DSHEA Weekly Digest – May 19, 2026






DSHEA Weekly Digest – May 19, 2026


DSHEA Preservation Alliance
Weekly Digest
May 19, 2026
Volume 2, Issue 3
What’s Inside This Week

The most consequential week for FDA leadership in years reshaped the regulatory landscape, as Commissioner Marty Makary abruptly resigned and Kyle Diamantas, the agency’s top food official and a known ally of the dietary supplement industry, was elevated to acting commissioner. The shake-up rippled through to the Human Foods Program, where 27-year FDA veteran Donald Prater stepped in as acting deputy commissioner. On Capitol Hill, more than 130 NPA members descended on Washington to fight mandatory product listing, demand reform of the drug preclusion clause, and push for federal preemption of state-level supplement restrictions. Across the Atlantic, EFSA delivered a long-awaited positive safety opinion on NMN, putting the longevity ingredient within reach of EU authorization just months after FDA restored its lawful status under DSHEA.

 
FDA Leadership & Regulatory Action

FDA Commissioner Makary Resigns After Tumultuous Tenure

NPR  ·  May 12, 2026

Dr. Marty Makary resigned as FDA commissioner on Tuesday, ending a 13-month tenure marked by clashes with the MAHA movement, the White House, and traditional regulatory stakeholders. President Trump named Kyle Diamantas, deputy commissioner for food, as acting head while the search for a permanent commissioner begins. Industry observers say the change creates fresh uncertainty around drug reviews, ingredient policy, and DSHEA modernization at a moment of historic upheaval at the agency.

FDA Shakeup: Makary Steps Down, Diamantas Steps Up

NutraIngredients  ·  May 13, 2026

Industry stakeholders welcomed the elevation of Kyle Diamantas, who has signaled that dietary supplement modernization is “top of mind” and that DSHEA’s regulatory framework has not adapted adequately to the industry’s growth over 30 years. Trade groups including AHPA, UNPA, and CHPA expressed confidence that supplement issues will not be sidelined, though CRN and NPA declined to comment. Sources warned that additional FDA leadership changes are expected as the administration continues reshaping the agency.

Donald Prater Steps In As Head of FDA Human Foods Program

NutraIngredients  ·  May 18, 2026

The FDA named Dr. Donald Prater acting deputy commissioner of the Human Foods Program, filling the vacancy left when Diamantas was elevated to acting commissioner. A 27-year FDA veteran and former acting director of CFSAN, Prater is charged with overseeing all human food operations, including policy initiatives that touch dietary supplement oversight. Secretary Kennedy said the search for a permanent FDA commissioner is moving forward “with urgency.”

 
DSHEA Reform & Industry Advocacy

NPA Fly-In Day 2026: Championing Health Freedom 90 Years On

NutraIngredients  ·  May 14, 2026

Over 130 NPA members descended on Capitol Hill on May 12 to urge lawmakers to oppose the Dietary Supplement Listing Act, reform the drug preclusion clause under section 201(ff)(3)(B), expand HSA and FSA eligibility for supplements, and pass federal preemption of state-level supplement restrictions. Members highlighted the NMN saga as evidence of FDA overreach and called for a public registry of investigational new drug filings to give companies clarity before investing in new ingredients. Representative Nick Langworthy (R-NY), sponsor of the Dietary Supplement Regulatory Uniformity Act, spoke at the closing reception about ending the state-by-state patchwork that overrides FDA authority.

 
NMN & The Drug Exclusion Clause

EFSA Issues Positive Safety Opinion on EffePharm’s NMN

NutraIngredients  ·  May 13, 2026

The European Food Safety Authority issued a positive safety opinion on EffePharm’s beta-NMN, concluding that 300 mg daily is safe for the general population, excluding pregnant and lactating women. Final EU authorization is expected within five to seven months, potentially opening the European market to the NAD+ precursor that has already become a longevity bestseller in the United States and Asia. The opinion follows FDA’s September 2025 reversal that restored NMN’s lawful status as a dietary supplement under DSHEA after a multi-year fight over the drug preclusion clause.

