Product Code Database
Cosmeceuticals are Cosmetics 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 Food additive 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 is required.
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: "According to the FDA, products that claim to treat or affect the body’s structure or function are classified as drugs and require prior approval, unlike cosmetics which do not undergo pre-market approval.
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
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