Balance of Nature's Parent Company: Evig LLC
Balance of Nature is a brand of whole food dietary supplements, not a standalone manufacturing entity. Its parent and marketing company is Evig LLC, which is based in St. George, Utah. Founded by Dr. Douglas Howard in 1997, the company built a business selling supplements that are designed to complement a balanced diet with whole fruit and vegetable ingredients. Evig LLC is responsible for the brand's marketing, distribution, and overall business operations. The company is the face of the brand to consumers, promoting its products through various channels, including radio, television, and online platforms. It was Evig LLC that received repeated warnings from the U.S. Food and Drug Administration (FDA) regarding unsupported and illegal claims about its products' ability to treat or cure diseases. The company ultimately entered a consent decree with the FDA following these violations.
The Role of Dr. Douglas Howard
Dr. Douglas Howard, a retired chiropractor, is the founder and formulator of the Balance of Nature supplements. He appears in promotional materials and is often featured in discussions about the product's philosophy. Howard's background and research led to the specific blend of fruits and vegetables used in the supplements. His vision for providing a convenient way to get a wide variety of whole food ingredients shaped the company's mission.
The Former Manufacturer: Premium Production LLC
While Evig LLC handles the marketing and distribution, the supplements themselves were manufactured by a separate company, Premium Production LLC. This distinction is crucial in understanding the FDA's enforcement actions. It was Premium Production LLC that was cited for failing to comply with Current Good Manufacturing Practices (CGMPs), which are required for all dietary supplements.
FDA Scrutiny of Manufacturing Practices
During inspections, the FDA found that Premium Production LLC failed to establish proper specifications for the identity, purity, strength, and composition of the ingredients and finished products. These manufacturing failures led the FDA to deem the supplements adulterated, as the public could not be confident that the products contained what they claimed to. The court-ordered shutdown in 2023 was a direct result of these long-standing manufacturing violations that were not corrected after repeated warnings.
The Aftermath of Legal and Regulatory Action
The actions taken by the FDA and state prosecutors in California significantly impacted both Evig LLC and Premium Production LLC. Evig LLC was targeted for its misleading advertising, while Premium Production LLC was held accountable for manufacturing failures. The result was a temporary halt in sales and manufacturing until the companies could demonstrate compliance.
Comparing the Companies: Evig LLC vs. Premium Production LLC
| Aspect | Evig LLC | Premium Production LLC |
|---|---|---|
| Role | Brand owner, marketer, and distributor | Contract manufacturer |
| Key Violation | Made unsubstantiated health claims, violating marketing regulations | Failed to meet CGMP requirements for manufacturing |
| Legal Action | Subject to FDA consent decree and false advertising settlements | Subject to FDA consent decree and ordered to stop manufacturing |
| Face of the Brand | Directly interacts with customers; sells products | Operates behind the scenes; handles production |
A New Path to Compliance
After the court order, Evig LLC stated that it was working with independent experts to assess and ensure its compliance with FDA regulations. The ability for Balance of Nature to resume operations depended on rectifying the issues that led to the consent decree. This included adhering to federal manufacturing and labeling requirements and receiving FDA approval. The situation underscores the importance of a transparent supply chain and strict adherence to regulatory standards, especially in the dietary supplement industry.
Conclusion
In conclusion, the company that makes the Balance of Nature brand of vitamins is not a single entity but a corporate structure consisting of at least two main players. Evig LLC serves as the parent company and distributor, handling marketing and sales. The manufacturing was formerly carried out by Premium Production LLC, which faced severe legal and regulatory issues with the FDA for failing to meet manufacturing standards. As of late 2023, both companies were under federal court orders to cease operations until they could prove compliance with FDA regulations. The history of FDA warnings, lawsuits, and the eventual court-ordered shutdown revealed the division of labor behind the brand and the serious consequences of regulatory non-compliance in the supplement industry.
For more details on the FDA's findings, you can review the FDA press release.
