Consumers are willing to pay a premium for skin and hair care products that they perceive as high-performance. 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 "those products that cure, treat, mitigate or prevent disease or that affect the structure or function of the human body" are classified as drugs and, as such, are "subject to an intensive review and approval process by FDA", while "cosmetics are not approved by FDA prior to sale". It further states "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, those marketing cosmeceuticals not regulated as drugs by the FDA must carefully label them to avoid making statements which would indicate that the products have drug properties. Any such claims made regarding the product must be substantiated by scientific evidence. 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. ==See also==