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Section: Regulations > Safety

Eighteen studies identified complications such as rash, irritation, immune system disorders, stratum corneum DNA damage and hormonal disruption.

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.

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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.

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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.

The FDA does not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, deadline.

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.

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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..."

The FDA reminded consumers to check its blacklist of hand sanitizers they should not use due to methanol content, insufficient active ingredient or false and misleading/unproven claims.

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.

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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.

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[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.

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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.

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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.

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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.

The FDA has received reports of serious side effects including skin rashes, facial swelling and discoloration from the use of skin brighteners containing hydroquinone.

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.

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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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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.

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.

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.

While the concerns expressed over these materials are not specific to cosmetics, and only two are currently listed as cosmetic ingredients, it is worth noting the potential safety issues of these materials as well as the likelihood of the bans initiated in California to spread nationwide.

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.

Product safety is paramount for fast-moving consumer goods such as cosmetics and personal care products. Recent recalls and class action suits highlight this fact.

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.

The U.S. Hemp Roundtable said the FDA’s comments signal 'the new year may offer some promise for the long-awaited regulation of hemp-derived extracts such as CBD.'

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?

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