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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The Name Game

THE INCI NAME GAME

So first of all... what is the INCI name of a product? Well the Personal Care Products Council (which has been around since 1894 and undergone numerous name changes) describes the INCI (International Nomenclature of Cosmetic Ingredients) as names used in the United States, the European Union, Japan, and many other countries, for listing ingredients on cosmetic product labels. There is this VERY expensive dictionary, if you are interested, called the "Council's International Cosmetic Ingredient Dictionary and Handbook. It is translated into many languages for individuals to be able to label INCI names in their national language. All INCI names are assigned by this committee, the International Nomenclature Committee to be exact.

INCI name is a reliable way when you shop from several different suppliers, to find a specific ingredient. Suppliers like to brand themselves, so they may change an emulsifier's name to suit their brand. So one type of emulsifier can have several brand names. Think of an INCI name as a generic name for cosmetic ingredients.

The INCI name also helps to understand what ingredients are in a product. One can determine if their avocado butter is blended with other butters and oils to make it more solid or if it has been hydrogenated to make it more solid.

The INCI doesn't help with trade secrets, one product may be a blend, but we may not know the percentage of each ingredient. Some suppliers or manufacturers may be kind enough to tell us a percentage of certain ingredients on their label, while others may not.

INCI names are those alien-looking hard to pronounce words that we see on cosmetic ingredients, usually Latin and English words. Some manufacturers are nice enough to put the INCI name and then the actual product name in parenthesis, for example, Vitellaria Nilotica (East African Shea) butter. Just keep in mind that they are only obligated to place the INCI name on the label.

Also, shopping in many markets in other countries, there are many spellings for one word, that is another reason to know the INCI name for the ingredients you are searching for everywhere.

There is a hidden issue with INCI names, some names may have been changed and some even have synonyms. For instance, Shea butter (from West Africa) used to be called, Butyrospermum Parkii. Now it is know as Vitellaria paradoxa. East African Shea is known by the INCI name of Vitellaria Nilotica. Phulwara butter has a multitude of synonyms not only with the INCI name but also with the common name. I have found a total of four different INCI names for Phulwara butter, Aisandra butyracea, Diploknema butyracea, Bassia butyracea, and Madhuca butyracea. Granted, I believe some of these are from different trees from the same family, kind of like East and West African Shea butter. As for the multiple common names for Phulwara butter, I also believe it depends on the region from which it is harvested.

So keep in mind, if you are selling products, especially in the USA, they must be properly labeled.
You should know your INCI names.

So catch me at my next blog about more FDA guidelines.

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