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278 Results
Section: Regulations
Safety
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.
Regional
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.
Regional
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.
Safety
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.
Claims/Labeling
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.
Regional
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.
Regional
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.
Regional
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.
Safety
U.S. FDA, Congress to Write CBD its Own Rules for Food, Supplements
After careful review, the U.S. Food and Drug Administration (FDA) has concluded that a regulatory pathway specific to CBD, rather than CBD foods and supplements, is needed to balance CBD product demand with the potential risks.
Safety
[interview] U.S. FDA on MoCRA: New Authority, Fragrance Allergens, Animal Testing and More
In this interview, the FDA describes its new MoCRA-mandated authorities, 5 requirements for industry (and how it will enforce them), the mandate for listing fragrance allergens, why animal testing was omitted from MoCRA and more.
Claims/Labeling
FDA Claims Warnings Strike Again: Using Terms 'Botox-like' and More
Once again, U.S. regulators are cracking down on beauty companies that have crossed over into unapproved drug claim territory based on how they are promoting their products online.
News
FDA Roundup: Cosmetics Seized, Unilever Recall, Cannabis/Public Health Hire and More
Recent stories from the U.S. Food and Drug Administration include: 5,000 lbs of eye shadow seized en route to Washington state, Unilever recalling dry shampoo, the appointment of cannabis expert Norman Birenbaum as public health advisor, and more.
Safety
FDA Debuts Digital SPL Xforms, Paper Forms for Cosmetics Facility, Product Submissions
The FDA has rolled out Structured Product Labeling (SPL) Xforms, a digital tool, and downloadable PDF forms to register cosmetic product facilities and list products, as mandated by MoCRA.
Regional
Fees Increased on U.S. FDA Color Additive Certification; Here's What You'll Pay
"The color certification process for synthetic organic colorants is an important aspect of color additive regulations that is unique to the United States," notes industry expert Kelly Dobos. "This fee had remarkably not been raised in nearly 20 years."
Regional
FDA Releases Update to Ongoing Activities Related to Serious Adverse Event Reporting for MoCRA
A responsible person is required to report serious adverse events associated with the use of cosmetic products in the U.S. to FDA within 15 business days.
Safety
Could the FDA's Delay to Rule on 3 Hand Soap Ingredients Spell Trouble for the Industry?
In a letter to the FDA, GSPI urged the agency to ban 3 antibacterial ingredients that have been in limbo for years. The NGO fears this delay could harm consumers as they keep using the ingredients. C&T fears it opens the industry to new scrutiny.
Safety
FDA Warns Consumers: Undisclosed Steroid in Skin-Cap Skin/Scalp Treatment Spray, Do Not Use
Per the agency, testing identified a high-potency glucocorticosteroid in the aerosol spray product that is not disclosed on the label or packaging. As such, consumers are warned not to use the products.
Safety
FDA's 2023 Talc Tests Find Zero Asbestos — Could a New Detection Method Make or Break These Findings?
The FDA's 2023 sampling of 50 talc-containing cosmetics, tested for asbestos by AMA using PLM and TEM methods, found negative results for the carcinogen — but a new test using fluorescently labeled asbestos-binding protein could lower the detection limit.
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