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FDA Issues New Guidelines on Dietary Supplement Labeling

by Rakesh Amin

On April 21  the FDA’s Office of Nutritional Products, Labeling and Dietary Supplements released new guidelines for the dietary supplement industry. Entitled “A Dietary Supplement Labeling Guide” the new document, posted on the FDA website but not published in the Federal Register, covers a wide range of topics regarding dietary supplement labeling and is designed to represent the Agency’s current opinions on the topic.

The question-and-answer format focuses on the most frequently raised questions about the labeling of dietary supplements and also includes the specifically applicable regulation as part of each answer. The FDA stated “[w]e have prepared this guide to help assure that the dietary supplements sold in the United States (U.S.) are properly labeled.” 1 

The Guide applies to both dietary supplement ingredients and finished dietary supplement products manufactured or produced domestically as well as those produced in foreign countries. It is separated into 8 chapters and 6 appendices. The Guide covers all aspects of dietary supplement labeling, including requirements related to statements of identity, net quantity listing supplement facts panels, ingredient listing, health and structure/function claims, and premarket notifications for new dietary ingredients.

The Guide is intended to address questions about dietary supplement labeling issues and reflects the FDA’s current position on these issues. However, it is not legally binding or precedent-setting but rather is merely an interpretation of the applicable statutes and regulations to educate the industry on how the FDA believes compliance can be met.

The Dietary Supplement Labeling Guide can be accessed at: http://www.cfsan.fda.gov/~dms/dslg-toc.html. More information regarding FDA Dietary Supplement Labeling is available by contacting Rakesh Amin at (312) 327-3382 or rakesh@amin-law.com.

Reference

1  U.S. Food and Drug Administration. Guidance for Industry: A Dietary Supplement Labeling Guide (April 2005).  Available at <http://www.cfsan.fda.gov/~dms/dslg-toc.html#toc>.