Balance of Nature ordered to stop selling supplements

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.

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.

Who needs a nutritional supplement

It’s not hard to see why nutritional supplements sell well. The products are often billed as simple, effortless treatments for a litany of ailments—from muscle aches to mental acuity, and everything in between—and backed up by the testimony of medical professionals. They claim to be made of the same whole fruits and veggies we don’t have time to prepare or eat and offer a no-stress respite from the concerns of thinking about our health.

According to the CDC, in 2015 less than 1 in 10 American adults—a shocking 9 percent—ate enough servings of fruit and vegetables each day. In 2019, 12.3 and 10 percent of surveyed adults were getting enough fruit and veg, respectively. So it’s not surprising that a market for one-size-fits-all nutritional magic bullets has burst into a $52.9 billion industry—one projected to grow more than 5 percent each year.

USDA, CSPI, and any nutrition expert worth their credentials will tell you that eating a variety of whole fruits and vegetables is a key to a healthy diet. Advice from health experts to eat fruits and vegetables is based on studies of people who eat those foods, not capsules of fruit or vegetable powder.

And when it comes to supplements like Balance of Nature’s products, the American Cancer Society advises buyers to be aware of the limitations:

Some supplements are described as containing the nutritional equivalent of vegetables and fruits. However, the small amount of dried powder in such pills often contains only a small fraction of the levels in the whole foods, and there is very little evidence supporting a role of these products in lowering cancer risk. Food is the best source of vitamins, minerals, and other important food components. If a dietary supplement is used for general health purposes, the best choice is a balanced multivitamin/mineral supplement containing no more than 100% of the ‘‘daily value’’ of nutrients.

But there are a handful of times when supplements are beneficial and necessary. For example:

• Folic acid can help people who are or may become pregnant reduce the risk of having a child with birth defects;
• A mix of nutrients (vitamins C and E, zinc, copper, and lutein) can slow vision loss in people with intermediate or advanced macular degeneration;
• Calcium and iron can help people who don’t get enough of those nutrients from food;
• Vitamin D can help people who don't get enough from fortified foods or from exposure to sunlight without sunscreen.
• Vitamin B-12 can help people over age 50 who  may be unable to absorb the B-12 in foods.

Learn more at NutritionAction: What a day’s worth of food looks like on a healthy diet