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Section: Regulations > Claims/Labeling

In the Land of the Blind: Applying a Single-blind Study to Finished Products

Following positive feedback from a previous column on the placebo effect, Wiechers readdresses clinical study design in relation to cosmetic claim substantiation—this time discussing when to perform double-blind studies and when to perform single-blind studies.

AHPA Supports Organic Certification of Soaps by NOP

The American Herbal Products Association filed comments in support of a document drafted by the US Department of Agriculture’s National Organic Program that suggests certifying and labeling soaps "organic" or "made with" under the Organic Foods Production Act (OFPA).

NAD Urges Cessation of Botox-like Claims for One Antiwrinkle Product

The National Advertising Division (NAD) has recommended that the Botox-like claims made for one OTC wrinkle treatment be discontinued after the test data submitted was deemed insufficient.

EPA Announces Public Comment Period for Nano TiO2 in Sunscreen

The Environmental Protection Agency (EPA) has opened the investigation of nanoscale titanium dioxide in water treatment and topical sunscreen with a draft document and a call for public comment.

Labeling Claims

Little is more confusing to marketers and cosmetic formulators than product claims regulations. Questions regarding the rules commonly arise.

Claims Support Literature Review-Part I, Skin Care

This article is the first in a several-part series focusing on claim support. Part 1, published here, centers around aloe barbadensis gel, AHAs, antimicrobials, biopeptides, Coenzyme Q-10, diethylenetriaminepentaacetic acid, evening primrose oil, flavonoi

Claims Support Literature Review-Part III, Hair Care

This article is the third in series focusing on claim support. Part 3, published here, focuses on cationic polymers, polyquaternium hair conditioning, alkaline hair relaxers, protein kinase C, cationic surfactants, penetration pathways, hair swelling and

Is Cosmetic Science Really "Bad?"

If one were to believe the opinion of science writer Ben Goldacre, PhD, in his new book titled Bad Science, cosmetic scientists seem to be telling a big bunch of lies. Who has had enough of the public's opinion of cosmetic science?

Claim Support Literature Review-Part IV, Skin Physiology and Properties

This article is the fourth in a series focusing on claim support. This installment focuses on research in skin physiology in relation to blood circulation, cell turnover, collagen formation, sebum regulation, enzymes, photodamage and wrinkles and line reduction.

The Labeling of Fragrance Allergens in the European Union

The 7th Amendment to the Cosmetic Directive of the European Union (EU) has added 26 new contact allergens that the EU states must be listed on the ingredient declaration if they exceed certain minimum levels.

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'Nessie' and The Precautionary Principle

Academia continues to conduct experiments demonstrating that nanoparticles do not penetrate into the deeper layers of the skin but skeptics and activist groups do not accept this evidence.

FDA and Academia: Institutions to Collaborate Under Nanotech Initiative

Over-arching goals have spurred a collaboration to develop safe and effective nano-engineered products. While these efforts concentrate on medical use, implications for personal care are on the horizon.

Substantiating Claims for a Tanning Magnifier

Tanning magnifiers, known in the United States as tanning accelerators, enhance the substrate or the production of melanin. One example is an innovative N-acyl derivative from L-tyrosine. This article describes a way to evaluate its pigmentation efficacy after UV irradiation. Also discussed is the regulatory status of tanning magnifiers.

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).

Sunscreen Claims: Demystified?

As you know, sunscreen products are regulated by the U.S. Food and Drug Administration (FDA) as drugs because they are “intended” to prevent disease (skin cancer). As such, they are required to follow the rules and regulations as mandated by the FDA. Thus, they must use Drug Facts labeling; list the drugs (sunscreen actives) using the proper drug nomenclature; list the percentage of drug used; specify the drug function (sunscreen) and label; warnings and directions for use, etc.

Cosmeceutical Regulations–A Global Overview

Cosmeceuticals are not regulated as such in the Europeon Union, United States or Japan. In the EU, most are considered cosmetics; in the United States, most are seen as drugs that probably have not been approved by the U.S. Food and Drug Administration (FDA). In Japan, they are regulated as quasi-drugs. As you can see, we go from the extremes of limited regulated cosmetics in the EU to pre-approvals in Japan, and fi nally a lack of enforcement in the United States.

The “Period After Opening” in the Jungle of EU Product Labeling

In the EU, a newly required “Period After Opening” designation on product labels has re-focused consumer information to address both a product’s safety and its functional performance over time. This has implications for consumers and for product testers.

Canadian Cosmetic Ingredient Labeling

The global harmonization of ingredient labeling is forever a dream that formulators will chase as new regulations are accepted and product labels are changed accordingly to meet each country’s specifications. In November 2004, Health Canada issued new cosmetics ingredient labeling requirements. 1 Before they were issued, Canada did not require ingredient declarations on labels. If ingredients were listed, formulators faced the unique challenge posed by French language laws in the province of Quebec—if a U.S.-approved label was used, the label needed translating into French, including all International Nomenclature Cosmetic Ingredient (INCI) designations.

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