“#1 Selling Neck Cream. Now even more tightening, lifting…”
“Use to treat dark spots and discolorations.”


For many, the above reflect common references to the benefits of personal care products. In 2015, FDA is reminding companies that the claims may also cause their products to be drugs.
Together with Happi, we have monitored FDA’s increased scrutiny of personal care products since 2011 and the increasing legal risk its scrutiny is imposing for personal care product companies. In February, FDA issued warning letters to L’Oreal andStriVectin alleging that these and similar claims caused their personal care products to be drugs.


The L’Oreal andStriVectin letters highlight three notable risks areas for companies in this space:


• Skin discoloration claims. While many companies are aware of the risks involved with anti-aging claims, FDA’s warning letter to L’Oreal also included a dark spot product intended to corrected skin discoloration. Notably, FDA considered the relatively vague statement “Recommended For: Hyperpigmentation and Dark Spots” to be a drug claim. This suggests that FDA is closely scrutinizing skin discoloration claims and that companies may want to specifically state that a product reduces the appearance of skin discoloration to further mitigate risk of a product being classified as a drug.


• Product websites. Both warning letters stemmed from FDA reviewing the product websites. Many times, companies will use more aggressive claims on a product website than on the product label, based on a belief that the website provides less risk of challenge or scrutiny by a regulator. FDA’s recent letters are a reminder that FDA may take regulatory action based on website claims alone.


• Use of “serum,” or terms used in drug indications (e.g., treats or relieves). A review of recent FDA warning letters reveals a pattern. Terms like “serum” appear to be correlated with a higher risk of FDA interpreting the relating claim as a drug claim (e.g., “Localized Redness Intensive Serum” and “Concentrated Dark Spot Correcting Serum”).  Companies marketing products intended to address unflattering discoloration or other skin conditions should be prepared to assume more risk by including “serum” or similar terms in a product claim. Similarly, companies interested in reducing risk of FDA considering their beautification product to be a drug may want to avoid using the terms “treats” or “relieves.” “Treat” and “Relieve” are commonly used by FDA and the drug industry to describe the intended use for drug products, and thus can increase the risk of FDA considering claims for a beautification product to be a drug claim. 


After hinting to industry in 2011 that it intended to monitor the category, FDA issued a series of warning letters in 2012 asserting its position that the use of hair removal, anti-aging and blemish removal related claims for products labeled as cosmetics actually caused such products to be drugs under the FDCA. In 2013, FDA reaffirmed these priorities with more warning letters regarding unapproved anti-aging, blemish removal and hair-removal product claims, while also highlighting some new areas receiving their consideration; specifically, the marketing of beautification devices, development of personal care products for diseased populations and reliance on third-party contractors. After a relatively quiet 2014, FDA started the new year off with a bang. 


FDA’s recent enforcement activity indicates that FDA intends to further assert its regulatory authority over personal care products. These steps can help to significantly reduce the risk profile for such products in 2015.


About the Author
Raqiyyah R. Pippins is a senior associate in the advertising and marketing and Food and Drug Law practices at Kelley Drye & Warren LLP in Washington, D.C. Contact her directly at [email protected]or learn more about the firm at www.kelleydrye.com.