FALL 2025
Past Editions—Need to Know Archives
IN THIS EDITION:
Here’s what retailers need to know:
- NEW California laws exclude supplements from ‘baby food’ testing, but will mandate consumer access to heavy metal testing for prenatal supplements
- CRN responds to Consumer Reports protein testing for heavy metals and AHA study linking melatonin to cardiovascular events
- NMN declared legal by FDA, and returns to market, but ingredient innovation pathway left unclear from FDA’s drug preclusion interpretation
- CRN breakfast briefing at NACDS TSE highlights retailer strategies and key trends driving today’s supplement marketplace
- CRN leaders chart path to make America healthier as FDA and states pursue sometimes inconsistent policy goals
NEW California laws exclude supplements from ‘baby food’ testing, but will mandate consumer access to heavy metal testing for prenatal supplements
While achieving some revisions, CRN cautions the law will deter usage of prenatals and spur race to remove essential nutrients
California Governor Gavin Newsom signed SB 862 into law in October, which expressly excludes dietary supplements labeled for use by children under 2 years old from the law enacted last year requiring heavy metal testing for “baby food.” The original bill sponsor expressed his view that the earlier legislation was not intended to cover dietary supplements, and this corrective provision enshrines that intent. CRN applauded the change. “This clarification ensures that consumers continue to have access to safe, beneficial supplement products for their families without unnecessary regulatory confusion,” said CRN President & CEO Steve Mister in a press release.
Separately, however, Governor Newsom also signed SB 899, which will require brand owners (including store brands) to provide test results for heaving metals on a website for all prenatal and postnatal supplements starting in 2027. Modeled after the baby food law, this bill requires brand owners to conduct lot testing for four heavy metals (arsenic, cadmium, lead and mercury), to post those results on their websites, and to add statements on their labels directing consumers to the site.
Calling for a veto of SB 899, CRN noted in a Capitol Weekly op-ed the law could unintentionally discourage women from taking prenatal supplements and push companies to strip essential nutrients to make labels look “cleaner.”
But CRN also obtained compromises to mitigate the law’s impact on industry—removing the label QR code requirement, changing monthly testing to lot testing (which is already required), and providing mandatory language for the testing websites to educate consumers with context about the unavoidable presence of minute levels of heavy metals.
The California Department of Public Health is expected to issue guidanceon implementation of the new requirements and CRN is planning an educational webinar for December. Contact Gretchen Powers (gpowers@crnusa.org) if you would like an invitation.
CRN responds to Consumer Reports protein testing for heavy metals and AHA study linking melatonin to cardiovascular events
CRN has urged caution regarding a new Consumer Reports study that tested protein powders for heavy metals. As noted in CRN's statement, the mere detection of heavy metals such as lead, cadmium, or arsenic does not equate to a health hazard.
- Modern testing methods are extraordinarily sensitive and capable of identifying trace amounts of naturally occurring elements that are found broadly in soil, water, and plants.
- Supplement manufacturers are already required under federal Good Manufacturing Practices to test for contaminants and ensure compliance with federal standards.
- Detectible levels of heavy metals do not translate into appreciable risks as people consume minute amounts of these naturally-occurring contaminants in many plant-sourced foods.
CRN noted its support of rigorous science-based evaluation of dietary supplements and functional foods, including protein powders.
“While we appreciate that Consumer Reports has published some detail on its methodology, we note that important context is missing—specifically how products were selected, whether testing reflected typical consumer use, and how its ‘levels of concern’ were derived. Without harmonization to established federal benchmarks, or even actual safety risk, such proprietary thresholds can overstate risk and cause unnecessary alarm," CRN's statement further advised.
In addition, responding to media coverage of an abstract being presented at the American Heart Association’s (AHA) Scientific Sessions 2025 suggesting an association between long-term melatonin use and increased risk of heart failure, CRN urged stakeholders to interpret preliminary findings with caution and context.
What we're saying: As AHA itself notes, this research represents early, non–peer-reviewed data that cannot establish cause and effect. Chronic insomnia—a condition shared by all study participants—may itself be a contributing factor to heart health outcomes, raising more questions than answers.
Melatonin supplements are not intended to treat chronic insomnia or other sleep disorders. CRN’s voluntary melatonin labeling guidelines, adopted in 2024, recommend upper dosage levels and include advisory statements such as “For occasional and/or intermittent use only” and “Consult a healthcare professional if you are experiencing long-term sleep difficulties.”
Consumers who use melatonin should consult their healthcare practitioners, particularly if they have cardiovascular concerns, before making any changes to their regimen.
CRN supports ongoing scientific research to better understand long-term use patterns of all dietary supplements and welcomes rigorous, peer-reviewed investigations that contribute to evidence-based guidance. However, no single study—especially a preliminary abstract—should serve as the basis for broad conclusions or alarmist headlines about dietary supplements.
NMN declared legal by FDA, and returns to market, but ingredient innovation pathway left unclear from FDA’s drug preclusion interpretation
FDA’s Sept. 29 response to CRN’s Citizen Petition will allow nicotinamide mononucleotide (NMN) to be sold in dietary supplements despite drug approval for the ingredient. But consumer access to affordable and accessible healthcare products will be stymied as a result of FDA's refusal to correct its flawed interpretation of the drug preclusion provision under Section 201(ff)(3)(B) of the Federal Food, Drug, and Cosmetic Act.
