The examples and perspective in this article deal primarily with the United States and do not represent a worldwide view of the subject. (December 2016) (Learn how and when to remove this template message)
Dermatological research suggests that the bioactive ingredients used in cosmeceuticals have benefits beyond the traditional moisturizer (e.g., Chen et al., 2005; Zettersten, Ghadially, Feingold, Crumrine, & Elias, 1997). However, despite reports of benefits from some cosmeceutical products, there are no legal requirements to prove that these products live up to their claims.
The "cosmeceutical" label applies only to products applied topically, such as creams, lotions and ointments. Products which are similar in perceived benefits but ingested orally are known as nutricosmetics.
Consumers are willing to pay a premium for skin and hair care products that they perceive as high-performance. The term "cosmeceutical" is often used in cosmetic advertising and may be misleading to the consumer. If the consumer interprets a cosmeceutical 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.
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".
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."
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.
- Zhou Chen, Jin Young Seo, Yeon Kyung Kim, Se Rah Lee, Kyu Han Kim, Kwang Hyun Cho, Hee Chul Eun,and Jin Ho Chung, Heat Modulation of Tropoelastin, Fibrillin-1, and MatrixMetalloproteinase-12 in Human Skin In VivoJ Invest Dermatol 124:70 –78, 2005
- Elizabeth M. Zettersten, MD, Ruby Ghadially, MD, Kenneth R. Feingold, MD, Debra Crumrine, BS, and Peter M. Elias, MD San Francisco, California. Optimal ratios of topical stratum corneum lipids improve barrier recovery in chronologically aged skin (J Am Acad Dermatol 1997;37:403-8.)
- 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.