A federal judge has ordered two individuals doing business as Sundial Herbal Products to stop distributing unapproved new drugs and misbranded drugs until they comply with federal law. According to the complaint, despite previous warnings from the U.S. Food and Drug Administration and repeated promises to correct violations, Sundial continued to violate the law and distribute their products.
“Americans expect and deserve medical treatments that have been scientifically proven to be safe and effective. Making claims that unproven drugs can cure or prevent diseases places consumers’ health at risk,” said FDA Chief Counsel Stacy Amin. “We remain committed to pursuing and taking swift action against those who attempt to subvert the regulatory functions of the FDA by repeatedly disregarding the law and distributing unapproved products.”
The court concluded that Sundial’s products have no published adequate and well-controlled studies to support their claims, and 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 diseases, including syphilis, cancer, and HIV/AIDS. For example, Sundial claimed that its Sundial Organic Hemp Seed Oil “suppresses the growth of cancer” and that Sundial Cassava Meal “prevents heart disease.” The FDA is particularly concerned that products that claim to cure, mitigate, treat or prevent serious diseases may cause consumers to delay or stop appropriate medical treatment.
As a result of these 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 Rahsan Hakim and Adoniiah Rahsan, individuals doing business as Sundial Herbal Products. The complaint, filed by the U.S. Department of Justice on behalf of the FDA, sought a permanent injunction against the Bronx, New York, drug distributor and its most responsible individuals.
This action follows multiple FDA inspections conducted at Sundial between 2012 and 2017. The FDA issued a warning letterExternal Link Disclaimer to Sundial in 2013 for similar violations. Despite assurances that the violations noted in the warning letter would be corrected, follow-up inspections revealed that the defendants did not make the necessary corrections.
Under the injunction, Sundial and the individual defendants cannot directly or indirectly receive, label, hold or distribute drugs at or from their facility until they take certain steps to ensure that all of these products comply with the Federal Food, Drug, and Cosmetic (FD&C) Act and other requirements listed in the order of permanent injunction including, among other requirements, recalling their drugs, hiring qualified experts to ensure conformity with the FD&C Act and other requirements and receiving written permission from the FDA to resume operations.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.