What FDA decided: CRN’s May 2023 petition—and a supplemental filing in March 2025—sought a practical, common-sense framework that aligns with Congressional intent, provides regulatory certainty, and preserves consumer access to safe, beneficial supplements. While FDA clarified that NMN (nicotinamide mononucleotide) is not precluded from dietary supplement use, the agency declined to fix the underlying policies that created unnecessary uncertainty in the first place.
What we're saying: “FDA missed a pivotal opportunity to bring clarity and balance to the line between pharmaceuticals and dietary supplements," CRN President & CEO Steve Mister observed in a press release following the agency's response. "At every juncture where FDA had the opportunity to choose between two interpretations of the statute, it chose one that favors pharmaceutical development over supplements."
Although FDA’s clarification on NMN resolves the immediate question for that specific ingredient, the decision fails to address the core structural problems that sparked the NMN confusion to begin with. By preserving secret investigational new drug (IND) triggers, U.S.-only marketing rules, and vague criteria for “substantial” investigations—without guidance or rulemaking—FDA keeps the industry in a cloud of ambiguity, stifling innovation and risking future consumer access when promising dietary ingredients enter the marketplace.
CRN urged FDA to revisit its interpretation of the drug preclusion clause and issue clear guidance—or, if the agency will not act, for Congress to restore balance so that consumers retain access to beneficial supplements while legitimate drug innovation proceeds.
CRN breakfast briefing at NACDS TSE highlights retailer strategies and key trends driving today’s supplement marketplace
CRN member sales executives gained timely insights at the association's Retailer Relations Forum Breakfast Briefing on August 24, during the National Association of Chain Drug Stores (NACDS) Total Store Expo (TSE), where leading retailers and consultants outlined trends shaping the supplement marketplace and practical strategies for success.
Presenters included a senior sourcing manager at Sam’s Club; Katie Niles, Pharm. D., VP of merchandising and marketing at Kinney Drug; and Alice Lee, director, client insights-wellness practice at Circana.
Circana data revealed nutritionals are the fastest growing aisle in consumer healthcare at a rate of 9%. With e-commerce growing at more than 17%, winning brands have to offer personalized assortments, clean and natural labeling, and specifically target unique generational needs of each demographic.
Attendees also learned about Sam’s Clubs’ drive for innovation tempered by a demand for claim substantiation for new products. Avram urged companies to invest in the research to support their claims before they bring new products to Sam’s, and he reminded them to build in lead time for pre-vetting of products for quality by third-party auditors.
Kinney Drug gave participants a peek at their new Wellness Triangle and several condition-specific locations in the store helping consumers navigate hydration, GLP-1 support, and women’s health issues. The company's initiative to educate pharmacists on guiding consumers toward better supplement choices presents opportunities for a more proactive mindset towards health.
What we're saying: “CRN breakfast briefing at members a real-world look at how top retailers and data experts are thinking about supplements right now,” said CRN President & CEO Steve Mister. “It was informative, practical, and a reminder of why these conversations are so important for companies looking to innovate and grow responsibly.”
CRN leaders chart path to make America healthier as FDA and states pursue sometimes inconsistent policy goals
Nutraceuticals World recently reported from CRN's CONVERGENCE '25 at the Ritz-Carlton, St. Louis in October, noting the event explored a range of challenges the dietary supplement industry is facing, including the influence of MAHA, regulatory changes at the federal level, a patchwork of inconsistent state laws, and increased scrutiny and misinformation.
Highlighting CRN President & CEO Steve Mister's address to attendees, Nutraceuticals World noted his observation that since the change in presidential administrations and development of the MAHA Commission, many in the industry were anticipating a “golden age” for dietary supplements, including clarification on a number of regulations, acknowledgement in public health strategies, and something more than “indifference and benign neglect” or “aggressive efforts to limit the industry” from FDA.
Mister further noted in his address, “When you think about our current requests of the administration and Congress, it’s still about protecting our consumers, not protecting ourselves. It includes getting supplements recognized as qualified medical expenses for FSAs and HSAs, so that more consumers can stretch their dollars and make their health ingredients more affordable. Or improving FDA’s inspection efficiency, creating a dietary supplement registry, directing investigation priorities toward facilities that impose the most risk, cracking down on unlawful products, all to ensure that consumers have these safe products… We’re much more aligned with the mission of making America healthy than we’re given credit for.”
In his board chair address, Bruce Brown, CEO of CRN member ReCellience 15, noted that the industry’s impact on public health often goes unsung. “No one thanks this industry for preventing illnesses that they never got … [including] every child whose eyes are impacted by simple vitamin A supplementation, or every mother whose folic acid supplementation helped manage a healthy pregnancy. These victories are silent, yet profound.”
Both Mister and Brown called for collaboration among industry stakeholders. “If we’re going to accomplish our aspirations, we have to find common ground and meet in the middle with our opponents and detractors, policy makers and regulators, MAHA allies and fellow trade organizations, our members, and non-member companies,” Mister said.