An industry-wide registry the Council for Responsible Nutrition is developing could become a gatekeeper for whether dietary supplements reach retailers' shelves even though registration will be optional for firms marketing products in the US.

CRN on April 13 announced that by the end of 2016 it will launch a registry for label and other information about vitamins, supplements, minerals and other nutritionals available in the US. The trade group will continue requiring its members to submit their product labels to a National Institutes of Health-managed database.

Marketers of adulterated supplement products, those with violative ingredients or that are made in noncompliant facilities, likely will not submit their label and other information to the industry registry, which will be available to retailers as a catalog of products entirely compliant with FDA regulations. FDA also would have access to the information, essentially giving the agency a view of whether firms providing supplements sold in stores and online are stating their regulatory compliance.

"We're hoping that this registry sort of becomes the ticket to play in the industry," says CRN President and CEO Steve Mister

However, when a firm submits information that indicates its product is adulterated, the registry, which will be administered by a third-party vendor CRN is hiring, will include some mechanism to highlight the product for evaluation.

"I would expect that there would be some self-policing of the registry. If we found there were illegal ingredients in a product that were on the label, I would suspect that there would be some consequence and it would be removed from the registry," said CRN President and CEO Steve Mister.

Firms would be allowed to present information supporting questionable products' listing, "but if there's something about the product that is patently illegal, I would suspect it would be removed," Mister said in an interview.

"In some ways it becomes self-selective about who's in" the registry, he said, adding, "We're hoping that this registry sort of becomes the ticket to play in the industry."

More Than Labels

CRN calls the database a registry to avoid confusing the information with the NIH Office of Dietary Supplements product label database and because the industry list will be more informative to retailers and FDA.

Mister said retailers need more than the label information on the ODS database to more fully understand the supplement products that more and more firms want to sell in their stores. The ODS database primarily is compiled for researchers to identify certain products and does not evaluate the information companies submit nor ask for additional information.

"With the ODS database, whatever they get in, they put in," he said.

Retailers, FDA officials and consumers will not find on the ODS label database information such as evaluations of product quality; whether a firm has had a third-party certification or seal for its products or a good manufacturing practices inspection of its facilities; and whether its health or qualified health claims are approved by FDA and it submitted structure/function claims for its products to the agency as well as whether its ingredients are genetically modified or organic, or whether its products are kosher or halal.

"Those kinds of questions about the product can be put into the registry and the retailers can make more informed decisions on whether they want those products on their shelves," Mister said.

CRN will maintain the requirement it established in December that its members submit their product labels to the ODS database ([A#05151116002]).

"We consider it a civic obligation to do that. If the government is putting together a label database, you ought to support it," Mister said.

CRN's board later in 2016 probably will decide whether to make listing products on the registry a requirement for membership. "As I look forward, I would expect that CRN's board would require our member companies that have finished products to be in the registry," he said.

Labels Are Tier One

Product information on the registry will be split into two tiers. Firms can list products on the first tier at no charge; the tier will be accessible to the public and will include labels and products' other consumer-facing information.

The second tier, accessible to retailers, FDA and other regulatory agencies, will include information that the ODS database does not and firms will be charged a fee for listing information on their products.

"There's going to be a vendor who's going to have to administer this," Mister said. CRN is funding the initial development and launch of the registry, "but for an ongoing project like this, to fund this register and keep it up, something has to provide a revenue source in order to pay for the costs of administering it over time."

GNC Holdings Inc. has encouraged development of an industry-wide product database in the initiative it is leading to improve compliance across the industry, including sharing its GMP compliance guidelines, and the American Herbal Products Association and the United Natural Products Alliance stated support for CRN's interest in creating a registry; CRN also supports AHPA's initiative to share is botanical collection best practices with other firms ([A#05160307008]).

CRN Targets 'Ticket To Play' With Supplement Registry

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