5 March 2026
From the press releases of the U.S Food and Drug Administration (FDA), Arex Advisor has rounded up a selection of regulatory highlights from the past month.
FDA revises policy on ‘no artificial colors’ claims
5 February 2026
The FDA has introduced a new approach allowing food companies to label products as containing ‘no artificial colors’ if they do not include petroleum-based colour additives. Previously, such claims were generally limited to products with no added colours at all, regardless of source; the update offers greater flexibility while supporting a shift towards natural alternatives. Read more
FDA moves to restrict non-approved GLP-1 products
6 February 2026
The FDA has announced plans to take action against the use of GLP-1 active pharmaceutical ingredients in non-FDA-approved compounded drugs that are being widely marketed as alternatives to authorised products. The agency said the steps are intended to protect consumers from medicines for which quality, safety, and efficacy cannot be verified, and to address potential violations of the Federal Food, Drug, and Cosmetic Act. Read more
FDA proposes framework to advance individualised therapies for ultra-rare diseases
23 February 2026
The FDA has issued draft guidance outlining a new framework to support development of targeted individualised therapies for ultra-rare diseases. The approach sets out how sponsors can generate substantial evidence of safety and effectiveness when randomised controlled trials are not feasible due to very small patient populations, aiming to facilitate access while maintaining regulatory standards. Read more
How do these changes affect you?
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