Care cosmetics are cosmetic products that are used to clean, deodorize, and perfume the body. In the industry they are commonly referred to as “cosmeceuticals”. This not an actual recognized term by law, but refers to products that are classified as both drugs and cosmetics. Products can be classified as both. A product is classified as a drug when its intended use is for mitigation, treatment, prevention, diagnosis, or cure for disease. Cosmetic products simply promote, alter, beautify and cleanse the body. In short if a product alters a natural body function or structure as part of a beautification process it is a cosmeceutical. A few examples are antiseptic mouthwash, antiperspirant, deodorant, medicated shampoos, etc. Intended use is a major factor in determining drug and cosmetic classifications under the law. Intended use is typically determined by these common factors.
- Claims stated on the product label, or through promotional advertising in any form.
- Common consumer perception of the products function. For example, asking via survey why a product was bought and what the expectation of the buyer was.
- If ingredients in the product are widely known to have a therapeutic effect. An example of this would be fluoride in toothpaste, or alcohol in mouthwash.
There is a very fine line between what is considered a drug and simply a cosmetic. The labeling requirements, production standards, and laws for market introduction are very different. If a cosmetic falls under the drug classification it must meet certain requirements and be approved by the FDA before it can be placed on the market. Cosmeceuticals must be approved by the NDA or be a monograph.
- NDA – New Drug Application, when a sponsor formerly asks the FDA to approve a pharmaceutical for sale in the U.S. The FDA must find that there is adequate data to prove a drug’s safety and effectiveness for the proposed use. For a drug to become an over the counter drug it must go through this same channel.
- Monographs are established OTC drug rules. They are all published in the Federal Register. These rules define what ingredients can be used, what concentrations they can contain, and how they should be used. Some examples are sunscreen, and acne medications.
