Last year, the Council for Responsible Nutrition (CRN) launched its “Supplement OWL” (Online Wellness Library) with the intention of establishing a single, authoritative, non-government clearinghouse for specific information about the dietary supplements and herbal products out on the market.
This online label registry, launched in the Spring of 2017, in collaboration with Underwriters Laboratory (UL), is a self-regulatory initiative to increase transparency, educate consumers and practitioners, and assist regulators.
The OWL provides a one-stop library where consumers, retailers, regulators, industry representatives—and practitioners—can view the exact ingredients, label claims, dosage forms (aka “serving sizes”), intended uses, and contact information for every supplement product on the market.
Though there’s still a long way to go before CRN obtains 100% industry coverage—according to some estimates there are as many as 80,000 different supplements out there--the project is off to a strong start.
In the 18 months since it launched, the OWL has amassed over 11,000 product labels, with 89 supplement companies now engaged.
“Participation is moving along really well,” says Gisele Atkinson, CRN’s Vice President of Quality & Technical Affairs. “It is being fully supported by other trade organizations, and the FDA has also been very supportive--showing interest, asking for updates, asking for meetings to learn how the OWL works.”
Steps Toward Transparency
Listing products on the OWL is voluntary, and there’s no charge for companies to post their labels and basic information.
But this year, CRN added a new feature—a fire-walled commercial data exchange—where, for a small fee, companies can post all their analytical testing data, certificates of analysis, 3rd party certifications, and any other quality assurance information they want to publish.
Atkinson says the idea is to create a fast and easy way for supplement makers to share all their product specifications with buyers, including practitioners who dispense supplements.
Participation in the OWL is a way for ethical brands to show the world that they have nothing to hide.
"Questionable companies tend to run away from things like the OWL, because they know they would be voluntarily exposing themselves to FDA scrutiny. The companies that participate want to expose themselves because they know they are compliant, and they are confident in their products.”-- Douglas "Duffy" MacKay, ND, Senior VP of Scientific & Regulatory Affairs, Council for Responsible Nutrition.
“There was a subset of companies that really wanted to go to full transparency about their supply chain. They wanted to post all their certifications, their GMP inspection results, everything. We knew that certain audiences might misuse or misunderstand some of this information, so we came up with the idea of having a fire-walled section,” explained Douglas “Duffy” MacKay, ND, CRN’s Senior VP of Scientific & Regulatory Affairs.
Anyone can access the OWL’s basic labels database free of charge. Access to the restricted portion of the registry is by permission only; CRN wants to ensure that only qualified people—supplement retailers, practitioners, regulators—have access to this more sensitive data.
He expects that as it grows, the OWL will be especially useful to clinicians—or their staff members—who manage in-house supplement formularies.
Several of the major practitioner channel brands, including Ortho Molecular, Douglas Labs, Innate Response, Integrative Therapeutics, Pharmax, and Pure Encapsulations, are already participating.
CRN does not verify or validate the label data that companies post on the OWL, but neither MacKay nor Atkinson are concerned that brands will try to game the registry with false or fraudulent information.
Says MacKay, “The reality is, questionable companies tend to run away from things like the OWL, because they know they would be voluntarily exposing themselves to FDA scrutiny. The companies that participate want to expose themselves because they know they are compliant, and they are confident in their products.”
“We operate on the principle that fresh air is a great disinfectant,” he added.
Ultimately, the CRN team hopes to set a “new minimum expectation” about label transparency.
“Participation is moving along really well. It is being fully supported by other trade organizations, and the FDA has also been very supportive--showing interest, asking for updates, asking for meetings to learn how the OWL works.” --Gisele Atkinson, VP of Quality & Technical Affairs, Council for Responsible Nutrition
As the industry grows and matures, it will likely come under increased regulatory scrutiny. This is particularly true in the practitioner segment, which, historically, has been too small to attract much attention from regulators.
But with practitioner sales nearing $4 billion per year, and annual growth rates between 8% and 10%, MacKay predicted that it is only a matter of time before the FDA starts taking a closer look.
And that might not be a bad thing, he says.
“Continued growth brings greater scrutiny. And we need that federal regulatory oversight to add a layer of legitimacy to the sector, so we can grow into the hospitals, larger clinics, federal programs, and perhaps eventually obtain insurance reimbursement.”
CRN has frequent contact with the FDA and other regulatory agencies. MacKay notes that the FDA is well aware of the health professional channel, but has never put a lot of resources into policing it simply because it was not big enough. That is starting to change.
By posting their labels to the OWL, participating companies are essentially declaring their willingness to be transparent and their confidence that their products can stand up to greater scrutiny.