Article by: Kelly Dobos

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.


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.


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.

Kelly Dobos

About the Author

Kelly Dobos

Kelly Dobos is a cosmetic chemist and expert in both skin care and make-up product formulation. She has the coolest job and a passion for teaching others the smartest ways to express their creativity through cosmetic chemistry.


  1. Pingback:Over the Counter Drug Monographs and Cosmetics – Part 1

  2. Kelly

    Whether or not a cosmetic is also a drug in the US is determined by the claims that are made. Inclusion of growth factors does not necessarily make the product a drug. You can find information regarding the OTC drug application process here.

  3. dahan

    Dear Kelly
    I noticed cosmaceutical creams containing growth factors – which are clearly drugs.
    Can you elaborate on the regulation process for such a cream? What would be the demands for approval of a known oral drug in a cosmaceutical?
    Many thanks

  4. Kelly

    Hi Cindy,
    You would take your formula to a contract packager for manufacture and there are plenty out there to choose from. Check this section on for a listing. The contract packer would be the one to voluntarily registered with the FDA and would submit information as needed. I would just ask the packager you work with if they are voluntarily registered, and any one worth their salt will be.

  5. Cindy

    Ok, as you can see I am a novice.. so my question is where do I go next. can I just take it to a manufacturer to produce or do I have to submit my information to the FDA first, and if so; is there a wait…
    I have read fda information but need some straight talk…
    I have the formula, packaging, distribution, etc, in place.

  6. Kelly Dobos
    Kelly Dobos

    Hi Cindy,
    In the case of camouflage, it is purely cosmetic to the FDA and not a drug. Information about the voluntary registration program for cosmetics can be found here It depends on distribution whether you could or not.

  7. Cindy

    Hi Kelly..I have a camouflage product for vitiligo patients, have done my own stability tests, do I now have to submit my info to fda before I can Manufacture.. It has no structural changes on the skin… just dont know where to go from here… thanks

  8. Kelly

    Hi Dana,
    Most cosmetic companies employ specialists in their regulatory group to keep track of the regulations in other countries because there is a lot of complex and changing information regarding each foreign country’s cosmetic and drug trade. So although I have a firm understanding of US regulations, I rely on my team of regulatory experts to guide me when formulating for other countries so I can keep focused on formulations.

  9. Dana

    Can you explain some of the major cosmetics regulated in the major countries. For example, in the USA sunscreens and antiperspirant are regulated. What about Japan, UK, China etc?

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