In April, the Supplement Online Wellness Library (OWL; www.SupplementOWL.org), an industry-wide dietary supplement product registry, became accessible to the public for the first time. The registry, which began accepting label submissions in November 2016, is a self-regulatory initiative spearheaded by the Council for Responsible Nutrition (CRN), a leading dietary supplement industry association, and developed in partnership with Underwriters Laboratories (UL), a global independent safety science company. Though it is considered primarily a tool for the dietary supplements industry, the Supplement OWL has begun to receive broad support from the natural products community, including endorsements by the American Botanical Council (ABC), Natural Products Association, and Consumer Healthcare Products Association. The registry will promote transparency in the manufacturing process, and regulators and retailers can use it see what ingredients are in the marketplace and who provides them.
The voluntary two-tiered registry provides a central location for labels of dietary supplement products. Tier 1 is free and includes images of supplement labels and information about the products’ ingredients, servings, and allergens. Companies also submit contact information for the product’s manufacturing and packaging facility that will be accessible only to the US Food and Drug Administration. Each product in the registry is assigned a unique identifier number.1
Some of these functions, such as allowing retailers to look at a product’s certifications or scientific substantiation, will come in the second phase of development, which is currently underway. Tier 2 of the program will provide benchmarks for understanding quality measures and a centralized location for maintaining and sharing information. “We aren’t a regulatory agency. We have no guns and badges, and we can’t stop non-compliance, but we feel transparency is valuable to avoid the activity of non-compliant players,” said Duffy MacKay, ND, CRN’s vice president of scientific and regulatory affairs (oral communication, March 27, 2017).
Tier 2, which does require the company to pay a fee, was designed so companies can upload quality and safety information and share it with customers as they choose. “We have heard loud and clear from retailers that they want more tools to understand industry and the activities in place to ensure compliance,” MacKay added.
According to CRN and UL, the program has gained significant momentum in recent months. However, the number of products registered in the database is still representative of the early stage of the project, MacKay said. The exact number of registered products is difficult to pin down, said Erik Eberhart, UL’s global development marketing manager for food, beverage, and nutrition (oral communication, April 3, 2017). “There has been a last-minute rush of people wanting to participate, so we are excited about that response and support,” he said.
A Potential Domino Effect
As the database debuts, MacKay noted that CRN is eager to see the effect when companies not in the registry notice that leading players are embracing it. The hope is that this will pull along those in the middle and smaller sectors that may not see it as a priority. “These bigger companies were around for passage of DSHEA [the Dietary Supplement Health and Education Act of 1994], the promulgation of GMPs [good manufacturing practices], and supported mandatory serious adverse events reporting,” he said. “They have seen the positive impact of these measures, which helped us to position our products as health promoting and responsibly made.”
The OWL database represents a multi-year effort in which the industry came together to increase transparency in the industry, but it has been a long time coming. The concept first came up years earlier as retailers began requiring their vendors to register products in the US National Institutes of Health’s (NIH’s) Office of Dietary Supplements (ODS) label database,2 and once in a bill sponsored by Senator Richard Durbin (D-Ill). (The bill, S. 1425, introduced August 1, 2013, amended the Federal Food, Drug and Cosmetic Act to expand registration requirements for dietary supplements.2) After the Durbin bill failed, MacKay recalled, “we realized [the proposed registry] was not that far-fetched and could be a reasonable addition to our regulatory cache.”
The idea was gaining traction in wider industry leadership circles when the actions of the New York attorney general heightened the sense of urgency in February 2015. Realizing the importance of industrywide buy-in, CRN worked with non-members and other industry associations to shape the idea. It then engaged UL as a third-party administrator so that the whole industry would feel comfortable with the registry as an appropriate way to show commitment to transparency and help regulatory partners better understand industry products.
Companies like GNC, Herbalife, and Pharmavite were early influencers, and they urged colleagues and competitors to seize the opportunity.3 There were also plenty of objections in the early phases of development. Some companies expressed concern about regulators using the database as a tool to scrutinize less than perfect manufacturing, processing, and labeling practices, MacKay explained (email, April 7, 2017). “If you are trying to hide something, then this is not the greatest idea,” he said. “But the industry is maturing, and the majority of companies are now operating under the premise that compliance with regulations is the minimum action needed to make dietary supplements, and they want to show additional efforts being made toward ensuring product quality to the world.”
