HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA’s Sunscreen Regulatory Approach Misaligned With Its Public Health Messaging, Trade Groups Say

Executive Summary

The Personal Care Products Council and Consumer Healthcare Products Association say FDA’s tentative final sunscreen monograph and related communications have given rise to confusion that could lead to reduced sunscreen use and negative public health consequences. The groups go one further: FDA should reissue a tentative final monograph proposing that the 12 chemical UV filters currently in question are GRASE.

You may also be interested in...



PCPC, CHPA Ask US FDA To Defer Final Rulemaking On Sunscreen Actives In GRASE Limbo

Industry continues working to support updated GRASE findings for UV filters avobenzone, homosalate, octinoxate, octisalate, octocrylene, oxybenzone, ensulizole and meradimate, which the FDA categorized more than two years ago as lacking data, a position it reprised in 2021 under its overhauled OTC monograph system.

FDA’s Follow-Up Sunscreen Trial Shows More Of The Same: Absorption Of All Tested UV Filters

The FDA emphasizes that findings from its second, more extensive clinical study on the absorption potential of sunscreen active ingredients are not in themselves signals that the UV filters are unsafe. However, they portend heavy work ahead for industry if the ingredients are to remain GRASE and available for use in OTC sunscreen drug products stateside.  

 

Sunscreen Industry's Plan For First Ingredient MUsT Estimates 2023 Completion

Personal Care Product Council submits work plan to FDA setting 2023 date for completing MUsT trial on one of eight UV filters, with additional trials to follow. Research firm considers the estimate consistent with the industry's experience with the trials, but says it could design and conduct the required pilot and pivotal studies in six months.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS148961

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel