Salicylic Acid

The US Food and Drug Administration (FDA) published the FY2027 OTC Monograph Drug User Fee (OMUFA) rates on 29 July 2026: USD 47,891 for monograph drug facilities (MDF) and USD 31,927 for contract manufacturing organisations (CMO), about 149% higher than in FY2026 (FY2026 was an unusually low point following a one-off statutory reserve adjustment). The payment date moves from June to October, with two equal instalments due on 1 October 2026 and 1 February 2027.

What to do: Contract manufacturers producing OTC monograph drugs for US brands (e.g. acne products containing salicylic acid or benzoyl peroxide, and sunscreens) must pay the official CMO fee of USD 31,927, with the first half (USD 15,963.50) due on 1 October 2026. The fee should be factored into the cost of US OTC business. Non-OTC product lines are not affected.

Source: FDA OMUFA

The US Food and Drug Administration (FDA) issued Final Order OTC000008-1 on 10–11 September 2026, removing aminobenzoic acid (PABA) and trolamine salicylate from sunscreen monograph M020. FDA states that no products currently marketed in the US contain these two ingredients, so the practical impact is limited; however, it is the first time FDA has formally removed previously permitted sunscreen active ingredients, which is a significant signal.

What to do: Companies with US sunscreen lines should watch for further reviews of other active ingredients.

Source: FDA Final Order OTC000008-1 · reviewed 22 Sep