PRINTABLE PDF | SEE 2022 REPORTS
CRN closed out its 50th anniversary year with a track record of accomplishments that continued to deliver on our mission:
To protect and advance a climate for our members to responsibly develop, source, manufacture, and market science-backed dietary supplements, functional food, and their ingredients, for better health and nutrition.
With the insight our 50-year history provides, the energy of our dedicated staff of professionals, and the collaboration with our member companies, CRN addressed the challenges facing the dietary supplement and functional food industry with a balance of advocacy and diplomacy.
For example, CRN leadership called FDA to task on enforcement as well as its interpretation of drug preclusion, and had substantives discussions with the FTC about its health products compliance guidance.
Read on for an overview of CRN’s accomplishments on behalf of its members in the fourth quarter of 2023.
FOLLOWING UP WITH FDA, FTC
CRN meets with FDA officials regarding re-organization
In two November 2023 meetings with Jim Jones, FDA’s new deputy commissioner for Human Foods, CRN staff discussed the association’s extensive self-regulatory activities, the commitment of its members to the highest standards, and the breadth of the industry as well as of consumer use of dietary supplements and functional food. With FDA’s reorganization of the Human Food Program moving forward despite concerns voiced by industry, Mr. Jones sought to assure CRN that current staffing, funding, and lines of authority would not be diminished under the new plan. While continuing to voice reservations about the “re-org,” CRN is also exploring ways to reduce its negative impacts and get commitments from FDA that staffing, budgeting and priorities for supplements will not be reduced.
CRN protects innovation for the supplement industry innovation by seeking clarity on drug preclusion
Despite FDA’s delay in providing a substantive response to CRN’s May Citizen Petition on the drug preclusion issue, the association declared its continued commitment to resolving the situation and restoring a level playing field between pharmaceutical companies and supplement manufacturers. Earlier this year, CRN called on the agency to officially revise and clarify its interpretation of the drug preclusion clause and to address the inequities that exist between drug and supplement incentives for innovation. As a result of CRN’s continued diplomacy on the matter, several FDA officials have indicated the agency is interested in exploring potential legislative changes to the drug preclusion provisions. CRN has begun working on introducing legislation addressing these issues, preferably with agency buy-in.
CRN dialogs with FTC to address health products claims guidance
CRN met with Federal Trade Commission staff following up on its September submission of a petition requesting the Commission clarify certain aspects of its Health Products Compliance Guidance. FTC staff were receptive to CRN’s recommendations for specific clarifications to the Guidance and acknowledged that the Guidance fails to recognize the flexibility of the substantiation requirements imposed by the courts. CRN is preparing a follow-up submission.
INFLUENCING NUTRITION POLICY IN THE U.S. AND GLOBALLY
CRN discusses ‘Supplements to Savings’ data, nutrition gaps at presidential workshop
CRN’s Andrea Wong, Ph.D., SVP, scientific and regulatory affairs, and Mike Meirovitz, senior director, government relations, represented the association at the President’s Council of Advisors on Science and Technology Advancing Nutrition Science Workshop in November. Dr. Wong and Meirovitz discussed the findings of CRN’s “Supplements to Savings” report and the importance of dietary supplements to bridge nutrition gaps. This engagement is part of CRN’s ongoing efforts to include dietary supplements as part of the conversation with the White House Conference on Hunger, Nutrition, and Health.
CRN-I symposium report published, calling for recommendations supporting resilience, optimal health and expanded healthspan
The CRN-International (CRN-I) 2023 symposium report, “Advancing Nutrition Science to Meet Evolving Global Health Needs,” was published in the European Journal of Nutrition. The CRN-I symposium provided a comprehensive overview of health challenges and policy recommendations to address growing gaps in nutrition and obstacles to better health, emphasizing the importance of precision and personalized nutrition.
CRN explores executive, judicial outreach on impending New York age restrictions
Following passage of a law in New York that will place age restrictions on weight management and sports nutrition products, CRN is in communication with the governor’s office and the state attorney general’s office to examine ways to ameliorate implementation of the most burdensome aspects of the law. The new law will prohibit the sale of certain dietary supplements to those under 18 years old. Despite vetoing the identical legislation last year, Governor Hochul surprised the industry and signed the measure in November. The association is evaluating a range of legal options. CRN continues its opposition to similar bills in other states (see next item) and has begun planning for a broader assault on these products in state legislatures in 2024.
