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Section: Formulas/Products

ADA Requests Tooth Whitener Classification from FDA

The American Dental Association (ADA) has published a statement requesting that the US Food and Drug Administration (FDA) establish appropriate classifications for tooth-whitening chemicals.

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Antibacterial Soap? You Can Skip It, Says FDA

The FDA is issuing a final rule under which OTC consumer antiseptic wash products containing the majority of the antibacterial active ingredients—including triclosan and triclocarban—will no longer be able to be marketed.

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FDA Sets Regulatory Framework for Regenerative Biological Therapies

It's a sign of the times when technology and innovation hit a point where the U.S. Food and Drug Administration must stop and write new rules to ensure consumer safety. That time, with respect to regenerative biological therapies, is now.

FDA Publishes its Draft Guidance for Cosmetic GMPs

The U.S. Food and Drug Administration (FDA) has published its Draft Guidance for Cosmetic Good Manufacturing Practices (GMPs), an update to its Cosmetic Good Manufacturing Guidelines/Inspection Checklist, mostly to include ISO 227 16:2007 as part of an effort to harmonize GMPs internationally.

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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.

FDA Releases Draft Guidance Toward Nanotech Regulation

The US Food and Drug Administration (FDA) has released a draft guidance outlining its view on how to identify whether regulated products contain nanomaterials or apply such technologies.

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 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.

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.

FDA Issues Final Guidance on Nanomaterials

On June 26, 2014, The U.S. Food and Drug Administration (FDA) issued Final Guidance for Industry: Safety of Nanomaterials in Cosmetics, a final guidance document addressing the use of nanotechnology in cosmetics.

Frequency of Use of Organic UV Filters as Reported to the FDA

The author reports on frequency of use of 17 organic UV filters in nearly 18,000 formulations voluntarily reported to the United States government as of May 2003.

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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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FDA Proposes Labeling Rule for Color Additives [Feb. 2, 2006]

The U.S. Food and Drug Administration (FDA) published a proposed rule in the Federal Register requiring the declaration of carmine and cochineal extract...

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[update] US FDA Orders Lead Ingredient Out of Hair Color

The final ruling is a response to a color additive petition over safety concerns of lead acetate, which allows for gradual color change in "progressive" hair dyes.

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FDA Warns 1,500 New Sanitizer Makers: Follow the Rules

Safety and fraudulent claims are new concerns in the hand sanitizer market. Since the U.S. Food and Drug Administration (FDA) eased restrictions, some 1,500 new hand sanitizer manufacturers have registered to help; but many are not following the FDA's policy.

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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.

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U.S. FDA Investigates B. cepacian Complex Outbreak Linked to Personal Care

A no-rinse foam cleanser has been linked to at least 10 confirmed cases of Burkholderia cepacia complex; Shadow Holdings dba Bocchi Laboratories has voluntarily recalled the product as the FDA investigates.

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