Printer Friendly

AHPA urges FDA to provide guidance on new laws & regulations.

The American Herbal Products Association (AHPA), Silver Spring, MD, wants the FDA to focus on several areas that will help the dietary supplement industry comply with regulations that cover new good manufacturing practices (GMPs), adverse event reporting, and new dietary ingredient (NDI) safety reviews. AHPA submitted its comments in early September in response to the FDA's request for input on the program priorities in the coming year at the Center for Food Safety and Applied Nutrition (CFSAN). According to AHPA, the dietary supplement industry faces two major new regulatory requirements, as does the agency: (1) a final rule on current good manufacturing practice (cGMP) for manufacturing, packaging, labeling and holding dietary supplements, which was released this past June; and (2) the Dietary Supplement and Nonprescription Drug Consumer Protection Act, a new law requiring serious adverse event reports (AERs) associated with dietary supplements and over-the counter (OTC) drugs be submitted to the FDA, which goes into effect this December. In its comments, AHPA requested that CFSAN ensure that sufficient agency resources are available to the industry so it can comply with both of these new requirements.

Further, citing FDA's "FY 2007 Report to Stakeholders," which was issued in June and listed a number of CFSAN program priorities, AHPA requested that CFSAN disclose how it identifies dietary supplement ingredients and products that raise safety problems, and that the agency act consistently and promptly to enforce against companies that sell products containing ephedra, which are illegal.

AHPA noted that while the agency generally meets its statutory requirement to review NDI pre-market notifications within 75 days, the agency should ensure that resources are provided so that requirement is always met. The FY 2007 Report to Stakeholders also listed CFSAN's intention to develop a new rule and guidance on what information should be filed with an NDI notification, a requirement established by DSHEA. In the absence of agency guidance on how to comply with this safety review for new ingredients, AHPA produced its own interim guidance document.

COPYRIGHT 2007 Rodman Publishing
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Title Annotation:TOP OF THE NEWS
Publication:Nutraceuticals World
Date:Oct 1, 2007
Previous Article:New vitamin D report reveals knowledge gaps.
Next Article:Glanbia acquires Pizzey's.

Related Articles
AHPA files citizen petition to require AERs for dietary supplements. (Top of the News).
FDA extends public comment deadline; Recordkeeping provision of Bioterrorism Act finalized.
United States: trade organizations submit comments to FDA on claim substantiation & new dietary ingredients (NDIs).
AHPA files additional comments on NDIs.
FDA issues new guidance on dietary supplement labeling.
New bill targets herbal supplements.
AHPA files further comments on NDIs.
Dietary supplement GMPs to be released in December.
Are all foods functional? In early December FDA held a hearing to discuss conventional foods being marketed as functional foods; it was by most...
AHPA seeks marketing clarification for OTC drug/supplement products.

Terms of use | Privacy policy | Copyright © 2021 Farlex, Inc. | Feedback | For webmasters |