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Section: Regulations

Translating Data into Claims and Interpreting Regulations: Science vs. Marketing

Substantial evidence, which the FDA requires to support claims for drugs, is applicable to personal care, especially considering the pharmaceutical direction products have taken. The present article considers whether the industry is benefiting from marketing without assuming the responsibility for potential effects. In addition, it considers the limitations of in vitro and in vivo test models.

General Assembly Discusses Endocrine Disruptors, Nano, Animal Alternatives and More

Cosmetics Europe—The Personal Care Association, formerly Colipa, held its annual General Assembly in Brussels, Belgium in June 2012. The scientific forum discussed topics of interest in EU legislation such as The Cosmetics Regulation, which was set to replace the Cosmetics Directive on July 11, 2013.

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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.

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J&J Voluntarily Recalls Benzene-containing Neutrogena and Aveeno Spray Sunscreens

Johnson & Johnson Consumer Inc. is voluntarily recalling all lots of five Neutrogena and Aveeno aerosol sunscreens as some were found to contain low levels of benzene.

FDA Closes Negotiations with ICMAD and PCPC, Prompting Industry Response

On Mar. 6, 2014, Michael Taylor, on behalf of th The U.S. Food and Drug Administration (FDA), responded to the Proposed Draft Legislation by the Personal Care Product's Council (PCPC) and the Independent Cosmetics Manufacturers and Distributors (ICMAD), effectively finding no common ground between the three and closing the negotiation.

NSF Launches Testing, Certification and Consulting Program for Cosmetic Safety

Global public health organization NSF International has launched the NSF Cosmetics and Personal Care Program in response to growing concerns from consumers and retailers regarding adulteration, mislabeling and counterfeiting issues.

Initially designated as drugs in the U.S., sunscreens have been stifled under regulations and bureaucracy. This article reviews how it came to this, where current regulations stand and proposes a few “pipe dream” solutions.

Sunscreens and Pipe Dreams for their Regulation in the US

Initially designated as drugs in the U.S., sunscreens have been stifled under regulations and bureaucracy. This article reviews how it came to this, where current regulations stand and proposes a few “pipe dream” solutions.

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Health Canada Updates Hotlist Ingredients: Colorants, Benzophenone, Talc and More

Concerns including adverse developmental and maternal effects were cited for the four ingredients added. Five amendments also were made, updating the hotlist for the first time since 2022. This follows a recent recall over henna cones containing phenol.

Voluntary Registration of Cosmetics and 2007 Frequency of Preservative Use

This report details recent trends in preservative use based on VCRP data submitted to the FDA by manufacturers. The author encourages companies to participate in this program to build credibility for self-regulation and to protect their own business interests.

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6 Sanitizer Offenses, Color Additives and Cosmetic Registrations: FDA Update

The U.S. Food and Drug Administration recently issued updates regarding color additives certification, voluntary cosmetic registrations and hand sanitizer violations.

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Methanol Content and How to Test for it: FDA Guidance

The U.S. Food and Drug Administration has outlined a policy for companies to test alcohol (ethanol) or isopropyl alcohol for hazardous methanol content prior to their use in hand sanitizer products.

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Cosmetovigilance and Safety Assessment in the World of Active Ingredients

It can be deduced from today's scientific literature that countless ingredients have been developed with the intent to alter the structure and function of human skin. This raises important questions in terms of how these products should be regulated and what types of safety standards they should be held to.

Testing Tactics: REACH and In vitro Alternatives: Skin Irritation Testing

Welcome back to a continuing discussion regarding the new Registration, Evaluation and Authorization of Chemicals (REACH) regulation and its impact on chemical testing. It is the purpose of this series of articles to provide an overview of these existing validated in vitro methods, as well as new methods that are being considered for validation.

Testing Tactics: REACH and In vitro Alternatives: Skin Irritation Testing

Welcome back to a continuing discussion regarding the new Registration, Evaluation and Authorization of Chemicals (REACH) regulation and its impact on chemical testing. It is the purpose of this series of articles to provide an overview of these existing validated in vitro methods, as well as new methods that are being considered for validation.

The inner packaging of a serum and product kit containing said serum listed SPF when the product has no SPF.

FDA Flags Color Additive, SPF and Contaminant Offenses, Urges 'Recall Readiness'

In recent months, the U.S. Food and Drug Administration (FDA) reported six voluntary recalls for an impermissible color additive, mislabeled SPF and several contaminants. It also urged companies to be "recall ready" and provided final guidance to do so.

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[video] Import Violations, Personalized Plasma Skin Care and Partnerships: Editor Picks

This week's top picks from Cosmetics & Toiletries include the Greenbrier International/Dollar Tree import violation, SoME— a personalized skin care collection which incorporates plasma and new partnership with Clariant and Plant Advanced Technologies (PAT).

EU Regulation No. 1223/2009 Part 2: Prohibited Ingredients, Definitions and More

In total, EC No. 1223/2009, often called the Recast or the 8th Amendment, is comprised of a preamble with 71 parts (justification), 40 articles (replacing the old 15) and 10 annexes (replacing the old nine).

Cosmetics Registration in California and the FDA's Electronic-only Drug Registration

The stars where poorly aligned on June 15, 2009, when California finally issued its registration procedure and forms for the California Safe Cosmetics Act of 2005. At the same time, the US Food and Drug Administration (FDA) moved to an electronic-only filing system for drug registrations. These two changes have created significantly more work for the personal care industry—and with questionable benefits.

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