A federal court today ordered Utah company Grandma’s Herbs, Inc. and its owners, Kevin Parr and Tracey Parr, to stop distributing unapproved and misbranded drugs in violation of the Federal Food, Drug, and Cosmetic Act (FDCA), the Department of Justice Department announced.
In a complaint filed on Oct. 18, the United States alleged that Grandma’s Herbs and the Parrs violated the FDCA by distributing products intended to cure, mitigate, treat or prevent disease that were neither approved by the U. S. Food and Drug Administration (FDA) nor exempt from approval. The complaint alleged that the defendants claimed on their website that some of their products have antimicrobial and antiviral capabilities, prevent heart disease or treat urinary tract infections, upper respiratory tract infections, allergies, epilepsy and ulcers, among other health claims. The complaint alleged that the products also were misbranded drugs, because their labeling failed to bear adequate directions for use, as required by the FDCA.
“Products intended to treat or cure diseases require FDA approval,” said Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division. “Consumers are entitled to know that the drugs they take have been shown to be safe and effective. The department is committed to ensuring that companies distributing drugs and nutritional supplements comply with federal law.”
“The U.S. Attorney’s Office is committed to working with our counterparts at the Department of Justice’s Consumer Protection Branch and the FDA to ensure that the health and well-being of consumers is protected from those that attempt to circumvent federal laws and sell potentially dangerous products,” said Acting U.S. Attorney Andrea T. Martinez for the District of Utah.
“The FDA’s action is aimed at protecting consumers who unknowingly put their health at risk by using products with claims to cure, treat or prevent a serious illness,” said Associate Commissioner Judy McMeekin, Pharm.D., for FDA Regulatory Affairs. “We urge consumers to seek proven treatments recommended by licensed health care professionals. We previously warned this manufacturer, but they continued to make claims that their products could treat or prevent serious diseases. We took action to protect consumers.”
The defendants agreed to settle the suit and be bound by a consent decree of permanent injunction. The consent decree requires, among other things, that the defendants stop manufacturing, processing, labeling, holding or distributing any drug, including products the defendants claim can treat or cure disease, until they comply with federal law. Defendants must either obtain FDA approval for all drug products or remove such drug claims from their labels, websites and other promotional materials.
The government was represented by Trial Attorney Ann Entwistle of the Justice Department’s Consumer Protection Branch, with the assistance of William Thanhauser of the FDA’s Office of Chief Counsel. The U.S. Attorney’s Office for the District of Utah provided assistance.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch.