The FDA says the supplement manufacturers violated good manufacturing practice requirements and claimed their products could treat specific health conditions.
On November 15, the FDA announced the U.S. District Court for the District of Utah, Central Division, has ordered the manufacturer of Balance of Nature dietary supplements to stop producing and selling their products until the company fully complies with federal regulations and requirements under the Federal Food, Drug, and Cosmetic Act.
Balance of Nature supplements are sold through Amazon, Walmart, and the company's online store.
The federal court entered two consent decrees of permanent injunction against Utah-based Evig LLC and its CEO, Douglas Lex Howard, as well as Premium Production LLC and the company's Manager, Ryan Petersen.
Why is the FDA ordering a cease in production?
According to the FDA, labels on Balance of Nature supplements claim the products could be used to diagnose, cure, mitigate, treat, or prevent diseases such as cancer, heart disease, cirrhosis, diabetes, asthma, and COVID-19, despite not being FDA approved for such claims.
The FDA says this type of labeling caused the products to fall under the unapproved new drugs and misbranded drugs category.
The agency also asserts that Premium Production LLC and Petersen manufactured Balance of Nature products in violation of multiple current good manufacturing practice (CGMP) requirements. These violations include failing to establish ingredient and finished product specifications for identity, purity, strength, and composition. This action reclassified the company's products as adulterated dietary supplements.
In 2019, the FDA issued warning letters to both companies after discovering CGMP violations at their facilities.
In the warning letter to Evig LLC, the agency presented evidence that specific supplement labels showed the products are intended for use as drugs. For example, Balance of Nature Whole Foods Fiber & Spice claimed to reduce the risk of heart disease by lowering cholesterol.
Earlier this year, Evig LLC paid $1.1 million to settle a consumer protection lawsuit in California. The suit claimed that the company made misleading statements about their products.
The 2019 warning letter sent to Premium Production LLC states the company "failed to establish specifications for any point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement."
Follow-up FDA inspections found both companies failed to address the violations, and the firms did not come into compliance with the agency's requirements. As a result, the FDA pursued injunctions against the manufacturers.
Michael C. Rogers, the FDA's Acting Associate Commissioner for Regulatory Affairs, explained, "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."
What are the next steps for Evig and Premium Production?
The consent decrees require both companies to hire CGMP experts, submit compliance documents, and obtain the FDA's approval to resume production.
Evig LLC must also employ a labeling expert to ensure the products no longer fit the new or misbranded drugs classification. The companies are prohibited from producing or selling their products until they complete these actions.
"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."