“CDX fills a critical void between manufacturers of dietary supplements and retailers,” explained Gisele Atkinson, CRN’s VP of quality and technical affairs, at the organization’s annual conference in Dana Point, CA this week.
“It will assist retailers in obtaining documentation that demonstrates a company’s compliance – so they can better evaluate potential clients/ product to place on store shelves.”
The pilot program, which is open exclusively to CRN member companies, seeks to improve the functionality of CDX, and will conclude in April 2019 to coincide with the OWL’s two-year anniversary. Interested companies have until December 31 to sign up.
From Tier 1 to Tier 2
The Supplement OWL (the Online Wellness Library) – the industry-wide, self-regulatory product label registry being spearheaded by the Council for Responsible Nutrition (CRN) – went live in April 2017.
“We have really focused on the basic OWL (Tier 1) and making sure we get our members and non-members in there,” Duffy MacKay, ND, CRN’s Sr VP, scientific and regulatory affairs, told NutraIngredients-USA. CRN member companies are required, as a condition of membership, to participate in the Supplement OWL, and the database is closing in on 12,000 labels uploaded.
“We were not focused on Tier 2,” he added. “So when we sat down to start on Tier 2 it was clear from input from retailers and our advisory panel that the vision was still relevant. It [the additional information required in Tier 2] is needed.”
To entice member companies to participate in the pilot program, CRN will waive the fee for the first 500 labels, limited to 25 per company (not brand).
“We’re seeing a variety of industry initiatives, like SSCI, GRMA, and CVS addressing this on their own. They all show that retailers are saying they need more information on who they are dealing with,” said Dr MacKay. “CDX perfectly positioned to help.”
What was clear from the conversations with stakeholders was that there needed to be some kind of document control, and it is important to be able to compare apples with apples. Therefore, the CDX requires documents that demonstrate compliance/ adherence in the following categories:
- Evidence of third party cGMP audits and inspections
- Finished product testing/ certifications
- Product attribute verifications – eg. Halal, kosher, GMO-free, gluten-free, allergen-free, etc
- Structure-function claim notification: FDA-assigned SFC notification number
- Post-market surveillance: AER: letter/ statement of compliance
“These really focus on the strengths in the regulations [for dietary supplements],” said Dr MacKay.
The OWL and CDX are about delivering transparency to consumers, regulators and retailers, explained Steve Mister, president and CEO of CRN, during his president’s remarks in Dana Point.
“We need to increase the number of labels in the basic OWL,” he said. “There are 80K + products in the marketplace so we have a long way to go.”
Mister then called on manufacturers to upload additional documentation to the CDX, and for retailers to make participation a de facto requirement to have products on their shelves.
“We all need to re-commit ourselves to build the registry, accountability to regulators, retailers and consumers,” he said.
For more information about the pilot program, please click here.
The registry has received widespread industry support, and has been endorsed by the United Natural Products Alliance, the Consumer Healthcare Products Association, the Natural Products Association, the American Botanical Council, and NSF International.