When companies market anti-aging with physiological impact on the body or one’s appearance, the cosmetic becomes a drug from Happi usa

14 January 2016

The unintentional conversion of personal care products through marketing.

By Jacqueline Sheridan, Dinsmore & Shohl LLP

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.


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