Characteristics of Claims Considered to be for a "Drug" or "Cosmetic"

The FD&C Act defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions. Included in this definition are products such as skin creams, lotions, perfumes, lipsticks, fingernail polishes, eye and facial make-up preparations, shampoos, permanent waves, hair colors, toothpastes, deodorants, and any material intended for use as a component of a cosmetic product. Soap products consisting primarily of an alkali salt of fatty acid and making no label claim other than cleansing of the human body are not considered cosmetics under the law.

Products that are cosmetics but are also intended to treat or prevent disease, or otherwise affect the structure or functions of the human body, are considered also drugs and must comply with both the drug and cosmetic provisions of the law. Examples of products which are drugs as well as cosmetics are anticaries toothpastes (e.g., "fluoride" toothpastes), hormone creams, suntanning preparations intended to protect against sunburn, antiperspirants that are also deodorants, and antidandruff shampoos.

Drugs of course are substances for which the claim is made that they treat or prevent a disease or affect the function or structure of the body. Generally a "drug" must go through the very expensive tests and trials and receive approval from the FDA.

Karl Note: Note that there is no cateogry for a "cosmetic" which also affects structure or function of the human body which are NOT drugs -- such as what would be classified as a "vitamin." In other words, you can swallow some pill, called a vitamin, more free of restrictions than you can apply a cream intended to deliver the same results as the vitamin, but do it topically.

Presumably if the "cream" is called a "topical supplement" and not a cosmetic, it would not fall under the drug or cosmetic rules?

For further data on the possibility of marketing a "skin cream" which would be neither a "cosmetic" nor a "drug" but could fall under the classification covered by the Dietary Supplement Health and Education Act read about that.

The final conclusion here is that it is the CLAIM and the PROMO material which is senior in importance, not the actual result obtained from use of the product.