Each year, Council for Responsible Nutrition (CRN) staff reviews the “strategic plan” adopted by our board of directors and develops policy priorities that will effectuate the goals our members have set for the association. Here is what we have planned for the coming year:
1. Expanding access. Starting in 2021, CRN’s board directed the association to focus energy and resources toward expanding access, both to better nutrition and nutrition education. Our board members recognized that, too often, portions of the population most likely to suffer from inadequate nutrition are those least able to afford healthy food choices or supplements. So, they instructed CRN to explore ways to change that reality, through both policy changes that expand opportunities to make supplements more affordable and more available, and by exploring industry initiatives that make better nutrition available to more people.
This year, CRN’s efforts to expand access will encompass a renewed push to include dietary supplements in Flexible Spending Accounts (FSAs) and Healthcare Savings Accounts (HSAs). We anticipate the introduction of legislation in Congress and substantive discussions to advance a bill through committee. In support of that effort, CRN’s newly released Supplements to Savings economic study demonstrates the monetary value of specific supplement regimens to lower healthcare costs. Additionally, we will invest in research to better understand how consumers leverage their FSAs and HSAs to lower healthcare expenses.
Government data demonstrates most Americans have nutrient gaps in their diets and these insufficiencies lead to a range of preventable health conditions. As the nation’s Supplemental Nutrition Assistance Program (SNAP) comes up for reauthorization this year, we will look for opportunities to expand the program to include multivitamins.
The CRN Foundation will also expand its #Act4Access with industry efforts to raise funds, product donations and volunteer resources directed toward improving nutrition within at-risk communities across the country. CRN will work to expand access to better nutrition and nutrition education to all Americans through government policies, industry initiatives and consumer education.
2. Making progress toward DSHEA modernization. The Dietary Supplement Health and Education Act of 1994 (DSHEA) will be 30 years old next year and, as with any law of that age, it’s ready for a revision that will reflect the changing marketplace and regulatory needs of an evolving industry. As CRN composes a list of wishes for consideration, chief among them will be the following: enacting the Dietary Supplement Listing Act; addressing the FDA inspection deficit; revising the drug preclusion provision; expanding allowable claims and use of research; clarifying the new dietary ingredient requirements; and protecting “grandfathered ingredients”—those marketed in the U.S. before Oct. 15, 1994—from removal from the category.
CRN will also advance changes to DSHEA that seek to preserve the balance between access and safety, while updating the law with new tools, better clarity and industry protections that will assure a level playing field for responsible firms and preserve consumer access.
3. Creating a legal pathway for CBD. After four years, it’s clear FDA is not going to address CBD as a self-care ingredient because the agency has now moved the issue to Congress to solve. FDA has prematurely called for a new regulatory category for cannabis-derived ingredients, without giving the dietary supplement pathway a chance to work. Citing drug preclusion and demanding an ever-increasing range of research to defend the safety of CBD, the agency has delayed the creation of a legal pathway, while a rapidly growing, unregulated CBD market was allowed to proliferate. Responsible marketers are now sidelined and without guidance while consumers are left to decipher the market. The new regulatory pathway FDA has suggested is needed could undermine the entire DSHEA framework, limit CBD access and leave consumers worse off.
Wary of a new regulatory category that could undermine DSHEA and set precedent for other ingredients, CRN will work with Congress this year to legislate a pathway for CBD as a dietary ingredient.
4. Addressing the drug preclusion provision. Drug preclusion language in DSHEA creates a “race to market” between supplements and drugs; it rewards drug firms with a monopoly over the ingredient if the article is sold first as a drug or if it is the subject of substantial, public clinical investigations before it is sold as a supplement. The provision was intended to balance supplement and prescription drug interests, not to stifle innovation in the supplement market, but that’s the effect today. Retroactive application of the law, changes in decisions at FDA, and overly broad interpretations of the provision threaten to unfairly bias it against the supplement industry.
CRN has begun examining revisions to the drug preclusion provision, advocating for changes in FDA’s interpretation of the current language, and calling on Congress to revise the section to clarify its original limited scope. We will address impacts on specific ingredients, especially among cautious retailers, and represent our members at FDA. But we will also address the application of the drug preclusion more generally to the supplement marketplace and assure that incentives for the creation of new drugs don’t stifle supplement innovation.
5. Optimizing FDA reorganization. Last month, FDA announced it would be “re-envisioning” its human foods program. Brought on, in part, by the infant formula crisis of the past year, FDA has acknowledged the lack of collaboration—even communication—among divisions of the agency, and shortfalls in coordination between policy and enforcement. The supplement industry has personally observed these issues. Promised changes at FDA provide opportunities for the agency to develop a more balanced oversight of the dietary supplement and functional food industry, which would include improved coordination between the Office of Dietary Supplement Programs and the Office of Regulatory Affairs (where the investigators reside).
CRN will use this opportunity to advocate for the right level of attention and resources needed to provide effective oversight of the dietary supplement industry that also appropriately prioritizes public safety. Innovative ways to increase FDA inspections and ensure inspectors are knowledgeable about supplement cGMP (current good manufacturing practices) requirements can be achieved, such as the long-promised “program alignment” of investigators trained specifically for each regulated category. CRN will educate the new Deputy Commissioner for Human Foods on our role in promoting better nutrition and health for all Americans.
6. Preparing for the final new dietary ingredient guidance. Another year has passed without the long-awaited final guidance from FDA on new dietary ingredients, despite assurances from the agency that its release was imminent. If FDA does release a final guidance this year, CRN will be ready. Some sources indicate the policy will more likely be released in multiple, smaller guidances, as CRN has recommended. If that happens, CRN is poised to review what is issued and respond, if necessary, through regulatory response, legislative action or judicial relief. And CRN is also ready for member education and compliance training when the FDA materials are released. CRN will prepare for the release of these documents, assist our members with compliance, and advocate for changes as appropriate with direction from our members.
7. Developing solutions for state-imposed age restrictions. Multiple state legislatures are proposing to restrict sales of certain dietary supplements to those under 18 under the misguided impression that dietary supplements lead to eating disorders. These proposals are not only flawed in their assumptions, which are not backed by reported adverse events or scientific research, they would lead to restricted access for all consumers. While the available data does not support a link between eating disorders and supplements, emotional appeals—and an urge to “do something, anything” to help consumers who are afflicted with an eating disorder—may influence legislators and require compromise.
With at least seven states poised to consider these age restrictions, CRN is preparing to oppose those that are not scientifically supported. CRN also will be ready to offer rational solutions that emphasize common ground and would inflict the least impact on legitimate products.
8. Engaging on sustainability solutions. New on CRN’s “to do” list is an ambitious initiative to assist our members in building a more sustainable industry. Some expectations for sustainability come from consumer demands, shareholder insistence on environmental, social and governance (ESG) goals, and self-imposed targets for carbon or post-consumer waste reduction. Others are mandated, such as the new California law on extended producer liability for packaging. Regardless of the impetus, CRN’s members are increasingly focused on reducing their footprint and creating a healthier world.
Sustainability issues are sweeping and seemingly endless for every industry and CRN is committed to helping our members solve these challenges as they relate to our market category. CRN will monitor legislation and align with other CPG stakeholders for fair solutions. We will address proposals specific to our products. CRN will provide our members with resources to implement their ESG goals and to comply with federal, state and local requirements. Following our members’ directions, CRN will advocate on their behalf regarding these sustainability issues.
In summary, while these are unquestionably ambitious priorities for a trade association, 2023 promises to be a dynamic and productive year for the industry and for CRN!
Steve Mister is president and CEO of the Council for Responsible Nutrition (CRN).