Promising “a dramatic and determined focus across the federal government to recognize the importance of food and nutrition in improving the health of all Americans,” the agenda is focused on strengthening food safety, advancing nutrition to combat chronic disease and enhancing chemical safety.
For the dietary supplement industry, there are four notable deliverables that the agency plans to advance: GRAS reform, regulating new dietary ingredients, dietary supplement oversight modernization and guidelines for caffeine labeling. Other deliverables that would impact some supplement companies include reducing contaminants in food for infants and young children via the Closer to Zero initiative, the adoption of natural color additives, a consumer exposure to contaminants in food study and more transparency in allergen labeling.
Ivan Wasserman, managing partner, Amin Wasserman Gurnani LLP, has been advising on dietary supplement regulation for over 30 years.
“If this ambitious agenda comes to fruition, we could be looking at the most impactful changes to the industry since the GMP regulations were promulgated in 2007,” he said, highlighting the many questions the agenda has generated.
“Of course we have all been waiting with baited breath for the promised proposed rule on ‘GRAS reform’, and the devil will be in the details. What will the effective date(s) be? Will it be different for ‘new’ ingredients versus ingredients with a long history of safe use? How will FDA ensure that administrative burdens and delays do not stifle innovation and consumer access to healthy ingredients? Ultimately, the big unknown is will a final rule ever be published and, if so, will it be subject to legal challenge for exceeding the agency’s statutory authority?”
Wasserman pointed to the section on New Dietary Ingredients (NDIs), where FDA stated its intent to release a final guidance in 2026.
“Will it be finalizing draft guidance documents issued by the previous administration or something brand new? What is meant by ‘HPP will also explore stakeholder communications to inform consumers’?” he asked. “FDA also pledges to ‘engage industry regarding [its] efforts to enhance NDI regulation,’ and to ‘streamline’ FDA’s review of NDI submissions–both are certainly very welcome.”
What does modernizing oversight entail?
Commenting on the document, Jim Emme, CEO of NOW Health Group, said the company supports many of the priority deliverables, but he expressed concerns over others.
“We have always been opposed to the use of petroleum-based food coloring ingredients, and you will not find these and other synthetic preservatives in our products. We applaud the efforts of the agency to promote the use of natural colors and preservatives as desirable alternatives to the petroleum-based offerings. We also support the efforts to reduce disease through better nutrition, which has a comprehensive list of goals that would make great strides towards better food choices,” said Emme. “As a responsible manufacturer of natural products, we are always supportive of achievable science-based standards for the reduction of heavy metals and other possible contaminants from our supply chain ingredients.”
Emme told NI that NOW is supportive of the development of a GRAS process that does not hinder innovation in new products, while having a process that uses science-based information to improve the GRAS processes that are currently in place.
He also agreed that there is work to be done regarding the current NDI processes and systems, but there is also a need for a course correction when it comes to the current drug preclusion clause.
“There have been multiple situations in recent years in which some dietary supplement ingredients have been pulled back by the FDA, with NAC and NMN being two examples where problems occurred—there needs to be a process in which these situations can be avoided," Emme said.
“We are also concerned with the general comment that DSHEA needs to be modernized but no specific ideas being listed. We will need to comment on these ideas as they come forward in this process.”
Modernizing oversight could be most impactful
Wasserman said FDA’s plan to modernize dietary supplement oversight is the one deliverable that has the potential to have the biggest impact on the industry—but it also comes with the most unknowns.
“FDA states that it will ‘continue to support dietary supplement priorities with targeted enforcement strategies on violative products,’ which hopefully suggests a smart, balanced approach to ‘level the playing field’ and keep safe, effective and compliant supplements available to consumers,” he noted.
“I think the most important takeaway from this for stakeholders is that now is the time to be informed, involved and engaged with FDA and your trade associations to ensure your voice is heard to help shape the future of the industry.”
Trade associations voice support, concerns
Haiuyen Nguyen, vice president of regulatory & nutrition policy at the Council for Responsible Nutrition (CRN), told us that much of what FDA outlined did not come as a surprise.
“The agency has been signaling for years that it intends to finalize new dietary ingredient guidance and modernize its oversight approach,” she said.
“We are pleased to see increased emphasis on enforcement and timely NDI notification reviews, areas CRN has flagged. FDA’s focus on caffeine labeling and online consumer transparency also aligns closely with voluntary guidelines CRN has already put in place, suggesting the agency is responding to responsible, proactive efforts by industry to improve consumer protection.”
