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January 31, 2016
The Council for Responsible Nutrition will require all members to submit their supplement product labels to the Dietary Supplement Label Database, the trade group has announced.
“This marks the start of a new era for our industry. Our members can no longer allow those companies skirting the laws to tarnish our reputation," said Steve Mister, president and chief executive officer of CRN. "This first step toward greater transparency for regulators and researchers is long overdue, and we strongly urge others in the industry to work with us on this and future initiatives that will ultimately build a stronger industry.”
The requirement applies to CRN member companies that are listed as the responsible party on the product label for all dietary supplement products marketed in the U.S. The National Institutes of Health created the Dietary Supplement Label Database in 2013 so that researchers, health care providers and consumers had one source to find the ingredients of thousands of dietary supplements.
The organization announced the requirement in mid-January, following overwhelming approval by CRN’s Board of Directors at its December meeting.
Although the Office of Dietary Supplements' database is public, consumers are not the intended audience. “But greater consumer accountability is the ultimate goal, and we will get there," Mister said. "Ours is a tale of two industries — companies that follow the law versus those who don’t — and we are starting today to create a clearer divide between those factions.”
Last year, CRN members formed a Product Transparency Working Group to address ways the association and the industry could better assist regulators in policing the industry and protecting the public. Using the working group's research to evaluate various options for establishing a more accurate registry of dietary supplements, the CRN Board selected the Dietary Supplement Label Database as the most appropriate place to start this project.
“The bottom line is, we need a central repository for all dietary supplement labels sold in this country, and the [Office of Dietary Supplements] label registry is already well-established and with a few tweaks could provide the kind of information that would be helpful for FDA," Mister said. "Given that ODS is currently re-evaluating its current contracted database administrator, it was also the right opportunity for us to make suggestions as to how to make the DSLD a more useful and comprehensive tool for regulators.”
CRN recently submitted to ODS a “wish list” of improvements that could strengthen the government’s database for regulators and also for researchers for whom the database was originally designed. For example, CRN would like to see increased allocated resources to allow expanded capacity and quicker processing; establish a process to update labels, denote products no longer on the market and respond to manufacturer-requested corrections to errors; develop a unique product identifier system that could better serve a variety of stakeholders, including consumers; and provide the FDA with confidential information that would allow it to more efficiently contact manufacturers and packagers.
Although CRN is the first association to mandate submission of product labels to a central database, Mister firmly believes it won’t be the only association. “We know that all the associations — and even those companies that are not yet members of an association — are having these kinds of discussions. It makes sense for us to combine our efforts.”
CRN intends to continue its ongoing dialogue with FDA, as well as pursuing additional registry solutions that could supplement the ODS DSLD by supplying confidential product information to FDA, if ODS is unable to make improvements that would result in a more robust database for regulators.
The Council for Responsible Nutrition (CRN), a Washington, D.C.-based national trade association for the dietary supplement industry, is a monthly contributor to the NewHope360.com blog. CRN’s thought-provoking commentary looks at issues impacting the dietary supplement industry and offers perspectives for addressing these issues.
Steve Mister Esq., President and CEO
Judy Blatman, Senior Vice President of Communications
John Hathcock, Ph.D., Senior Vice President of Scientific and International Affairs
Douglas “Duffy” MacKay, N.D., Vice President of Scientific and Regulatory Affairs
Mike Greene, Vice President of Government Relations
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