CRN testifies against proposed age restrictions on supplements in Massachusetts
Adding to its opposition efforts in several states that have proposed age restrictions on certain dietary supplements, CRN in November presented testimony in Massachusetts against a bill that would prohibit access to safe and beneficial dietary supplements to consumers 18 years of age and younger—and limit access to these products by consumers of all ages. CRN’s testimony emphasized there is no credible scientific data that the products or ingredients identified in the legislation lead to, or cause, body dysmorphia, eating disorders or mental health issues. CRN also noted the numerous challenges that Massachusetts consumers, retailers and regulators would face if the bill was enacted.
CRN’s Michael Meirovitz testified on Beacon Hill against age-restriction legislation for supplements.
CRN supports next generation of nutrition scientists through educational awards
CRN in October welcomed 2023 winners of the CRN and American Society for Nutrition Foundation (ASNF) Program for Scholars (CAPS) award to its Science in Session event. As part of CRN’s efforts to support the nutrition research community and enhance awareness of the role dietary supplements play in nutrition, CAPS award winners are selected from graduate student members of the American Society for Nutrition (ASN) based on their academic record and commitment to research.
Pictured here are mentors Angela Mastaloudis, Ph.D., Chief Scientific Officer, Brassica Protection Products; Susan Hazels Mitmesser, Ph.D., Vice President, Science & Technology, Pharmavite; honorees Inah Gu, Josephine Dudzik, and Joseph Arballo; and mentors Eric Ciappio, Ph.D., R.D., Strategic Development Manager, Nutrition Science Balchem.
CRN wraps economic impact study, slated for early 2024 release
CRN, working with Dunham Associates, completed data collection for its economic “footprint” report summarizing the dietary supplement industry’s contributions to U.S. national, state, and local economies with estimates of the industry’s impact on jobs, pay, and taxes. The data analysis will be promoted to news media and shared with regulators, policy makers, members of Congress, and state legislators to demonstrate the positive impact of the dietary supplement industry on the economy.
PUSHING BACK ON MISINFORMATION
CRN puts JAMA melatonin letter in perspective, highlighting safety
A November JAMA Letter on pediatric melatonin use merely underscores the popularity of these safe products, CRN noted in response to the publication, which cited irrelevant and flawed data and raised unnecessary alarm about pediatric use of melatonin. CRN President & CEO Steve Mister said the Research Letter “should be received as a call to pediatric doctors to have candid and open conversations with parents about their children’s sleep patterns, and about the use of melatonin, which these findings, and our own data, show is used safely by millions of American families.”
CRN steps up pushback of media misrepresentation
In addition to its personal outreach to educate journalists on the facts about dietary supplements, particularly that they are well-regulated, CRN has increased engagement with reporters via social media to counter the “unregulated industry” myth. The association is calling attention to errors that mischaracterize dietary supplements as unregulated and missed opportunities to provide balance in reporting on topics including melatonin and vitamin D, noting the CRN Foundation’s Supplements to Savings data.
ADVANCING SELF-REGULATORY EFFORTS
CRN’s Board of Directors adopts new e-commerce voluntary guideline
CRN’s Bboard of Directors unanimously endorsed a new voluntary guideline for dietary supplements and functional food that are sold in e-commerce. The guideline calls for marketers of finished products to provide the same information on online product retail platforms and online sales pages that they control as would be available to consumers who could read a label during an in-store purchase. The new guidelines will be officially rolled out in January 2024.
CRN melatonin task force reviews guidelines for potential updates
Work is underway to update CRN’s Melatonin Voluntary guidelines, driven by a task force of CRN members. Changes will be presented for approval by CRN’s Board of Directors in March 2024. Updates to the recommended labeling statements and precautions, allowable overages, and serving size recommendations for melatonin products are expected. The task force is also evaluating whether to recommend industry guidelines that companies use child deterrent packaging on melatonin-containing products likely to be attractive to small children and will make its recommendations in March.
CRN gummy format task force drafts voluntary labeling, packaging guidelines
A policy subgroup of CRN’s gummy format task force is developing voluntary guidelines that address manufacturing, labeling and packaging recommendations for gummy dietary supplements. This dosage form has faced scrutiny on 2023 because of overages in manufacturing, the stability of ingredients in these products, and concerns about possible accidental ingestions. Updates from the task force are expected in the first quarter of 2024.
