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Section: Regulations

FDA Warns Brazilian Blowout for Methylene Glycol Formulation

The US Food and Drug Administration (FDA) has sent a warning letter to Brazilian Blowout for its Açai Professional Smoothing Solution. The FDA finds the product to be misbranded by stating on its label that it does not contain formaldehyde and is adulterated by containing methylene glycol, a liquid form of formaldehyde.

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UPDATED: FDA Bans 24 Antiseptic Ingredients Including Triclosan

Along with triclosan, the FDA has banned 23 other ingredients used in health care antiseptics, finding their safety and efficacy insufficient.

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FDA Scrutinizes Food, Drink Packaging of Hand Sanitizers

Beer cans, children’s food pouches and water, juice and vodka bottles are among the types of consumable packaging being used for hand sanitizers and raising concerns with the U.S. Food and Drug Administration.

FDA Cautions Against DEG-containing Toothpaste from China

Cautioning consumers, the FDA warned against using toothpaste made in China and issued an alert to prevent DEG-containing toothpaste from entering the United States.

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Chinese Hand Sanitizers Make FDA's Growing Hot List

Recent additions to the U.S. Food and Drug Administration's hand sanitizer "hot list" include several products from China, Mexico and Korea.

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FDA Commissioner Resigns; Agency Updates 2017 Asbestos Findings

Scott Gottlieb, who assumed the role in May 2017, cited the commute from Connecticut to Washington, D.C., as motivation for his resignation. The organization also released an update on 2017 findings of asbestos in cosmetics.

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Ned Sharpless to Serve as Acting FDA Commissioner

The announcement comes following the resignation of Scott Gottlieb, who devoted his tenure to addressing youth e-cigarette use and modernizing food safety.

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[update] Asbestos in Talc? Latest FDA Tests Find No Evidence

Asbestos fibers were not detected in any of the 50 samples tested via PLM or TEM. While this is good news, one expert highlights how the report demonstrates the FDA's fundamental lack of understanding of chemistry and formulations.

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Methanol Content and How to Test for it: FDA Guidance

The U.S. Food and Drug Administration has outlined a policy for companies to test alcohol (ethanol) or isopropyl alcohol for hazardous methanol content prior to their use in hand sanitizer products.

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Diatomaceous Earth and Comfrey Root Catch the FDA's Eye

This is a good reminder for cosmetic manufacturers to be careful when straddling the line between a cosmetic and drug. It's all in the claims.

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US FDA Plans First Cosmetic Allergen Survey in Decades

The proposed survey is meant to help the organization better understand adverse events caused by allergens in cosmetics, and is the first of its kind since 1975.

Comparatively Speaking: US FDA Categories of Hand Sanitizer Actives

Anthony J. O’Lenick, Jr. turns to David R. Macinga, PhD, and James W. Arbogast, PhD, to explain the differences between the US FDA categories used to classify hand sanitizer actives.

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[update] FDA April Meeting for June ICCR-14 Meeting Cancelled

In light of the COVID-19 outbreak, the FDA has cancelled the public meeting originally scheduled for April 14, 2020, to discuss topics for the international ICCR-14 meeting on cosmetics regulation, still planned (thus far) to be held from June 8 to June 10, 2020.

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[updated] FDA Oversight Becomes Closer to Reality for US Cosmetics

According to the bill's authors, it is supported by the leading cosmetic manufacturers and would give the FDA unprecedented authority. Editor's note: This report now includes CIR commentary.

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FDA's Quarterly Color Additives Report: Red Alert

"Most notable in this certification report is the total absence of Red 6 Lake," Kelly Dobos reports.

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FDA Flags Eskbiochem Hand Sanitizers for Possible Methanol Content

The U.S. Food and Drug Administration has issued a warning statement to consumers over the use of Eskbiochem's hand sanitizers, which may contain methanol, i.e., wood alcohol.

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FDA Warns About Stimulating Collagen, Lightening and Other Claims

This article reminds us that the FDA has issued a warning about claims which would imply certain cosmetics would be considered drugs under the Federal Food, Drug and Cosmetic Act.

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FDA Cautions: Hair-smoothing Products Can Release Formaldehyde

The U.S. Food and Drug Administration recently released a statement warning users of the potential for hair-straightening products to release formaldehyde gas, a known carcinogen, during heat treatments.

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