controlled studies to support their claims, and that the FDA has not approved any application for any of Sundial’s drugs, despite Sundial claiming that their products can cure, treat, or prevent a wide variety of disease such as syphilis, cancer, and HIV/AIDS. For example, Sundial claims that the hemp seed oil “suppresses the growth of cancer” and the cassava meal “prevents heart disease.”
Under the injunction, Sundial and the named individuals cannot directly or indirectly receive, label, hold, or distribute drugs at or from their facility until steps are taken to ensure all products comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act) and other requirements listed in the injunction, including recalling their drugs, hiring qualified experts to ensure conformity with the FD&C Act, and receiving written permission from the FDA to resume operations.
Sundial had received previous warnings from the FDA and, according to the federal complaint, repeatedly promised to correct any violations. For example, FDA conducted multiple inspections at Sundial between 2012 and 2017, as well as issued a warning letter to Sundial in 2013. According to the FDA, Sundial did not make any of the necessary corrections.