Nine companies served as beta-testers and worked with UL to improve the process. The beta-testers, for example, helped UL identify challenges unique to the supplements industry and provided feedback on early versions of the database, Eberhart said. Adapting the program to upload different label formats was one of those challenges, and the UL team worked to capture and record information that might be in multiple places. “What came out of the first beta test is the ability to search on an ingredient level, find specific information that might be available in different places, and see all the synonyms associated with [an ingredient],” he explained.
What also became clear, Eberhart added, is that the registry provides an opportunity to help the industry manage information more efficiently. “[UL has] experience in multiple industries doing business process automation, what we call robotics,” he said. “For example, in the chemical industry, if they change something in a database, it can be automatically updated in all the safety data sheets associated with that product. That is an opportunity in this registry.”
Defining Success
The NIH’s ODS Dietary Supplement Database currently contains labels from approximately 50,000 products in the US marketplace.4 MacKay, however, cautioned that comparing the two databases is tricky because the ODS database may include individual listings for products based on pill count and flavor, which would create duplicate listings, and may not account for discontinued products in its current total.
“[One] of the unique things about this database is that we will be able to tell how many SKUs [stock keeping units] are out there, and which ones are part of a single product,” said Eberhart. “Ultimately, we will be able to provide better numbers to the industry.”
As such, success is based on full participation, MacKay added. After conversations with critics, media, and regulators, he is confident that the registry is a step in the right direction for manufacturing transparency. “It symbolizes a maturing industry and a willingness to be more transparent, although many critics would like to see a more mandatory program,” he said. “But we are satisfied that we can do this on a voluntary basis.”
—Karen Raterman
SIDEBAR: ABC Endorses Supplement OWL
On March 31, 2017, ABC sent a letter to CRN endorsing the new Supplement Online Wellness Library, a self-regulatory initiative spearheaded by CRN for use by the dietary supplement industry to help create a more complete picture of the dietary supplement marketplace in the United States. In the ABC endorsement letter to CRN President Steve Mister, ABC Founder and Executive Director Mark Blumenthal wrote:
ABC has long advocated for measures by nonprofit organizations and/or members of the botanical and natural products industries to increase sustainability, quality control, transparency, appropriate scientific and clinical research, and responsible communication about the activities and benefits of these ingredients as they are employed in consumer products.
[W]e believe that this new program, in principle, helps fill a vital need in the dietary supplement industry and extended community and the general public — for researchers, health professionals, regulators, members of industry, and consumers to gain relatively easy access to relevant information on specific commercial dietary supplement products in the US marketplace.
ABC encourages its members in the botanical and dietary supplement industry that market branded botanical dietary supplement products to participate in the Supplement OWL by submitting product information for inclusion. More information about the Supplement OWL and how to participate is available from CRN by contacting Gisele Atkinson at gatkinson@crnusa.org, from UL by contacting Erik Eberhart at erik.eberhart@ul.com, or by visiting www.SupplementOwl.org.
References
- The Supplement Owl has landed — New dietary supplement product registry ready to accept product labels [press release]. Washington, DC: Council for Responsible Nutrition; November 1, 2016. Available at: www.crnusa.org/newsroom/supplement-owl-has-landed-new-dietary-supplement-product-registry-ready-accept-product. Accessed March 22, 2017.
- S. 1425 – Dietary Supplement Labeling Act of 2013. 113th Congress (2013-2014). Available at www.congress.gov/bill/113th-congress/senate-bill/1425. Accessed April 7, 2017.
- Industry leaders collaborate to develop the Supplement OWL — New product registry a hallmark of industry maturation [press release]. Washington, DC. Council for Responsible Nutrition. October 3, 2016. Available at: www.crnusa.org/newsroom/industry-leaders-collaborate-develop-supplement-owl-new-product-registry-hallmark-industry. Accessed March 22, 2017.
- Dietary Supplement Label Database. Available at: https://ods.od.nih.gov/Research/Dietary_Supplement_Label_Database.aspx. Accessed April 5, 2017.