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Regulatory Focus™ > News Articles > 2021 > 6 > Enhancing consumer confidence and supplement access through harmonized retail standards

Enhancing consumer confidence and supplement access through harmonized retail standards

Posted 24 June 2021 | By Megan Olsen, JD  | PDF Link PDF | ©

Enhancing consumer confidence and supplement access through harmonized retail standards

Although third-party audit, certification, and retail standard programs highlight reputable companies and help ensure that dietary supplements on store shelves are safe and unadulterated, multiple standards create a complicated patchwork of requirements that are difficult for manufacturers and consumers to navigate. Responsible industry has emphasized the need to harmonize standards by eliminating duplicative, costly testing and allowing retailers to confirm a manufacturer’s compliance with applicable dietary supplement laws and regulations by evaluating the quality systems already in place.
 
Introduction
Manufacturers, retailers, and industry are heeding consumer demands for more transparency for the products they purchase. For years, dietary supplement third-party manufacturing audit programs have served to ensure manufacturing facilities are compliant with the laws and regulations governing dietary supplement manufacturing practices and quality standards. By law, supplement manufacturers must comply with current good manufacturing practices, which include testing procedures of both raw materials and the finished product, labeling and storage requirements, the use of manufacturing systems that ensure the safety and uniformity of products, and other practices enforced by regulatory agencies at both federal and state levels.1
 
Third-party audits
Third-party audits are designed to review an entity’s manufacturing practices against these legal requirements. Audit standards have continually evolved to provide increasing quality and transparency into the process. For example, retailer and manufacturer collaborative organizations such as the Global Retailer and Manufacturer Alliance have recently developed standards that allow the audit practices of the third-party auditors themselves to be evaluated and compared and allow these auditors to use the same audit standard for evaluating manufacturers.2 This example of harmonization of manufacturing audits helps ensure audits are being conducted in a uniform manner. It also allows manufacturers to reduce the number of audits by having one audit conducted under a standard that is recognized by many retailers and it represents how retailers and manufacturers can collaborate to produce positive results for both the industry and consumers. 
 
Third-party certification programs are similar to audit programs in that they look at a supplement company’s compliance with legal requirements, but also require rigid product testing and other reviews that may go beyond legal requirements. The purpose of obtaining a third-party certification is different than the purpose for which third-party manufacturing audits are generally conducted. Third-party audit programs are designed to ensure products meet legal requirements (a standard everyone in the industry must meet), whereas the third-party certification programs are generally designed so a supplement manufacturer can advertise to consumers that a third party has conducted a deep-dive into all aspects of safety, quality, and legal compliance. 
 
Standard retail programs
Distinguishable from third-party audits and certifications, are retail standard programs. Retailers have started to implement their own requirements – which may differ from those found in third-party audit and certification programs – that serve as a set of quality checks retailers impose on dietary supplement products before allowing them on their store shelf. Retailer standards may include components of the above programs, such as requiring a third-party audit or recognizing certain third-party certification programs, but also often impose their own testing requirements for example, and do not always uniformly recognize the compliance and quality check programs already in place. In design, retail standards exist to help identify responsible dietary supplement companies and work to keep less reputable players out of the supplement aisle. However, in practice, these standard programs create a complicated and duplicative patchwork of requirements that can limit flexibility, add unnecessary burdens and costs, and cause confusion among manufacturers and consumers.
 
Impact of varying requirements
Varying requirements will limit dietary supplement manufacturers’ flexibility to use their own in-house laboratories and restrict their ability to select a third-party certifier to work with. Often, manufacturers have an established relationship with a third-party auditor or certifier or use their own in-house or partner-labs, which are more experienced and familiar with the company’s particular formulations or ingredients. Instead of implementing duplicative and burdensome testing measures, retailers should confirm that manufacturers have a qualified system in place, which they can do through already well-established third-party audit programs.
 
Duplicative or inconsistent requirements will place unnecessary burdens and costs on manufacturers. Some industry executives have estimated that the various retailers’ duplicative testing requirements add several hundreds of thousands of dollars per year to the cost for each product.3 It is likely that those increased costs will trickle down to consumers, potentially affecting the public’s ability to purchase affordable dietary supplement products on which they rely daily to support their health and wellness.
 
