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Section: Regulations > Regional

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FDA Issues Draft Guidance for Topical Drugs

Contact dermatitis from topical drugs and human safety are the topics in a recently issued guidance document made available by the FDA. Comments are sought through May 8, 2020.

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VIDEO: Is there a Future for Hand Sanitizers?

In this third video in a series, David C. Steinberg predicts the outlook for future consumer hand sanitizers in light of the FDA's triclosan ruling.

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Here Comes the Sun Protection: ISO Test Methods

Our knowledge of the sun and its effects on skin has increased over the years, including the damaging effects of UVA and UVB light. Testing methods for UVA and UVB rays differ; the following is a review of the testing protocols of the European Union and United Kingdom. (Click through to the Digital Edition)

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Is it Toxic? EU Mandate, Part 10: Safety

For each cosmetic product placed on the EU market, a safety evaluation must be performed. This includes a review of the toxicological profile of its ingredients, with a particular focus on genotoxicity. This mandate is described here.

Sunscreen Regulations: Why 'Final' is Not the Right Word

Over the past 25 years, no category of “cosmetics” has seen change like sunscreens. This discussion reviews how current regulations have come to be, and looks to where they are headed.

Canada Adds Isoprene and Epichlorohydrin to Ingredient Hotlist

The Canadian government announced the publication of final conclusions and initial risk management approaches for Batch 2 substances in the Chemicals Management Plan. Batch 2 included 16 substances.

FDA Issues Warning Letter for Injectable Tan Product

The US Food and Drug Administration (FDA) has issued a warning letter to Melanocorp Inc. concerning the sale and marketing of the product Melanotan II.

Israel Manufacturers Association Creates Label for Dead Sea Products

The Israel Manufacturers Association has developed a quality label for skin care products that are formulated with ingredients from the Dead Sea.

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China Issues Standards for Cosmetics Safety and Efficacy Claims

China's cosmetic regulators have released evaluation standards for efficacy claims and technical guidelines for safety assessments, all of which come into effect on May 1, 2021.

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FDA Issues More Sanitizer Warnings, Posts Microbe-related Recalls

Sanitizer warning letters and "hotlist" additions, plus microbe-related recalls are among the latest cosmetic-relevant updates from the U.S. Food and Drug Administration.

China could be phasing out animal testing for many cosmetic categories.

Is China Ending Pre-market Animal Testing for Cosmetics?

Hair dye, sunscreen and select other products would be exempted.

China Sees Contamination and Product Recall Issues with Exports

China is undoubtedly one of the biggest cosmetic and personal care manufacturers in the world. However, it has been experiencing product recall and contamination issues with exported goods over the last six months.

Establishing the Dividing Line: Is Your Product a Drug?

To avoid regulatory penalties, a company developing an OTC product must institute properly administered shelf-life testing programs as an integral part of its product development and marketing efforts.

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P&G Detects Benzene in Antiperspirant and Body Sprays, Issues Recall

P&G has voluntarily recalled specific lots of Old Spice and Secret aerosol spray antiperspirants and Old Spice Below Deck aerosol spray products due to the detection of benzene.

End of REACH Preregistration: The First Deadline is Here

The industry has met the end of the REACH preregistration phase. However, it will not stop meeting new challenges as it attempts to comply with the demands posed by future phases.

The European Regulation for Cosmetics: Who is the Responsible Person?

The Cosmetics Regulation (EC) No 1223/20091 is the main regulatory framework for finished products when placed on the EU market and introduces the notion of the responsible person.

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Why the FDA's 'Sunscreens in the Bloodstream' Study is Flawed

A recent study published in the Journal of the American Medical Association tested the potential systemic absorption of certain sunscreens. Results identified their presence in subjects' bloodstreams; however, as industry expert David Steinberg explains, the study is misleading and fails to consider crucial variables.

US Regulations Update: FDA Issues Final Monograph for Skin Protectants

On June 4, 2003, the FDA published the Final Monograph (FM) for Skin Protectant Drugs for Human Use.

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