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This article discusses the role industry self-regulation plays in fostering trust from regulators, lawmakers, and consumers. It introduces an important self-regulatory initiative for the dietary supplement industry - the Supplement Online Wellness Library (OWL) - laying out its history and how it will serve regulatory audiences, retailers, and ultimately, consumers.
When the Dietary Supplement Health and Education Act (DSHEA) was enacted in 1994 industry rejoiced.1 Finally, there was an official regulatory structure specifically for dietary supplements which granted FDA the authority and ample enforcement tools to protect consumers while still allowing them the desired access to a wide variety of affordable, high quality, safe, and beneficial dietary supplement products.
Responsible industry welcomed the viable framework for the dietary supplement industry as the law clearly defined dietary supplements and provided industry with specific requirements for how to make these products, how to label them, and what kind of consumer educational information to include.
Now, 23 years later, the dietary supplement industry is booming. More than 170 million Americans take dietary supplements each year,2 and in 2016, the industry had an overall economic impact of $122 billion in the United States.3 As the popularity and usage of dietary supplements continues to grow, responsible industry recognizes the importance of imposing additional requirements and guidelines upon itself—self-regulation—in order to complement the regulation established by DSHEA and its subsequent amendments to the Federal Food, Drug and Cosmetic Act.
"Self-regulation" can be defined as a process by which an industry monitors its self-adherence to legal, ethical or safety standards.4 The supplement industry is indeed regulated, but to demonstrate to critics and allies alike, responsible industry understands it must do more than simply follow the rules. As an industry that takes regulation and consumer safety seriously, dietary supplement manufacturers strive to find new ways to meet and exceed the stringent requirements and standards governing their businesses.
Self-regulation does not replace the need for companies to follow myriad regulations and laws, but rather, fosters trust among industry stakeholders and demonstrates a desire to improve industry from within.
In talking with stakeholders, industry felt the need to create a cohesive database to give interested audiences a more complete picture of the marketplace. The Office of Dietary Supplements (ODS) Dietary Supplement Label Database (DSLD)5 was, and still is, a useful tool, but industry wanted to create a mechanism to survey the marketplace in real time—a database that excludes historical and outdated information clouding the search engine.
To answer this call, individual companies and industry trade associations worked together to create the Supplement OWL™ (Online Wellness Library)6, the dietary supplement product registry. This online product registry is designed to provide a more complete picture of the dietary supplement marketplace for government and private stakeholders, including legislators, regulators, retailers, industry, and ultimately, consumers. The database, launched in April of 2017, exists as a resource to help audiences identify dietary supplements, their key ingredients, product label information and claims, and the companies making and marketing those products.
The Council for Responsible Nutrition (CRN) spearheaded the effort by providing initial funding and conceptual project management of the Supplement OWL. UL, a global independent safety science company, is investing resources in the development and administration of the registry and the technology that will drive the database.
The Supplement OWL starts with a simple premise: regulators should know what ingredients and products are in the dietary supplement marketplace and who sells them. Companies manufacturing and marketing dietary supplements have a responsibility to share this basic information.
A registry, created and fully-maintained by the industry itself, provides product and label information from the company and is maintained to reflect an accurate snapshot of the marketplace at any given time. Through this direct involvement, the Supplement OWL provides visibility, transparency, and accountability.
Although primarily for regulatory and retailer audiences, anyone can access the registry and browse the labels. The Supplement OWL demonstrates that companies voluntarily entering their labels are not operating undercover and that they are not afraid to stand behind their products and provide information about their products to regulators and other stakeholders.
The OWL consists of two informational Tiers. Tier 1 assigns a unique identifier to the product and includes a product image, a complete product label and various fields of information about the product such as ingredients, dosage form, and product claims from the label. Companies submitting their labels also will be required to provide manufacturing and packaging facility contact information, accessible only to FDA. The OWL is designed to be easily searchable, so FDA can quickly identify products containing a particular ingredient or manufactured in a specific facility. There is no cost to upload product labels into Tier 1.
To upload finished product labels, companies are presented with four options to determine the method that best suits their unique needs: 1. electronic transfer from an existing IT system, 2. conversion from the ODS label database, 3. manual data entry or 4. a third-party upload service. Companies work in tandem with UL to ensure information is accurately displayed in the registry and are responsible for updating entries as appropriate.
Tier 2 allows companies to upload additional information and supporting documents regarding quality practices for their products for a nominal fee (e.g., ingredient documentation, third-party certification, certificates of analysis, evidence of identity and purity testing). The product marketer controls this information. Only those entities with permission from the marketer can view these materials. Of note, Tier 2 of the OWL can offer retailers access to a wealth of information to help them make more informed decisions when determining which products they have confidence placing on their store shelves, offering a new decision point for improving reputations as responsible vendors. As the Supplement OWL gains traction with retailers, product labels not in the registry may raise questions as to why these products are missing.
The dietary supplement industry is committed to bringing to market safe, reliable products consumers can trust. The Supplement OWL aims to enhance federal regulation already governing supplement manufacturing and marketing through meaningful self-regulation by providing regulators (particularly FDA) with new visibility into the industry it is charged with regulating. It allows stakeholders to identify, sort, and search for products by brand, contents, label claims, and other attributes. The registry also will help foster trust with industry stakeholders and demonstrates a commitment to improve industry from within.
Having only recently launched in April 2017, the Supplement OWL has room to grow and develop. Enthusiasm from the industry is apparent. The registry is rapidly gaining momentum, and stakeholders have taken notice, but for the Supplement OWL to reach its full potential, it must reach critical mass. Increasing numbers of companies begin the label upload process each day, and the registry will soon serve as the go-to resource for regulators looking to get a real-time look at the supplement marketplace.
For more information on the Supplement OWL, visit www.SupplementOWL.org.
Andrea Wong, PhD, is vice president, scientific and regulatory affairs for the Council for Responsible Nutrition (CRN). Wong is an integral part of CRN's science and regulatory affairs department, responding to emerging regulatory issues as well as advocating for science-based nutrition. Wong provides scientific expertise in evaluating research relevant to the benefits and safety of ingredients and dietary supplements, and in support of CRN's nutrition policy activities. She also leads proactive self-regulatory initiatives, including the development of best practices guidelines for industry on product labeling and formulation. Wong earned her PhD in toxicology from the University of Toronto. She may be contacted at email@example.com.
Cite as: Wong, A. "The Supplement OWL: the Dietary Supplement Industry's Hallmark Self-Regulatory Initiative." Regulatory Focus. October 2017. Regulatory Affairs Professionals Society.
Tags: Dietary, Supplements