July 14, 2020

Permanent Injunction Against Sundial Herbal Products For Unapproved Drugs

A federal judge has entered an order of permanent inunction against Sundial Herbal Products to stop distributing their products because they have been labeled unapproved new drugs and misbranded drugs. Despite previous warnings from the FDA, the company “continued to violate the law and distributed their products,” according to a new release issued by the FDA.

Permanent Injunction Against Sundial Herbal Products For Unapproved Drugs

FDA Chief Counsel Stacy Amin said in a statement, “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. 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 found that Sundial Herbal Products products have no published adequate and well-controlled studies to support their claims. The FDA has not approved any application of any of Sundial’s products. The company claims that their products “can cure, treat, or prevent a wide variety of diseases, including syphilis, cancer, and HIV/AIDS.”

For instance, the company states that their Sundial Organic Hemp Seed Oil “suppresses the growth of cancer,” and Sundial Cassava meal “prevents heart disease.” The government is concerned that these products that claim to cure, treat, mitigate, or prevent serious disease may cause consumers to delay or end appropriate medical treatment.

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 Rashan Hakim and Adoniiah Rashan, individuals doing business as Sundial Herbal Products. That company is located in the Bronx, New York.

Multiple FDA inspections between 2012 and 2017 were conducted at the company’s facility. A warning letter was issued in 2013. While the company assured the FDA they would correct the violations, they were not made.

Under the injunction, Sundial and 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.”

 

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