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FDA's Sanitizer Hotlist Cites Nevada Distributor, Calls Out Subpotency and Methanol

Since last quarter, the U.S. FDA has added 20+ listings to its "Do Not Use" hand sanitizer database, which were flagged for subpotency and methanol-related issues. One Nevada-based manufacturer also made the list.

The 'Skin Facts!' Initiative aims to help consumers understand the potential risks and to help identify whether the products they purchase contain these harmful ingredients.

FDA Issues Warnings, Pushes Consumer Education of OTC Skin Lightening Products

The FDA is once again cracking down on companies selling skin lightening products containing hydroquinone or mercury. Its public health campaign, Skin Facts!, urges consumers to get educated on skin care ingredients.

The inner packaging of a serum and product kit containing said serum listed SPF when the product has no SPF.

FDA Flags Color Additive, SPF and Contaminant Offenses, Urges 'Recall Readiness'

In recent months, the U.S. Food and Drug Administration (FDA) reported six voluntary recalls for an impermissible color additive, mislabeled SPF and several contaminants. It also urged companies to be "recall ready" and provided final guidance to do so.

US Regulations Update: FDA Issues Final Monograph for Skin Protectants

On June 4, 2003, the FDA published the Final Monograph (FM) for Skin Protectant Drugs for Human Use.

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FDA Raises Methanol Alarm with Import Alert; Adverse Events, Deaths Reported

The FDA has heightened measures to prevent toxic methanol-containing hand sanitizers from reaching the U.S. market. These include an import alert, more product warnings, recalls and a growing "do not use" list of products due to contamination and adverse health effects—including death.

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Is Your Microbiology Lab FDA-compliant? Part I: Personnel, Facilities and Equipment

This two-part article provides an overview of areas relevant to the U.S. Food and Drug Administration’s (FDA’s) inspection of cosmetic microbiology laboratories. Part II will appear in our July 2018 edition.

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[video] FDA Survey, Oskia Pollution Balm and Objective Science: Editor's Picks

What happened this week in cosmetics R&D? Hear our top headline picks in this video report—alongside our rundown of other industry news.

FDA To Report Lead and Arsenic Levels for Batch Approval of Specific Colorants

The U.S. Food and Drug Administration (FDA) has announced that it will report specific values of lead and arsenic for a number of color additives before Certificate of Analysis (CoA) are granted for their batches.

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[video] FDA Warnings on CBD; Hair Softness; and User-induced Product Contamination

Back from break, here's Cosmetics & Toiletries' Rachel Grabenhofer, with her top headline picks in cosmetics R&D news. Watch now!

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FDA Updates: VCRP Tally, Color Additives and Lead Acetate in Hair Dyes

The U.S. Food and Drug Administration (FDA) provides the latest tally on voluntarily registered cosmetics, color additives and lead acetate in this collective fall 2021 update.

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FDA Approves Dermavant’s VTAMA Cream, 1%, for the Treatment of Plaque Psoriasis in Adults

Approved for mild, moderate and severe psoriasis with no restrictions on duration of use or body surface, see why VTAMA Cream, 1%, may help your patients.

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900+ Hand Sanitizer Poisonings, Mexican Imports Put on FDA Alert

CBS News recently reported 900+ Americans were accidentally poisoned by hand sanitizers in January 2021 alone. In relation, the FDA has placed an import alert on all Mexican sanitizers, which have been the source of multiple offenses.

A letter from the FDA to Valisure, dated Dec. 5, 2022, highlighted 'methodological deficiencies' and 'analytic descrepancies' in the company's testing.

FDA, Unilever and GSK Challenge Valisure's Benzene Findings, Test Methods

The FDA recently raised concerns over the test methods of Valisure, the Connecticut-based lab whose reports over benzene in sunscreen and dry shampoo products from Unilever, GSK and others have prompted recalls and class action suits.

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FDA Proposes MoCRA-mandated Tests to Detect Asbestos in Talc-containing Cosmetics

On Dec. 26, 2024, the FDA proposed test methods by which cosmetic manufacturers would be required by MoCRA to assess talc-containing products for asbestos, along with enforcement provisions.

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Pick and Choose—Balancing Sunscreen Benefits: Sun Protection or Vitamin D?

It’s well-known that over-exposure to UV light is harmful to the body, yet it is vital for production of essential vitamin D. Understanding the balance between the benefits of sun protection and vitamin D synthesis is not yet well understood.

FDA Dispels Lead in Lipstick Reports with Sensitive Method for Lead Analysis

The FDA announced that it has developed a new method of testing lead in lipsticks and retested all lipsticks reported to contain high amounts of lead.

Regulatory Review—US and Canada Updates: Canadian Cosmetic Harmonization and the FDA's Claim Crackdown

Several major regulatory changes are coming in cosmetics from Canada, while in the United States, the U.S. Food and Drug Administration (FDA) has been active in sending out warning letters to cosmetic companies making unapproved drug claims. This column provides an overview of them.

October was the deadline but it came and went without a MOCRA portal to show for it.

FDA to Industry: Review SLP Guides, Gather Data Until MOCRA Portal Launches

October was the deadline but it came and went without a MOCRA portal to show for it. As the industry waits, the FDA advised members to continue collecting data and reviewing guidance documents — including the latest one for Structured Product Labeling.

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