American Herbal Products Association (AHPA) > Bookstore > Publications

Interim Guidance for New Dietary Ingredient Notifications for Manufacturers and Distributors of NDIs

Published in May 2006 and revised September 2011

This guide explains the new dietary ingredient (NDI) regulations and identifies information to include-and exclude- in an NDI notification

Adverse Event Reporting: Considerations & MedWatch Worksheet for Receiving AERs Associated with Dietary Supplements

The information provided here addresses internal policies that may be established by companies in preparation for receiving an adverse event report and also presents ideas for communicating with the reporter of such an event.

Interim Guidance for New Dietary Ingredient Notifications for Manufacturers and Distributors of NDIs

this in-depth and practical guide explains the new dietary ingredient (NDI) regulations and identifies information to include-and exclude- in an NDI notification.

Shelf Life Dating of Botanical Supplement Ingredients and Products

Overview of federal regulations and compliance strategies

This document provides an overview of federal regulations regarding the use of shelf life dates for dietary ingredients and dietary supplements sold in the United States, with a particular emphasis on botanical ingredients and products. In addition it presents various strategies for meeting those requirements.

Background on California Proposition 65: Issues Related to Heavy Metals and Herbal Products

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The backgrounder provides invaluable information on the regulatory and liability implications of Proposition 65 on heavy metals that may be present in herbal products sold in the State of California.

2006–2010 Tonnage Survey of Select North American Wild-Harvested Plants

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This fifth AHPA harvest survey report includes quantifications of harvests from 2006 to 2010 for 26 botanical commodities derived from 22 plant species, including a number of high-volume herbal commodities.

AHPA Primer on Products Liability Insurance for the Dietary Supplement Industry

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This document provides a basic understanding of products liability insurance and the processes involved in purchasing this insurance by dietary supplement companies.

Good Documentation Practices Manual

This manual focuses on documentation systems in the context of manufacturing, packing, or holding dietary supplements

Heavy Metals: Analysis and Limits in the Herbal Dietary Supplements

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This document provides proposed limits with accompanying explanations as to how they were determined for lead, mercury, cadmium and arsenic, and accompanying explanations as to how these limits were determined.

Guidance for Addressing FDA cGMP Inspections of Dietary Supplement Facilities

Understand your rights and obligations when FDA conducts a cGMP inspection

This Guidance for Addressing FDA Inspections of Dietary Supplement Facilities has been prepared to assist AHPA members in understanding their rights and obligations when the U.S. Food and Drug Administration conducts an inspection of a facility in which dietary supplements or ingredients are manufactured, processed, packed or held. It provides descriptions and analyses of the current federal laws that are relevant to inspection of dietary supplement facilities and suggestions of how to prepare for and conduct inspections in a manner that fully complies with these laws.
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