Proposal to Revoke the Color Additive Listing for Use of Citrus Red No. 2 on the Skins of Mature Oranges
FDA proposes to revoke the color additive listing for Citrus Red No. 2 on orange skins, effective 30 days after final rule. This directly impacts pharmaceutical manufacturers using this dye in coatings or excipients, requiring reformulation or relabeling.
Aforeworn detected this change in the Pharmaceutical Manufacturing (FDA/DEA) space on July 22, 2026 and published this briefing so affected operators are forewarned rather than caught off guard. It is rated High urgency. Branded drug makers, generic/ANDA manufacturers, API & contract manufacturers, compounding outsourcing (503B) that use Citrus Red No. 2 in any drug product (e.g., tablet coatings, liquid suspensions). should confirm how it applies to their specific situation before acting. There is a time constraint attached: 30 days after publication of final rule (proposal comment period ends 60 days from publication; final rule likely within 6-12 months).. Acting after that point can mean penalties, a lapsed licence, or lost eligibility — exactly the kind of surprise Aforeworn exists to prevent. Aforeworn monitors Pharmaceutical Manufacturing (FDA/DEA) continuously and turns every detected change into a plain-English briefing like this one, so you always know first. Forewarned is forearmed.
What changed
FDA proposes to revoke the listing of Citrus Red No. 2 as a color additive for use on orange skins. While the current proposal targets food use, the same additive may be used in pharmaceuticals; if finalized, any drug product containing Citrus Red No. 2 would be adulterated.
Who it affects
Branded drug makers, generic/ANDA manufacturers, API & contract manufacturers, compounding outsourcing (503B) that use Citrus Red No. 2 in any drug product (e.g., tablet coatings, liquid suspensions).
What you must do
Identify any drug products containing Citrus Red No. 2; prepare reformulation or removal; submit necessary supplements (e.g., prior approval supplement for NDAs/ANDAs) before effective date.
Deadline
30 days after publication of final rule (proposal comment period ends 60 days from publication; final rule likely within 6-12 months).
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