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Section: Regulations > Safety

On May 8, 2023, a federal judge ordered J&J and the attorneys representing the plaintiffs to begin settlement negotiations while the second bankruptcy filing is reviewed.

J&J's $8.9 B Talc Offer Rejected, Mediations Ordered, Bankruptcy Revisited

Last month, J&J agreed to pay $8.9 billion through subsidiary LTL Management to settle lawsuits alleging its talc products caused cancer. Mediations to negotiate those settlements have been ordered while a second bankruptcy filing is under review.

Proposals for the restriction of PFAS will be accepted by the ECHA through Sept. 25, 2023.

ECHA Updates: 8 Chemicals for REACH Authorization and Call for PFAS Proposals

The ECHA proposed adding eight chemicals to the REACH Authorization list, including some cosmetic ingredients. The agency also is calling for PFAS proposals, and it shared consultations on conforming restriction proposals and SEAC draft opinions.

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.

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.

'This new Brazilian norm is a welcome next step in the right direction ... However, a domestic testing ban on its own will not prevent the import and sale of newly animal-tested cosmetics from other countries.'

Brazil Prohibits Animal Testing for Cosmetics, Mandates Alternatives

The use of vertebrate animals, except human beings, in the R&D and quality control of personal hygiene products, cosmetics and perfumes that use ingredients or compounds with safety and efficacy already scientifically proven is prohibited.

While some (if not many) of these allegations may be unfounded or misguided, it underscores the critical role of safety and toxicity testing even under non-typical product use conditions.

Unilever, J&J, Olaplex and L'Oreal Still Treading Legal Waters Over Lilial, Benzene

Olaplex, Redken, OGX, Dove, Nexxus, Suave, Tigi and Tresemmé brands are still making headlines as they tread legal waters over alleged Lilial and benzene content. Following are recent updates.

The chemicals include some borate compounds, lily aldehyde, cyclotetrasiloxane, trichloroacetic acid, styrene and certain colors (see full list below).

[update] 26 More Chemicals That Could Get Your Products Banned in California

Assembly Bill 496, introduced on Feb. 7, 2023, proposes the addition of 26 chemicals to the state of California's existing Toxic-free Cosmetics Act. If passed, the bill would ban cosmetics containing them from being sold in the state.

These examples clearly call into question what it means to consumers when they see the 'reef friendly' claim on a label.

'Reef Friendly' Claims Put Hain Celestial, Hawaiian Tropic in the Hot Seat

While Edgewell's Hawaiian Tropic sunscreen was dismissed from the alleged deceptive claim of "reef friendly," Hain Celestial's Alba Botanica is still in the hot seat. How are reef safe claims being interpreted?

PFAS are used in cosmetic products to condition and smooth the skin, or to adjust product consistency and texture. They may also be unintentionally added and present as impurities.

Five European Nations, ECHA Propose PFAS Bans/Restrictions

Five European nations submitted a proposal in January to the European Chemicals Agency (ECHA) to restrict and/or ban PFAS. The agency released details of the proposal on Feb. 7, 2023, and announced next steps.

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.

A 2019 petition to the House of Commons stated, 'We, the undersigned residents of Canada, draw the attention of the House of Commons ... [that] animal testing is unnecessary to prove the safety of cosmetic products.'

After 8+ Years, is Canada Ready to Ban Animal Testing for Cosmetics?

Health Canada confirmed plans are in the works to implement an animal testing ban for cosmetics, according to The Globe and Mail.

'We have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm.'

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.

Germany, Denmark, the Netherlands, Norway and Sweden have submitted a proposal to restrict per- and polyfluoroalkyl substances (PFAS) under REACH. The ECHA will publish the detailed proposal, reportedly one of the broadest in the EU’s history, on Feb. 7, 2023.

ECHA Adds to Hazardous Chemicals List, Reviews PFAS and Classification Proposals

The ECHA has added one cosmetic-related ingredient to the "hazardous" list, and received a five-nation proposal to restrict PFAS and three intentions/proposals to harmonize classification of cosmetic-related substances. See which ones are named.

A grand gesture may be necessary to convince nay-sayers of the industry's commitment to consumer safety — regardless of ethnic heritage.

Color of Change to Retailers: Remove 'Toxic' Hair Products and 'Anti-Blackness'

Color of Change is calling on consumers to petition Target, ShopRite and other retailers to remove "toxic" lye relaxers and hair dyes that disproportionately affect Black consumers from shelves. This comes as the industry is making inclusivity inroads.

A cosmetic can contain, 'no more than a trace amount of mercury and such trace amount [must be] unavoidable under conditions of good manufacturing practice, and less than 1 part per million (0.0001 percent), calculated as the metal,' per the Code of Federal Regulations.

Mercury-contaminated Cosmetics Make Headlines, Raise Consumer Alert

Per Google Trends, the search phrase "cosmetics with mercury" is up by 350%. Recent headlines have certainly kept it top of mind for consumers, as they should for quality control.

The carcinogenicity hazard of titanium dioxide is linked solely to certain respirable titanium dioxide particles, when they are present in a certain form, physical state, size and quantity.

European Union Annuls Carcinogenic Titanium Dioxide Label

The carcinogenicity hazard of titanium dioxide is linked solely to certain respirable titanium dioxide particles, when they are present in a certain form, physical state, size and quantity.

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?

The long-awaited legislation advances product safety and innovation for the science-driven beauty and personal care industry and reinforces consumer confidence, according to the PCPC.

U.S. House/Senate, President Biden Pass 2023 Consolidation Act; PCPC Applauds Cosmetic Inclusion

The long-awaited legislation will advance product safety and innovation for the science-driven beauty and personal care industry and reinforce consumer confidence, according to the Personal Care Products Council (PCPC).

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