Nguyen added that CRN looks forward to engaging with FDA to provide input on modernizing dietary supplement regulation and oversight.
Regarding dietary supplement oversight modernization, Jonathan Emord, general counsel for the Alliance for Natural Health (ANH) USA said that the FDA continues to suppress truthful health information indispensable to the exercise of informed consumer choice.
Just last week, ANH filed a federal lawsuit against the FDA over the agency’s recent rejection of a petition to allow 114 ‘government-backed’ disease risk reduction health claims.
“It has yet to accept the constitutional mandate of Pearson v. Shalala by favoring disclosure over suppression," Emord told NI.
“Central to dietary supplement oversight reform is major change in the FDA’s Office of Nutrition and Labeling to ensure that the higher law of the First Amendment is honored in practice by movement to usher into the market the wealth of science supported nutrient-disease risk reduction health claims. The MAHA goals of transparency and elimination of chronic disease will never be achieved unless Americans at the point of sale in food and dietary supplement markets have access to precise information on labels and in labeling concerning how nutrients in healthy foods and supplements can reduce their risks of age related disease.”
Emord underscored others concerns, pointing out that NDI regulation must ensure that FDA does not unreasonably restrict what evidence it accepts as proof of pre-October 15, 1994 marketing of dietary ingredients in the United States, i.e., of proof of the exception to NDI status under 21 USC 350b.
“If FDA effectively expands its definition of new dietary ingredient to restrict the availability of dietary ingredients commonly consumed or to disallow reasonable evidence of prior marketing, it will deny consumers freedom of choice without any corresponding benefit to health.”
Emord did express some optimism, noting that if FDA gets GRAS reform right, it could eliminate unhealthy food additives without robbing consumers of additives they have relied upon safely for decades.
Daniel Fabricant, PhD, CEO and president of the Natural Products Association (NPA), said his association welcomes the FDA’s commitment to provide final guidance on safety and identity information for new dietary ingredient (NDI) notifications, emphasizing that effective enforcement against noncompliance is essential for protecting consumers and promoting fair competition.
NPA stressed that questions surrounding peptides and other emerging substances must be addressed alongside NDI guidance, noting that such unresolved issues chill innovation and inject uncertainty into the marketplace. The NPA went on to call for an FDA public hearing on ingredient innovation and advocated against mandatory product listings, arguing they would not enhance safety but could hinder innovation and burden small businesses. The NPA urged the FDA to improve enforcement transparency and act consistently and in real time against noncompliant companies, which it asserts undermines consumer confidence.
“NPA and its members look forward to reviewing the proposed GRAS rule, which is currently under White House review,” Fabricant said. “We will vigorously advocate to ensure the rule does not destabilize the dietary supplement market, is not weaponized against lawful ingredient innovation, does not weaken DSHEA and remains grounded in established scientific principles. Any modernization of the GRAS framework must reinforce— not erode—the legal and scientific foundations that have allowed the dietary supplement industry to responsibly innovate while protecting public health."
The American Herbal Products Association (AHPA) welcomed FDA’s focus on regulatory reform.
“We are committed to working with the agency to ensure that reforms to the NDI and GRAS processes protect pathways to innovation and promote access to botanicals and dietary ingredients rather than potentially create new barriers for responsible industry,” said Graham Rigby, president & CEO of AHPA. “It is essential that updates to the NDI notification process support efficiently bringing safe botanicals to market and that GRAS reform respects the legal standing of self-affirmed GRAS products currently in compliance with the law.”
The Consumer Healthcare Products Association (CHPA) expressed support for the FDA’s efforts to modernize dietary supplement policies, particularly to enhance consumer understanding and optimize regulatory resources.
Duffy MacKay, senior vice president of dietary supplements at CHPA, said that the recent updates to the Dietary Supplement Health and Education Act (DSHEA) disclaimer labeling illustrate a practical modernization approach that aims to clarify consumer information while maintaining appropriate safeguards.
CHPA also said it welcomes the FDA’s commitment to finalizing new dietary ingredient guidance by 2026, highlighting this as a more definitive step toward streamlining reviews and adhering to statutory timelines.
“As FDA moves forward on broader ingredient and regulatory updates, CHPA will continue supporting science-based approaches that improve transparency and further reinforce consumer safety,” MacKay said. “At the same time, it’s critical that those efforts be applied consistently through a single, clear national framework for dietary supplements, as patchwork policymaking risks limiting access to safe, regulated products or making them more expensive for consumers.”
