How 21 CFR Part 111 Helps Dietary Supplement Companies

By Master Control

On June 1, 2008, the FDA’s Good Manufacturing Practices (GMP) rule for dietary supplements (21 CFR Part 111) went into effect for companies having more than 500 employees. The staggered phase-in for smaller companies is as follows:

• June 1, 2009 for companies having between 21 and 499 employees
• June 1, 2010 for companies having fewer than 20 employees

Also referred to as “the GMP rule,” the regulation is an effort by the FDA to protect consumers while quelling fears of FDA “over-regulation”—a prospect that alarms not only manufacturers and distributors of dietary supplements, but also consumers.

As this paper shows, however, the FDA’s final Good Manufacturing Practices (GMP) rule will benefit both consumers and manufacturers/distributors of dietary supplements.

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