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Prescription vs Cosmeceuticals vs Cosmetics

Posted December 02, 2014 in Products


I am constantly looking at skin care products for myself and my practice.  The labels and characterizations that are given to some products are just confusing.  So, I thought some background on what the categories mean would be interesting.  Skin care products come in three form cosmetics, cosmeceuticals and prescriptions.  We all know the difference between prescriptions and the other two categories, but the line between cosmetics and cosmeceuticals is not as clear.  

The U.S. Food, Drug and Cosmetic Act does not recognize the term “cosmeceuticals”.  However, the cosmetic industry uses the term to refer to cosmetic products that have medicinal or drug-like benefits.  While drugs are subject to a review and approval process, cosmetics are not subject to the same stringent guidelines and do not have to have the same evidence to back up their claims.  The cosmeceutical companies often perform studies to show their efficacy.  These are helpful, but are funded and sometimes conducted by the company, so can be biased.

Also, keep in mind that the FDA does not have to approve the labeling or claims of a cosmetic prior to going on the market, but the company can be penalized after the release for misleading labeling.  A cosmetic cannot claim that it treats or prevents disease or otherwise affects the structure or function of the body.


Drugs and cosmetics are differentiated by their intended use.  The intended use is determined by the labeling, promotional materials and claims made in advertising, consumer perception, or using ingredients with well known therapeutic uses.  According to the Federal Food, Drug and Cosmetic Act, cosmetics are “articles to be rubbed, poured, sprinkled, sprayed on, introduced into or otherwise applied to the body for cleansing, beutifying, promoting attractiveness or altering the appearance”.  Drugs are defined as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles intended to affect the structure or any function of the body of man or other animals”.

If the company is making the claim that the product is somehow affecting the structure of the body, they must apply with the FDA as a new over the counter drug and go through the approval process.  Cosmetics can register their product with the FDA’s Voluntary Cosmetic Registration Program, but this does not constitute FDA approval.

An alert was issued by the FDA in May about skin care products that were unlawfully labeled as “Anti-Aging Creams” that lists the cosmetic companies that are subject to further investigation, which can be accessed by anyone.  The list is surprisingly long and includes a number of well-known companies.

The U.S. Food, Drugs and Cosmetic Act defined cosmetics as “articles” to be rubbed, poured, sprinkled, sprayed on, introduced into or otherwise applied to the body for cleansing, beutifying, promoting attractiveness or altering the appearance.  These do not alter the structure or function of the skin and do not have any lasting impact on the skin.  These are items sold in the drug store and are often features in advertisements.  Cosmeceuticals are a hybrid of cosmetic-pharmaceutical item that provide additional health-related benefits.  They are topical, but the difference is that they contain ingredients that can change the skin’s biological function.  These are frequently sold in physician’s offices, but I have seen them online, as well. Since they are a hybrid, discerning which products fit into this category can be difficult.  A good way for you to determine the difference is where they are sold.  Cosmetics can be sold in a physician’s office, but cosmeceuticals are not sold in chain retail stores (drug stores, etc).

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