Is my product a cosmetic or a drug?

Want to violate the law? Market your product that is a cosmetic as a drug or market a drug as a cosmetic. First, we need to determine if a product is a drug or a cosmetic, there are laws and regulations determined by a product’s intended use.

Federal Food, Drug and Act’s definition of a cosmetic?

“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)]. They even provide us with examples of products included within the definition as skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product.

Federal Food, Drug and Act’s definition of a drug?

“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” [FD&C Act, sec. 201(g)(1)].

So… what if it is both a cosmetic and a drug?

A perfect example of a product that meets the criteria for being both a cosmetic and a drug is anti-dandruff shampoo.  Also products marketed as a sunscreen and antiperspirants are considered both. Keep in mind that the FDA does not recognize the term “cosmeceutical.”

Be careful of product claims, if it is stated that your product can treat and/or prevent disease or the product affects the structure of functions of the human body… it is a drug. Examples of this are, skin lightening or cellulite reduction claims. If you are making claims that your product is a treatment, prevents or cures diseases or other ailments…it is a drug. So do not place those claims on your product label, advertise the claims on the internet, television or other promotional items. Now if you want to make those claims, just follow the rules and guidelines set forth by the FDA.

Earthly Oils sells carrier (base) oils, for the most part, these oils are for cosmetic purposes. Some are used by massage therapists as lubricants, this places our products within the cosmetic category. However, if the oil/butter is said to relieve joint pain or it is for other therapeutic purposes, we would have to sell them as drugs and follow the FDA's guidelines and labeling protocol.

Does my product require FDA approval?

Cosmetic products and ingredients do not require FDA approval before being placed on the market (does not include color additives). If your product is considered a drug, it needs premarket approval by the FDA through the New Drug Application (NDA) process, after a drug category is determined; it goes through the FDA’s Over-the-Counter (OTC) Drug Review.

Do I have to register my product?

Well it depends. If you are selling a drug, then the answer is definitely “yes.” For cosmetics, there is a program that is maintained by the FDA called the Voluntary Cosmetic Registration Program. This program is voluntary for cosmetic establishments and formulations. The FDA does not require cosmetic establishments or product formulations to be registered.



Labeling a combination drug and cosmetic product.



 

Labeling a product that is both a drug and cosmetic?

Combination drug/cosmetic products must have labeling that reflects the nature of its combo status. Drug ingredients are listed as “Active ingredients” (listed in order alphabetically) and cosmetic ingredients are listed as “Inactive ingredients” (listed with the most predominant ingredients in descending order) on the label.

Well, what category is soap in?

It is a cosmetic according to the FD&C Act section 201(i)(1) because it is used for cleansing. But FD&C Act section 201(i)(2) excludes it from being defined as a cosmetic. The FDA does not regulate soap. It is regulated by the Consumer Product Safety Commission. 

The FDA interprets soap as:

-          “the bulk of the nonvolatile matter in the product consist of an alkali salt of fatty acids and the product’s detergent properties are due to the alkali-fatty acid compounds, and

-          the product is labeled, sold, and represented solely as soap.”

Is my cleanser regulated by the FDA?

Well, if the product consists of detergents or primarily of alkali salts of fatty acids and is intended not only for cleansing but also for cosmetic uses (deodorant, or skin moisturizer); it is to be regulated as a cosmetic.

If  the product consists of detergents, or primarily of alkali salts of fatty acids, and is intended not only for cleansing but also to cure, treat, or prevent disease, or to affect the structure of any function of the human body: it is regulated as a drug (antibacterial cleanser that treat acne), or both a drug and cosmetic.

If a product is intended solely for cleansing the human body, has the characteristics consumers generally associate with soap, and does not consist primarily of alkali salts of fatty acids; these may be labeled as a soap but have to be regulated as a cosmetic.

Check out the FDA's section on cosmetics for more information; http://www.fda.gov/Cosmetics/default.htm

Let's learn more about labeling in my next post.
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