Federal Regulatory Snapshot for Dietary Supplements (2026)

Proposed Bills: Important, but Not Current Law

MAHA: What Has Actually Happened

FDA's Human Foods Program ties its 2026 priorities to the Make America Healthy Again (MAHA) strategy. Separating concrete agency actions from political messaging takes work. Here is what has actually moved.

FDA 2026 Priority Deliverables

The FDA's Human Foods Program published its 2026 priority list, and two items stand out for supplement operators:

• •GRAS reform: FDA published a proposed GRAS rule in the Federal Register on August 11, 2026 (docket FDA-2025-N-3262); comments are due December 9, 2026. If finalized, the proposal would require GRAS notices for uses of human and animal food substances claimed to be GRAS. The current notification program is voluntary. Dietary ingredients used in dietary supplements are outside it: the proposal says they are excepted from the food additive definition and are not eligible for GRAS classification (proposed 21 CFR 170.205(c)).
• •NDI guidance: FDA said it will release final guidance during 2026 on the safety and identity information required for NDI notifications. As of September 29, 2026, FDA's guidance page on NDI notifications and related issues still carries a draft (dated April 2024). A final version would clarify what evidence manufacturers need to submit.

Concrete actions taken so far

• •Red No. 3 formally revoked by FDA (January 2025), with a reformulation deadline of January 2027 for foods. The remaining synthetic food dyes (Red 40, Yellow 5, Yellow 6, Blue 1, Blue 2, Green 3) are part of a voluntary industry phase-out that FDA and HHS announced in April 2025 with an end-of-2026 target. As of mid-2026 that phase-out remains voluntary; no binding rule sets the 2026 deadline.
• •The Dietary Supplements Access Act (H.R.8933 and S.4587, introduced May 20, 2026) would treat dietary supplements as qualified medical expenses payable from health savings account (HSA) funds, up to $500 a year ($250 for a married person filing separately). Both bills are in committee; neither has become law.
• •$234.6 million was requested for MAHA priorities in the FY2026 President's Budget for the FDA Human Foods Program (FDA FY2026 budget summary). This is the administration's request figure, not a final congressional appropriation.

State-Level Regulation: The Growing Patchwork

While federal bills move slowly, states are moving on their own supplement restrictions. The most active area is age restrictions on sales of weight loss and muscle building products to minors. Two states have enacted such laws: New York's is in effect, and California's takes effect January 1, 2027.

• •New York enacted the first such law (General Business Law Section 391-oo). Signed in 2023 and effective April 22, 2024, it bans selling over-the-counter weight loss and muscle building supplements to minors under 18. If you sell these products, you are already subject to it in New York.
• •California's AB 1341 passed the legislature but was vetoed by Governor Newsom. Its successor, AB 2030, was signed on September 28, 2026 (Chapter 720, Statutes of 2026) and takes effect January 1, 2027: it bars selling weight-loss or muscle-building supplements to anyone under 18 and requires age verification for shipped orders.
• •In 2026, Hawaii (SB 2106) and Rhode Island (S 2774) introduced their own age-restriction bills. Hawaii's cleared an initial committee and was then deferred in committee on February 26, 2026, so it did not advance in the 2026 regular session. Rhode Island's was held for further study in committee on April 14, 2026. Neither has become law.
• •Similar measures have been introduced in other states, including Massachusetts, New Jersey and Ohio (HB 943, in committee since May 20, 2026).

The Natural Products Association (NPA) has argued against state age restrictions and for federal preemption (SupplySide column, December 8, 2025). The federal H.R.7366 bill (covered above) would preempt these state restrictions if it passes, unless FDA exempts a state's rule on that state's application, but that bill remains in committee. Until it advances, brands selling weight management or sports nutrition products should track legislation in their key sales states.

