Court Enjoins Two Utah Companies from Distributing and Manufacturing Adulterated and Misbranded Dietary Supplements

On November 15, a federal court prohibited two Utah-based companies from distributing and manufacturing adulterated and misbranded dietary supplements, the Department of Justice announced.

In a complaint filed Oct. 11 in the U.S. District Court for the District of Utah at the request of the U.S. Food and Drug Administration, the United States alleged that Evig LLC and the CEO of the company, David Lex Howard, violated the federal Food, Drug, and Cosmetic Act (FDCA) by distributing adulterated and misbranded dietary supplements. In a separate complaint filed the same day, the United States alleged that Premium Productions LLC and the company's manager, Ryan Petersen, violated the FDCA by manufacturing adulterated dietary supplements. According to the complaints, the dietary supplements in question are marketed throughout the United States under the brand name Balance of Nature.

The lawsuit against Evig LLC and Howard alleges that the defendants claimed that their dietary supplements can cure, treat and prevent a variety of diseases and health conditions, including cancer, heart disease, diabetes and coronavirus. According to the complaint, the supplements were neither approved by the FDA nor exempt from approval, making them unapproved and misbranded new drugs under the terms of the FDCA. The lawsuit further alleges that FDA inspections showed that the defendants had no system for handling customer complaints, despite receiving reports that their products may have caused allergic reactions to ingredients not identified on the label.

The lawsuit against Premium Productions LLC and Petersen alleges that the defendants' operation failed to follow required current good manufacturing practices and failed to develop good operating procedures and adequate quality controls, resulting in their products being adulterated under the FDCA.

The FDA sent warning letters to both companies in August 2019 explaining that their conduct did not comply with the FDCA. According to the government's complaints, the defendants did not take adequate steps to comply with the regulations after receiving those letters.

"Products intended to treat or cure diseases require FDA approval," said Principal Deputy Attorney General Brian M. Boynton, head of the Justice Department's Civil Division. “Dietary supplement manufacturers must also comply with federal health and safety requirements. “The department will continue to work closely with the FDA to stop the distribution of unapproved, adulterated and misbranded dietary supplements.”

"This FDA action ensures that dietary supplements distributed to American consumers are appropriately labeled, legally manufactured, and prevents products that potentially endanger the health of people with unproven claims to cure, treat, or prevent serious disease." said Acting Associate Commissioner Michael C. Rogers of the FDA's Office of Regulatory Affairs. “We previously warned Evig LLC and Premium Production LLC, but they have demonstrated repeated violations of manufacturing requirements and the public cannot trust their products to be what they say they are. “The FDA will continue to protect U.S. public health by taking appropriate action when companies violate the law.”

In both cases, the defendants agreed to settle the lawsuits and be bound by permanent injunction consent decrees. The orders issued by the court permanently prohibit the defendants from violating the FDCA and require improvements to the manufacturing process.

Lead Trial Attorney Sarah Williams of the Civil Division's Consumer Protection Division is prosecuting the case, assisted by Assistant U.S. Attorney Amanda Berndt for the District of Utah and Chief Deputy Counsel Todd Miller of the Office of the Counsel. principal of the FDA.

Additional information about the Consumer Protection Branch and its law enforcement efforts can be found at www.justice.gov/civil/consumer-protection-branch.

The claims resolved by the precautionary measures announced today are only allegations. There has been no determination of responsibility.

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