FDA is on the prowl

By Raqiyyah Pippins, Kelley Drye & Warren LLP

The past few years have been marked with an increase in scrutiny of personal care products by the Food & Drug Administration (FDA),[1] including FDA efforts to define the regulatory boundaries governing different classes of personal care products and clarify the regu-----latory distinction between cosmetics and drugs.  After hinting to industry in 2011 that it intended to monitor the category, FDA issued a series of warning letters in 2012 emphasizing its concerns regarding the use of hair removal, ant-aging, and blemish removal related claims for products labeled as cosmetics, asserting its position that such claims cross the “lines” for cosmetic products and cause such products to be drugs under the FDCA.[2]   In 2013, FDA re-affirmed its position regarding the types of beautification claims that it considers to be  drug claims, while also highlighting some new-areas for consideration:  specifically, the regulatory lines governing beautification devices, personal care products for diseased populations, and third-party contractors.

Reaffirming Past Priorities

Last year, we discussed FDA’s scrutiny of personal care products and the manner in which a personal care product’s regulatory classification can significantly impact the regulatory standards governing the product’s manufacturing, marketing and labeling.[3] For example, before being marketed, products classified as OTC drugs must either receive pre-market approval by FDA or conform to FDA monographs- -essentially an FDA-approved formula for a drug product. In contrast, while cosmetic manufacturers are responsible for ensuring product safety, products classified as cosmetics do not need to obtain pre-market FDA approval or conform to a specified pre-approved FDA formula.[4]

How FDA categorizes a personal care product is determined, in part, by what FDA concludes to be the manufacturer’s “intended use” for the product.  Among other things, FDA reviews product covers (e.g., advertisements, websites, labeling, and ingredient statements) as evidence of a product’s intended use.   Products marketed with drug claims—claims that a product is “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body”—without pre-market approval by FDA or conforming to FDA monographs are considered “unapproved new drugs” and cannot be legally marketed in the United States.[5]

In 2013, FDA reaffirmed these priorities with more warning letters regarding unapproved anti-aging, blemish removal, and hair-removal product claims that caused the products to be unapproved new drugs.  For instance, FDA’s March 2013 warning letter to Keystone Laboratories, Inc.[6] regarding its personal care products is an example of FDA’s efforts to continue monitoring the category.  The letter was largely consistent with previous FDA action challenging the use of claims and/or ingredients that FDA considers to be evidence that a product is intended for use as an unapproved new drug, including allegations that the inclusion of recognized drug ingredients (e.g., hydroquinone 2% and padimate o 1.5%) as active ingredients and blemish removal claims (e.g., “fades skin discoloration by lightening dark spots such as frecklAir Jordan IV 4 Retro Pinnacle Croc Pony Hair