Cosmeceuticals are cosmetic products with bioactive ingredients purported to have medical benefits. In America, there are no legal requirements to prove that these products live up to their claims. The name is a
portmanteau
A portmanteau word, or portmanteau (, ) is a blend of wordspharmaceuticals". Nutricosmetics are related dietary supplement or food or beverage products with
additives
Additive may refer to:
Mathematics
* Additive function, a function in number theory
* Additive map, a function that preserves the addition operation
* Additive set-functionn see Sigma additivity
* Additive category, a preadditive category with fi ...
that are marketed as having medical benefits that affect appearance.
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
The is a cabinet level ministry of the Japanese government. It is commonly known as in Japan. The ministry provides services on health, labour and welfare.
It was formed with the merger of the former Ministry of Health and Welfare or and the ...
is required.
Criticism
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" 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
A medication (also called medicament, medicine, pharmaceutical drug, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the medical field and ...
. This may allow the
retailer
Retail is the sale of goods and Service (economics), services to consumers, in contrast to wholesaling, which is sale to business or institutional customers. A retailer purchases goods in large quantities from manufacturing, manufacturers, dire ...
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
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food s ...
(FDA), the
Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of f ...
"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.NMN Raw Material - Uthever /ref>