FDA Issues New Guidelines for Dietary Supplement Labeling

This guidance document appears to be a very thorough review of the federal regulations that need to be considered when labeling a dietary supplement product."

- Michael McGuffin, president of the American Herbal Products Association

The Food and Drug Administration's Office of Nutritional Products, Labeling and Dietary Supplements has posted a series of new guidelines on its Web site.Titled A Dietary Supplement Labeling Guide, the guidelines cover a variety of topics related to dietary supplements, including the listing and placement of ingredients on product labels, usage of qualified health claims, and other issues, and are designed to present the agency's "current thinking" on the labeling of dietary supplements.

The labeling guide is divided into eight chapters and six appendices, with the text in each chapter presented in a question-and-answer format. Topics covered include:

• general dietary supplement labeling;
• statement of identity;
• net quantity of contents;
• nutrition labeling;
• ingredient labeling;
• claims;
• premarket notification of new dietary ingredients;
• other labeling information.

"This guidance document appears to be a very thorough review of the federal regulations that need to be considered when labeling a dietary supplement product," said Michael McGuffin, president of the American Herbal Products Association. "This new guidance should be especially useful to companies that are new to the trade, but will also provide a helpful review for established firms."

A Dietary Supplement Labeling Guide is currently available online at www.cfsan.fda.gov/~dms/dslg-toc.html. As we go to press, the FDA has announced plans to publish a more-user-friendly version of the guidelines in the near future.

Resources

1. A Dietary Supplement Labeling Guide. U.S. Food and Drug Administration, April 2005.
2. FDA issues new guidance on dietary supplement labeling. NIPCenter.com, April 22, 2005.