A federal judge has entered an order of permanent injunction to stop a New York company from selling unapproved and misbranded drugs until it complies with the law.
The order follows a complaint, filed by the U.S. Department of Justice on behalf of the Food and Drug Administration, following multiple inspections conducted at Sundial Herbal products in the Bronx, New York, from 2012 to 2017 and a warning letter filed in 2013.
But after the company’s repeated promises to correct the violations, Sundial Herbal Products – run by Rahsan Hakim and Adoniiah Rahsa – continued to distribute the products without making the necessary corrections, according to an FDA statement.
The company claimed that its Sundial Organic Hemp Seed Oil suppresses the growth of cancer and other products cure, treat or prevent diseases, including syphilis, cancer and HIV/AIDS.
Under the injunction, Sundial Herbal products and the two individuals running the business may not directly or indirectly receive, label, hold or distribute products at or from their facility until they take steps to ensure that the products comply with the Federal Food, Drug and Cosmetic Act and other requirements in the injunction, including:
- Recall drugs.
- Hire qualified experts to ensure conformity with the FD&C Act.
- Receive written permission from the FDA to resume operations.
The FDA has sent multiple warning letters to hemp and CBD companies for making unsubstantiated medical claims about their products. This is the first known federal injunction against a company selling a hemp product.
“Making claims that unproven drugs can cure or prevent diseases places consumers’ health at risk,” said FDA Chief Counsel Stacy Amin in the agency’s statement.
“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.”