Cosmeceuticals are cosmetic products with bioactive ingredients purported to have medical benefits. In the US, there are no legal requirements to prove that these products live up to their claims. The name is a portmanteau of "cosmetics" and "pharmaceuticals". Nutricosmetics are related dietary supplement or food or beverage products with additives that are marketed as having medical benefits that affect appearance.[1]
Quasi-drug (labelled 医薬部外品 or 薬用) is a Japanese term that refer to many of the same products with functional claims, albeit regulation is stronger as pre-market approval from the Ministry of Health, Labour and Welfare is required.[2][3]
Consumers are willing to pay a premium for skin and hair care products that they perceive as high-performance.[4] The term "cosmeceutical" is often used in cosmetic advertising and may be misleading to the consumer. If the consumer interprets a "cosmeceutical" or "nutricosmetic" to be similar to a pharmaceutical product, he or she may conclude that cosmeceuticals are required to undergo the same testing for efficacy and quality control as required for medication. This may allow the retailer to charge the consumer more for a product which may actually be less effective and/or of poorer quality than perceived.[1][5]
However, according to the United States Food and Drug Administration (FDA), the Food, Drug, and Cosmetic Act "does not recognize any such category as "cosmeceuticals". A product can be a drug, a cosmetic, or a combination of both, but the term "cosmeceutical" has no meaning under the law".[6]
Additionally, the FDA states that: "Food, Drug and Cosmetic Act defines drugs as those products that cure, treat, mitigate or prevent disease or that affect the structure or function of the human body. While drugs are subject to an intensive review and approval process by FDA, cosmetics are not approved by FDA prior to sale. If a product has drug properties, it must be approved as a drug."[7]
To avoid inquiry and punitive action by the United States Federal Trade Commission, cosmeceuticals which do not intend to be regulated as drugs by the FDA are carefully labeled to avoid making statements which would indicate that the product has drug properties. Any such claims made regarding the product must be substantiated by scientific evidence as being truthful.
Generally speaking, it is to the financial benefit of the cosmeceutical manufacturer that their products are not regulated by the FDA as drugs, because the FDA review process for drugs can be very costly and may not yield a legally marketable product if the FDA denies approval of the product. However, as mentioned above, the reputation of the product may be falsely enhanced if the consumer incorrectly believes that a "cosmeceutical" is held to the same FDA standards as a drug.[8]
^ abLange, Catherine de (27 September 2015). "Can a drink really make skin look younger?". the Guardian.
^"Cosmetics and Quasi-drug Notification in Japan - Japan - Personal and Home Care Products - CIRS Group". www.cirs-group.com.
^"Understanding the Concept of Quasi-Drugs OEM: Japanese Cosmeceuticals". 株式会社OEM. quasi-drugs are the only products that can openly be marketed as effective for "whitening" and "hair growth" in Japan.
^. September 30, 2005. Archived from the original on June 24, 2006.
^"Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)". U.S. Food and Drug Administration. U.S. Department of Health and Human Services. April 30, 2012.
^. Archived from the original on December 30, 2006.
Ando, H; Matsui, MS; Ichihashi, M (18 June 2010). "Quasi-drugs developed in Japan for the prevention or treatment of hyperpigmentary disorders". International Journal of Molecular Sciences. 11 (6): 2566–75. doi:10.3390/ijms11062566. PMC2904932. PMID 20640168.
April 10, 2024
cosmeceutical, examples, perspective, this, article, deal, primarily, with, united, states, represent, worldwide, view, subject, improve, this, article, discuss, issue, talk, page, create, article, appropriate, december, 2016, learn, when, remove, this, templa. The examples and perspective in this article deal primarily with the United States and do not represent a worldwide view of the subject You may improve this article discuss the issue on the talk page or create a new article as appropriate December 2016 Learn how and when to remove this template message Cosmeceuticals are cosmetic products with bioactive ingredients purported to have medical benefits In the US there are no legal requirements to prove that these products live up to their claims The name is a portmanteau of cosmetics and pharmaceuticals Nutricosmetics are related dietary supplement or food or beverage products with additives that are marketed as having medical benefits that affect appearance 1 Quasi drug labelled 医薬部外品 or 薬用 is a Japanese term that refer to many of the same products with functional claims albeit regulation is stronger as pre market approval from the Ministry of Health Labour and Welfare is required 2 3 Contents 1 Criticism 2 See also 3 References 4 External links 5 Further readingCriticism editConsumers are willing to pay a premium for skin and hair care products that they perceive as high performance 4 The term cosmeceutical is often used in cosmetic advertising and may be misleading to the consumer If the consumer interprets a cosmeceutical or nutricosmetic to be similar to a pharmaceutical product he or she may conclude that cosmeceuticals are required to undergo the same testing for efficacy and quality control as required for medication This may allow the retailer to charge the consumer more for a product which may actually be less effective and or of poorer quality than perceived 1 5 However according to the United States Food and Drug Administration FDA the Food Drug and Cosmetic Act does not recognize any such category as cosmeceuticals A product can be a drug a cosmetic or a combination of both but the term cosmeceutical has no meaning under the law 6 Additionally the FDA states that Food Drug and Cosmetic Act defines drugs as those products that cure treat mitigate or prevent disease or that affect the structure or function of the human body While drugs are subject to an intensive review and approval process by FDA cosmetics are not approved by FDA prior to sale If a product has drug properties it must be approved as a drug 7 To avoid inquiry and punitive action by the United States Federal Trade Commission cosmeceuticals which do not intend to be regulated as drugs by the FDA are carefully labeled to avoid making statements which would indicate that the product has drug properties Any such claims made regarding the product must be substantiated by scientific evidence as being truthful Generally speaking it is to the financial benefit of the cosmeceutical manufacturer that their products are not regulated by the FDA as drugs because the FDA review process for drugs can be very costly and may not yield a legally marketable product if the FDA denies approval of the product However as mentioned above the reputation of the product may be falsely enhanced if the consumer incorrectly believes that a cosmeceutical is held to the same FDA standards as a drug 8 See also editAngel dusting Cosmetovigilance NutraceuticalReferences edit a b Lange Catherine de 27 September 2015 Can a drink really make skin look younger the Guardian Cosmetics and Quasi drug Notification in Japan Japan Personal and Home Care Products CIRS Group www cirs group com Understanding the Concept of Quasi Drugs OEM Japanese Cosmeceuticals 株式会社OEM quasi drugs are the only products that can openly be marketed as effective for whitening and hair growth in Japan Epstein H 2009 Cosmeceutical vehicles Clin Dermatol 27 5 453 60 doi 10 1016 j clindermatol 2009 05 007 PMID 19695476 Cosmeceutical makers can charge a premium September 30 2005 Archived from the original on June 24 2006 Is It a Cosmetic a Drug or Both Or Is It Soap U S Food and Drug Administration U S Department of Health and Human Services April 30 2012 What are cosmeceuticals Archived from the original on December 30 2006 NMN Raw Material UtheverExternal links editLegal Affairs Artfully Made up Cosmeceuticals eMedicine comFurther reading editAndo H Matsui MS Ichihashi M 18 June 2010 Quasi drugs developed in Japan for the prevention or treatment of hyperpigmentary disorders International Journal of Molecular Sciences 11 6 2566 75 doi 10 3390 ijms11062566 PMC 2904932 PMID 20640168 Retrieved from https en wikipedia org w index php title Cosmeceutical amp oldid 1193961285, wikipedia, wiki, book, books, library,
