Although this guidance appears to provide some flexibility to drug manufacturers who want to replace a color with another color, one certainly hopes that this is not just another way to try to encourage drug manufacturers to do replacements of high quality synthetic colors which are completely safe with exempt (“natural”) colors that do not work well in pharmaceutical applications due to their poor stability and potential seasonal variability. There is no safety reason that should drive this type of reformulation effort which would cause significant cost without providing any safety benefit to patients!!
If a drug manufacturer wants to replace a color with a different color for a good reason, that’s one thing, but this type of change should never be driven by misinformation about the safety of these colors as we are hearing from RFK Jr. and Dr. Makary.
Sent from my mobile device.
Original Message:
Sent: 5/30/2025 9:23:00 AM
From: Mark Arnold
Subject: FDA Draft Guidance on Replacing Color Additives
Today, the FDA released a draft guidance for public comment on "Replacing Color Additives in Approved or Marketed Drug Products". Comments are due by 29Jul25. In the e-mail announcement, the FDA noted its earlier withdrawal of FD&C Red No. 3 from use in food and drugs and said that this guidance covers more than just this colorant.
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/replacing-color-additives-approved-or-marketed-drug-products
#fda #coloradditive
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]
Bioanalytical Solution Integration
LinkedIn: https://www.linkedin.com/in/markearnoldphd/
Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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