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Type: News

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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.

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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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.

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 Director Honored

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

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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.

The FDA Discusses Technology

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

FDA Eyes "Functional Foods"

The FDA recently announced plans for a public hearing focused on foods being marketed as "functional foods."

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FDA Increases Presence in China

The US Food and Drug Administration (FDA) is establishing a regulating presence in China to monitor exported food and cosmetics.

EU, FDA Work Toward Harmonization

The Transatlantic Economic Council (TEC) meeting made an important step forward in harmonization between the EU and the FDA.

ICMAD Testifies at FDA Hearings

Independent Cosmetic Manufacturers and Distrubutors (ICMAD) board member Craig Weiss, president of Consumer Product Testing, testified on March 25, 2014, during recent U.S. Food and Drug Administration (FDA) hearings on modernizing over-the-counter drugs.

FDA Fellowship to Attract Scientists

A two-year fellowship program launched by the US Food and Drug Administration (FDA) is aimed at attracting scientists, engineers and health professionals to the agency to aid in decision-making.

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A Chance For FDA Regulatory Clarification

The Independent Cosmetic Manufacturers and Distributors (ICMAD) Association will return to southern California for the 27th edition of its FDA Cosmetic Regulations Workshop.

FDA to Focus on Nanotech Trend

The FDA announced plans to focus on nanotechnology at a public meeting to be held later this year...

FDA Hones in on Cosmetic Claims

The FDA issued five such letters since November 2014, the most recent being sent to StriVectin. Following those letters, the FDA has also issued a document that clarifies cosmetic versus drug claims for the consumer to highlight what cosmetic companies are able to say.

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 Begins Expediting Recall Information

The agency is increasing transparency in the product recall process.

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