FDA NEWS RELEASE
Media Inquiries: Tara Goodin, 240-402-3157, firstname.lastname@example.org
Consumer Inquiries: 888-INFO-FDA
Company fined more than $80,000 for continuing to manufacture and sell unapproved new drugs despite court order
Federal judge Sam E. Haddon of the District of Montana found that Toby McAdam, owner of Risingsun Health, continued to violate a November 2010 consent decree that barred the company from developing and selling topical bloodroot and graviola products, new drugs, new animal drugs and dietary supplements in violation of the law.
The U.S. Department of Justice initiated the case against Risingsun Health and McAdam on behalf of the FDA in February 2010, in response to the advertisement and sale of unapproved drugs that claimed to treat cancer on various Risingsun Health websites. In November 2010, the court entered a consent decree that resolved the case. In February 2013, the United States sought an order of civil contempt because McAdam and his company continued to manufacture and distribute products, including bloodroot-containing products, in violation of the consent decree, despite receiving several letters from the FDA about the violative conduct. A hearing on the government’s contempt motion was completed on Oct. 21, 2013.
In addition to finding McAdam in contempt, Judge Haddon’s order requires McAdam to cease selling dietary supplements and new drugs, and to pay both $80,000 in liquidated damages and $4,936.48 in attorneys’ fees.
“We will continue to take strong action against those who disobey federal court orders, especially when such orders are instituted to protect public health” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs. “The court’s ruling will ensure that this business cannot harm consumers physically or economically by selling unapproved drugs and deceptive dietary supplements.”
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Read our Blog: FDA Voice
RSS Feed for FDA News Releases