Dietary Supplement Labeling Compliance Review
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Dietary Supplement Labeling Compliance Review
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Author : James L. Summers
language : en
Publisher: John Wiley & Sons
Release Date : 2008-02-28
Dietary Supplement Labeling Compliance Review written by James L. Summers and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-02-28 with Technology & Engineering categories.
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
Dietary Supplement Labeling Compliance Review
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Author : Summers, James Lee Summers
language : en
Publisher:
Release Date : 2004
Dietary Supplement Labeling Compliance Review written by Summers, James Lee Summers and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004 with Food categories.
Food Labeling Compliance Review
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Author : James L. Summers
language : en
Publisher: John Wiley & Sons
Release Date : 2008-02-28
Food Labeling Compliance Review written by James L. Summers and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-02-28 with Technology & Engineering categories.
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.
Food Labeling Compliance Review
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Author : James L. Summers
language : en
Publisher: Wiley-Blackwell
Release Date : 2003-07-07
Food Labeling Compliance Review written by James L. Summers and has been published by Wiley-Blackwell this book supported file pdf, txt, epub, kindle and other format this book has been release on 2003-07-07 with Technology & Engineering categories.
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.
Dietary Supplement Good Manufacturing Practices
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Author : William J. Mead
language : en
Publisher: CRC Press
Release Date : 2016-04-19
Dietary Supplement Good Manufacturing Practices written by William J. Mead and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2016-04-19 with Medical categories.
Dietary Supplement GMP is a one-stop "how-to" road map to the final dietary supplement GMP regulations recently issued by the FDA covering the manufacture, packaging, and holding of dietary supplement products.The recent regulations, outlining broad goals, intentionally avoid specifics to allow for future technological advances-leaving implementati
Commission On Dietary Supplement Labels Report To The President Congress And The Secretary Of The Department Of Health And Human Services
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Author : United States. Commission on Dietary Supplement Labels
language : en
Publisher:
Release Date : 1997
Commission On Dietary Supplement Labels Report To The President Congress And The Secretary Of The Department Of Health And Human Services written by United States. Commission on Dietary Supplement Labels and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997 with Consumer protection categories.
Contains the Commission's recommendations for regulations and provides guidance to government agencies and the dietary supplement industry relative to safety, label statements, health claims, substantiation of claims, and botanical supplements. Emphasizes the need for public access to the evidence on which label statements are based so that consumers can make informed decisions about the use of dietary supplements.
Fda And Usda Nutrition Labeling Guide
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Author : Tracy A. Altman
language : en
Publisher: CRC Press
Release Date : 1998-06-05
Fda And Usda Nutrition Labeling Guide written by Tracy A. Altman and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 1998-06-05 with Technology & Engineering categories.
A workbook for day-to-day decisions Nutrition labels on various food products must comply with numerous, ever-changing requirements. Items such as meat and poultry products, food packages, and dietary supplements are subject to stringent federal regulations-and the costs of compliance are often significant. The Nutritional Labeling and Educ
Food Labeling Compliance Review
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Author : James L. Summers
language : en
Publisher: John Wiley & Sons
Release Date : 2008-02-28
Food Labeling Compliance Review written by James L. Summers and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-02-28 with Technology & Engineering categories.
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. This comprehensive manual and fully searchable, accompanying CD-ROM are designed to aid in understanding the requirements of the FDA. Food Labeling Compliance Review 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 new fourth edition of Food Labeling Compliance Review fully covers recently enacted provisions requiring labeling for allergens, trans fats, and qualified health claims. 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. Current, complete, and accurate food labeling guidance concerning FDA regulations Covers new requirements for labeling allergens, trans fats, and qualified health claims Essential for all food manufacturers, packers, labelers, relabelers, and distributors Fully illustrated with clear Q and A explanations Fully-searchable CD-ROM enables quick look ups
Dietary Supplements
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Author : Mindy J. Allport-Settle
language : en
Publisher: Pharmalogika
Release Date : 2010-10
Dietary Supplements written by Mindy J. Allport-Settle and has been published by Pharmalogika this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-10 with Law categories.
This book is designed to be a unified reference source for the U.S. Food and Drug Adminstration's Dietary Supplements regulations, guidance, and associated documents. Dietary Supplements Regulations and Guidance: * FDA Overview and Orientation * Introduction to Dietary Supplements * Part I: Regulations - Part 111: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements - Part 101: Food Labeling - Part 190: Diettary Supplements * Part II: Legislative Acts and Significant Amendments - Dietary Supplement and Nonprescription Drug Consumer Protection Act - Dietary Supplement Health and Education Act of 1994 * Part III: Guidance and Associated Documents - Dietary Supplements Final Rule - Dietary Supplement Current Good Manufacturing Practices (CGMPs) and Interim Final Rule (IFR) Facts - Dietary Supplement Labeling Guide - Structure/Function Claims, Small Entity Compliance Guide - Notification of a Health Claim or Nutrient Content Claim Based on an Authoritative Statement of a Scientific Body - Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act - Responses to Questions about Codex and Dietary Supplements Reference Tools * Part IV: Combined Glossary and Index
Dietary Supplement Regulation In The United States
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Author : Taylor C. Wallace
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-10-01
Dietary Supplement Regulation In The United States written by Taylor C. Wallace and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-10-01 with Science categories.
Contrary to the common belief that dietary supplements are “unregulated” in the United States, nutrients and other dietary ingredient-containing products have been regulated in this country for a little over a century at least in some capacity, initially through the Pure Food and Drug Act (PFDA) of 1906 and culminating with the many anticipated regulations to be implemented following the recent enactment of the Food Safety Modernization Act of 2010 (FSMA). The goal of this brief is to review and discuss the current statutes and regulations surrounding the ingredients, manufacturing standards, safety, and labeling of dietary supplements for the purpose of protecting consumers.