“A first, and necessary, step”: CRN to require members submit product labels to ODS label database
The decision was made following overwhelming approval by CRN’s Board of Directors at its December Board meeting, and it is being called “a first, and necessary, step” toward improving transparency in the supplement industry.
The mandatory requirement of membership, which applies to those CRN member companies listed as the responsible party on the product label for all dietary supplement products marketed in the US, will start in 2017, Steve Mister, CRN President & CEO, told NutraIngredients-USA.
“We’re encouraging members to start providing labels as soon as practicable, and we’ll be doing outreach with our members to make them familiar with it, explain who to submit their labels to, and so on,” he said.
When companies renew their memberships in November and December they will be required to certify that their labels are in the database.
“The start of a new era”
“This marks the start of a new era for our industry,” said Mister. “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 added that although the ODS DSLD is public, and therefore the information can be accessed by consumers, at this stage consumers are not the intended audience. “But greater consumer accountability is the ultimate goal, and we will get there. 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.”
Assessing the options
What is the ODS DSLD?
The Dietary Supplement Label Database (DSLD) is a joint project of the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) and National Library of Medicine (NLM). The database contains the full label contents from a sample of dietary supplement products marketed in the United States. It can be found HERE.
As we reported back in November, CRN convened a Product Transparency Working Group to investigate various options for establishing the product registry from both existing databases and the possibility of creating a new platform. After evaluating the various options for establishing a more accurate registry of dietary supplements, based on the research of this working group, the CRN Board selected the ODS DSLD as the most appropriate place to start this project.
“The ODS DSLD is very attractive because it’s already up and running, and a number of CRN’s member companies already have label data in the database, either by affirmatively participating or ODS has loaded them up already,” explained Mister.
“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,” he said. “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.”
Some things about the ODS database are lacking and CRN has submitted comments to the ODS. If those comments are taken on board then it would make it much more robust, said Mister, and CRN would stay with it. If those comments do not result in satisfactory changes and agreement cannot be reached with the ODS then the association would reassess its position, he added.
The CRN’s “wish list” of improvements that could strengthen the government’s database for regulators and also for researchers includes:
- An increase in allocated resources to allow expanded capacity and quicker processing;
- Establish a process to update labels (and 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; and
- Provide FDA with confidential information that would allow it to more efficiently contact manufacturers and packagers.
“These are not things that will require a great hike in resources,” said Mister.
The wider industry
Although CRN is the first association to mandate submission of product labels to a central database, Mister 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.”
The other trade associations were notified of CRN’s intention to explore mandatory submission of labels for its members after the association’s annual conference in Palm Springs last October (Michael McGuffin from AHPA and Scott Melville from the CHPA were in attendance at the event). After CRN’s December Board meeting Mister said that he formally contacted the other trade associations and invited them to join his announcement.
(AHPA currently recommends its member companies to submit their labels but it doesn’t require it, and McGuffin has repeatedly said that industry and government should work together on improving existing ODS DSLD.)
So what’s to stop rogue players from putting labels in the database? Nothing, said Mister. “We had a very robust discussion with the Board of Directors on this very issue,” he added. “You can have a database that is intended to be a reflection of the industry as whole, warts and all, or you can limit it to people who have specific certifications or meet certain acceptance criteria. It comes down to what the intention of the database is. The ODS DSLD is intended to be a snapshot of the whole industry, which includes the less than perfect players.”
“If someone is in there with DMAA in their products then it will be very easy for the FDA to do an ingredient search and find those companies.”
The association 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.
Mister added: “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.’”
