It is estimated Americans will spend over $60 billion on beauty products in 2015.[1]  With so much at stake, manufacturers have tried to aggressively promote their products. In many cases, this promotion has resulted in unintentional product misbranding. 

 
The Food, Drug, and Cosmetic Act (FD&C Act) provides the US Food and Drug Administration (FDA) with regulatory authority over cosmetics to ensure they are not adulterated or misbranded.[2]  See 21 U.S.C. § 361, 362. While the market for non-essential beauty products has increased dramatically during the past couple of decades, the FD&C Act has changed very little since its enactment nearly 80 years ago. 

 
This could be changing with the introduction of the Personal Care Products Safety Act (PCPSA), which seeks to significantly expand the FDA’s authority over cosmetic products sold in the US and eliminate many of the regulatory differences between cosmetics and drugs.[3]  Nevertheless, the PCPSA fails to address the issue of unintentional product misbranding in the context of product marketing. 
 

Cosmetic or a Drug
 

The FD&C Act defines cosmetics 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.”[4] 

Cosmetics include “skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial make-up preparations, cleansing shampoos, permanent waves hair colors, and deodorants,” or any of their component parts.[5]  Cosmetics marketed in the US, whether they are manufactured here or are imported from abroad, must comply with the labeling requirements of the FD&C Act.

 
By contrast, drugs are defined as products that are “intended for use in diagnosis, cure, mitigation, treatment or prevention of a disease.”  FD&C Act, sec. 201(g)(1). Some products are both a cosmetic and a drug. An example of this is an SPF moisturizer, which acts as both a cosmetic in its moisturizing function and a drug in its ultraviolet protection. Products that are both cosmetics and drugs are often referred to as“cosmeceuticals,” and must comply with both the drug and cosmetic provisions of the law.[6] 
 

The focus in defining both cosmetics and drugs is on their intended use.  Intended use can be established through marketing, consumer perception, or the ingredients used.[7] In regulating the cosmetics industry, the FDA has spent a considerable amount of energy focusing on the product labeling, advertising, internet, or other marketing activities that may operate to establish the product as a drug based upon its intended use. When companies market anti-aging products as having a physiological impact on the body or one’s appearance, the cosmetic becomes a drug. 


Regulatory Overview
 
If a manufacturer’s product is classified as a drug, the manufacturer is subject to a whole host of regulations it would not otherwise be subject to if the product is classified as a cosmetic. Under the FD&C Act, there is no FDA review of cosmetics prior to marketing, with the exception of color additives. Further, unlike pharmaceuticals and medical devices, there is no testing by the FDA of cosmetics prior to their sale to consumers.[8]  By contrast, if a product is categorized as a drug and is not generally recognized as safe and effective, the cosmetic manufacturer must subject their “cosmeceutical” product to a rigorous New Drug Approval (NDA) process, which includes safety and efficacy testing.[9] 
 

Another difference between cosmetics and drugs is that cosmetic manufacturers have no obligation to engage in adverse event reporting. While cosmetic manufacturers are encouraged to engage in adverse event reporting, there is no requirement under the FC&A Act to report adverse events, regardless of their severity.[10]  Since the creation of the FC&A Act, cosmetic manufacturers have controlled the safety testing of their products. Further, if they choose not to engage in safety testing, they only need to indicate in the product labeling the safety of the product has not been adequately substantiated prior to marketing.[11]  By contrast, if a product is categorized as a drug and is not generally recognized as safe and effective, the cosmetic manufacturer must subject their product to a rigorous New Drug Approval (NDA) process, which includes safety and efficacy testing.[12]