Federal Court Enters Injunction Against Herbal Drug Manufacturer For Selling Misbranded And Unapproved Drugs In Violation Of The Federal Food, Drug, And Cosmetic Act

Defendants Had Claimed that “Tonics” and “Herbal Teas” Cured HIV, Cancer, Ebola and Other Serious Illnesses

  Geoffrey S. Berman, the United States Attorney for the Southern District of New York, and Stacy Amin, Chief Counsel for the U.S. Food and Drug Administration (“FDA”), announced today that the United States District Court for the Southern District of New York has entered an injunction against defendants RAHSAN A. HAKIM (“Hakim”) and ADONIIAH A. RAHSAN (“Rahsan”) (collectively, the “Defendants”) for repeated violations of the Food, Drug, and Cosmetic Act.  HAKIM and RAHSAN do business as Sundial Herbal Products (“Sundial”). 

U.S. Attorney Geoffrey S. Berman said:  “If you threaten the public health by selling unapproved or misbranded drugs, we will stop you.  There is no place for modern-day snake oil salesmen.”

FDA Chief Counsel Stacy Amin said:  “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 Complaint

According to the Government’s complaint, Defendants manufactured and sold various herbal products – often referred to as “tonics” and “herbal teas” – that constitute unapproved new drugs.  Defendants claimed that these products cure, treat, and/or prevent numerous diseases and conditions, including HIV, cancer, syphilis, diabetes, high blood pressure, arthritis, asthma, and heart disease.  None of Defendants’ products had been tested or approved by the FDA for safety or effectiveness.  These products were also “misbranded” in that they failed to include instructions for their safe use.  Defendants’ sale of such products pose a threat to public health because the products’ disease treatment claims may cause consumers to delay appropriate medical care for these serious medical issues.  Sundial had been inspected by the FDA multiple times, including during the pendency of the lawsuit, and, despite repeated promises to do so, Defendants failed to correct their violations of the Food, Drug, and Cosmetic Act (“FDCA”).

The United States filed this lawsuit seeking to enjoin Defendants from manufacturing and selling drugs in violation of the FDCA.

The District Court’s Findings

On May 26, 2020, the District Court found that Defendants have repeatedly violated the law by distributing unapproved new and misbranded drugs.  Among other things, the Court concluded that:

• “The labels that the FDA collected . . . indisputably establish that Defendants claimed that their products were intended for use in diagnosing, curing, mitigating, treating, and/or preventing a wide variety of diseases.”
   
• The drugs sold by Defendants were “unapproved new drugs” because, among other things, they are “not generally recognized as safe and effective” and have not been approved by the FDA.
   
• Defendants’ drugs were “misbranded” because “the record shows that many of Defendants’ drugs are intended for treating serious diseases or conditions such as HIV, cancer, and Ebola, all of which require diagnosis and management by a physician . . . . As such, they are only safe for use under the supervision of a physician, which brings them within the definition of prescription drugs.”  Furthermore, “Defendants’ drugs are also misbranded because they lack adequate instructions for lay use.”
   
• “Defendants’ past violations are also egregious, as they made claims that their products could cure cancer, HIV, and Ebola, among other serious diseases,” and “absent injunctive relief, nothing prevents Defendants from returning to their old ways.”
   

Permanent Injunction 

After finding that Defendants had committed “egregious” violations of the law, the Court entered a permanent injunction prohibiting Defendants from manufacturing or selling these products or any drug unless and until either: (1) a new drug application is approved for their drugs; or (2) they meet various requirements demonstrating compliance with the FDCA.  Such requirements include that Defendants must:

• Remove all claims in labels, promotional material, websites, and social media pages that these herbal remedies diagnose, cure, mitigate, treat, or prevent disease.
   
• Recall and destroy, at their own cost, under the FDA’s supervision, all drugs manufactured, packed, labeled, held, and distributed from 2014 through the present.
   
• Retain, at their own cost, a qualified, trained, and experienced drug labeling expert to review and report to the FDA on Defendants’ compliance with the issued injunction and FDCA.
   
• Arrange for annual audits by an independent third-party to confirm ongoing compliance.

Mr. Berman thanked the investigators and attorneys of the FDA for their valuable assistance on this matter.