A federal court on Nov.
15 enjoined two Utah-based companies from distributing and manufacturing adulterated and misbranded dietary supplements, the Justice Department announced.
In a complaint filed on 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 company’s CEO, 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 manager’s, Ryan Petersen, violated the FDCA by manufacturing adulterated dietary supplements.
According to the complaints, the dietary supplements involved are marketed throughout the United States under the brand name Balance of Nature.
The complaint against Evig LLC and Howard alleges that the defendants claimed 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 FDA nor exempt from approval, making them unapproved new drugs and misbranded under the terms of the FDCA.
The complaint further alleges that FDA inspections showed the defendants had no system in place to handle customer complaints, despite receiving reports asserting that their products may have caused allergic reactions from ingredients not identified on the label.
The complaint against Premium Productions LLC and Petersen alleges that the defendants’ operation did not follow required current good manufacturing practices and failed to develop good operating procedures and adequate quality controls, making their products adulterated under the FDCA.
FDA sent both companies warning letters in August 2019 explaining that their conduct did not comply with the FDCA.
According to the government’s complaints, the defendants failed to take appropriate steps to come into compliance after receiving those letters.
“Products intended to treat or cure diseases require FDA approval,” said Principal Deputy Assistant Attorney General Brian M.
Boynton, head of the Justice Department’s Civil Division.
“Dietary supplement makers also must abide by federal health and safety requirements.
The department will continue to work closely with 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, lawfully manufactured and prevents products that potentially put people’s health at risk with unproven claims to cure, treat or prevent a serious illness,” 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 have confidence that their products are what they purport to be.
The FDA will continue to protect the U.
S.
public health by taking appropriate actions when companies violate the law.
”
In both cases, the defendants agreed to settle the suits and be bound by consent decrees of permanent injunction.
The orders entered by the court permanently enjoin the defendants from violating the FDCA and require manufacturing process improvements.
Senior Trial Attorney Sarah Williams of the Civil Division’s Consumer Protection Branch is handling the case, with assistance from Assistant U.
S.
Attorney Amanda Berndt for the District of Utah and Assistant Chief Counsel Todd Miller of the FDA’s Office of the Chief Counsel.
Additional information about the Consumer Protection Branch and its enforcement efforts can be found at www.
justice.
gov/civil/consumer-protection-branch.
The claims resolved by the injunctions announced today are allegations only.
There has been no determination of liability.
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