U.S. Attorney Sues Herbal Drugmaker Over Unapproved Drugs
The U.S. Attorney for the Southern District of New York filed a lawsuit against an herbal drug manufacturer for selling unapproved drugs using claims that they can cure or prevent conditions including diabetes, syphilis, arthritis, cancer, heart disease and asthma.
The complaint accuses Rahsan A. Hakim and Adoniiah A. Rahsan, doing business as Sundial Herbal Products, of manufacturing and selling misbranded and unapproved drugs. None of the products were approved for their claims by the FDA and the manufacturers could not guarantee their identity, purity, strength or composition.
The defendants were the subject of multiple FDA inspections and failed to correct the violations. Many of the drugs were considered misbranded because the labeling did not include sufficient directions for use and the drugs did not qualify for an exemption from the labeling requirement. The defendants also illegally introduced or delivered misbranded drugs into interstate commerce, according to the complaint submitted by U.S. Attorney Geoffrey S. Berman.