COSMECEUTICALS: DRUGS VERSUS COSMETICS in .NET

Printing QR Code ISO/IEC18004 in .NET COSMECEUTICALS: DRUGS VERSUS COSMETICS

COSMECEUTICALS: DRUGS VERSUS COSMETICS
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According to the United States Food and Drug Administration (FDA), a personal care product can be classified as a drug, a cosmetic, or both Moisturizers with skin protection factor (SPF) and antidandruff shampoos are examples of dermatologic products classified as both a drug and a cosmetic The term cosmeceutical was introduced approximately 25 years ago by Albert Kligman, MD, at a meeting of the Society of Cosmetic Chemists because he felt that a new category of regulation should exist1 Although this topic has been debated for decades, the category cosmeceuticals has still not been codified or officially recognized In other words, it has no legal meaning The term, however, is increasingly a part of the mainstream vernacular and frequently used to describe products that are known to have a biologic action but are regulated as cosmetics (eg, products containing retinol) Although it is well known that retinol stimulates retinoic acid receptors resulting in biologic activity, retinol is a popular ingredient contained in numerous cosmetics Companies often list retinol as an inactive ingredient on product labels to avoid regulatory action by the FDA The stage for this unforeseen regulatory loophole in which cosmeceuticals reside was set in 1938 when the US Congress passed a statute known as The Federal Food, Drug, and Cosmetic Act (FD&C Act), which outlined formal criteria for classification of drugs and cosmetics In this document, cosmetics were defined as: articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance In contrast, a drug is defined as a substance intended to affect the structure and function of the body Based on this definition, the actual intent of the product and not its actions govern how it is classified This allows for the classification of retinol as a cosmetic
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CHAPTER 28 COSMETIC AND DRUG REGULATION
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individuals oppose such an enactment because it would likely lead to the regulation of most cosmetic products For example, in Europe, under the European Economic Cosmetic Directive of 1993, the requirements for cosmetic product labeling became formidable and complex2 In contrast, companies in the US do not have to demonstrate either efficacy or safety prior to marketing their products Of course, all reputable companies ensure the safety of their products before distributing them; however, astonishingly, they are technically not required to do so What should cosmetic dermatologists do to protect patients and themselves in an atmosphere in which companies are not required to research, or to release their research, on the efficacy and safety of cosmetic products Fortunately, many individuals are beginning to independently investigate these products and their claims and to publish the findings in peer-reviewed journals Poster presentations at meetings are also a helpful source of information Companies seem more likely to present their findings in a poster format; however, it is important to remember that these posters are often not peer reviewed Some companies will provide unpublished research data on request to interested physicians The Cosmetic Toiletry and Fragrance Association (CTFA) publishes a helpful guide called the Cosmetic Ingredient Review It is designed to review and document the safety of cosmetic ingredients An expert scientific panel examines worldwide published and unpublished safety data in an independent and unbiased manner Finally, all cosmetic dermatologists who hope to preserve and enhance the integrity of the field should insist that manufacturers of cosmetic products and procedures supply wellcontrolled published studies to support their claims If these dermatologists and, later, consumers refuse to buy products lacking an evidence-based medicine approach, the studies will eventually be performed and certainly lead to exciting new developments in the field of cosmeceuticals
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false claims about products The NAD renders a decision, with the intention of objectively, quickly, and privately reaching a settlement The goal is to promote truth in advertising and, in the process, keep government from getting involved in the process and avoid costly litigation The US Federal Trade Commission (FTC) also can play a role and sanction companies that lack the data to support its claims Of dermatologic interest, the NAD recently recommended that Skin Doctors Cosmeceuticals alter its claims regarding its Eyetuck AntiBag Technology, particularly its favorable comparisons to plastic surgery The NAD deemed that it was inappropriate for manufacturers of a product that works only on the skin surface compare, without substantiating evidence, their cream/serum to plastic surgery procedures that penetrate into the skin3
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