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.<\/p>\n
Human Foods Program priority deliverables<\/p>\n
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<\/a>, 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. <\/p>\n While dietary supplement are not the program\u2019s 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\u2019s three core risk pillars. <\/p>\n 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<\/a> to get a handle on an industry that has exploded in size, scale and scope over the last 30 years.<\/p>\n Closing the GRAS loophole<\/p>\n Revisiting Generally Recognized as Safe (GRAS) substances<\/a> has become one of the Human Foods Program\u2019s highest-profile and \u201cbiggest update\u201d regulatory priorities. Sitting squarely under the food chemical safety pillar of the priority deliverables, it is also one of the dietary supplement industry\u2019s most impactful wait-and-sees.<\/p>\n 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.<\/p>\n To close what it describes as the \u201cGRAS loophole\u201d, the agency announced plans to publish a proposed rule requiring GRAS notices to the FDA for all new substances claimed to be GRAS. <\/p>\n On July 3, the White House\u2019s Office of Information and Regulatory Affairs (OIRA) released its 2026 Regulatory Agenda, which included a proposed rule that would amend FDA\u2019s 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\u2019s use is not GRAS. The proposed rule is tentatively scheduled to be published in December 2026.<\/p>\n 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.<\/p>\n Exploring the scope of dietary substance<\/p>\n The FDA\u2019s March 27 public meeting<\/a> regarding the scope of permissible dietary ingredients continues to be one of the most closely watched developments.<\/p>\n 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.<\/p>\n 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 \u201cdietary ingredient\u201d as a \u201cdietary substance for use by man to supplement the diet by increasing the total dietary intake.\u201d.<\/p>\n Expanding state regulation<\/p>\n State policy makers continue to shape the regulatory landscape for dietary supplements through legislation, enforcement actions and environmental initiatives. <\/p>\n 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.<\/p>\n States are also taking the lead in addressing the federal \u201cGRAS loophole\u201d by enacting state-level by implementing strict disclosue databases and ingredient bans that promote greater transparency and strengthen safety oversight. <\/p>\n 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.<\/p>\n Congressional proposals<\/p>\n 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.<\/p>\n