Cosmetic Definition

Is it a cosmetic, a drug, or both?

The Federal Drug and Cosmetic Act defines cosmetics by their intended use:

“Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.”

The FD&C Act defines drugs in part by their intended use, as “Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease,” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.”

How can a product be both a cosmetic and a drug?

Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs.

Fragrances:

This principle also holds true for essential oils in fragrance products. A fragrance marketed for promoting attractiveness is a cosmetic but a fragrance marketed with certain “aromatherapy” claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use.

Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials need to be correct. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. This is where you will need Techlink International expertise to guide you in the correct direction. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, or revitalize cells.  Ingredients may cause a product to be considered a drug because they have a well known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.

There is a fine line of definition between items which may be considered cosmetics or drugs, and which will require different types of labeling, warnings and claims allowed.

Techlink International has the knowledge and expertise to guide you in the correct direction from the beginning.

Contact us today for more details.