Balance of Nature’s ‘whole food’ capsules are advertised to imply they cure serious diseases, including diabetes, cancer, and multiple sclerosis. Following false advertising suits and repeated failures to comply with the Food, Drug, and Cosmetics Act, Balance of Nature has been ordered to stop production and sales until they come into compliance with FDA regulations.
Update: Evig LLC (Balance of Nature) resumed normal operations in November 2023.
Balance of Nature, a brand of so-called whole food supplements—Fruits, Veggies, and Fiber & Spice—are marketed as a Whole Health System that supplants some portion of the real whole foods people should be eating to stay healthy. Balance of Nature’s Utah-based parent company, Evig LLC, its manufacturer, Premium Production LLC, and two executives have been court ordered to stop manufacturing and selling the products until they demonstrate compliance with FDA regulations.
In a news release, the FDA asserts that Balance of Nature’s products are marketed and labeled in a way that renders them “unapproved new drugs and misbranded drugs.” Further, because Evig LLC never established ingredient and finished product standards for “identity, purity, strength, and composition” that would ensure each capsule contained what the packaging and ads claimed and nothing else, Balance of Nature products are also considered “adulterated dietary supplements.”
The permanent injunction provides Balance of Nature a pathway to resume operations, but it may be the final blow for the brand, which has a history fraught with lawsuits, warnings, and failures to comply with regulations and requirements.
Michael C. Rogers, the FDA’s Acting Associate Commissioner for Regulatory Affairs, stated, “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.”
Previous FDA warning letters
Companies that manufacture, package, label, or store dietary supplements must comply with Current Good Manufacturing Practices (CGMP) established in FDA Regulations. The CGMPs ensure a reliable, unadulterated, and consistent dietary supplement by setting restrictions around how a supplement is made and what it may (and may not) contain, requiring methods for testing purity and composition, and outlining strict rules for labeling that distinguish supplements from drugs.
In 2019, Evig LLC and Premium Production LLC were both issued warning letters from the FDA. Evig LLC was alerted that Balance of Nature’s labeling and advertising “establish that these products are drugs … because they are intended for use in the cure, mitigation, treatment, or prevention of disease.” The advertising violations were particularly audacious; the FDA cited multiple videos and written materials in which Balance of Nature supplements were credited with treating (or even curing) diseases and ailments like asthma, diabetes, multiple sclerosis, arthritis, high cholesterol, and cancer.
Premium Production was cited for failing to comply with CGMPs, specifically for failure to develop standards and test the products for composition and purity, and notified that products sold would be considered adulterated “because they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.”
Despite repeated violations, the FDA could not issue any penalties against Balance of Nature. Under federal law, the agency can only issue warning letters or recommend that the Department of Justice pursue criminal charges against dangerous or fraudulent supplements.
False advertising complaints against Balance of Nature
In July 2023, Balance of Nature agreed to a $1.1 million settlement, part of which will go to refund California residents who purchased a Balance of Nature supplement. The California Food, Drug and Medical Device Task Force filed the complaint against Evig, LLC, over Balance of Nature’s claims that its products “could prevent, treat, or cure serious diseases including diabetes, fibromyalgia, arthritis, heart disease, and cancer.”
“Balance of Nature made dubious claims that their products could treat or cure serious diseases placing the public’s health in danger,” said Napa County District Attorney Allison Haley in a statement. “Customers have the right to expect the products they purchase to work as advertised.”
In addition to misleading ads and unproven medical claims, California alleged that Balance of Nature illegally billed customers under an automatic subscription service that didn’t adequately disclose its terms and conditions, didn’t seek consumers’ affirmative consent, and didn’t allow customers who signed up for the program online to cancel online.
