Is Your Product a Drug or a Cosmetic

Posted by Lisa Capote | May 05, 2011 | 0 Comments

Under the FDA laws a cosmetic is defined by its intended use, as “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. A drug on the other hand is defined a “(a) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease…and (b) articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Do you know what your product is classified as?

Many distributors and manufacturers do not realize that a moisturizer is a cosmetic, but the moment an ingredient to is added for sun protection the product is now a combination product, cosmetic/over-the-counter drug.  The implications of being a drug versus a cosmetic are widespread. For example, a cosmetic does not require FDA registration. However, an over-the-counter drug requires facility registration, labeling submission and what is known as a national drug code number provided by FDA.

The time involved in obtaining the necessary FDA registrations for an over-the-counter drug can be lengthy. This is why it is imperative that a distributor or manufacturer have their product reviewed before going to market, to ensure compliance with all applicable regulations.

Moreover, the statements made on a cosmetic's labeling may subject it to classification as a drug.  One example is claims regarding diseases.  A product, regardless of how it is marketed, that claims to assist with a disease, say rosecea, will be considered a drug for purposes of FDA laws.

An attorney whose practice focuses on FDA matters and international trade can be a vital component. FDA attorneys are qualified to interpret regulations to ensure that the claims being made are compliant while still being able to market the product.


About the Author

Lisa Capote

Ms. Capote is the founder and Managing Partner of Capote Law Firm. She founded the minority, woman owned law firm in 2006 with the goal to provide quality service to FDA regulated companies. Since that time her practice has grown to include other US federal agencies as well as an international trade component.


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