When developing products we often walk a fine line in terms of formulating for efficacy and marketing claims. It is important to understand the regulatory and legal implications of the decisions we make.

Cosmetic or Drug?

In the United States, the Federal Food, Drug and Cosmetic Act defines cosmetics as “article intended to be rubbed, pour, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body… for cleansing, beautifying, promoting attractiveness, or altering the appearance.” Examples include blush, lipstick, nail polish, shampoo, and toothpaste.

But once the product claims venture into diagnosis, treatment, or prevention of disease and alleges to affect the structure or any function of the body, the product is a drug. Drugs are subject to stringent regulations, labeling (actives are called out from other ingredients) and testing requirements, which result in the investment of both time and money.

Products can be both cosmetic and drug if the intended use meets both definitions. Moisturizers with sunscreens, moisturizing hand sanitizers, and anti-dandruff shampoos all fall into this category. These cosmetic/drug combinations are subject to the regulations for both drugs and cosmetics. They are considered OTC or Over the Counter drugs.

Soaps

True soaps represent an additional category and are regulated by the Consumer Products Safety Commission, not the FDA. True soaps are made purely of fat and alkali. Soaps made with any other ingredient or claim any other benefit like moisturization or deodorizing are cosmetics.

Cosmeceuticals

One other classification of products is cosmeceuticals. The oft-controversial but significant contributor to our field, dermatologist Dr. Albert Kligman, coined the term cosmeceutical almost 30 years ago. He defined cosmeceuticals as topically applied products that do have a physiological effect on the skin. The industry was quick to respond because the potential regulation of cosmetics as drugs could cripple innovation due to time and cost. Kligman, however, intended to draw attention to the potential biological effects of all cosmetics that did not just merely camouflage or add color. In fact he said it was “scientifically silly to pretend that cosmetics did not do anything” and that cosmetics might actually be doing a lot of good.

The term cosmeceutical is not recognized as part of the Federal Food, Drug, and Cosmetic Act. But whether you agree or disagree, this term has become part of our consumer’s vernacular. The controversy and conversation the term has created remains, in my mind, one of Kligman’s great contributions to cosmetic science.

Further information can be found on the FDA’s website.

My first experience with cosmetic labeling came in college when I turned over the bottle of a shampoo and looked at the ingredient list. It was right around the time when I was learning how to name chemicals and I was confused why I couldn’t recognize almost any of the ingredients. It turns out that the cosmetic industry doesn’t follow the IUPAC system which is what they teach you in college. It follows the system set up by the Personal Care Products Council (PCPC) as described in the INCI Dictionary. See our previous post on cosmetic labeling and the naming conventions in it.

But the ingredients names in your formula are only part of the labeling process. You also have to follow the labeling rules laid out by the FDA that affect ingredient order, placement on the label, text size, language and more. Here are the relevant facts.

Cosmetic ingredient list

In the United States, it is a requirement that all cosmetics be labeled with their ingredients. The LOI (list of ingredients) is supposed to be printed on the container and needs to follow some rules when listing ingredients.

1. Ingredients above 1% need to be listed in order of concentration
2. Ingredients 1% or below can be listed in any order
3. Exception: Color ingredients are listed at the end

The names of the ingredients must be those found in the INCI (International Nomenclature of Cosmetic Ingredients) Dictionary.

Where does the list go?

Once you have the list, you’ll have to put it on the package in the proper position. The FDA requires that it be put on the principle display panel which in most cases just means somewhere on the primary package where people can read it. See this for details.

What kind of font?

To ensure that the ingredient list is readable, the FDA requires that the font size be no smaller than 1/16th of an inch unless your packaging is really small in which case you can make the font 1/32nd of an inch.

What language?

Products sold in the United States must be written in English.

What else do you include?

Other information you need to list includes

1. Name of the product (e.g shampoo, lipstick, eyeshadow)
2. Name of manufacturer or distributor
3. Address of manufacturer including city and zip code
4. Net contents in container
5. Warning statements if required

For more details about what and how you specifically need to list information on your labels in the United States, see this section on the FDA website.