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Section: Regulations

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FDA 'Do Not Use' Hand Sanitizer List and Methanol, 1-Propanol Warnings

The U.S. Food and Drug Administration (FDA) has issued a guide for consumers to explain the dangers of methanol and 1-propanol, and to search and find hand sanitizers on its "do not use" list; some 165 entries are on it so far.

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EU Effectively Bans D4 and D5 in Wash-off Products

Wash-off cosmetic products containing a certain concentration of D4 and D5 will not be allowed on the European market after Jan. 31, 2020.

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.

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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.

Recent stories from the FDA include 5000 lbs of eye shadow that were seized en route to Washington state, Unilever recalling dry shampoo and the appointment of Norman Birenbaum in the FDA.

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.

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7 Recent Recalls: Babygenics, Tom's of Maine, Amika, HiBAR and Others

From hair spray and repair cream, to tattoo ink, children's sunscreen, toothpaste and others, several products have been recalled in recent months due to safety hazards and regulatory non-compliance. Following is an overview.

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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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EU's Chemical Strategy for Sustainability to Rewrite Cosmetics Regulation and Risk Management

"...Centralizing chemical reviews and promoting risk-management uniformity across sectors make Cosmetics Europe believe cosmetics regulatory changes lie ahead."

New U.S. UV Filters and the Cosmetic Outlook in Canada for Sunscreens

Skin cancer is the most common cancer today, but only recently has industry pressure and political leadership compelled changes in the North American regulatory paradigm of sunscreen products. The passage of the Sunscreen Innovation Act in the United States and the suggestion to regulate sunscreens as cosmetics in Canada would give regulators the tools to reboot a stalled approval system.

Regulatory Review—Cosmetic Ingredient Update: The Ugly, the Good and the Bad

This review takes a look at updates to ingredient regulations as of the first quarter in 2012. While “the ugly” refers to the EU Chemical Agency’s (ECHA’s) release of the first ingredients to be evaluated under REACH, the good news relates to the battle in Canada to save D5. “The bad” are the state of California’s addition of three ingredients to the Proposition 65 list, as well as Health Canada’s caution against labeling using generic terms.

The Regulatory Interface: When is it a Cosmetic and When a Drug?

Both the cosmetic industry and the Food and Drug Administration (FDA) have had a long and interesting history. FDA’s history began in 1906 with the enactment of the Pure Food and Drug Act. This was the first attempt to regulate the safety of products (or additives). For almost 100 years Congress has set the standards and published them in the United States Code (USC). FDA and other federal agencies promulgate regulations through notice and comment rulemaking. Proposed regulations are published in the Federal Register (FR) and the public is given an opportunity to comment. The agencies then publish in the Federal Register final regulations together with a preamble discussing each comment. Industry and regulatory scientists eagerly follow these changes and access them on the Web. Final regulations are compiled in the Code of Federal Regulations (CFR).

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.

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Global Cosmetics Regulation in Flux: Policy Reforms, Recalls and Market Access Shifts

Reforms for cosmetics across the U.S., EU, UK and China are reshaping product safety, market access and compliance obligations.

Na True Takes Steps to Define Natural and Organic Personal Care

Recently, Na True published a definition for natural and organic cosmetics as well as criteria for a three-tiered label system that is expected to become valid throughout Europe.

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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.

REACH Update: Exposure Scenario Annexes and Other Changes to the SDS

The statutory basis for safety data sheets (SDSs) is laid down in Article 31 of REACH, and Annex II details the requirements for the compilation of an SDS in accordance with this article.

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[podcast] Sunscreen Innovation Act Update: MUsT Test and Penetration Potential

"What’s changed with respect to sunscreen evaluation is ... the test model they are using now is designed for drugs ...and has never been applied previously for the sunscreens," Epstein reports.

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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.

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