Dietary Supplement Labeling Handbook

Concise Guide for Labeling based on 21 CFR 101

ISBN: 978-1-5323-7912-3
By: Leon, Gisela

ABOUT THE BOOK

The Supplement Labeling Handbook aims at providing a clear understanding of the regulatory labeling requirements for dietary supplements. This valuable tool identifies the source of the requirements, easily enables deeper studies and offers instructions and tools to navigate the regulatory requirements for the labeling of conventional foods quickly and thoroughly. It provides bullet point arranged instructions for quick application. The many tables created for this handbook enable an excellent overview of a specific labeling subject and at the same time offer details to resolve particular labeling questions. The labeling subjects are grouped to the most likely occurring questions even though they are regulated by different regulations. E.g. the flavor designation is discussed with the statement of identity; incidental additives are discussed in the chapter for the list of ingredients. The handbook covers general labeling requirements; however, it cannot replace the Federal Food, Drug, and Cosmetic Act and its amendments or the regulations in 21 CFR or FDA issued guidance documents. The information in this handbook is accurate to the best of the author’s knowledge reflecting the status as of June 2018.

ABOUT THE AUTHOR

Gisela Leon

Gisela Leon has over 30 years of expert knowledge in international labeling. She is well-experienced in U.S. labeling requirements for food, dietary supplements and cosmetics, in European food laws and multi-language labeling. As a regulatory consultant, she focuses on a concise review process, having reviewed hundreds of labels for U.S. compliance and brought international products into compliance with U.S. regulations. Her international labeling background allows her to point out differences and similarities with other countries. With her over 20 years of extensive knowledge of work processes in the food industry, she experienced the need for easily accessible regulatory information, which led to the development of this handbook for labeling.