Manhattan U.S. Attorney Sues Herbal Drug Manufacturer For Selling Misbranded And Unapproved Drugs In Violation Of The Federal Food, Drug, And Cosmetic Act
Geoffrey Berman, the United States Attorney for the Southern District of New York, and Melinda Plaisier, Associate Commissioner for Regulatory Affairs for the U.S. Food and Drug Administration (“FDA”), announced today the filing of a Complaint against defendants RAHSAN A. HAKIM (“Hakim”) and ADONIIAH A. RAHSAN (“Rahsan”) for repeated violations of the Food, Drug, and Cosmetic Act. HAKIM and RAHSAN do business as Sundial Herbal Products.
U.S. Attorney Geoffrey Berman said: “As alleged in the complaint, the defendants are the modern incarnation of snake oil salesmen, selling the unsuspecting public unapproved or misbranded drugs that they claim, without basis, will cure cancer, diabetes, and other serious illnesses. They have repeatedly been warned that their conduct violates the law, yet have continued to sell unapproved, adulterated, and misbranded drugs. Our lawsuit seeks an injunction preventing them from continuing this illegal conduct.”
FDA Associate Commissioner for Regulatory Affairs Melinda Plaisier said: “Dietary supplements pose a public health risk when they claim to treat medical conditions, such as asthma, diabetes or cancer, which puts them into the category of misbranded and unapproved drugs. The FDA will continue to take action to protect the public when companies violate the law.”
The Complaint, filed today in federal court in Manhattan, alleges that defendants manufacture and sell various unapproved drugs and dietary supplements that claim to cure, treat, and/or prevent numerous diseases and conditions, including but not limited to syphilis, diabetes, high blood pressure, arthritis, asthma, heart disease, and cancer. None of their products has been tested or approved by the FDA for safety or effectiveness. Their sale of such products poses a threat to public health because the products’ disease treatment claims may cause consumers to delay appropriate medical care for the serious medical issues described above. Further, defendants cannot guarantee the identity, purity, strength, and composition of their dietary supplements.
Defendants have been inspected by the FDA multiple times, and, despite repeated promises to do so, have failed to correct their violations of the Food, Drug, and Cosmetic Act.
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The Complaint seeks an order enjoining defendants from manufacturing and selling drugs and dietary supplements in violation of the Food, Drug, and Cosmetic Act.
Mr. Berman thanked the FDA for its work leading to the Complaint.
This case is being handled by the Office’s Environmental Protection Unit in the Civil Division. Assistant United States Attorney Emily Bretz is in charge of the case.