PRINTABLE PDF | SEE 2022 REPORTS
While many may think of summertime as a more relaxed season when it comes to work, that was not the case for us during July, August, and September of this year.
The CRN team was busy working on key issues to protect and advance our dietary supplement and functional food industry members’ interests, whether responding to FDA’s proposed reorganization plans, a Congressional inquiry on cannabidiol, or a California legislator’s questions on titanium dioxide—just to name a few issues that were in play this summer.
In addition, CRN’s Executive Committee developed an ambitious strategic plan for 2024–2026 during a planning session in July that was subsequently adopted by the Board of Directors in September.
Read on for a summary of CRN’s progress highlights during the third quarter of 2023.
FROM THE PRESIDENT'S OFFICE
CRN establishes 2024–2026 strategic plan
The CRN Board of Directors adopted a new CRN strategic plan for 2024 through 2026, following the Executive Committee’s retreat with CRN staff to establish goals within each of five areas, instructing the association to:
- Expand Self-Regulatory Initiatives: Champion self-regulatory initiatives that demonstrate our members’ commitment to transparency, accountability, and responsible behavior to sustain and improve trust in our members’ products and to distinguish responsible companies.
- Influence Public Policy: Build and maintain a positive legislative, regulatory, and commercial environment for our members’ products to foster consumer confidence and industry growth.
- Improve Consumer Access: Improve consumer access to reliable information about the roles dietary supplements and functional food play for nutrition and health, and increase access to our members’ products.
- Cultivate Positive Public Perceptions: Create and foster awareness, perception and understanding of the safe and valuable roles our members’ products play on individual, family, and public health.
- Expand Membership: Lead the industry and build association resources through industry-focused education, member services, and community building that foster broad membership in CRN and differentiates CRN among industry associations.
CRN President & CEO provides topline report, video updates on association efforts
Following the September Board of Directors meeting, CRN President & CEO issued a topline report from the session summarizing the business conducted.
Prior to that, in August, Mister shared video updates for members on several hot topics including:
- FDA Commissioner Robert Califf's blog about dietary supplements under the proposed agency reorganization and the CRN team's call with agency officials
- FDA's Master Files Guidance
- Congressional questions on CBD
- CRN's response to the U.S. Government Accountability Office on prenatal supplements
- FDA Commissioner Califf’s speaking engagement during CRN's Now New Next
This 3Q report goes on to address many of these points in more detail.
PUSHING BACK ON INAPPROPRIATE POLICY INTERPRETATIONS AND LEGISLATION
CRN sounds alarm over FDA’s downgrading of dietary supplements in proposed agency restructuring
CRN highlighted concerns about proposed structural changes at FDA that would eliminate the FDA Office of Dietary Supplement Programs (ODSP) under the current Center for Food Safety and Applied Nutrition (CFSAN), after a careful assessment of a stakeholder relations call held by agency officials on June 28. In addition, CRN wrote FDA Commissioner Robert M. Califf, M.D., expressing grave concerns about the proposed reorganization of the agency’s Human Foods Program, which downgrades FDA’s regulation of dietary supplements under the proposed new framework. CRN would have the opportunity to publicly question Commissioner Califf even further about the reorganization during a live virtual fireside chat at its annual conference in October.
CRN details concerns with FTC guidance via citizen petition
CRN submitted a petition to FTC raising concerns about its updated claims substantiation guidance that was released in December 2022, identifying four specific issues with how the guidance would apply to claims for dietary supplements. The submission was developed in collaboration with members of our Legal and Regulatory Affairs Committees.
- A “Take 5” video with SVP and General Counsel Megan Olsen and Katie Bond, partner at associate member Keller & Heckman, who prepared the FTC petition provides a summary of the issues.
CRN responds to Congressional request for information on CBD
CRN in August submitted responses to a Congressional request seeking comprehensive information from industry stakeholders on CBD in order to develop “a regulatory pathway for non-intoxicating hemp-derived cannabinoid products that prioritizes consumer safety and provides certainty to the U.S. markets.” CRN stated:
- FDA has ample authority to regulate these products as food, dietary supplements, cosmetics and over-the-counter and prescription drugs with the prescribed authorities in the current federal Food, Drug, and Cosmetic Act (FDCA) and related regulations. Even though Congress and industry have requested that FDA use this authority there has been no substantive action. As a result, the CBD industry has since languished.
CRN noted, “If FDA had worked expeditiously on a regulatory pathway to legally market CBD when the 2018 Farm Bill was enacted, the questions raised in this RFI would have already been addressed.”
