CRN has submitted comments to the Office of Dietary Supplements at the National Institutes of Health, the agency that administers the database. The database as it currently stands has several drawbacks that prevents it from being a more comprehensive and useful representation of the products on the market, according to the association. A more streamlined and functional database could perform the function of a national dietary supplement registry, an idea that CRN and others have been leaning toward in this climate in which industry stakeholders are questioning whether its time to add on to the regulatory structure for the industry as set up by DSHEA.
“We have done some research and we have seen the importance of having a central repository for this information,” Andrea Wong, PhD, CRN’s vice president of scientific and regulatory affairs told NutraIngredients-USA. “To get to that point we know that several improvements in the database’s accuracy and ease of use are needed.”
Among the issues that CRN has identified in the current database setup are a lack of bandwidth to accept the number of monthly submissions that would pour in if the database was universally employed, difficulty in correcting errors and in removing superannuated products from the current listing, and a numbering system that is cumbersome and provides less information than it could.
One the bandwidth front, CRN advocates that the infrastructure be beefed up to be able to accept significantly more than the current rate of 1,000 submissions a month.
“That’s what they are currently processing. If we were to get more industry participation they would need more capacity. If they got more industry participation, they would have less of a need to use their own time searching online for products to add to the database,” Wong said.
Maintaining accuracy of listings
The organization also recommends that ODS establish a framework for how long it takes for a product to show up in the database once label information has been submitted. At present this happens on an ad hoc basis, with some labels becoming searchable within the database far more rapidly than others. That improvement could be a key element of having the database possibly function as a pre-market registry for dietary supplements. Companies are unlikely to buy into the idea if they might have to wait an indeterminate amount of time for product to appear in the listing before going to market.
And CRN has heard from members that it is too difficult at present to update and correct submissions to the registry.
“We have found some errors in the database, and we have found that these errors are not readily corrected,” Wong said.
Another thing that is difficult to correct in the current setup is denoting products that are no longer on the market. Wong said CRN is aware that the database’s prime function at the moment is to act as a tool for researchers, and so all products, both those currently marketed and those that have fallen by the wayside, should continue to be listed. But she said it would make more sense to have off market products appear in search only when an additional search parameter such as “off market” were entered. As matters stand when a search is conducted on a given category of products all the labels show up, no matter if the products are still being sold or not.
CRN has also recommended that products which do not qualify under the regulations as dietary supplements be removed from the database. Currently there are a number of such products appearing in the listings.
Specific numbering system
As far as the number associated with a registration goes, CRN suggests a new system in which the number would identify the product as a dietary supplement via a prefix and have a numeric suffix that would be specific to the responsible party submitting the label. The numbering system that is currently used is not particularly useful, Wong said, because it is sequential, and the only information it really adds is when in the history of the database the label information was received. Having a more specific number associated with each label is information that manufacturers could choose to list on the labels themselves on the shelf and would provide the kind of additional assurance of what’s on the market and who is responsible for it that some legislators seem to be seeking.
ODS is entering into a bid process for selecting a database administrator, a process that will extend further into 2016, Wong said. She said CRN hopes the changes the association is suggesting will help inform that process.
“We recognize some of these changes could mean additional expense. But we have to take this first step. The ODS database is something that already exists and with some changes it could become a very useful tool for self regulation. If it were to include this additional information it could also be used by FDA as a regulatory tool,” Wong said.
To read the full text of CRN’s comments, click here.