Part 3: Definitions Related to Drugs and Cosmetics
We are continuing our series on "Cosmetics for Special Populations and for Use as Compounding Vehicles." Many compounding pharmacists are already involved in this area, and there are many opportunities available as follows:
- Compounding cosmetics for ingredient-sensitive patients
- Compounding special vehicles to meet patient-specific needs, and
- Compounding cosmeceuticals, as appropriate.
This week, we will look at some related definitions involving cosmetics.
- The word "cosmetic" is derived from the Greek kosmētikos, meaning "having the power to arrange, skilled in decorating," from kosmēin, "to adorn," and kosmos, "order, harmony." The true origin probably lies still further in antiquity; early cave paintings depict the use of body adornment in the rituals of mating and hunting.
Cosmetics (as Defined by the FDA)
- The U.S. Food and Drug Administration (FDA) 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.
- This definition includes the following types of products, plus their component materials: baby products, bath oils, bubble baths, deodorants, eye and facial makeup, fingernail polishes, hair coloring, lipsticks, lotions, mouthwashes, perfumes, permanent waves, powders and sprays, and skin-care creams.
Drugs (as Defined by the FDA)
- Products that are intended to treat or prevent disease or otherwise affect structure or function of the human body are considered drugs. Any cosmetic that makes a therapeutic claim is treated as both a drug and a cosmetic and must meet the labeling requirements for both. Such products can be identified by labels that list the "active ingredient." The manufacturer of such a product must have proof that the ingredient is safe for its intended use. In labeling, the active ingredient of these products is listed first. Examples include antiperspirant deodorants, dandruff shampoos, fluoride toothpastes, and foundations and tanning preparations that contain sunscreen. These products must have been proven to be safe and effective for their therapeutic claims.
The term "cosmeceutical" is not officially recognized by the FDA, but the cosmetic industry uses it to refer to products that have medicinal or druglike benefits. Depending on their intended use, these products are regulated as cosmetics or drugs, or both.
Certain claims can cause a product to qualify as a drug even if the product is marketed as a cosmetic (e.g., claims to restore hair growth, reduce cellulite, treat varicose veins, or revitalize cells).
The same is true for essential oils in fragrance products. A fragrance marketed for promoting attractiveness is a cosmetic. But a fragrance marketed with "aromatherapy" claims (e.g., that the scent will help the consumer sleep or quit smoking) meets the definition of a drug because of its intended use.
A product's intended use is established in several ways:
- by the claims stated on the product label, in advertising, on the Internet, or in other promotional materials;
- by consumer perception; and
- by the ingredients contained in the product.
Next week, "Regulatory Considerations."
Loyd V. Allen, Jr., PhD, RPh
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition