CRN – Regulatory Updates: New Voluntary Industry-Driven Stability Testing Tool – March 7, 2011

March 7, 2011 By


The Council for Responsible Nutrition (CRN), the dietary supplement industry’s leading trade association, today announced its support of the release of a new voluntary Stability Testing Guideline for dietary supplement manufacturers. This industry stakeholder-driven and transparent initiative is geared toward ensuring that supplement firms have the appropriate science-based evidence needed to support expiration dating on product labels.

The dietary supplement Good Manufacturing Practices (GMPs) do not currently require expiration dating, but the Food and Drug Administration (FDA) regulations require scientifically valid data to support expiration dates included on product labels. While almost all dietary supplement products voluntarily use an expiration date on their labels, there is not currently a recognized industry guideline specifically for dietary supplements that manufacturers can utilize to help develop their own internal stability testing programs.

Codex Standard for Marine Oils: Comments from the Council for Responsible Nutrition

The CRN Omega-3 Voluntary Monograph was developed by a CRN working group in response to concerns about the quality of some omega-3 EPA and DHA products on the market. A number of manufacturers of fish oils requested that CRN form a working group of companies that wished to establish a monograph prescribing analytical methods and standards of quality. The working group was established, and in 2002 published a quality monograph1 which is widely recognized as an industry standard and demonstrates self-regulation. In 2006, the working group expanded its activities further and established itself as an independent entity, now known as the Global Organization for EPA/DHA Omega-3 (GOED). CRN members have identified several critical points that should be considered by the Codex Committee on Fats and Oils (CCFO) to help guide the decision whether to adopt the Proposal for New Work that has been submitted by the Swiss delegation.

CRN is supportive of the development of global standards that facilitate access to safe and efficacious dietary supplements. These standards must not have the unintended consequence of serving as a barrier to international trade or obstacle to future innovation. If the Marine Oils Standard Proposal for New Work is adopted by the CCFO, CRN will be attentive of the standard development process to ensure the technical issues highlighted above are closely considered.


“Roadmap for Retailers: Safely Navigating What You Say About Dietary Supplements.” The “Roadmap” is an educational tool that reminds the supplement industry about its responsibilities with regard to the laws and regulations under which supplements are sold. The document provides suggestions for selling and marketing supplements without running afoul of the law.