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35 Results
Section: Regulations > Safety
Literature/Data
Literature Review Connects Sunscreen Absorption with Potential Adverse Effects
A literature review published in
Dermatology Research
suggests the potential adverse effects, i.e., irritation, rashes, hormone disruption, etc., of sunscreen ingredients absorbed into human skin and present in human plasma and urine.
Sun Care
Benzene in Sunscreens Prompts FDA Citizen Petition, PCPC Responds
Benzene has been detected in several brands and batches of sunscreens above the 2 ppm threshold, Valisure LLC reported, though most likely as a contaminant, another source noted. The firm has petitioned the FDA to act; the PCPC is carefully reviewing these findings.
SPF/Sun
FDA Moves to Improve Quality, Safety and Efficacy of Sunscreens
The U.S. Food and Drug Administration announced recent activities that are part of its ongoing implementation of new authorities for certain over-the-counter drugs including sunscreens.
Safety
FDA Delays MoCRA Enforcement by 6 Months
The U.S. Food and Drug Administration (FDA) announced it will delay the enforcement of facility registration and product listing requirements under MoCRA for six months after the Dec. 29, 2023, deadline to give the industry "sufficient time" to submit.
Regional
FDA to Withdraw Temporary Hand Sanitizer Production Policies
"In recent months, the supply of alcohol-based hand sanitizer from traditional suppliers has increased and now, most ... are no longer having difficulty obtaining these products. Therefore, we have determined it’s appropriate to withdraw the temporary guidances..."
Safety
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.
Regional
FDA's Quarterly Color Additives Report: Red Alert
"Most notable in this certification report is the total absence of Red 6 Lake," Kelly Dobos reports.
Literature/Data
[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.
Safety
FDA Issues Warning on Certain OTC Analgesic Topical Products
The FDA has asked six companies to respond to the warning letters within 15 days of receipt stating how they will address these issues or provide their reasoning and supporting information as to why they think the products are not in violation of the law.
Safety
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.
Regional
FDA Calls Out Contaminants, Methanol and Packaging in Latest Alerts
Methanol content, yeast contamination and packaging resembling beverage bottles are among the U.S. Food and Drug Administration's latest hand sanitizer and product recall alerts.
Regional
FDA Flags 12 Companies for Illicit Hydroquinone-containing Skin Brighteners
The products contain the active drug hydroquinone, rendering them unapproved over-the-counter (OTC) drugs rather than cosmetics.
Regional
FDA to Explore CBD, Hemp Regulations for Food and Supplements
The U.S. Food and Drug Administration (FDA) is exploring whether legal cannabis is safe in food or supplements and expects to make recommendations in the coming months for regulating such products. Could this translate to cosmetics?
Safety
Benzene, Methanol and Lead Headline Recent Class Actions and FDA Alerts
Methanol in hand sanitizers and lead in a baby skin care are cited in the latest U.S. Food and Drug Administration recall notices, while benzene content in dry shampoo and spray sunscreens persists among class action suits. Following is a roundup.
Safety
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.
Actives
FDA Flags 13 More Sanitizers, Issues One Warning for Methanol Content
Methanol content or possible associations therewith account for 12 of the 13 latest additions by the U.S. Food and Drug Administration (FDA) to its "do not use" hand sanitizer list, along with one warning letter.
Safety
5 Key Facets of Talc Testing: FDA Paper Outlines Expert Consensus
The goal was to improve the sensitivity and consistency of analyses and inter-laboratory concurrence relevant to reporting asbestos and similar particles in talc that could potentially affect cosmetic product safety.
Safety
California Bans 4 Food Additives, FDA Proposes Same for BVO Emulsifier
On Oct. 7, 2023, the State of California banned four food and beverage additives reportedly linked to health issues: potassium bromate, propyl paraben, Red Dye No. 3 and brominated vegetable oil (BVO). The FDA may follow suit with BVO.
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