The complaint, filed on Oct. 11 at the request of the U.S. Food and Drug Administration, alleged that Evig LLC and the company’s CEO, David Lex Howard, violated the Food, Drug and Cosmetic Act (FDCA) by “distributing adulterated and misbranded dietary supplements.” A separate complaint, filed the same day, also alleged that Premium Productions LLC and the company’s manager, Ryan Petersen, also violated the same act.
The dietary supplements pushed by these two companies were reportedly marketed throughout the country under the brand name Balance of Nature.
Howard, who runs Evig LLC, was accused of claiming that the company’s supplements can “cure, treat and prevent a variety of health conditions, including cancer, heart disease, diabetes and coronavirus,” a release states.
The complaint reportedly said that the supplements were neither approved by the FDA nor made exempt from approval. It also claimed that the company had no system in place for handling customer complaints, despite allegedly receiving multiple reports that its products may have caused allergic reactions from ingredients not identified on the label.
The complaint against Premium Productions LLC, and Petersen, alleged that the operation “did not follow required current manufacturing practices and failed to develop good operating procedures and adequate quality controls, making their products adulterated under the FDCA,” according to the release.
“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.”
Both companies were reportedly sent warning letters by the FDA back in Aug. 2019, explaining that their conduct did not comply with the FDCA. The defendants did not take the appropriate steps to come into compliance, the release states.
“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.”
The defendants agreed to settle the suits in both cases.
The claims resolved by the injunctions announced today are allegations only. There has been no determination of liability.