Varying standards are also likely to confuse consumers in the supplement aisle. Inconsistent requirements across different retailers may affect changes on product labels, varying seals, or even difficulty finding products from one retailer to the next. This is especially concerning, as consumer data reveal how expansive supplement usage is among Americans and that supplement users prioritize the product label and rely on it to make their purchasing decisions.
 
Nearly three-quarters of Americans report taking dietary supplements, according to results of the 2020 CRN [Council for Responsible Nutrition] Consumer Survey.4 Findings revealed that product labels do matter and consumers are paying attention. Results demonstrated that 67% of supplement users cited the product label as the most important purchasing factor. Among supplement users who report the product label as the most important purchasing decision, nearly one-third (30%), cite a quality seal from a third-party certification program (e.g., NSF International, Nutrasouce, UL (Underwriters Laboratories), USP (US Pharmacopeia), Eurofins, Informed Choice, and Banned Substance Control Group) as the most important label consideration.4
 
Addressing harmonization and consistency
To address these duplicative standards, industry is advocating for harmonized standards to help create consistency for all industry players. A single retailer standard will allow manufacturers and retailers to streamline the audit process and ensure that each product manufactured to a single set of obligations goes to market meeting the strict expectations of lawmakers, retailers, and consumers.
 
To further develop this initiative, CRN started an internal Retailer Standards Working Group to help facilitate conversations with retailers about streamlining standards for dietary supplements. The working group, along with other industry leaders, aims to foster a dialogue between retailers and manufacturers. Through personal outreach and educational events, responsible industry is working to bring retailers and manufacturers to the same table. In response to the facilitated dialogue, some major retailers have started to update their supplement requirements to provide further clarity and allow for more flexibility for retailers.
 
Conclusion
Retailers and industry must continue to collaborate and discuss a path forward to standardize retailer standards that are already in place and those that are in process. Harmonizing standards across retailers supports consistency across certifying bodies and enhances consumer confidence in the industry.
 
About the author
Megan Olsen, JD, is vice president and associate general counsel at CRN. She provides legal counsel and advice to CRN’s staff and members in the areas of legislation, regulatory compliance and advocacy, and international policy development. In addition, she works with CRN’s science department to prepare challenges to dietary supplement advertising through CRN’s Advertising Review Program with the National Advertising Division. Before joining CRN, Olsen was special counsel for Wiley Rein LLP in Washington, DC. She earned her law degree from the Catholic University of America Columbus School of Law in Washington, DC, and received a bachelor’s degree in business management from Gettysburg College in Pennsylvania. She can be contacted at molsen@crnusa.org

Citation Olsen M. Enhancing consumer confidence and supplement access through harmonized retail standards. https://www.raps.org/news-and-articles/news-articles/2021/6/enhancing-consumer-confidence-and-supplement-acces. Regulatory Focus. Published online 24 June 2021.
 
References
  1. Federal Regulations. Part 117 – Current good manufacturing practice, hazard analysis, and risk-based preventive controls for human food. https://www.ecfr.gov/cgi-bin/text-idx?SID=327ce4144f480bc37e39cef12d25851b&mc=true&node=pt21.2.117&rgn=div5. Current as of 14 June 2021.
  2. Global Retailer and Manufacturer Alliance. ANAB Completes Highly-Anticipated GRMA pilot accreditation program [press release]. https://grmalliance.org/press-releases/anab-completes-highly-anticipated-grma-pilot-accreditation-program /. Released 17 March 2017.
  3. Council for Responsible Nutrition. Retailer standards and certification programs for dietary supplements: An overview and discussion of future collaboration and harmonization [webinar]. https://www.crnusa.org/events-education/crn-members-only-webinar-retailer-standards-and-certification-programs-dietary. Presented 26 January 2021.
  4. Council for Responsible Nutrition. 2020 CRN consumer survey on dietary supplements: Consumer intelligence to enhance business outcomes. https://www.crnusa.org/resources/2020-crn-consumer-survey-dietary-supplements-consumer-intelligence-enhance-business. Conducted July 2020.
 
 
 

 

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