The settlement, which was announced last week, related to a complaint filed on October 18 in which the United States alleged that Grandma’s Herbs and the Parrs violated the Federal Food, Drug, and Cosmetic Act (FDCA) by distributing products intended to cure, mitigate, treat or prevent disease that were neither approved by the US 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.
The company had previously received a warning letter from the FDA in 2017 relating to the sale of unapproved and misbranded drugs and adulterated products.
“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 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.