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Consultant and long-time FDA food and dietary supplement labeling expert James Summers offers a comprehensive guide to understanding and complying with the dietary supplement labeling requirements of the Food and Drug Administration (FDA) in Dietary Supplement Labeling Compliance Review, Third Edition. Available in book or searchable CD-ROM (view CD-ROM version) formats, this updated review is composed of three essential parts: Sections I through V consist of the introduction and how-to information. Sections VI through IX consist of the compliance step-by-step review procedure (in the form of questions and responses,) and other labeling requirements. Sections X through XV consist of guidance and information for decision making. Clearly illustrated with dozens of charts, sample label panels, and supplement facts boxes, this manual is the straightforward, no-nonsense tool both inexperienced and experienced dietary supplement label reviewers need to assure labeling compliance

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Dietary Supplement Labeling Compliance Review

Consultant and long-time Food and Drug Administration (FDA) food labeling expert James Summers answers the many questions surrounding FDA food labeling regulations and compliance in Food Labeling Compliance Review. Now in its third edition, the manual is a comprehensive food labeling compliance handbook designed to aid in understanding the requirements of the FDA. This reference is a must-have for regulatory officials, industry personnel, and others responsible for assuring that the label and labeling of domestic and imported food products in interstate commerce comply with the requirements of the Federal Food, Drug and Cosmetic Act, as amended. The manual is available in book or searchable CD-ROM formats (or both together if you order the first choice on the right). The text is composed of three essential parts: 1.) Introduction and how-to information, including the outline of a compliance review. 2.) Compliance step-by-step review procedure (in the form of questions and answers) for the food label reviewer to establish the degree to which a product’s label complies with applicable laws and regulations. These sections also provide a basis for developing a label for prospective food products, as well as a foundation for responding to label deviations observed during the review. 3.) Guidance and information for decision making such as ready references, charts, illustrations, regulations, Federal Register indexes and tables of content for related publications. Clearly illustrated with dozens of charts, sample label panels and “Nutrition Facts” boxes, Food Labeling Compliance Review is the practical, no-nonsense tool needed by both the experienced and inexperienced food label reviewer. About the Author: James L. Summers is a senior consultant at AAC Consulting Group, Inc. (Rockville, MD), a firm providing consulting services in food, dietary supplement, cosmetics and other areas which fall under the jurisdiction of FDA. He has been offering expert labeling and compliance advice to AAC clients since he ended his 32-year tenure at FDA. He has held positions as Aquatic Sampling Specialist, Supervisory Microbiologist, Public Health Sanitarian, General Biologist, FDA Inspector, Regional Shellfish Specialist, and Consumer Safety Officer (in the Division of Regulatory Guidance). In his last position at FDA, he served as Supervisory Consumer Safety Officer, Branch Chief in the Office of Food Labeling. There he was the focal point for handling the most controversial, complex, and precedent-setting problems involving regulatory compliance issues dealing with food labeling. He participated in the development of policies and regulatory strategies regarding the enforcement of NLEA and other food labeling regulations. Contributor: Elizabeth J. (Betty) Campbell joined AAC after a 35-year career with the FDA where she served as Director of Programs and Enforcement Policy in the Office of Food Labeling in the Center for Food Safety and Applied Nutrition, and as Acting Director of the Office of Food Labeling. Ms. Campbell played a key role in writing the Nutrition Labeling and Education Act (NLEA) regulations in the early 1990s, and then had major responsibility for implementing those regulations.