Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

CRN Structure/Function Claim Substantiation Document Under Development

This article was originally published in The Tan Sheet

Executive Summary

The Council for Responsible Nutrition is in the process of drafting substantiation criteria for dietary supplement structure/function claims

The Council for Responsible Nutrition is in the process of drafting substantiation criteria for dietary supplement structure/function claims.


The proposed standards will be based on models such as the Federal Trade Commission's guidance on dietary supplement advertising, the Commission on Dietary Supplement Labels' report and various World Health Organization publications about alternative medicine claims, CRN says.


The trade group mentioned the initiative in Aug. 20 comments on the Center for Food Safety & Applied Nutrition's priorities for FY 2003, urging FDA to establish structure/function claim substantiation criteria of its own.


In addition, CRN suggests CFSAN modify its 10-year supplement strategic plan by identifying "those activities directly related to the implementation of the [Dietary Supplement Health & Education Act]" and targeting them for completion by the end of FY 2004.


CRN also alludes to the importance of implementing an effective adverse event reporting system. CFSAN Director of Scientific Analysis & Support Ken Falci is holding a briefing on the progress of the AER system on Aug. 29. The recent publicity surrounding Metabolife's handling of ephedra AERs has given the issue renewed prominence.


In an Aug. 20 letter, the Consumer Healthcare Products Association echoes the import of the AER system and reiterates its concern with the prioritization method used by the Institute of Medicine's Dietary Supplement Ingredient Safety Review.


Expanding on its remarks at an IoM meeting in July, CHPA contends the program should be subject to the normal "notice and comment process" (1 (Also see "IoM Supplement Framework Should Reflect “Relative” Safety – CHPA" - Pink Sheet, 29 Jul, 2002.), p. 3).


In Aug. 19 comments, the National Nutritional Foods Association calls on CFSAN "to develop a survey to assess what consumers want to know about the content of the food products they purchase and to act on that information."


NNFA also highlights the need for small business guidances on the information needed in new dietary ingredient premarket notifications, the boundary between conventional foods and other product categories and the procedure for obtaining an export certificate.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS094441

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel