FDA To Publish GMPs Guide for Small Businesses

The U.S. Food and Drug Administration is seeking comments on a document aimed at helping small supplement makers better understand good manufacturing practices for dietary supplements, which they are now obligated to follow.

“Current Good Manufacturing Practices in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements—Small Entity Compliance Guide" (http://federalregister.gov/a/2010-31613) is a welcome sight for those having trouble understanding the regulations. The document essentially restates the final rules in simplified language and formatting. FDA pointed out that the document also breaks down the requirements for petitioning for an exemption from 100% identity testing of ingredients.

Published in WholeFoods Magazine, February 2011