CRN 2023 Q2: How CRN has strengthened the dietary supplement and functional food industry by advancing our board-driven program of work

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CRN advanced its 2023 policy priorities during the second quarter and convened in-person gatherings including the WellComms event for marketing and communications professionals in the wellness space, the 11th annual Dietary Supplements Legal, Regulatory, and Compliance Forum, and the association’s Day on the Hill lobbying fly-in—as well as virtual educational opportunities.

Register now for CRN’s signature 50th anniversary events, taking place Oct. 3–6 at the Ritz-Carlton, Laguna Niguel in Dana Point, California.

Read on for an overview of CRN’s progress on behalf of its members during the second quarter of 2023.

ADVOCATING FOR BALANCED AND EFFECTIVE REGULATION

CRN petition calls on FDA to rethink drug preclusion

CRN submitted a Citizen Petition to FDA calling on the agency to reconsider its interpretation of the “drug preclusion” clause in the Dietary Supplement Health and Education Act (DSHEA). CRN noted how FDA is misapplying drug preclusion to dietary supplement ingredients the agency has previously acknowledged as lawfully marketed, which threatens future innovation in the supplement marketplace. 

“Without a reexamination of FDA’s position, and guidance that lends clarity and predictability to the process, manufacturers are discouraged from continued innovation of new ingredients, and retailers are not sure whether they should, or are able to, continue to make these products available to the public for fear of selling ‘illegal’ supplements,” CRN President & CEO Steve Mister said in a statement.


CRN criticizes FDA safety review of CBD as ‘disingenuous’ and ‘incomplete’

CRN responded to FDA’s publication of a “Review of the Oral Toxicity of Cannabidiol (CBD),” with a letter to FDA Commissioner Robert M. Califf, M.D., calling for the agency’s determination of safety to include consideration of the totality of relevant evidence—data on substances that reflect the ingredients intended for use and at the levels that will be consumed. CRN’s letter criticizes FDA’s focus on concerns related to high-dosage, prescription Epidiolex. CRN SVP Scientific & Regulatory Affairs Andrea Wong, Ph.D., discussed issues with FDA’s approach in a video for the association’s new “Take 5” series.

 

CRN opposes age-restriction bills in the states; seeks compromise

Despite rigorous opposition from CRN and other stakeholders—and the association’s ability to thwart similar bills in other states—age restriction legislation has advanced to the governor’s desk in New York. CRN is continuing pushback at the executive branch level—last year the governor vetoed similar legislation—underscoring the findings of a review of the scientific literature (see next item) demonstrating a lack of connection between eating disorders in young people and dietary supplement use, addressing age-restriction advocates’ assertions. 

CRN highlights the disconnect between dietary supplements and eating disorders

Review author Sue Hewlings, Ph.D., R.D., spoke in CRN “Take 5” video about her findings published in Nutrients, “Eating Disorders and Dietary Supplements: A Review of the Science.” Providing a science-based perspective in opposition to age restrictive legislative proposals in several states, Dr. Hewlings explained why public health policy should focus on scientifically established approaches to reduce the prevalence of eating disorders, rather than inappropriately connecting dietary supplement use.


CRN upholds the science on titanium dioxide safety

CRN is also pushing back against a petition requesting FDA repeal regulation authorizing the use of titanium dioxide (TiO2) as a color additive in food and has formed a Titanium Dioxide Task Force to develop comments, in addition CRN is tracking California legislation (AB 418) that would prohibit the sale or distribution of any food product containing the common whitening ingredient.

CRN engages on EPR bills in the states

CRN’s Government Relations team is tracking extended producer responsibility (EPR) legislation in Connecticut and Massachusetts (H 776S 471S 572), similar to California’s SB 54. CRN has been sharing information on implementation of SB 54 from CalRecycle with members and heading into the third quarter, information on legislation passed in Oregon and opportunities to comment on implementation.

CRN calls for flexibility from FTC on ‘Green Guides’

CRN urged FTC to recognize the need for flexible standards and to explore how updates can encourage state harmonization of environmental claim laws, regulations, and guidance in comments submitted on the commission’s “Green Guides” review.

CRN advised that FTC should not initiate rulemaking at this time, noting Guidance (as opposed to rulemaking) allows for both flexibility and agility to address changes in technology, innovation, consumer perception, the patchwork of state laws and standards, and the market for sustainable goods and recycled material.

