The U.S. Food and Drug Administration has now published the long-awaited small entity compliance guide (SECG) for very small firms under the current Good Manufacturing Practices (cGMPs) for dietary supplements (21 CFR Part 111). The guidance was developed by the agency in conjunction with the staggered phase in of the rule based on firm size to limit disruption to small businesses. The SECG was the only guidance that was committed to by the agency in the publication of the final rule. The Natural Products Association will review the guidance, and quickly share with NPA members our analysis of the most important aspects.

The Natural Products Association has long been a leader in the GMP arena. NPA were first in the industry to hold GMP education; offering a webinar within 48 hours of the publication of the final rule, and in-person training two weeks following its publication. Please look for NPA to uphold our tradition of excellence in GMP information and education.

The guidance can be found at this link: Guidance for Industry: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements Small Entity Compliance Guide