CRN’s Executive Committee and the Board of Directors held their first quarterly meetings of the new year last week, on Wednesday and Thursday, March 27th and 28th in Washington, DC. CRN’s leadership took action on behalf of the association and received reports in the following areas:
Changes to CRN’s Voluntary Guidelines on Melatonin Supplements—CRN’s Board of Directors has adopted broad revisions to CRN’s Voluntary Guidelines for Melatonin-Containing Dietary Supplements for Sleep Support. The Board-approved changes will include:
- A recommendation that products containing melatonin that are in flavored chewable forms should be in child deterrent packaging.
- Recommendations on allowable overages in melatonin products.
- New mandated label statements such as: “For occasional and/or intermittent use only,” “Melatonin may cause drowsiness. If you feel groggy, do not drive or operate machinery,” and “Do not take with alcohol.”
- New mandated label statements for melatonin products marketed for children that include: “Consult the child’s healthcare professional for ongoing sleep difficulties,” and “Product should not be a substitute for healthy sleep practices.”
CRN members will have 18 months to implement these revised guidelines. Further communication from CRN staff about the new guidelines will be issued next week.
New Voluntary Program for Gummy Form Supplements—CRN’s Board also adopted new Voluntary Guidelines applicable to all gummy form supplements. These recommendations:
- Call for label statements indicating the product’s intended age group.
- Recommend label statements to “Keep out of reach of children,” and “Take only as directed/Do not exceed recommended intake/Do not exceed suggested serving [unless recommended by a healthcare professional].” (or similar language)
- To reinforce recommended labeling statements, firms may consider packaging gummy products in containers with child deterrent closures. Unlike the melatonin guidelines, these only suggest marketers consider product attributes in making packaging choices.
- CRN members will have 24 months to implement these gummy form Guidelines.
CRN Lawsuit Opposing Age Restrictions in New York—CRN’s General Counsel, Megan Olsen, summarized the status of CRN’s litigation seeking to prevent enforcement of a new law in the State of New York that would place age restrictions on a broad swath of supplements. She thanked at least eight CRN members who have committed to provide Declarations describing the negative effects the law will have on their businesses. Ms. Olsen told the Board CRN plans to file a motion later this week seeking a preliminary injunction to prevent enforcement of the law during the pendency of the legal proceedings. CRN is seeking member contributions to a litigation fund to help defray the legal fees associated with the lawsuit.
Economic Impact Study—CRN’s Government Relations team displayed a new economic “footprint” study (released in January) commissioned by CRN that summarizes the dietary supplement industry’s contributions to the national, state, and local economies with estimates of the industry’s impact on jobs, taxes, salaries and more. This data is being promoted to news media and will be valuable as CRN and individual CRN members speak with regulators and policy makers, members of Congress, and state legislators to demonstrate the positive impact this robust industry has on the economy. Members are encouraged to visit CRN’s website and use the tailored data with their own elected officials.
New Office of Dietary Supplements Director—Dr. Stefan Pasiakos, the new Director of the Office of Dietary Supplements (ODS) at NIH, addressed the Board to provide his perspectives on reimagining the ODS. Dr. Pasiakos’ background is in the U.S. Army Research Institute of Environmental Medicine where he conducted research on dietary recommendations for soldiers. He outlined his goals for expanding NIH research on supplements across biological, population and analytical science. One upcoming initiative later this year will review the state of the science for prenatal supplements and examine if levels of key nutrients in these products are appropriate to achieve specified health outcomes. Another will define measures and metrics that best capture resilience within health domains, examining parameters for determining the quantitative, qualitative, and outcome-specific measures of resilience.
Vitamin & Mineral Safety (and more)—It’s been ten years since CRN last updated its CRN’s Vitamin and Mineral Safety Handbook, which is widely used by industry and regulators around the world for establishing maximum safe levels of nutrients. Dr. Andrea Wong, Senior Vice President, Scientific & Regulatory Affairs, presented a proposal to update the volume with new science from 2014 forward and add new chapters for additional bioactives that are widely used in supplementation (e.g. omega 3s, lutein, choline). CRN would contract the scientific review to a third party, prioritizing those chapters by member interest and funding. Chapters could be completed in stages and published online as they become available. A Board discussion was supportive of this approach and authorized Dr. Wong to proceed with a plan for identifying a consultant, securing member funding, and beginning the research.
Revised 2024 Budget—The Board adopted a revised budget for 2024 that scales back CRN’s expenses to accommodate lower revenue projections for the year. The budget projects just over $6.8 million in revenue and similar expenses that would produce a “break even” budget for the year. CRN President & CEO, Steve Mister, stressed that the projections depend on strong member involvement in CRN’s activities and recruiting trends to attract new members. CRN members were urged to be active ambassadors to their vendors, customers, and colleagues to encourage more companies to join the association.
Congressional Dietary Supplement Caucus—The Congressional Dietary Supplement Caucus (CDSC) has been officially re-established for the 118th Congress. CRN played an instrumental role in securing the Caucus Co-Chairs, Rep. John Curtis (R-UT-3) and Rep. Tony Cárdenas (D-CA-29). The bipartisan, bicameral group serves as a forum for the exchange of information and policies related to dietary supplements and facilitates educational briefings to inform members of Congress and their staff members about the legislative and regulatory landscape facing the industry. Currently, the Caucus is comprised of 35 Members of Congress. The first luncheon briefing of the Caucus will be held on Wednesday, May 1st on Capitol Hill and will cover the recent Supplements to Savings healthcare cost-savings study commissioned by CRN.
Finance Committee & Audit Committee—At the recommendation of Mr. Mister, and in light of continued financial pressures on the association, the Board voted to create a Finance Committee of the Board. The Committee will regularly review CRN’s financial reports and make recommendations to improve the financial resources of the association. The 2023 Audit Committee also reported the annual independent audit has been completed by Rogers & Company, and once again, CRN received a “clean” unqualified opinion. The CRN audit is available to members upon request.
New CRN Members—The Board approved the following companies for Voting Membership: Focus Consumer Healthcare, Nalu Bio, Nutraforia, and Purple Tree Labs. Vitafor, a Brazilian-based company, was approved for International Membership.
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The next Executive Committee meeting will take place on Thursday, June 27, 2024. The next meeting of CRN’s Board of Directors is scheduled to take place on Friday, June 28, 2024. Both meetings will be held virtually.
All CRN members are invited to attend any meeting of the Board of Directors, except when it meets in Executive Session, so please let me know if you would like to attend a future meeting as a guest of the Board.
If you have questions about the discussions or outcomes of the Board of Directors meeting or would like more information about any of these topics, please feel free to contact me directly at smister@crnusa.org.