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“This marks the start of a new era for our industry,” says CRN President and CEO Steve Mister.
The Council for Responsible Nutrition (CRN; Washington, D.C.) announced today that all CRN members will be required to submit their supplement product labels to the Dietary Supplement Label Database (DSLD), a joint project of the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) and National Library of Medicine (NLM).
The mandatory database requirement is designed to improve transparency in the supplement industry, says CRN, and applies to “those CRN member companies listed as the responsible party on the product label for all dietary supplement products marketed in the U.S.”
CRN advises its members provide their product labels to the database by December 31, 2016. Beginning in 2017, participation in the DSLD will be a requirement for CRN membership renewal or acceptance for new membership.
“This marks the start of a new era for our industry,” said Steve Mister, president and CEO, CRN, in this morning’s announcement. “Our members can no longer allow those companies skirting the laws to tarnish our reputation. 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.”
Mister tells Nutritional Outlook that the decision to mandate participation in the database was made with overwhelming support from the CRN board.
“Since we sent the notice out alerting our members to it, I have gotten only positive feedback,” says Mister.
Why Use DSLD?
There was discussion within CRN as to whether industry would be best served with a more inclusive database or one that has certain requirements for participation, such as outside certifications or inspections. But the CRN board ultimately chose to take the more inclusive approach with ODS, says Mister.
“We think that the database serves its purpose by being a reflection of what the industry really looks like,” says Mister. “Good, bad, ugly-all of that. We hope that everybody else in the industry will agree to put their labels in as well, so that the database really can be a mirror of what’s in the marketplace.”
Based on the research of a Product Transparency Working Group formed by CRN’s members last year, the CRN Board selected the ODS DSLD as the most appropriate place to establish a registry of dietary supplements. The database was first launched in 2013 and currently contains full label contents for more than 50,000 dietary supplement products marketed in the United States.
“The bottom line is we need a central repository for all dietary supplement labels sold in this country, and the ODS label registry is already well-established, and with a few tweaks, could provide the kind of information that would be helpful for FDA,” said Mister, in the announcement. “Given that ODS is currently reevaluating 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.”
On December 31, 2015, CRN submitted a list of comments to ODS suggesting potential improvements to the database. Here are a few of CRN’s recommendations:
· Increase allocated resources to allow for 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 down the road
· Provide FDA with confidential information that would allow it to more efficiently contact manufacturers and packagers
The American Herbal Products Association (AHPA; Silver Spring, MD) recently encouraged its own members submit dietary supplement labels for inclusion in the DSLD. Additionally, AHPA recommended several changes to the database, such as archiving labels for products no longer available for purchase, providing a readily accessible mechanism to indicate product forms when conducting a search of labels, and ensuring the language of DSLD website’s disclaimer is consistent with FDA’s Online Label Repository.
Not Ready for Consumers Yet
Although the ODS database is public and can be accessed by consumers, Mister says at this stage, researchers and regulators are the intended audience for the database, rather than consumers. However, if ODS is able to incorporate enough of CRN’s recommendations into the database, it may then be able to evolve into a place that FDA, the media, and consumers can all use, says Mister.
“For instance, we really believe that there ought to be a confidential part of the database that includes information that might not be accessible to consumers, but that would be accessible to regulators,” Mister says. The function might be especially valuable in the case of contract manufacturing, he explains, where consumers may only be familiar with the distributor of a product, but regulators need to know which contract manufacturer actually made the product.
“Currently that doesn’t exist in the database, but if ODS can figure out a way to configure that, well then that checks the box,” says Mister.
CRN is the first association to mandate its members submit product labels to a central database, but Mister believes other associations will join CRN in taking this step. In the meantime, CRN says it will help familiarize its members with the ODS database and the process of uploading labels in an electronic format.
Mister also emphasizes that, while a positive step, using this database will not “solve the consumer crisis concerns overnight.” He advises that there will be more announcements to come and this step “is not the end of the road.”
“We know some will say this first step isn’t enough, but to those critics we say, ‘today we are setting in place a critical cornerstone that begins to identify the scope of the dietary supplement industry, and ultimately makes it easier to navigate,’” concluded Mister, in the announcement.
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