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Regulatory Focus™ > News Articles > 2020 > 6 > Herbal products firm must stop unfounded health claims, says federal judge

Herbal products firm must stop unfounded health claims, says federal judge

Posted 01 June 2020 | By Kari Oakes 

Herbal products firm must stop unfounded health claims, says federal judge

A company that claims its products can suppress cancer and prevent heart disease must stop distribution and recall its products, according to a ruling in federal court.

New York-based Sundial Herbal Products is making the claims about products that “have no published adequate and well-controlled studies to support their claims,” said the US Food and Drug Administration (FDA) in a press release announcing the court decision.

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 made the claim of cancer suppression about its Organic Hemp Seed Oil and claims that its Cassava Meal product prevents heart disease.

FDA Chief Council Stacy Amin said that “Americans expect and deserve medical treatments that have been scientifically proven to be safe and effective…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 injunction came on 27 May from US District Judge Edgardo Ramos of the US District Court for the Southern District of New York. Judge Ramos’ injunction followed a complaint filed by the US Department of Justice on the FDA’s behalf.

Sundial had received a warning letter in 2013 for making similar claims, and was inspected by the FDA numerous times between 2012 and 2017, according to the agency: “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.”

The judgment was issued against Sundial and its two principles, Rahsan Hakim and Adonilah Rahsan. The company and the defendants as individuals are enjoined from receiving, labeling, holding and distributing drugs at or from their facility until their products comply with the Federal Food, Drug, and Cosmetic Act. They must also take other steps, including a product recall, and must have written permission from the FDA before resuming any operations.

 

Tags: FDA, US

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