‘Repeated Violations’ Close Door On Utah Supplement Marketer And Contract Manufacturer
Consent decrees in federal court come four years after FDA warned both Evig and Premium Production about noncompliant claims for Evig’s Balance of Nature brand supplements and GMP violations at Premium’s plant.
You may also be interested in...
Smart Women’s Choice agrees to consent decree requiring it to halt production and sales of namesake brand product promoted as being hormone-free and with claims including “immobilizing sperm” and “preventing fertilization.” Related company with similar name, product and claims continues sales.
“Wise Women’s Choice, formerly known as Smart Women’s Choice contraceptive cream is 99.8% effective,” FDA reports finding on firm’s website.
A February 2019 inspection of Balance of Nature’s manufacturing facility in St. George, UT, led FDA to claims on the firm's branded website and YouTube channel, which the agency says mark its products as unapproved drugs. Meanwhile, the site inspection turned up quality control and procedural documentation issues that still need to be resolved.