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AHPA Calls for Withdrawal of "Hugely Flawed" NDI Notification Guidance in Comments to FDA

AHPA requests FDA to issue new guidance

The American Herbal Products Association (AHPA), in comments filed with the Food and Drug Administration (FDA), called for the agency to withdraw what it called the "hugely flawed" "Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues."

Interim Guidance for New Dietary Ingredient (NDI) Notifications for Manufacturers and Distributors

NDI guidance published in May 2006 and revised September 2011 - Log-in to download

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

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.

Guidance on Adverse Event Reporting (AER)

Considerations and MedWatch Worksheet for receiving AERs associated with dietary supplements - Log in to download

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.

Guidance on 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.

2011 AHPA Awards

AHPA is proud to announce the winners of its fifth annual AHPA Awards to recognize individuals and companies making substantive, positive contributions to the herbal products industry

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

AHPA Members log-in to download this free document

[Archive: This guidance was updated in 2017.] This guidance provides 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

AHPA Members log-in to download this free document

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.

Guidance on good documentation practices

Documentation systems for manufacturing, packing, or holding dietary supplements - Log-in to download

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

2010 AHPA Awards

AHPA is proud to announce the winners of its fifth annual AHPA Awards to recognize individuals and companies making substantive, positive contributions to the herbal products industry

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2022 Annual Fund Sponsors

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