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FDA Proposes Labeling Rule for Color Additives
[Feb. 2, 2006]

The U.S. Food and Drug Administration (FDA) published a proposed rule in the Federal Register requiring the declaration of carmine and cochineal extract...

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.

Naturally Speaking: Debating the “Safety” of Chemicals

Following is a collection of statements easily found on the Internet. I did a Google search got thousands of hits for documents attacking the cosmetic/personal care industry in general, and various ingredients, products and chemists in particular on grounds of safety or efficacy.

Mind Over Matter: Cosmetic Claim Substantiation Issues Facing the Future

It is generally accepted by the public that effective cosmetic products can positively influence the well-being of individual consumers. Whereas we can easily measure the skin moisturizing properties of a cosmetic formulation, measuring its precise effects on well-being is much more complex.

Staking a Claim

The bottom line for any company is to make a profit, and one of the most obvious and visible ways to do this is to claim that their product provides everything the consumer wants.

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

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.