The online product registry will include full label information for dietary supplements and be accessible via the web. CRN member companies will be required as a condition of membership to input all their product labels into the product registry by July 2017.
Speaking at the recent 4th Annual Legal, Regulatory, and Compliance Forum on Dietary Supplements run by the American Conference Institute and CRN, Dr Duffy MacKay, CRN’s Sr VP of scientific and regulatory affairs, said “We’re hoping in 2017 to be asking entire industry to participate in this product registry.
“All of the industry will be strongly encouraged to participate at no cost.”
A two-tiered registry is being planned: Tier one is basic product information which will be accessible to anyone and will permit participating manufacturers/marketers to add their products at no charge. Tier two will involve a fee and allow a company to provide more in-depth information about the products. Access to this additional information will be restricted to select audiences, such as regulators and retailers.
Beta testing
The agreement between CRN and UL calls for the registry to go into an immediate development stage, and beta testing is scheduled to occur this summer with about a half dozen companies, ranging from small to very large dietary supplement companies.
“We spoke with a number of very capable companies for this important project, but UL best fit the bill because of its broad knowledge of the supplement industry, its technical prowess and its brand recognition for consumer safety,” said Steve Mister, CRN President & CEO.
“We were also impressed with UL’s flexibility in accommodating the range of data fields we want to include that address the important quality discussions taking place within the industry. We are confident that the dietary supplement product registry will provide a viable, adaptable product registry that will serve regulators, retailers, manufacturers, and ultimately consumers, over time.”
Transparency
Mike O’Hara, General Manager for UL’s Global Nutraceuticals division, said: “We know the industry and we understand the sensitivities, complexities and determination involved in developing the right product registry that will allow for a core product accompanied by customization. We take our responsibility here very seriously and look forward to working with CRN, its members and any company that wants to bring the industry to a higher level of accountability for its customers.”
Earlier this year, CRN announced what it called “a first, and necessary step” toward improving transparency in the supplement industry by requiring all CRN members as a condition of membership submit their supplement product labels to the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) Dietary Supplement Label Database (DSLD). The new product registry will serve as a companion piece to the DSLD.
In addition to transparency, Dr MacKay told attendees at the recent ACI-CRN event that the registry also has to be sustainable. “We have to demonstrate we’re a pro-active and responsible industry,” he said.
The registry is one part of a wider framework to strengthen the industry’s relationship with FDA, which also include botanical raw material GMPs for ingredient quality, the 21 CFR 111 cGMP benchmark for finished product quality, and the product registry for information transparency. All of these efforts need to be strategically aligned with the other trade associations and organizations to avoid duplicate efforts, he added.
FDA appreciation
The US Food and Drug Administration has previously said that it appreciated the initiative from CRN. In an email statement to NutraIngredients-USA in April, Steve Tave, Acting Director of the Office of Dietary Supplement Programs at the FDA, said: “The FDA appreciates CRN’s efforts to promote industry compliance through self-regulation and we look forward to learning more about how CRN’s program will be implemented.
“However, all dietary supplement manufacturers and distributors are required to comply with federal regulations, and the agency continues to be focused on ensuring that there is full compliance throughout the industry.”