Gustafson speaks at congressional Hemp Roundtable briefing
CRN VP of Government Relations Julia Gustafson was among the dietary supplement industry panelists speaking at a U.S. Hemp Roundtable briefing to congressional staff in September, promoting legislative proposals that would direct FDA to regulate hemp-derived CBD as a dietary supplement. The discussion focused on regulatory policy, FDA inaction, product safety, and consumer protection.
CRN provides written testimony on CBD to House Committee
In advance of a July 27 hearing, CRN provided written testimony to the U.S. House of Representatives Committee on Oversight and Accountability, Subcommittee on Health Care and Financial Services, asking that Congress demand FDA complete the work Congress directed the agency to do under the 2018 Farm Bill by permitting CBD and other hemp-derived cannabinoids to be lawfully marketed as dietary supplements using the appropriate safeguards found in the existing law.
CRN tracks California legislation that would prohibit titanium dioxide in food, supplements
CRN continued to track CA Assembly Bill 418 in the third quarter. The bill would have prohibited the sale of food in California containing titanium dioxide (TiO2), but CRN worked to limit the scope of the legislation and protect the dietary supplement industry. Through its ground team in Sacramento, CRN engaged the bill author Asm. Jesse Gabriel (D) throughout the legislative process resulting in the removal of TiO2 from the law, which later passed and was signed into law in October. Although the industry avoided the TiO2 ban, stakeholders have expressed concern over the California law's “direct challenge to FDA's authority to regulate food additives in the U.S.,” and said it “sets a very dangerous precedent where a state can simply decide to ignore FDA's scientific opinion on a food additive and ban whatever they want for political reasons.”
CRN underscores QA practices for prenatals with GAO
The U.S. Government Accountability Office (GAO) tapped CRN as a trusted subject matter expert for information on over-the-counter prenatal supplements, including pre- and post-market quality assurance practices. CRN’s response explained how its members responsibly develop and market prenatal dietary supplements, including information on: voluntary guidelines/best practices; the importance of product listing; and the Dietary Guidelines for Americans, pointing to CRN comments calling for formal recognition of current expert recommendations regarding nutrient supplementation during pregnancy, lactation, and birth to 24 months.
CRN submits comments on FDA Q&A on ‘Dietary Guidance Statements in Food Labeling: Draft Guidance for Industry’
CRN advised FDA to first issue a final rule on the definition of the “healthy” nutrient content claim before finalizing the guidance on Dietary Guidance Statements to ensure consistency in how the agency views attributes of healthy or nutritious food products. FDA should confirm that dietary supplements, as well as other products, including conventional foods, can continue to be associated with otherwise truthful and non-misleading statements without triggering the requirements for Dietary Guidance Statements when not relying on recommendations from consensus reports. FDA should acknowledge that current and future consensus reports, including the Dietary Guidelines for Americans, as well as certain authoritative medical organizations, may recommend the use of certain dietary supplements.
ADVOCATING FOR INCREASED CONSUMER ACCESS TO SUPPLEMENTS
CRN calls for consideration of supplementation recommendations in Dietary Guidelines for Americans
CRN urged the 2025 Dietary Guidelines Advisory Committee (DGAC) to “consider special nutrient concerns at each life stage and recommend reasonable options for meeting nutrient needs and optimizing health, including dietary supplements and functional foods.” VP of Regulatory and Nutrition Policy, Haiuyen Nguyen, provided comments during a public meeting in September.
- See video of Nguyen’s comments on the DGAC meeting website at 1:33:58.
The Dietary Guidelines for Americans provides advice on what to eat and drink to meet nutrient needs, promote health, and prevent disease.
CRN has successfully advocated for inclusion of dietary supplements in previous iterations of the recommendations.
CRN joins U.S. House Representatives in support of FSA/HSA supplement legislation
CRN applauded the introduction of the bipartisan Dietary Supplements Access Act introduced by Reps. Darin LaHood (R-IL), Brendan Boyle (D-PA), John Curtis (R-UT), and Josh Gottheimer (D-NJ) to provide greater choices to consumers by allowing them to use Flexible Spending Accounts (FSAs) and Health Savings Accounts (HSAs) to purchase dietary supplements, giving millions of Americans increased health and wellness options for better self-care. In Q2 CRN released results of a survey confirming most Americans who currently have an FSA or HSA want the flexibility to choose how best to use their pre-tax dollars to stay healthy by using these accounts to purchase dietary supplements.
