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FDA Warns Moms Against Nipple Cream with Chlorphenesin

The US Food and Drug Administration (FDA) has warned consumers against using Mommy's Bliss Nipple Cream, a nursing cream by MOM Enterprises Inc.

'The FDA has stopped accepting and processing submissions to the VCRP as a result of [the] FDA’s plans to develop a program for submission of the facility registrations and product listings mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).'

U.S. FDA Shuts Down Voluntary Cosmetic Registration Program

In an unexpected move, the U.S. Food and Drug Administration (FDA) has shuttered the Voluntary Cosmetic Registration Program (VCRP) and underscored this data will not migrate to the MOCRA portal.

FDA and Academia: Institutions to Collaborate Under Nanotech Initiative

Over-arching goals have spurred a collaboration to develop safe and effective nano-engineered products. While these efforts concentrate on medical use, implications for personal care are on the horizon.

The FDA has issued 15 warning letters to companies selling products containing CBD.

U.S. FDA Issues 15 Warning Letters Over CBD Products

“We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe," said FDA principal deputy commissioner Amy Abernethy, M.D., Ph.D.

The Council Calls for Greater FDA Personal Care Regulation

The Personal Care Products Council has effected an initiative through which the U.S. Food and Drug Administration (FDA) would have a greater role in assessing ingredient safety for personal care products sold in the United States.

The FDA reminded consumers to check its blacklist of hand sanitizers they should not use due to methanol content, insufficient active ingredient or false and misleading/unproven claims.

FDA on Hand Sanitizers, Topical Irritation Testing and Biosimilars

Recent FDA activities include education for consumers on hand sanitizers and biosimilars, and guidance for testing the irritation/sensitization potential of topicals in relation to abbreviated new drug applications. Following is a roundup.

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FDA Opens Cosmetics Direct Registration Portal for MoCRA

Cosmetics Direct is an FDA Structured Product Labeling authoring tool that, according to the FDA, features user-friendly data entry forms.

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FDA Warns CBD Company Making Unsubstantiated Marketing Claims

The agency has issued a warning letter to Curaleaf Inc., for illegally selling unapproved products containing cannabidiol (CBD) online. The company is accused of making unsubstantiated claims that the products treat cancer, Alzheimer’s disease and opioid withdrawal, among other conditions or diseases.

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.

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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Talcum and Toxins Lawsuit Escalates, FDA Calls Meeting on Talc Testing

Several major talcum powder marketers are being slapped with a new lawsuit alleging their products contain undisclosed dangerous substances. In relation, the U.S. FDA has called a public meeting, to be held on Feb. 4, 2020, regarding testing for asbestos in talc and talc-containing cosmetic 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] 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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[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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