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Section: Regulations

FDA Adds Cosmetic Manufacturers to Import Alert for Drug Claims

The US Food & Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) has re-issued an import alert that scrutinizes cosmetic manufacturers importing antiaging products into the United States that make drug claims.

While the overall trend for color cosmetics has been positive, a return to pre-pandemic levels appears to be progressing slowly.

Lipstick Forecasts Not So Rosy, FDA Color Additives Report Reveals

Many trend agencies and news outlets are reporting an increase in lipstick sales for 2022 but those numbers may not paint the full picture. Here's what the latest FDA Color Additives report reveals, as outlined by industry expert Kelly Dobos.

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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...

FDA Cracks Down on Medicinal Claims Regarding Bee By-products

The US Food and Drug Administration (FDA) cracked down on Wisconsin-based Beehive Botanicals Inc. after the company did not comply with requests to remove and change misbranded and unapproved claims from its Web site and labels.

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6 Sanitizer Offenses, Color Additives and Cosmetic Registrations: FDA Update

The U.S. Food and Drug Administration recently issued updates regarding color additives certification, voluntary cosmetic registrations and hand sanitizer violations.

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Nature Essence Small Molecule Co. Pinged by FDA Warning Letter

In addition to several food and beverage violations, the U.S. FDA cited adulterated cosmetics and new drug claims in its warning letter to the company.

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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.

In response to the FDA's proposed ten cent per pound fee increase, Dobos explains how the price has not been adjusted since 2005 and represents an approximately 30% increase.

Dobos Responds to U.S. FDA's Proposed Color Additive Fee Increase

Considering the U.S. Food and Drug Administration's (FDA's) proposed ten cent per pound fee increase on color additives, Dobos responds here noting that the price has not changed since 2005 but it also represents an approximately 30% increase.

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When it Comes to CBD, the FDA Wants to See the Receipts

The agency held its first hearing on cannabidiol (CBD) in Silver Spring, Maryland, on Friday, May 31, 2019.

ICMAD Responds to Suit Against FDA Over Nanotechnology

In response to the suit filed against the US Food and Drug Administration (FDA) by a coalition of six consumer safety and environmental groups over the FDA's lack of nanotechnology regulation, Independent Cosmetic Manufacturers & Distributors (ICMAD) has sent an exclusive response to Cosmetics & Toiletries magazine, as shown here.

FDA Recalls Face Paint Due to Adverse Reactions

The FDA has learned of a cluster of adverse events in children exposed to various colors of the face paint. All exposures occurred on the same day at an organized event and included rashes, itchiness, burning sensation, and swelling where the face paints were applied.

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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.

FDA Closes Negotiations with ICMAD and PCPC, Prompting Industry Response

On Mar. 6, 2014, Michael Taylor, on behalf of th The U.S. Food and Drug Administration (FDA), responded to the Proposed Draft Legislation by the Personal Care Product's Council (PCPC) and the Independent Cosmetics Manufacturers and Distributors (ICMAD), effectively finding no common ground between the three and closing the negotiation.

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FDA Recalls: 24 Benzene Reports + 1 Off-taste Toothpaste Account

Since mid-April 2024, the U.S. Food and Drug Administration highlighted 24 cosmetic recalls due to benzene content and one toothpaste recall for "off-taste." Here's a rundown.

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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.

Advocacy Groups File Suit Against the FDA Over Nanotechnology Regulation

A coalition of six consumer safety and environmental groups is suing the US Food and Drug Administration (FDA) over its lack of nanotechnology regulation, specifically for sunscreen.

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ACI, CHPA Urge FDA: Withdraw Allowance for Emergency Sanitizer Production

Citing public safety concerns, the American Cleaning Institute (ACI) and Consumer Healthcare Products Association (CHPA) are urging the U.S. Food and Drug Administration (FDA) to withdraw its temporary guidance allowing non-traditional manufacturers to produce hand sanitizers.

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US FDA to Assess Cosmetic Safety Through Manufacturing Survey

The survey "is part of the FDA’s ongoing effort to add to [its] understanding of the cosmetic industry and manufacturing practices" in order to ensure cosmetic safety.

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