 

CRN represents US industry with international Codex committees and working groups

CRN participated as an official non-governmental organization (NGO) at the 47th Codex Committee on Food Labelling (CCFL) in Ottawa, Canada during the second quarter following up on its first-quarter engagement in Düsseldorf, Germany. Jim Griffiths, Ph.D., CRN SVP scientific and international affairs, tracked topics of interest to CRN members discussed at the CCFL meeting, including sustainability labeling claims; e-commerce; and use of technology for conveying food information. CRN signed on to a letter of support for full and adequate funding for the U.S. Codex Office in the Fiscal Year 2024 Agriculture-FDA Appropriations bill. CRN is joining the relevant Codex electronic Working Groups (eWGs) on these issues, and will engage members, incorporating input as these issues progress.

CRN signaled support of Codex seeking consensus on sustainability labeling in comments to the U.S. and Canadian delegations to the Codex Committee on Food Labelling (CCFL) and the CCFL Secretariat’s sustainability labeling claims discussion paper. Active in Codex matters relevant to dietary supplements, CRN supports the international body’s work in this area to help ensure consumers are appropriately informed, marketplaces are fair, and the transition towards more sustainable food systems is accelerated.

 

DEFENDING AND PROMOTING SAFE AND BENEFICIAL DIETARY SUPPLEMENT PRODUCTS AND THE SCIENCE SUPPORTING THEIR USE

CRN pushes back on JAMA Research Letter that raises false alarm over melatonin levels in gummies

CRN responded to a JAMA Research Letter, “Quantity of Melatonin and CBD in Melatonin Gummies Sold in the U.S.,” saying it “does a complete disservice to a safe product when it is used according to manufacturer’s instructions.” Citing the National Center for Complimentary and Integrative Health at the National Institutes of Health, CRN notes that the JAMA Research Letter raises unnecessary concern about melatonin products and evidences a complete lack of understanding of the federal requirements for dietary supplements as well as the strong safety profile of melatonin among users of all ages. CRN President & CEO Steve Mister provided commentary for the public and for CRN members in short videos.

 

CRN amplifies the good news about multivitamins and memory

CRN shared findings from the COcoa Supplement and Multivitamin Outcomes Study (COSMOS) ancillary study, COSMOS-Web, published in the American Journal of Clinical Nutrition. Jim Griffiths, Ph.D., who was a participant in the study spoke to NutraIngredients-USA about his experience and the outcomes. In addition, CRN issued a statement noting the significance of the results, that multivitamins slowed down the memory decline that usually happens with age by 3.1 years. 

CRN highlights health care cost savings, quality of life benefits from CRN Foundation ‘Supplements to Savings’ report

CRN continued to share data from relevant chapters of the “Supplements to Savings” report in conjunction with monthly national observances, for example:

CRN promotes science supporting nutritional approaches to optimal health

A report from CRN’s 2022 “Science in Session” symposium was published in the journal “Advances in Nutrition,” discussing gaps and opportunities for optimizing health with nutrition. “The role of nutrition in health has evolved beyond correcting malnutrition and specific deficiencies and has begun to focus more on achieving and maintaining optimal health through nutrition,” the authors observe, calling for “team communication and close collaboration to properly message and communicate to the population at large, and ultimately, improve the health of the nation.”

CRN hosts Congressional ‘fly-in’; educates Congress on the value of dietary supplements and functional food for public health and the economy

CRN’s Government Relations team hosted members in Washington, DC, for its first post-pandemic Day on the Hill fly-in lobbying event. 

By the numbers:

  • 32 CRN member company representatives participated in
  • 34 meetings with legislators and staff from
  • 20 states.

CRN’s lobbying teams discussed:

  • The public health impact of members’ products in improving quality of life and reducing U.S. health care costs—as presented in the CRN Foundation’s Supplements to Savings report.
  • The value of increased consumer access to dietary supplements through HSA/FSA tax revisions.
  • The drug preclusion problem—how FDA’s interpretation of this clause in the Dietary Supplement Health and Education Act (DSHEA) has impacted the regulatory status of CBD, as well as other ingredients, and threatens innovation in the supplement space as well as consumer access to safe and beneficial products.

 

CRN reaches influential RDs with research that supports supplementation

CRN produced continuing professional education (CPE) content for Academy of Nutrition and Dietetics (Academy) registered dietitian (RD) members, “Nutrition Throughout the Lifespan: Role of Dietary Supplements.”

  • The CPE module presents recent research on the contribution of dietary supplements to nutrient intakes in the overall U.S. population, presented by Regan L. Bailey, Ph.D., M.P.H., R.D., and Tieraona Low Dog, M.D.

CRN also sponsored a scientific session, “Fuel for Life: Nutrition for Active Women” with Abbie Smith-Ryan, Ph.D., at the Academy’s Nutrition Trends Forum April 26–28, moderated by Eric Ciappio, Ph.D., R.D., strategic development manager, nutrition science, Balchem.

