HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

FDA Sunscreen Guidance: Absorption Data Is A MUsT For GRASE Review

This article was originally published in The Rose Sheet

Executive Summary

The agency maintains maximal usage trials are essential in sunscreen ingredient GRASE assessments, despite industry objections that the tests have not been used for UV filters and no protocol is established. FDA’s final guidance closely mirrors its draft issued a year ago, which stakeholders projected would further delay consumer access to updated sunscreen products.

You may also be interested in...



Key West Bans Purported Coral-Killing Sunscreens, With Florida-Wide Proposal Now On The Table

The City Commission voted 6-1 at its Feb. 5 meeting to prohibit the sale of sunscreens formulated with oxybenzone and/or octinoxate beginning Jan. 1, 2021. That same day, Florida state Senator Linda Stewart proposed similar legislation that would push the effective date up to July 1, 2019, also citing the ingredients’ suspected role in coral declines.

FDA To Try Its Hand At Sunscreen Absorption Study, A MUsT For TEA Sponsors

Agency may be teaming with an outside party to conduct a maximal usage trial on sunscreen formulations. FDA guidance advises MUsTs to assess systemic exposure to sunscreen drug ingredients, but ingredient sponsors have been loath to invest in such tests due to questions about cost and viability.

GAO Report Casts Shade On Sunscreen Ingredients' Chances With FDA

GAO report requested by leadership of House and Senate committees with oversight of FDA adds evidence behind an argument that the agency's monograph process for sunscreen and other OTC ingredients should be changed substantially to facilitate making more pharmaceutical remedies available nonprescription.

Related Content

Topics

UsernamePublicRestriction

Register

LL038093

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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