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Section: Regulations > Regional

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FDA Warns CBD Company Making Unsubstantiated Marketing Claims

The agency has issued a warning letter to Curaleaf Inc., for illegally selling unapproved products containing cannabidiol (CBD) online. The company is accused of making unsubstantiated claims that the products treat cancer, Alzheimer’s disease and opioid withdrawal, among other conditions or diseases.

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Diatomaceous Earth and Comfrey Root Catch the FDA's Eye

This is a good reminder for cosmetic manufacturers to be careful when straddling the line between a cosmetic and drug. It's all in the claims.

Comparatively Speaking: US FDA Categories of Hand Sanitizer Actives

Anthony J. O’Lenick, Jr. turns to David R. Macinga, PhD, and James W. Arbogast, PhD, to explain the differences between the US FDA categories used to classify hand sanitizer actives.

PCPC Responds to CDC's Request for Skin Cancer Comments

The Personal Care Products Council's (PCPC) Farah Ahmed submitted comments to the Centers for Disease Control and Prevention (CDC) in response to the CDC’s request for information about reducing exposure to UV radiation in order to reduce skin cancer rates.

Challenges in Creating NPA- and WFM-compliant Natural Formulations

Where does the formulation chemist begin when facing a marketing request for a product stamped with a “natural” label claim? The first step is to identify the certifying organization or government under which the formulation is to be sold, followed by the choice of preservatives. The basic approach to composing natural products is outlined here.

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Here Comes the Sun Protection: ISO Test Methods

Our knowledge of the sun and its effects on skin has increased over the years, including the damaging effects of UVA and UVB light. Testing methods for UVA and UVB rays differ; the following is a review of the testing protocols of the European Union and United Kingdom. (Click through to the Digital Edition)

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FDA Permits Compounding, Alcohol-based Hand Sanitizer Production

The U.S. Food and Drug Administration (FDA) has issued two guidance documents to communicate its policy for the temporary manufacture of certain alcohol-based hand sanitizer products, in response to the coronavirus (COVID-19) pandemic.

Revisions include adding “special cosmetics” and “cosmetics using new ingredients” to the key categories of sampling testing.

China Revises Cosmetic Sampling Testing Rules, Calls for Comments

The measures will focus on testing in children’s cosmetics, special cosmetics and cosmetics containing new ingredients. Measures are open to public comment through July 14, 2022.

The EC's roadmap will include legislative and non-legislative actions to further reduce animal testing and aim to ultimately move to an animal-free regulatory system under chemicals legislation.

European Commission to Expedite Phasing Out of Animal Testing

Responding to the ECI, the EC provided a comprehensive overview of the EU's legislative and policy framework for animal testing and proposed creating a "roadmap" to further reduce animal testing.

FDA Commissions Study of its Drug, Biologics Application Processes

The U.S. Food and Drug Administration (FDA) released a new report that examines the way the agency reviews applications for drugs and biologics that have not previously been approved by the FDA.

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FDA Commissioner Resigns; Agency Updates 2017 Asbestos Findings

Scott Gottlieb, who assumed the role in May 2017, cited the commute from Connecticut to Washington, D.C., as motivation for his resignation. The organization also released an update on 2017 findings of asbestos in cosmetics.

W.S. Badger Recalls Baby/Kids Sunscreen Due to Compromised Preservatives

W.S. Badger Co. Inc. is voluntarily recalling all lots of its 4-ounce SPF 30 Baby Sunscreen Lotion and one lot of its 4-ounce SPF 30 Kids Sunscreen Lotion due to microbial contamination that stems from a compromised preservative system.

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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Cruelty-Free Cosmetics Act Advances in Canadian House of Commons

The bill aims to prohibit any and all animal testing for cosmetic purposes in the country. It would also ban the sale of cosmetic products or ingredients that rely on the results of new animal-testing performed anywhere else in the world.

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European Regulatory Update: Cosmetic Ingredient Changes Coming in 2025-2026

This article looks to changes in 2025-2026 to the status of ingredients in the EU and UK. Examples include nanomaterial and UV filter bans/restrictions, limits on actives, labeling formaldehyde-releasing preservatives and allergens, ecodesign and others.

According to the company, the tool can save organizations hours in time typically spent on regulatory and retailer standards review.

Cosmex AI Takes Regulatory Compliance for Cosmetics to the Next Level

Those who were wondering how artificial intelligence (AI) might take cosmetic product development to the next level now have their answer. Cosmex AI can scan 30,000+ ingredients to instantly indicate if a product complies with regulators or retailers.

A Modernization of Cosmetics Regulation Act (MoCRA) Compliance Checklist

Your proactive work to ensure compliance will help the industry move forward, increase consumer trust and loyalty and strengthen your own business.

While Estée Lauder's virtual try-on tool, powered by YouCam, offers a link to the company's privacy policy, that material reportedly does not disclose that 'the makeup company collects, captures, possesses or otherwise obtains consumers' sensitive biometric data.'

The Estée Lauder Companies' Virtual Try-on Targeted by Lawsuit

Plaintiffs allege that The Estée Lauder Companies, Inc. engaged in "undisclosed collection of consumers’ biometric facial scans in Illinois."

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