HIGHLIGHTING INDUSTRY LEADERS
CRN presents supplement company heads as drivers of economic growth, value to public health
CRN continued publishing profiles of dietary supplement industry leaders from its member companies, via its “Profiles in Leadership” series, closing the year with SierraSil’s Michael Bentley, Plexus Worldwide’s Mike Beardall, and Kyowa Hakko’s Karen Todd. Previous profiles in 2023 included Pharmavite’s Jeff Boutelle, Alkemist Labs’ Elan Sudberg, and Cypress Systems’ Michelle Martin.
GROWING MEMBERSHIP
CRN closes 50th anniversary year welcoming new members
CRN announced the addition of five ingredient supplier firms joining its growing list of member companies in the fourth quarter: Jungbunzlauer; Lycored, Ltd.; Mibelle Biochemistry; SuanNutra Inc., and Verb Biotics.
EDUCATING INDUSTRY
CRN presents FDA’s Califf, top industry CEOs, and more for 50th anniversary events
CRN’s 50th anniversary events—Now, New, Next, and Science in Session—held Oct. 3–6, at the Ritz-Carlton, Laguna Niguel, provided a valuable educational and networking experience for attendees in the dietary supplement and functional food space. CRN President & CEO Steve Mister’s thought-provoking fireside chat with FDA Commissioner Robert M. Califf, M.D., resulted in several industry trade press articles and analysis of his comments.
Mister also spoke with industry CEOs, giving attendees "the view from the corner office," engaging Pharmavite's Jeff Boutelle, Chromadex's Rob Fried, and Nutrafol's Giorgos Tsetis, in discussion of a range of topics, including innovation, consumer trust, and the importance of delivering high-quality, science-backed supplements.
Mister delivered his President’s Address, reviewing how CRN’s founding principles remained the same for five decades and how the association has been at the forefront of every issue impacting the industry since its founding in 1973. Tara Martin delivered the CRN board chair address, discussing the association’s new strategic plan, proactively navigating a course forward and creating the agenda and defining the priorities for the industry.
In addition, Science in Session coverage examined whether nutrition science is reliable enough to make solid public and personalized health recommendations.
CRN provides educational content for SupplySide West sessions
CRN staff presented in and presided over educational sessions at SupplySide West in October, including:
- Supplements 101: Fundamentals for a successful journey with CRN SVP, Scientific and Regulatory Affairs, Andrea Wong, Ph.D.
- A comprehensive look into the health and nutrition legal and regulatory landscape with CRN SVP and General Counsel Megan Olsen
- Sports nutrition quits the gym and goes mainstream with CRN VP Scientific & Regulatory Affairs Luke Huber, N.D
In addition, CRN was a sponsor of the What’s Up With Supps Retro Toy Party at the trade show, supporting networking among dietary supplement industry professionals and displaying a light-hearted side of association collegiality.
CRN keeps members updated on EPR developments
Through its weekly member newsletter and Government Relations Committee, CRN provided members with updates on extended producer responsibility (EPR) developments across several states in the U.S. For example, a Michigan bill that would make it possible for localities in Michigan to regulate the use, sale, or taxation of “auxiliary packaging” such as bags, cups, bottles, or other packaging designed for transporting, consuming, or protecting merchandise, food, or beverages from or at a food service or retail facility. In addition, CRN kept members updated on CalRecycle’s Producer Responsibility Organization (PRO) developments for SB 54 implementation, including a review of the PRO application process.
Dietary supplements and the U.S. military webinar presents ODS director and other government experts
CRN gathered leading voices providing an overview of operations dedicated to troops’ performance and resilience and veterans’ health and wellness, as reported by NutraIngredients-USA.com. Presenters for the members-only webinar, including Stefan Pasiakos, Ph.D., FACSM, director of the National Institutes of Health Office of Dietary Supplements, who formerly served as chief of the Military Performance Division (2021–2023), deputy chief of the Military Nutrition Division (2019–2021), and research physiologist (2008–2019) at the U.S. Army Research Institute of Environmental Medicine.
CRN announces kickoff of educational webinars, events in 2024
CRN announced two webinars taking place in January 2024 (with additional opportunities announced in Q1 2024) the first of several virtual and in-person educational opportunities:
- Tuesday, Jan. 10, 2–3 pm Eastern: FSA & HSA Programs: The Current State of Dietary Supplements—now available on demand
- Tuesday and Wednesday, Jan. 23 and 24, 1–3 pm Eastern: GMP Inspection: Being Perfectly Prepared When the FDA Comes Knocking
CRN also announced open registration for the 12th annual Legal, Regulatory & Compliance Forum taking place June 25–26 in New York.
