What did the FDA consent decrees against Balance of Nature specifically require and which entities were named?
Executive summary
Two federal consent decrees entered in the U.S. District Court for the District of Utah named the Balance of Nature marketer and distributor Evig LLC and its CEO Douglas Lex Howard, and the contract manufacturer Premium Production LLC and its manager (sometimes described as CEO) Ryan Petersen, and imposed permanent injunctions forbidding manufacture or distribution of the company’s products until specific corrective steps were completed and certified to the FDA [1] [2] [3]. The decrees require remediation of both labeling and manufacturing defects: cessation of disease claims that render products “unapproved new drugs,” correction of CGMP (current good manufacturing practice) failures that render products adulterated, outside expert oversight and written certifications, documentary submissions to FDA, and pre-approval by the agency before resuming sales [1] [4] [5].
1. Who was named and in what roles
The court entered two consent decrees against Evig LLC of St. George, Utah—the distributor and marketer of Balance of Nature—and Evig’s CEO, Douglas Lex Howard, and separately against Premium Production LLC of St. George, Utah—the manufacturer—and its manager, Ryan Petersen (reported variably as manager or CEO in coverage) [1] [2] [6]. Reporting and the FDA press release consistently identify those four individual corporate defendants as the parties bound by the permanent injunctions [1] [3].
2. The central prohibitions: stop selling and stop manufacturing until compliant
Both consent decrees bar the defendants from distributing or manufacturing Balance of Nature products until they are in full compliance with the Federal Food, Drug, and Cosmetic Act’s labeling and CGMP requirements; the injunctions operate as a block on sales and production unless and until the FDA is satisfied the companies have fixed the violations [4] [7] [8].
3. Labeling and disease-claim fixes required
The FDA alleged that Balance of Nature labeling and promotional materials made claims that effectively intended the products to diagnose, cure, mitigate, treat, or prevent diseases—a characterization that renders them “unapproved new drugs” or “misbranded” under federal law—so the consent decrees require removal or correction of those representations and independent labeling review and certification before products may be offered again [1] [9] [10].
4. Manufacturing and CGMP remediation: audits, experts, and certifications
Premium Production was cited for multiple CGMP failures—such as failing to establish ingredient and finished-product specifications for identity, purity, strength and composition—so the decrees compel remediation of those manufacturing deficiencies; both companies must hire qualified outside experts to audit practices, implement corrective actions, produce written audit reports, and certify compliance with CGMP regulations to FDA prior to resuming operations [4] [5] [10].
5. Complaint-handling, documentation, and ongoing oversight
FDA inspections reportedly found no adequate system for handling consumer complaints, including reports of allergic reactions and unlabeled ingredients; the consent decrees require establishment and independent review of a Complaint Handling Program, documentation of investigations, and written certification by an expert that the program complies with the decree and applicable regulations [5] [10] [11].
6. Pre-approval, possible recalls, and continuing FDA control
The remedies are procedural and supervisory: defendants must submit documents and certifications to FDA and obtain the agency’s approval before resuming distribution, and the decrees preserve FDA authority to seek recalls in the future if products remain adulterated or misbranded; coverage emphasizes that emerging compliance is subject to costly, ongoing oversight rather than merely a one-time fine [4] [5] [10].
7. Context, prior warnings, and the defendants’ posture
The consent decrees follow earlier FDA warning letters and inspections dating to 2019 that flagged both labeling and CGMP problems, and media reports note the companies did not contest the orders—Evig reported entering the consent decree voluntarily without admitting liability—while observers described the decrees as onerous, expensive, and difficult to exit once in place [9] [3] [5] [11].