Sources: SupplySide (December 2025); state legislature bill records for California, Hawaii, Rhode Island and Ohio

Enforceable Federal Baseline Right Now

FTC substantiation rules

FTC's Health Products Compliance Guidance remains one of the clearest primary sources for supplement advertising risk. FTC says claims about the health benefits or safety of dietary supplements require competent and reliable scientific evidence, and the agency's 2023 notice campaign warned approximately 670 companies that unsupported claims can trigger penalties if prior notice doctrines apply.

FTC penalty exposure

FTC's 2025 inflation adjustment raised the relevant maximum civil penalty to $53,088. That is the current figure to cite for 2026 as well: OMB memo M-26-11 (April 2026) cancelled the 2026 inflation adjustment, so agencies carry the 2025 amounts forward. An older $50,120 amount, which was the 2023 figure, still appears in many third-party summaries; the 2024 amount was $51,744. The maximum applies to violations under Sections 5(l) and 5(m) of the FTC Act (order violations, knowing rule violations, and penalty offenses), not automatically to every first-time deceptive claim.

FDA structure/function claim rules

FDA's structure/function claims page remains the primary official reference for supplement claims basics. In general, a dietary supplement may use structure/function claims if the claim is truthful and not misleading, the required FDA disclaimer is used when applicable, and the manufacturer notifies FDA no later than 30 days after first marketing the product with that claim. The regulation, 21 CFR 101.93(d), requires the disclaimer to appear on each panel or page where a structure/function statement appears, placed adjacent to the statement or linked to it with a symbol such as an asterisk. In a December 11, 2025 letter to industry, FDA said it is likely to propose amending that rule and, meanwhile, intends to exercise enforcement discretion on the each-panel requirement. FDA does not extend that discretion to putting the disclaimer on the label and linking it to each claim. Enforcement discretion does not change the regulation's text, so confirm any relabeling decision with regulatory counsel.

Amazon as a de facto regulator

In December 2025, Amazon expanded its cGMP documentation requirement to all supplement categories sold on the platform. Multiple independent trade sources confirm the change: NutraIngredients (December 22, 2025), AHPA, Certified Laboratories, and EAS Consulting Group. While this is not federal law, it applies to every brand that sells supplements on Amazon. Brands that sell through Amazon should treat cGMP documentation as a baseline operating requirement, not an optional checkbox. For a detailed walkthrough, see our Amazon supplement compliance guide.

What This Guide Does Not Treat as Settled Fact

• •Unverified monthly warning-letter trendlines that are not grounded in current FDA primary-source counts.
• •Speculative MAHA forecasts beyond the concrete actions and published FDA priorities documented above.
• •Older FTC penalty figures that were superseded by the 2025 inflation adjustment.

Primary Sources Checked

Recorded sources checked between July 17, 2026 and October 1, 2026. Re-check before using this page for a board memo, investor update, or legal compliance decision.

• Congress.gov, S.3677: Dietary Supplement Listing Act of 2026
• Congress.gov, H.R.8370: Dietary Supplement Listing Act of 2026 (House companion to S.3677)
• Congress.gov, H.R.7366: federal preemption bill affecting state supplement restrictions
• FTC, Inflation-Adjusted Civil Penalty Amounts for 2025
• FTC, 2023 Notice to Almost 700 Marketing Companies About Substantiation
• FTC, Health Products Compliance Guidance
• FDA, Structure/Function Claims
• FDA, Human Foods Program 2026 Priority Deliverables
• FoodNavigator-USA, FDA and USDA staff cuts raise food safety risks (February 2026)
• SupplySide, State overreach poses supplement industry threat
• FDA, Letter to the Dietary Supplement Industry on the DSHEA Disclaimer (December 11, 2025)
• Federal Register, Substances Generally Recognized as Safe (proposed rule, August 11, 2026)
• California Legislative Information, AB 2030 bill history (Chapter 720, Statutes of 2026)
• FDA, FY 2026 President's Budget Summary
• eCFR, 21 CFR 101.93 (structure/function claim disclaimer placement)