On November 16, a U.S. District Court for the District of Utah issued a consent decree against Evig, LLC and its president and Premium Production LLC and its manager for violating the Federal Food, Drug, and Cosmetics Act by selling their “Balance of Nature” product that violated manufacturing practice regulations for dietary supplements. Just two weeks later, the company reports it has resumed selling and shipping its controversial product. They report they have changed their labels and are now “in compliance” with the consent decree, the agreement that had been reached between Evig and the federal Food and Drug Administration (FDA).

Television viewers are no doubt familiar with the omnipresent Balance of Nature ads that show happy, active senior citizens engaged in healthy activities surrounded by friends, fellow gym goers, and often smiling grandchildren. They all describe how Balance of Nature has improved their health and their lives.

Unfortunately, when Balance of Nature marketed its capsules as “dietary supplements,” that label “classified them as unapproved new and misbranded drugs.” A press release from the FDA that accompanied the consent decree said, “The FDA has not approved Balance of Nature products for any use, despite the company’s claims that its products could be used to diagnose, cure, mitigate, treat, or prevent diseases such as cancer, heart disease, cirrhosis, diabetes, asthma and COVID-19.”

FDA’s Acting Associate Director for Regulatory Affairs also provided background on the Agency’s most recent action. “We previously warned Evig 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.” In 2019, the FDA issued the two companies warning letters that informed them that Balance of Nature’s labels were unapproved and contained misbranded drugs. The firms “failed to address the deviations and come into compliance.” Injunctions were then pursued.

The government’s consent decree faulted Evig and Premium Production for selling an “adulterated product,” that was misbranded because it “fails to bear adequate directions for use.” It also contained “new drugs… that are neither approved…nor exempt from approval under 21 U.S.C. § 355(i), a law that says, “no person shall introduce or deliver for introduction into interstate commerce any new drug, unless an approval of an application is effective with respect to such drug.”

The consent decree also provided for oversight of Balance of Nature products by independent experts. One would inspect the company’s Complaint Handling Program and establish procedures that would “review and investigate product complaints.” Another would be a Labeling Expert who would “review Defendants’ representations for each product on product labels.” The company also had to remove all “representations” that lacked FDA approval and would subject it to regular, written Audit Reports.

Although not in the consent decree, there have also been concerns about Balance of Nature’s controversial business practices. First, customers are required to consume six capsules each day, which makes each jar only last 30 days. In addition, the company makes buyers purchase both the 90-capsule fruit powder called “Fruits” and the 90-capsule vegetable powder called “Veggies” at the current cost of between $69.95 and $89.95 per container, although various discounts are available. “Preferred Customers” for example, pay a one-time fee of about $24. 95 for “automatic monthly deliveries” and first-time buyers get discounts as well if they enter a discount code on their order. The company does not give refunds for unopened purchases.

The Balance of Nature website describes its Fruits & Vegetable supplements by saying they are “made from fresh, whole produce,” and touts their “advanced vacuum-cold process” to preserve the “vitamins, minerals, and phytonutrients” so you can get that vital nutrition in each capsule.” Many critics, including Forbes Health, however, write that “purchasing real fruits and vegetables may be more cost-effective instead.”

Balance of Nature CEO Douglas Lex Howard issued a statement about the company now being in compliance with the terms of the consent decree and now being “in full operation.” He said, “We are excited and well–prepared to meet the heightened demand and expectations of our amazing customers…and we remain committed to delivering the highest quality products and exceptional service.”

ConsumerLab.com, however, ran an article by Tod Cooperman, M.D., on November 20 that reported, “We found that ‘fruits’ and ‘veggies’ supplements were not substitutes for getting the recommended daily intakes of fruits and vegetables, despite marketing claims for some saying they are. At best, only one-fifth of the adult daily requirement might be met with a suggested daily serving of these products…Adults need about 500 grams of fresh fruit and veggies per day. If dried and made into powders this would equal about 50 grams per day….In fact, you can get more fruit (and fiber) from a single apple than from most fruit supplements, and at much lower cost.”