  • Attendees included Academy RD spokespeople, whose interviews reached an audience of approximately 12.4 billion and generated 2,100 media placements between June 1, 2021, and May 31, 2022. Attendees received swag from CRN members Herbalife, Nestlé Health Science, and Pharmavite.

 

CRN educates academic and clinical stakeholders at NIH supplement practicum

Researchers and graduate students in the scientific and medical communities learned about the dietary supplement industry from CRN President & CEO Steve Mister, who spoke at the National Institutes of Health (NIH) Office of Dietary Supplements (ODS) research practicum in May (recordings available here). Mister shared information on several of CRN’s initiatives and policy priorities reflective of a responsible, trustworthy industry with much to offer the public health and health care system, including:

  • Supplements to Savings, the CRN Foundation report detailing billions in potential savings to U.S. health care costs from the targeted use of supplements.
  • The Supplement OWL product database and advocating for supplement listing.
  • FDA’s interpretation of the “drug preclusion” clause—a provision of the 1994 Dietary Supplement Health and Education Act (DSHEA).
  • Supplement inclusion in FSAs/HSAs.

 

PROVIDING EDUCATIONAL AND NETWORKING OPPORTUNITIES FOR MEMBERS AND THE INDUSTRY

CRN conducts third annual Toxicology Workshop—Assessing the safety of dietary supplement formulas

CRN presented toxicology and regulatory affairs experts for a half-day virtual event for CRB members focusing on assessing the safety of a dietary supplement formula, with sessions on topics including ingredient reputation management, risk assessments related to quality deviations, and more (now available on demand).


CRN helps companies protect their brands against counterfeiting

CRN presented a two-part webinar exclusively for members featuring Amazon representatives who discussed online retailer’s Counterfeit Crimes Unit and information on brand protection and compliance tools (now available on demand).


CRN convenes WellComms for marketing and communications professionals

CRN’s “WellComms: Ignite!” event brought members and attendees from the public together to hear how immersive experiences and AI are changing marketing and communications conventions, expert analysis of e-commerce trends, real talk about the state of social media influencing, and actionable advice from top PR, marketing, and legal pros.

The CRN/ACI 11thAnnual Legal, Regulatory, and Compliance Forum on Dietary Supplements presented experts that underscored the need for certainty, preparedness, and industry unity as issues such as implications of FDA’s draft guidance on new dietary ingredients (NDI) notifications, proposed investigational new drug (IND) amendments, and updates to its definition of “healthy” along with its interpretation of the “drug preclusion,” along with FTC claims substantiation guidance, the future of mandatory product listing and more were discussed. CRN President & CEO Steve Mister also interviewed Gerie Voss, director of FDA’s Office of Dietary Supplement Programs’ Division of Policy and Regulations Implementation.


CRN member and staff expertise on display

CRN launched a new Q&A vehicle showcasing staff expertise on timely topics as well as member insights from their fields. “CRN Members/Experts Explain.” Between its launch in April and the end of the second quarter, the following Q&As have published:

 

CRN drives critical communications in the face of sexism, racism

CRN Senior Director of Communications Craig Muckle participated in a panel for Inicivox webinar series, “Identifying the Elephant in the Room.” Muckle joined the group presenting their ideas on how to take direct action on sexism as well as racism in the natural products industry. 

CRN educates, connects with industry at SupplySide East

CRN SVP and General Counsel Megan Olsen spoke on a SupplySide East panel, “Send Lawyers, Supps and Money,” with FDA’s Cara Welch, Ph.D., and other experts, on April 18.

Other CRN team members on site included President & CEO Steve Mister, who spoke with industry trade press, and VP, Membership Development Carl Hyland, and Director, Government Relations, Mike Meirovitz, who met with members and prospective members.

CRN opens registration for 50th anniversary signature events, taking place Oct. 3–6 in Dana Point, California

CRN announced open registration for its “Science in Session” and “Now New Next” events for the dietary supplement and functional food industry, taking place Oct. 3–6 at the Ritz-Carlton, Laguna Niguel, in Dana Point, California. Early-bird rates are available through Aug. 4 for these exciting events with presenters including:

  • Dr. Vin Gupta, MD, MPA, innovation leader, NBC News Medical Analyst, health policy expert, and chief medical officer, Amazon Pharmacy
  • Dr. Sammy Ramsey, inspirational changemaker in science and society, cutting-edge communicator, and founder & director of the Ramsey Research Foundation
  • Tiffani Bova, Wall Street Journal bestselling author, “The Experience Mindset: Changing the Way You Think About Growth,” and global growth evangelist, Salesforce
  • John Harwood, award-winning political journalist & White House correspondent
  • Paul Zikopoulos, future trends expert, and VP of Technology Group Skills Vitality & Enablement, IBM
  • And many more

See our events website for details and registration options.