Differentiating Between Drugs and Cosmetics

It’s often hard to understand a product’s label. Take lotion for instance. There are some lotions considered drugs others considered cosmetics and some just considered plain lotion. From a legal standpoint, the difference lies in the product’s intended use. There are different laws and regulations depending upon the type of product that define proper labeling. However, not all companies follow the law when marketing their product. There are many cosmetics marketed as drugs and vice versa daily.

The Federal Food, Drug, and Cosmetic Act defines ad drug as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect he structure or function of the body of man or other animals” (FD&C Act, sec201(g)(l). The act states cosmetics are “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” (FD&C Act, sec. 201(i). Although the lines can be blurry for some products, products included under the cosmetic label perfumes, skin moisturizers, lipsticks, fingernail polishes, toothpastes, deodorant, facial and eye makeup, permanent waves, and hair color.

If a product has two intended uses, it may qualify as both a cosmetic and a drug. For instance, toothpaste that contains fluoride is both a drug and cosmetic. Moisturizers with sun protection fall in both categories as well. Products like these may be marketed under either label.

The phrase cosmeceutical has become a trendy these days. However, don’t let it fool you. It has no significance. It is simply a name marketers made up. The Federal Drug & Cosmetic Act does not have a “cosmeceuticals” category. By law, the term has no meaning.

A product’s intended use is established through various ways. First, any claim on the product label or made through advertising can establish intended use. Secondly, consumer perception that is established through a product’s reputation establishes use. Therefore, if a consumer purchases a product with a certain expectation in mind, that is it’s “intended use”. Lastly, if the product contains an ingredient that causes the product to be considered a drug by the mainstream. Toothpaste would be an example of this. Fragrances that are marketed as aromatherapy can meet the definition of a drug.

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