The Council for Responsible Nutrition asked FDA to issue a Direct Final Rule confirming that a single, prominently displayed boxed DSHEA disclaimer linked to structure/function claims by an asterisk satisfies 21 C.F.R. § 101.93(d). The petition follows FDA’s December 2025 enforcement discretion announcement and aims to shut down a wave of plaintiffs’ bar litigation that has exploited regulatory ambiguity despite decades of FDA acceptance.

Karen Howard and Todd Harrison detailed a comprehensive proposal that would create a mandatory post-market product listing system without premarket approval, rewrite the drug preclusion provision under section 301(ll) and establish federal preemption of state supplement rules. The framework also introduces a grandfather reset for pre-1994 and pre-2015 ingredients, a voluntary third-party NDI review pathway and tax code changes allowing supplements to qualify for FSA and HSA reimbursement.

A three-judge panel of the U.S. Court of International Trade in New York issued a split 2-1 ruling on May 7 finding the interim 10 percent tariffs imposed in February invalid. The decision is not a universal injunction and applies only to the small business plaintiffs and the State of Washington, leaving Section 122 tariffs in place for most supplement ingredient importers ahead of their July 24 expiration.

Operations chiefs from three of the largest U.S. supplement brands described tariffs as a structural feature rather than an episodic shock, with Pharmavite’s planning dating back to 2019 and Nature’s Way pointing to cascading impacts from packaging components to botanicals. The executives also flagged a fragmenting state-level regulatory landscape, particularly extended producer responsibility rules, as a growing compliance investment.

A Women in Nutraceuticals tour of Adept Life Sciences, Arizona Custom Blends and 21st Century HealthCare walked through the identity testing, microbiological screening, batch records and cGMP inspections that sit behind every bottle. Executives pushed back on the persistent narrative that the supplement industry operates outside FDA oversight, emphasizing the role of cGMP enforcement and quality control at every stage of production.

The International Creatine Organization and Network, a new 501(c)(6) led by industry veteran Dave Slagle, launched with a per-lot purity certification program developed in partnership with SGS. The group’s 99.5 percent threshold exceeds the existing USP creatine purity standard of 98 percent and arrives as a recent Heliyon analysis found that only 8 percent of finished creatine products carry third-party certification.

A 12-week, four-arm randomized controlled trial of 108 vitamin D-deficient women, published in Nutrients, showed a dose-dependent response to daily 400 to 800 IU vitamin D3 delivered in a fortified chocolate wafer. By week 12, the 800 IU arm achieved sufficiency in 65.4 percent of participants compared with 7.4 percent for placebo, supporting the case for nutritionally relevant daily dosing rather than mega-dose loading.

SupplySide’s cognitive health feature mapped emerging brain health categories that supplement formulators are testing across lifespan-spanning use cases, from focus and stress to mid-life cognitive maintenance. The piece highlights how rising consumer literacy is pushing brands to substantiate claims with clinical data, a trend that aligns directly with the structure/function claim guardrails embedded in DSHEA.

Coverage around National Women’s Health Week tracks how supplement formulators are segmenting offerings across fertility, prenatal, perimenopause and postmenopause use cases, one of the fastest-growing VMS categories. The maturation of women’s health science is also accelerating regulator and trade-group attention to evidence standards, clinical trial inclusivity and structure/function claim integrity.

The NutraIngredients Europe Awards recognized 16 winners on May 6 in Barcelona, spanning innovative ingredients for muscle recovery, mood and sleep. The awards offer a useful read on which evidence-backed branded ingredients are gaining traction with European regulators and formulators, with read-through for U.S. NDI strategies in the year ahead.

CRN’s Citizen Petition is now on the public docket. Comments from manufacturers, retailers and consumers will shape whether FDA codifies 25 years of disclaimer placement practice or leaves the industry exposed to opportunistic state-court litigation.

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