HBW Insight

Qualifying Suppliers For US Supplement Ingredient Identity Requirement Still An Option With Thorns

04 Aug 2022

Failing to qualify suppliers “one of the more common citations” FDA inspectors find at supplement facilities, says ORA deputy director Michael Dutcher. “If you're not sort of reconfirming once in a while it could lead to a problem with your products that you weren't even expecting.”

Among the most common quality-control deficiencies in dietary supplement manufacturing is one that a Food and Drug Administration says US regulations “are kind of quiet on,” and that the industry has wrestled with since the requirement was imposed.

Failing to qualify suppliers “is one of the more common citations” FDA Office of Regulatory Affairs inspectors find at facilities manufacturing supplements marketed in the US, said Michael Dutcher, deputy director of the ORA’s Office of Human