While no single event has fundamentally altered the regulatory landscape, the cumulative effect of FDA oversight modernization initiatives, expanding state legislation, congressional proposals and continued litigation is prompting companies to reassess compliance strategies and regulatory risk.
Human Foods Program priority deliverables
Less than a month into the year, the Human Foods Program (HFP) at the U.S. Food and Drug Administration (FDA) published its updated 2026 priorities, outlining a roadmap that organizes key deliverables aligned with the MAHA agenda around three primary risk pillars: food chemical safety, nutrition and microbiological food safety.
While dietary supplement are not the program’s sole or main focus, the Office of Dietary Supplement Programs (ODSP) now sits within the newly established Office of Food Chemical Safety, Dietary Supplements & Innovation, positioning dietary supplements within one of the HFP’s three core risk pillars.
As a result, these priorities emphasize stronger risk-based enforcement, modernization initiatives, implementation of broader food safety priorities and regulatory efficiency, with federal officials encouraging out-of-the-box thinking to get a handle on an industry that has exploded in size, scale and scope over the last 30 years.
Closing the GRAS loophole
Revisiting Generally Recognized as Safe (GRAS) substances has become one of the Human Foods Program’s highest-profile and “biggest update” regulatory priorities. Sitting squarely under the food chemical safety pillar of the priority deliverables, it is also one of the dietary supplement industry’s most impactful wait-and-sees.
FDA argues that the current system allows companies to self-determine that an ingredient is GRAS and market it without notifying the agency because participation in the GRAS notification program is voluntary.
To close what it describes as the “GRAS loophole”, the agency announced plans to publish a proposed rule requiring GRAS notices to the FDA for all new substances claimed to be GRAS.
On July 3, the White House’s Office of Information and Regulatory Affairs (OIRA) released its 2026 Regulatory Agenda, which included a proposed rule that would amend FDA’s regulations at 21 CFR parts 170 and 570 to require mandatory GRAS notices for certain human and animal food substances, establish a comprehensive GRAS notice inventory and clarify how FDA determines that a substance’s use is not GRAS. The proposed rule is tentatively scheduled to be published in December 2026.
For industry, the mandatory GRAS notification system could increase FDA scrutiny of novel ingredients, raise compliance costs and timelines, influence ingredient innovation strategies and provide greater regulatory transparency for companies marketing ingredients across both conventional food and supplement sectors.
Exploring the scope of dietary substance
The FDA’s March 27 public meeting regarding the scope of permissible dietary ingredients continues to be one of the most closely watched developments.
Discussion is focused on whether FDA should modernize its interpretation of dietary ingredients to keep pace with scientific and technological advancements like precision fermentation, cell culture technology and recombinant production that have led to an increase in the development of novel ingredients.
Also under consideration is the identity of notable supplement ingredients like proteins, enzymes and microorganisms not specifically listed in section 201(ff)(1) of the Food Drug, and Cosmetic Act, which defines a “dietary ingredient” as a “dietary substance for use by man to supplement the diet by increasing the total dietary intake.”.
Expanding state regulation
State policy makers continue to shape the regulatory landscape for dietary supplements through legislation, enforcement actions and environmental initiatives.
This has created an increasingly fragmented compliance environment, representing a greater day-to-day compliance burden than federal rulemaking for companies navigating a patchwork of state regulations.
States are also taking the lead in addressing the federal “GRAS loophole” by enacting state-level by implementing strict disclosue databases and ingredient bans that promote greater transparency and strengthen safety oversight.
Although these intiatives focus primarilty on conventional food additives rather than dietary supplements, they reflect a broader trend of states filling regulatory gaps where federal oversight is perceived as lagging.
Congressional proposals
Congressional action focused on three main pieces of legislation. All bills remain in the committee stage, primarily centering on a debate between increased federal oversight, state regulation and consumer access.
The reintroduction of the Dietary Supplement Listing Act of 2026 is particularly significant because it is Senator Dick Durbin’s third legislative attempt to secure a federal registry and final push before he retires in January 2027 from a 44-year congressional career.
He asserts that when Congress passed the Dietary Supplement Health and Education Act (DSHEA) of 1994, the absence of a provision requiring companies to register their products with FDA left the agency without the information needed to properly understand or oversee a market that has grown from 4,000 to an estimated 100,000 products over the last 30 years.
FTC health claims enforcement
Federal Trade Commission (FTC) enforcement activity in the first half of the year has reaffirmed the agency’s continued focus on substantiating consumer-facing claims with competent and reliable evidence.
Areas drawing the greatest scrutiny remain weight loss and body composition claims, performance and cognitive benefit claims, influencer marketing and broad “natural,” purity, and sustainability positioning.
One headline-grabbing enforcement action saw FTC sue multilevel marketer Amare Global, its principals and related entities, for allegedly misrepresenting that its supplements marketed to adults and children could treat or cure health conditions such as depression, anxiety and ADHD, and for misleading its seller recruits about their potential earnings as “brand partners.”
And beyond regulation or enforcement at any level, private litigation remains one of the industry’s fastest-growing risks with plaintiffs increasingly relying on state consumer protection statutes, false advertising laws and unjust enrichment theories. Even companies with strong compliance remain vulnerable to consumer litigation.
