On September 24, 2021, FDA took steps aimed at improving the quality, safety, and efficacy of sunscreens as part of its implementation of new authorities for certain over-the-counter (OTC) drugs.
FDA posted the deemed final order for sunscreens which sets the current requirements for marketing OTC sunscreen products.
FDA also posted the proposed order for sunscreens to amend and revise this deemed final order for OTC sunscreens products.
The proposed order reflects FDA’s proposed requirements for OTC sunscreen products for the future.
About Deemed Final Order (DFO) for sunscreens
The deemed final order for sunscreens includes certain requirements about active ingredients from the 1999 final monograph regulation for OTC sunscreen products, which never took effect.
It also includes labeling and effectiveness requirements from a final 2011 labeling and effectiveness testing rule.
- Dosage Forms: The deemed final order does not address the GRASE status of sunscreens in specific dosage form
- Labeling: The deemed final order contains the same labeling requirements that have been in effect for sunscreen products since 2011.
Manufacturer Compliance With the new DFO
Under the provisions of section 505G as added by the CARES Act, sunscreens that conform to the requirements in the deemed final order and all other applicable requirements are deemed to be GRASE and not new drugs.
If manufacturers do not comply with the deemed final order and all other applicable requirements, the FDA’s responses may include issuing a warning letter to the company, or seeking an injunction, seizure, or consent decree.
This order will remain in effect until the FDA issues another final order revising it.
Read more about it click here: Labeling and Effectiveness Testing: Sunscreen Drug Products for Over-the-Counter Human Use.
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