We are expanding self-regulatory initiatives.
In 2022, CRN added new best practices for proprietary blends to its library of self-regulatory guidance for the supplement industry and continued to grow the Supplement OWL. In addition, CRN held its second annual toxicology workshop, this year with the theme, "Assessing the Safety of Ingredients in a Formulation" to advance safety evaluations of products beyond legal requirements.
Industry’s responsibility amid regulatory uncertainty
At the start of 2022, CRN President & CEO Steve Mister contributed a bylined article to Nutrition Industry Executive,"The Industry’s Responsibility in an Era of Regulatory Uncertainty." It underscores numerous challenges stemming from the lack of clear direction and predictable enforcement from FDA and exemplifies CRN’s commitment to advancing quality and safety, whether the regulators are watching or not. Mister observed, "During this time of FDA instability, it’s not surprising that other actors are lining up to impose their own agendas upon the industry...The best way to deter would-be enforcers is to demonstrate a strong commitment throughout the industry to self-police and observe high levels of quality, even if regulators are distracted or disengaged. That’s why our members agree to adhere to CRN’s guidelines and best practices. Now is the time as an industry to renew our adherence to best practices and consider gaps where we should develop new ones." Mister included dietary supplement listing (also known as mandatory product listing) among the new tools industry should advocate for to help FDA do better. (See the annual report section on influencing public policy).
Mister also spoke to this issue during his address at CRN’s Now, New, Next event, sharing how the association is advocating for new tools and resources—while preserving the principles that have served the industry well, preparing for would-be enforcers who would fill the void, strengthening self-regulation to fill the void ourselves, and communicating proactively to demonstrate the value of our products.
CRN continued to grow the Supplement OWL, the voluntary industry-wide database of dietary supplement labels that serves as a model for the kind of mandatory product registry that the Dietary Supplement Listing Act would have required.
- Ten new companies added their products to the Supplement OWL in 2022.
- The OWL now has 107 companies representing 170 brands in the registry.
- The largest companies in the dietary supplement industry participate in the OWL, making this a source of information on the most commonly consumed dietary supplements in the U.S.—13,500 visible products.
Proprietary Blends: Regulatory Responsibilities and Best Practices
CRN’s board of directors adopted a new self-regulatory document to promote responsible labeling of proprietary blends:
In 2021 the board reaffirmed CRN’s longstanding support for the treatment of proprietary blends in the Dietary Supplement Health and Education Act (DSHEA), but expressed concern that the practice should not mislead consumers about the quantity of individual ingredients.
A CRN task force developed the 2022 document explaining regulatory requirements related to listing dietary ingredients, disclosing proprietary blend quantity, and label claims structure/function claims. Best practices outlined in the document provide guidance on what qualifies as a proprietary blend, dietary ingredients in a proprietary blend, product claims pertaining to proprietary blends, and good manufacturing practices.
Coming together to manage opportunity and risk
Hear from SierraSil President Michael Bentley, former board of directors member, currently participating in CRN's Communications and Media Outreach Committee and Regulatory Affairs Committee. "We're in a big fragmented industry and being part of the CRN is really important to us. It helps give us a voice and it helps us be more effective in managing the long term of our business..."