Legal Alert - American Herbal Products Association (AHPA)

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FDA: Botanical Compounds May Not be Legal Dietary Ingredients

Just because a compound is found in a botanical doesn't mean FDA considers it a part of the food supply, according to Daniel Fabricant, Ph.D., Director, Division of Dietary Supplements, FDA, during his featured presentation at SupplySide West. Thus, if a supplement company introduces an isolated botanical substance to the market without submitting a new dietary ingredient (NDI) notification, the agency is likely to consider it an adulterated product.

Author: Anonym
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FTC Charges HCG Marketer with Deceptive Advertising

Defendants Promised Dietary Supplement Would Cause Substantial Weight Loss
The Federal Trade Commission has sued an Arizona man who markets HCG Platinum diet products by falsely claiming the products will cause consumers to lose substantial amounts of weight. Kevin Wright and his companies must respond to the complaint in federal court.

 

Author: Anonym
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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with the Food and Drug Administration (FDA), called for the agency to withdraw what it called the "hugely flawed" "Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues."
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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.
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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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