UPDATING DATA ON TODAY’S DIETARY SUPPLEMENT CONSUMER
CRN fields annual consumer survey on dietary supplements
CRN convened its consumer survey subcommittee of its Communications, Marketing, and Media Outreach Committee to review and shape the annual questionnaire and worked with Ipsos to field the 2023 CRN Consumer Survey on Dietary Supplements online with more than 3,000 respondents during the third quarter. CRN offered members a pre-launch opportunity to purchase the full survey data at the best price. (In Q4 following 2023 topline data’s big reveal at CRN’s annual conference, the survey became available for purchase to all, with special pricing remaining in place for CRN members.)
DEFENDING THE SCIENCE SUPPORTING FISH OIL CLAIMS
CRN responds to JAMA Cardiology report
CRN provided context and perspective on a JAMA Cardiology report discussing fish oil health claims released in August. CRN pushed back on the assertion that additional regulation of dietary supplement labeling is needed to prevent consumer misinformation, noting that “current regulations permitting structure/function claims provide consumers with the information they need to make informed choices” and “any attempt to limit the diversity of claims and dosages available to consumers would only hinder their ability to choose supplements that align with their personal preferences and needs.”
REINFORCING RETAILER RELATIONS
CRN names new Retail Relations Forum chair
CRN announced the appointment of Chuck Tacl, senior vice president, sales and business development, for Mason Vitamins as chair of its Retail Relations Forum (RRF), succeeding Todd Johnson, senior director of field sales at i-Health who had served as chair since May 2021. Tacl will lead the RRF in fostering industry-retailer connections, which includes identifying mutually beneficial business opportunities and helping to expand education programs with retailers and other stakeholders—including a breakfast meeting at the NACDS Total Store Expo in San Diego (see next item).
CRN holds breakfast meeting connecting top retailer executives with supplement stakeholders at NACDS event
CRN’s Retailer Relations Forum breakfast engagement at the National Association of Chain Drug Stores (NACDS) Total Store Expo convened dietary supplement industry and retail leaders for discussions about supplement aisle trends, retailer requirements for companies regarding quality, claims and product testing, and more.
GROWING CRN MEMBERSHIP
CRN welcomes new members
In the third quarter, the CRN Board approved the following companies for Voting Membership: Abode Biotec; Acutia, Inc.; and K. Patel Phyto Extractions Pvt. Ltd. The Board also approved alliantgroup; Imagine Health; and Luminize as Associate members.
EDUCATING SUPPLEMENT INDUSTRY STAKEHOLDERS
CRN taps member probiotics experts for live Q&A
CRN hosted the first in a “Live Q&A” series, with the inaugural session focusing on probiotics. Participants heard from Jeremy Bartos, Ph.D., Chief Science Officer, MeriCal, Andrzej Benkowski, Technical Manager, Eurofins, and Shihka Snigdha, Ph.D., Director of Scientific Affairs, OLLY, who discussed topics including: manufacturing a dry dosage probiotic supplement; testing for enumeration, identification, and product safety; and separating fact from hype when it comes to clinical studies in probiotics. The session recording and slides are now available on demand.
CRN’s Mister gives ‘Washington Watercooler’ talk during Natural Products Expo East supplement session
CRN President & CEO Steve Mister discussed the latest legislative and regulatory updates from Washington and what they mean for dietary supplement and functional food businesses as part of the Natural Products Expo East “Supplement Symposium” session which also featured a keynote by renowned mycologist Paul Stamets.
Wong talks precision health at Linus Pauling Institute conference
CRN SVP Scientific & Regulatory Affairs Andrea Wong, Ph.D., in September spoke as part of a keynote panel on precision health with Holly Nicastro, Ph.D., MPH, and Cindy Davis at the Oregon State University Linus Pauling Institute's Diet and Optimum Health Conference, organized by Emily Ho, Ph.D. and sponsored by several CRN member companies.
AND JUST AFTER THE CLOSE OF Q3...
CRN convenes top industry professionals, thought-provoking speakers, for annual events
CRN was pleased to welcome attendees to its 50th anniversary events, Oct. 3–6, at the Ritz-Carlton, Laguna Niguel. Science in Session and Now New Next were well-attended and impactful to those who learned from the array of substantive sessions and connected with their industry colleagues. The industry trade press widely covered the discussions, including a virtual fireside chat with FDA Commissioner Robert M. Califf, MD as well as the evolution of dietary supplement research over the years, and CRN’s Consumer Survey on Dietary Supplements.
More to come on post-conference developments in our Q4 report, coming out in early 2024.