FDA Lessens Hurdles for Color Additive Changes in Drugs

• On May 30, 2025, FDA issued a draft guidance titled “Replacing Color Additives in Approved or Marketed Drug Products.” • Neither the draft guidance nor FDA’s Federal Register notice announcing its availability refers explicitly to the recent effort by HHS and FDA to encourage food manufacturers to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 However, the draft guidance will be helpful to any drug manufacturer wishing to replace color additives for any reason.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 i