FDA and Regulation

The U.S. Food and Drug Administration decides which drugs may be sold, how foods and dietary supplements may be labelled, which additives are allowed, and how new treatments are tested. Its notices, rules and actions shape what reaches the shelf and the clinic.

This section reports those actions on foods, supplements, remedies and plant medicines from the primary documents — the FDA announcement, the Federal Register notice and its docket — stating what each one does, what it asks, what it does not do, and the dates that matter. Each page links the related topic pages elsewhere on the site.

FDA Actions (11)

In date order, oldest first. The stars rate each action's legal weight: ★★★★★ a final action that changes what is sold or labelled nationwide; ★★★★ a proposed rule or order, or a final action of narrower reach; ★★★ a formal safety review or a final guidance; ★★ a request for information or a public meeting.

🎨Feb–Jul 2026★★★★★

FDA Food Dye Actions in 2026

2026: the FDA revoked Orange B, proposed revoking Citrus Red No. 2, approved beetroot red and widened spirulina extract, and relaxed “no artificial colors” claims.

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🧪Feb–May 2026★★★★★

FDA Safety Reassessments of BHA, BHT and ADA (2026)

2026: the FDA opened post-market safety reassessments of the preservatives BHA and BHT and the dough conditioner azodicarbonamide, and finalized its chemical-review framework.

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🌸Feb 12, 2026★★★★★

FDA Approves New Menopausal Hormone Therapy Labels (2026)

February 2026: the FDA approved the first six hormone therapy labels without boxed-warning statements on heart disease, breast cancer and probable dementia.

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💊Mar 27, 2026★★★★★

FDA Public Meeting on What Counts as a Dietary Ingredient (2026)

March 2026: the FDA asked for public input on how the “dietary substance” category applies to fermentation-made, cell-cultured and recombinant supplement ingredients.

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🧬Apr–Jul 2026★★★★★

FDA Review of Compounded Peptides Including BPC-157 (2026)

2026: BPC-157 and other peptides left the FDA’s significant-safety-risk category; in July the FDA proposed not listing any of the seven it took to its advisory committee.

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💉Apr 30, 2026★★★★★

FDA Proposal on Compounded Semaglutide and Tirzepatide (2026)

April 2026: the FDA proposed keeping semaglutide, tirzepatide and liraglutide off the list outsourcing facilities may compound from bulk ingredients, finding no clinical need.

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🍃Jul 6, 2026★★★★★

7-OH Kratom Products: The 2026 Scheduling Steps

July 2026: the DEA moved to place concentrated 7-OH in Schedule I, with HHS and FDA support; natural kratom leaf is not the target.

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🍄Jul 14, 2026★★★★★

FDA Final Guidance on Psychedelic Drug Trials (2026)

July 2026: the FDA finalized its guidance on designing clinical trials of psychedelic drugs and held a public hearing on possible future therapeutic use.

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🧾Aug 11, 2026★★★★★

FDA Proposal to Make GRAS Notices Mandatory (2026)

August 2026: the FDA proposes requiring companies to notify it whenever they conclude a food ingredient is GRAS; comments close December 9, 2026.

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🌿Sep 3, 2026★★★★★

FDA Request for Input on Botanical Drugs (2026)

September 2026: the FDA asked for public input on obstacles to developing plant-based prescription drugs, from quality standards to study design; comments close November 3.

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🫀Oct 6, 2026★★★★★

FDA Ibogaine Research Notice (2026)

October 2026: the FDA asks for public comment on how early clinical trials of ibogaine should be designed (comments through November 20, 2026).

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Earlier Years (2)

Connections