/>i- On May 30, 2025, FDA issued a draft guidance titled “Replacing Color Additives in Approved or Marketed Drug Products.”
- Neither the draft guidance nor FDA’s Federal Register notice announcing its availability refers explicitly to the recent effort by HHS and FDA to encourage food manufacturers to discontinue the use of certified color additives in food or to FDA’s revocation of its regulations authorizing the use of FD&C Red 3 in foods and ingested drugs. However, the draft guidance will be helpful to any drug manufacturer wishing to replace color additives for any reason.
- Unlike other inactive ingredients in drug products, color additives must be used only in accordance with a regulation issued by FDA authorizing their use. The color additives that are authorized by FDA for use in drugs can be found in 21 CFR part 74, subpart B (those that are subject to batch certification) and 21 CFR part 73, subpart B (those that are exempt from batch certification). Color additives that are provisionally listed for use in drugs can also be found in 21 CFR part 82.
- Ordinarily, the holder of an approved new drug application (NDA) or an approved abbreviated new drug application (ANDA) must submit a prior approval supplement (PAS) to FDA asking FDA to approve any changes to their drug formula (even if just replacing one inactive ingredient with a new one).
- This draft guidance proposes that holders of approved NDAs and ANDAs would generally be able to submit a “changes-being-effected supplement” (CBE-30) prior to making a color additive change to their drug formula. The CBE-30 gives FDA 30 days’ notice of a proposed color additive change, but holders of an approved NDA or ANDA can implement that change without waiting for FDA to approve it. Effectively, FDA is downgrading the regulatory hurdle from PAS to CBE-30 for color additive changes.
- Importantly, this change only applies to drugs marketed under an approved NDA or ANDA. Drugs marketed under an OTC monograph do not have approved applications, so those manufacturers would not submit a CBE-30. However, manufacturers without approved applications still must meet other requirements, as noted in the draft guidance.
- Keller and Heckman will continue to monitor regulatory developments related to color additives.
- Anyone can comment on FDA guidance at any time. To ensure comments on this draft guidance are considered before FDA prepares a final version, they must be submitted by July 29, 2025.
FDA Lessens Hurdles for Color Additive Changes in Drugs
Saturday, June 7, 2025
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