Vitamins and Supplements
Premium Production, LLCInformation and Alerts
Alert Details
This business has 1 alert.
Government Actions
FDA Consent Decree
The following describes a government action that has been resolved by either a settlement or a decision by a court or administrative agency. If the matter is being appealed, it will be noted below.
On November 16, 2023, U.S. Food and Drug Administration (FDA) announced that a dietary supplement distributor, manufacturer, and two executives have been ordered by a federal court to stop producing and selling their products until they come into compliance with federal regulations and requirements under the Federal Food, Drug, and Cosmetic Act.
The U.S. District Court for the District of Utah, Central Division has entered two consent decrees of permanent injunction against Evig LLC, which does business as Balance of Nature, and the company's CEO, Douglas Lex Howard, as well as manufacturer Premium Production LLC, and its Manager, Ryan Petersen.
Balance of Nature products are marketed as dietary supplements, with labeling that rendered them unapproved new drugs and misbranded drugs. 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. In addition, they violated current good manufacturing practice (CGMP) requirements, which rendered its products adulterated dietary supplements.
Premium Production LLC manufactured Balance of Nature products in violation of multiple CGMP requirements, such as failing to establish ingredient and finished product specifications for identity, purity, strength, and composition, which rendered them adulterated dietary supplements.
In 2019, the FDA issued warning letters to Evig LLC and Premium Production LLC after facility inspections identified CGMP violations at both companies' facilities. Following the 2019 warning letters, FDA inspections showed that the companies failed to address the deviations and come into compliance with the FDA's requirements.
The consent decrees prohibit Evig LLC and Premium Production LLC from distributing or manufacturing products until they are in compliance with CGMP and labeling regulations. Under the consent decrees, both companies must hire CGMP experts, submit documents demonstrating compliance, and receive FDA's approval to resume operations. In addition, Evig LLC must hire a labeling expert to ensure their products are no longer considered new and/or misbranded drugs.
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