FDA announced today (here) that, after reviewing timely submitted comments to its September 27, 2021 notice of availability of the proposed order OTC000008 titled Amending Over-the-Counter (OTC) Monograph M020, that it is removing two ingredients, para-aminobenzoic Acid (PABA) and trolamine salicylate from the monograph.
The notice states that “FDA has determined that there are no conditions under which a drug product containing PABA or trolamine salicylate as a sunscreen active ingredient is GRASE under section 201(p)(1) of the FD&C Act because FDA’s review of the available safety data for PABA and trolamine salicylate shows that the risks associated with use of these active ingredients in sunscreen drug products outweigh the benefits”.
FDA notes that it will issue additional information regarding the finalization of the monograph order; however, based on prior notice of the FDA’s intent to declare these two ingredients as NOT generally recognized as safe or effective, the continued inclusion of these ingredients in the US has been basically eliminated and reformulation of products has already occurred. This final order formalizes the FDA’s position regarding these two ingredients. The notice does not provide any information regarding enforcement activities involved with the issuance of this final order. If you have any old sunscreen containing either of these ingredients, you should likely discard them.
