06.02.20
According to the U.S. Food and Drug Administration, 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.
The New York-based company has been accused of selling a variety of unapproved new drugs sourced from natural ingredients which have health claims attached to them regarding a myriad of serious and fatal diseases.
According to the complaint, Sundial continued to violate the law and distribute their products despite previous warnings from the FDA and “repeated promises to correct violations.”
“Americans expect and deserve medical treatments that have been scientifically proven to be safe and effective,” FDA Chief Counsel Stacy Amin said. “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 their products can cure, treat, or prevent a wide variety of diseases including syphilis, cancer, and HID/AIDs. Sundial claimed that its Sundial Organic Hemp Seed Oil “suppresses the growth of cancer,” and that Sundial Cassava Meal “prevents heart disease,” for example. 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.
On May 27, 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, the individuals doing business as Sundial Herbal Products. The complaint sought a permanent injunction against the company and its most responsible individuals.
The action follows multiple FDA inspections conducted between 2012 and 2017, as well as a warning letter issued by the FDA to Sundial in 2013 for similar violations. Follow-up inspections revealed that the necessary violations were not corrected after the warning letter, FDA said.
Under the injunction, Sundial and the individual defendants cannot directly or indirectly continue activities related to the sale of their products, and are also required to recall their products. If they wish to resume operations, they will be required to hire experts ensuring conformity with the FD&C Act and other requirements, and must also receive written permission from the FDA.
The New York-based company has been accused of selling a variety of unapproved new drugs sourced from natural ingredients which have health claims attached to them regarding a myriad of serious and fatal diseases.
According to the complaint, Sundial continued to violate the law and distribute their products despite previous warnings from the FDA and “repeated promises to correct violations.”
“Americans expect and deserve medical treatments that have been scientifically proven to be safe and effective,” FDA Chief Counsel Stacy Amin said. “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 their products can cure, treat, or prevent a wide variety of diseases including syphilis, cancer, and HID/AIDs. Sundial claimed that its Sundial Organic Hemp Seed Oil “suppresses the growth of cancer,” and that Sundial Cassava Meal “prevents heart disease,” for example. 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.
On May 27, 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, the individuals doing business as Sundial Herbal Products. The complaint sought a permanent injunction against the company and its most responsible individuals.
The action follows multiple FDA inspections conducted between 2012 and 2017, as well as a warning letter issued by the FDA to Sundial in 2013 for similar violations. Follow-up inspections revealed that the necessary violations were not corrected after the warning letter, FDA said.
Under the injunction, Sundial and the individual defendants cannot directly or indirectly continue activities related to the sale of their products, and are also required to recall their products. If they wish to resume operations, they will be required to hire experts ensuring conformity with the FD&C Act and other requirements, and must also receive written permission from the FDA.