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Section: Regulations

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White House Proposes US FDA Slim-down

A new proposal from the Trump administration would alter the U.S. Food and Drug Administration's name and remove food safety from its purview, among other changes.

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FDA Warns About Mercury in Beauty Products

Even though these products are often promoted as cosmetics, they also may be unapproved new drugs under the law, says Linda Katz, director of FDA’s Office of Cosmetics and Colors.

FDA Issues Warnings for Cosmetics, Website Claims

The FDA has taken recent compliance actions by issuing warning letters for cosmetics claims and unapproved ingredients.

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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."

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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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FDA Recalls Tattoo Inks for Bacteria Contamination

The tattoo inks were manufactured or distributed by four firms inspected under an ongoing assignment.

FDA Finds Harmful Bacteria in Antimicrobial Products

The US Food and Drug Administration (FDA) has warned consumers to avoid the use of Clarcon skin products. According to the FDA, there is a risk of bacterial contamination associated with the products.

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ICMAD to Host FDA Cosmetics Regulations Workshop

The meeting will include a mixture of presentations and panel discussion on topics related to manufacturers and marketers of cosmetics and over-the-counter (OTC) drugs, such as I.S. FDA activities and changes in OTC drug regulations

FDA Requests Notifications for Adverse Reactions to Cosmetics

The US Food and Drug Administration (FDA) has requested that consumers notify the agency of all adverse reactions to beauty, personal hygiene and color cosmetic products.

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FDA Funds Safety Monitoring and Expects Hydroquinone Monograph

The Center for Food Safety and Applied Nutrition (CFSAN) recently received US$66.8 million in funding out of the US$150 million allocated for the US Food and Drug Administration (FDA).

Olumiant is a Janus kinase (JAK) inhibitor, which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation, thereby, treating patients with alopecia areata.

FDA Approves First Systemic Alopecia Areata Treatment

Olumiant is a Janus kinase (JAK) inhibitor, which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation to thereby treat patients with alopecia areata.

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.

FDA Issues Warning Over Hand Sanitizer Claims

The US Food and Drug Administration (FDA) has issued a warning letter to Procter & Gamble Co. over hand sanitizer claims.

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FDA Clears the Air on CBD Reform Efforts

While CBD is trending across market segments, the rules in play to ensure public health and market direction are baffling at best. As such, the FDA has issued an update outlining its efforts to provide clarity.

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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.

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Road to Regulation: Microneedling Devices Defined by FDA

Microneedling devices have, for some time, been without widely enforced regulation. As such, the U.S. Food and Drug Administration released a draft guidance on Sept. 15, 2017, defining when tools are considered esthetic vs. medical in nature, along with potential regulatory changes.

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CTFA Files Nanoparticles Commentary with FDA

The Cosmetic, Toiletry and Fragrance Association (CTFA) announced it has filed comprehensive comments with the FDA regarding nanoparticles in personal care products.

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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