 
Botanicals & Global Regulatory Action

Indian High Court Grants Interim Stay on Ashwagandha Leaf Ban

NutraIngredients  ·  May 15, 2026

A Bangalore High Court issued an interim stay on India’s blanket prohibition on ashwagandha leaf use, ruling in favor of seven petitioning supplement and ingredient companies including Sami-Sabinsa, OmniActive, and K Patel Phyto Extractions. Petitioners argued the FSSAI advisory was arbitrary, disproportionate, and unsupported by verified scientific research, and could only be imposed through formal amendment of India’s 2016 nutraceutical regulations. The next hearing is set for June 8, with the ban remaining stayed only for the petitioning companies until then, leaving global supply chains for one of the industry’s most-used adaptogens in continued uncertainty.

 
GMPs, Labeling & Litigation Risk

FDA Investigator Outlines Issues With Gummy Manufacturing

NutraIngredients  ·  May 18, 2026

Siobhan Taylor, the FDA’s national expert on dietary supplements, told the East Coast SoCal Dietary Consortium that gummy production carries elevated cGMP risk because the products are consumed without any kill step. She flagged starch mold reuse, allergen cross-contamination, moisture content, and environmental contaminants ranging from ceiling-fan dust to fiberglass as inspection priorities. The remarks land as the gummy supplements market accelerates toward a projected $67 billion by 2031, raising the stakes for compliance under DSHEA’s GMP regime.

NAD Decision on Magnesium Gummies Raises Questions Around Compound Weight Claims

NutraIngredients  ·  May 14, 2026

The National Advertising Division ruled against Nature’s Truth’s Magnesium Glycinate Gummies, finding that the “200 mg per serving” front-label claim was unsubstantiated because the product contains only 22 mg of elemental magnesium. The decision, brought by competitor Pharmavite, reignites a long-running debate about whether brands should advertise compound weight or elemental nutrient content. NAD attorney Zheng Wang told NutraIngredients that “an advertiser must substantiate all messages reasonably conveyed, even if that message is unintended,” a standard with direct implications for class action exposure across the category.

 
Market Trends & Innovation

Trendspotting at Vitafoods Europe: Mashups, Hybrids and the Industry’s New Pillars

NutraIngredients  ·  May 19, 2026

At Vitafoods Europe 2026 in Barcelona, Nutrition Integrated managing director Nick Morgan identified hybrid “mashup” products, combining protein with hydration, electrolytes, fiber, and other functional ingredients, as the defining trend for the year. Morgan noted that whey protein faces significant price pressure and supply constraints, accelerating brand interest in plant, fermentation-derived, mycoprotein, and yeast-based alternatives. Creatine and functional gummies featuring lion’s mane and other targeted ingredients continue to expand mainstream consumer reach as GLP-1 and longevity become foundational industry pillars.

AI Set to Reshape Nutra Industry, But Success Hinges on Trust and Oversight

NutraIngredients  ·  May 13, 2026

Mintel senior analyst Yunn Lim said AI is poised to transform preventative health and accelerate product innovation across the nutraceutical industry, but consumer acceptance and human oversight will determine whether the technology delivers. A new systematic review of 16 randomized and cohort studies found short-term improvements in glycemic control, weight reduction, and symptom severity for AI-supported interventions, though most evidence remains preliminary. Industry experts caution that data privacy, algorithmic bias, and regulatory accountability must be addressed before AI tools can be safely embedded in chronic disease management.

Your Voice Matters

FDA leadership is in transition and DSHEA modernization is moving on Capitol Hill. The drug preclusion clause, mandatory product listing, and state preemption are all in play. Add your voice before the framework that protects 30 years of consumer choice is rewritten without you.

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