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FDA Moves to Improve Quality, Safety and Efficacy of Sunscreens

The U.S. Food and Drug Administration announced recent activities that are part of its ongoing implementation of new authorities for certain over-the-counter drugs including sunscreens.

Sunscreen Innovation Act Introduced into Congress to Amend FDA's TEA Program

On Mar. 13, 2014, U.S. Senator Jack Reed (D-RI) and U.S. Congressman Ed Whitfield (R-KY) introduced the bipartisan, bicameral Sunscreen Innovation Act (S. 2141 and H.R. 4250, respectively), which has been supported by the Public Access to SunScreen (PASS) Coalition.

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Croda Ingredients Aligned with FDA New Proposed Regulations for Safer Sunscreens

Croda offers a range of metal oxide dispersions that have been identified as the preferred route to safe and effective UV protection.

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PCPC, CHPA Respond to FDA’s Latest Findings on Sunscreen Absorption

In response to part two of the FDA’s sunscreen ingredient maximal usage trial, published in January 2020 in JAMA, the (PCPC) and (CHPA) released a statement reassuring consumers of product safety.

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Sunscreen Absorption Makes Waves Again, FDA Shifts Toward Test Sample Selection

Questions of sunscreen absorption made waves once again in a recent report in the Wall Street Journal. Prior reports found no cause for concern while more recently, the FDA turned its focus to the selection method for sunscreens used in absorption tests.

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FDA Pushes Higher Limits, New Labeling and More Data for Sunscreens

Broad spectrum sunscreens are critical for preventing skin cancer and UV damage, yet many of their essential requirements have not been updated in years. This was the driver for new sunscreen regulatory rules proposed by the FDA.

FDA Publishes Opinion on Two Sunscreen TEAs and Is Urged for More Action by PASS

The end of February was busy for the U.S. Food and Drug Administration (FDA), which published two letters on the Time and Extent Applications (TEAs) for diethylhexyl butamido triazone (Uvasorb HEB) and amiloxate (Neo Heliopan E 1000), finding insufficient scientific evidence to claim either as generally recognized as safe and effective (GRASE) and denying their addition to the OTC Sunscreen Monograph.

Sunscreen Innovation Act Passes: What Does it Mean?

The Public Access to SunScreens (PASS) Coalition applauded the U.S. Senate's passage of the Sunscreen Innovation Act (S. 2141). While the Act aims to streamline the approval process for new sunscreen actives, will it? Industry expert David Steinberg gives his take.

FDA Workshop

Apr 25th, 2013Apr 25th, 2013

FDA Director Honored

Cosmetic Ingredient Review (CIR) director and scientific coordinator Alan Andersen, Ph.D., has been awarded with the Distinguished Alumni Award...

ICMAD FDA Workshop

Apr 28th, 2011Apr 28th, 2011

The FDA Discusses Technology

The first public meeting on FDA-regulated products containing nanomaterials will take place on October 10, 2006.

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FDA Questioning Hydroquinone

In an August Federal Register the US Food and Drug Administration suggested that OTC skin bleaching products should require an approved new drug application.

FDA Cosmetic Regulations Workshop

Apr 26th, 2012Apr 26th, 2012

FDA Alert on Hydroquinone

After reviewing literature on hydroquinone, the FDA announced additional studies are needed to rule out its potential carcinogenic risk.

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FDA Overhauls Advisory Committee

The US Food and Drug Administration (FDA) has disclosed details of its efforts to improve its advisory committees of experts.

FDA Appoints General Counsel

Gerald F. Masoudi has been appointed as associate general counsel/chief counsel of the Food and Drug Division of the United States Department of Health and Human Services' Office of the General Counsel.

FDA Releases Nanotech Report

The International Center for Technology Assessment (ICTA) has reported that the US Food and Drug Administration (FDA) will be releasing an internal task force report and recommendations on nanotechnology oversight by the end of this month.

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