Other safety alerts
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| The United States: Federal judge enters consent decrees against Utah-based dietary supplement distributor and manufacturer of Balance of Nature products |
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The US Food and Drug Administration (FDA) announces that dietary supplement distributor and manufacturer (Evig LLC and Premium Production LLC), 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.
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, Evig LLC violated current good manufacturing practice (CGMP) requirements, which rendered its products adulterated dietary supplements. Evig LLC distributes Balance of Nature dietary supplement products online. Premium Production LLC manufactured Balance of Nature products in violation of multiple CGMP requirements, such as failing to establish ingredient and finished products specifications for identity, purity, strength, and composition, which rendered them adulterated dietary supplements.
Please refer to the following website in FDA for details:
http://www.fda.gov/news-events/press-announcements/federal-judge-enters-consent-decrees-against-utah-based-dietary-supplement-distributor-and
In Hong Kong, there is no registered pharmaceutical product manufactured by Evig LLC and Premium Production LLC.
Ends/Friday, Nov 17, 2023
Issued at HKT 16:00
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