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Section: Formulas/Products > Skin Care

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.

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U.S. FDA Hand Sanitizer Solutions Explained

The U.S. Food and Drug Administration has liberalized the compounding of alcohol-based hand sanitizers such that any registered compounder can create these products as long as they follow the published formulas and guidelines. This article clears up the math on what these guidelines allow.

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FDA Cracks Down on Skin Lighteners

Skin whitening products walk the line between cosmetics and drugs, and often carry dangerous side effects. Flawless Beauty's injectable whitening products were struck down by a federal judge, putting lightening products under the lens.

Prescription Polymer Nail Treatment Approved by the FDA

The U.S. Food and Drug Administration (FDA) has approved a prescription polymer treatment for brittle nail symdrome (nail dystrophy).

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VIDEO: 2 Questions on the FDA's Triclosan Ruling

The FDA's ruling on triclosan raises two questions, which David C. Steinberg describe in this fourth video in our series. However, he concedes that fighting the ruling is like "doubling down on an already-lost bet."

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.

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FDA Alert: New J&J Baby Powder Recall

According to the FDA, a test sample from one lot was found to contain chrysotile fibers, a type of asbestos. As such, Oct. 18, 2019, Johnson & Johnson voluntarily recalled the product.

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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.

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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.

FDA Clears Isoprenylcysteine Analog for Rosacea Treatment

A isoprenylcysteine (IPC) analog manufactured by biopharmaceutical company Signum Dermalogix Inc. (Dermalogix) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of rosacea.

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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 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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FDA Flags 13 More Sanitizers, Issues One Warning for Methanol Content

Methanol content or possible associations therewith account for 12 of the 13 latest additions by the U.S. Food and Drug Administration (FDA) to its "do not use" hand sanitizer list, along with one warning letter.

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