The Safe Cosmetics Act Of 2011 (H.R. 2359): Implications For The Cosmetics Industry

The Safe Cosmetics Act of 2011 (H.R. 2359): Implications for the Cosmetics Industry

Regulation of the cosmetics industry has garnered significant national attention in recent months. On March 27, 2012, nine months after legislators introduced the Safe Cosmetics Act of 2011, H.R. 2359, a subcommittee of the U.S. House of Representatives convened a hearing about the "current state of cosmetics."1 One day earlier, Reps. Dingell (D-MI) and Pallone (D-NJ) introduced a similar legislative bill, the Cosmetics Safety Enhancement Act, H.R. 4262. And just last April, Rep. Lance (R-NJ) introduced the Cosmetic Safety Amendments Act of 2012, H.R. 4395. While each of these bills is slightly different, their collective introduction is indicative of a referendum for reform that could profoundly impact the cosmetics industry.

This Client Alert discusses the current regulatory framework for cosmetics, analyzes the Safe Cosmetics Act of 2011, the bill that seemingly prompted the March 2012 House hearing and introduction of the two other bills, and offers related best practices and compliance advice to cosmetics companies. Today's cosmetics are not regulated rigorously by the federal government, as the Food, Drug, and Cosmetic Act of 1938 ("FDCA") only requires the U.S. Food and Drug Administration ("FDA") to monitor cosmetics.2 States have taken steps to fill this space, passing divergent, sometimes conflicting, regulatory measures, which subject cosmetics companies to ambiguous responsibilities and a risk of litigation. The Safe Cosmetics Act of 2011 would, for the first time, set a national safety standard for cosmetics, including strict labeling, reporting, and testing requirements. Thus, it is critical that cosmetics companies understand the nuances and implications of this proposed legislation.

Lipstick Jungle Demystified: The Current Regulatory Framework for Cosmetics

Modern cosmetics, with their pharmaceutical-type properties and drug-like ingredients, are poles apart from the cosmetics sold in 1938, when Congress passed the FDCA. In the past, cosmetics offered temporary, superficial alterations.3 Today, cosmetics contain drug-like ingredients and are marketed as "treatments" and "serums," capable of "ultra correction" and "rescue."4 While cosmetics have evolved, federal law has not. Consequently, when consumers allege injury from alpha-hydroxy acids in creams, lead in lipsticks, or formaldehyde in hair treatments, cosmetics companies face the prospect of multiple punishments for the same alleged harm.

Federal Regulation of Cosmetics

The federal law that confers "regulatory powers" for cosmetics on the FDA provides scant authority. While the FDCA prohibits adulteration and misbranding of cosmetics, it does not oblige cosmetics companies to submit proposed products or components, other than color additives, for pre-market review and approval; to register with the FDA; or to advise the FDA of product ingredients pre-market introduction.5 Further, the FDCA does not set forth good manufacturing practice requirements for cosmetics.6 In short, the FDCA's blunted language makes the FDA a reactive federal agency, dependent upon post-market release consumer complaints and the cosmetic industry's voluntary provision of information.7

State Regulation of Cosmetics

States have acted to fill the perceived vacuum created by the FDCA, passing statutes to address cosmetics. Many of these laws do no more than echo or support enforcement of the FDCA.8 However, some states have passed more comprehensive regulations. In California, for example, the California Safe Cosmetics Act of 2005 ("CSCA") compels manufacturers to advise state regulators about cosmetics that "contain any ingredient that is a chemical identified as causing cancer or reproductive toxicity," including chemicals used for fragrance or flavoring.9 The CSCA also grants the state broad investigative authority for cosmetics containing "ingredients of concern," including the power to order manufactures to submit data about health effects and related studies.10 Meanwhile, in Washington, the Children's Safe Products Act of 2008 restricts the use of phthalates in cosmetics made for or marketed to children, and permits the state to force manufacturers to generate reports about cosmetics containing "high priority" chemicals.11 As another example, New York has passed a statute that restricts the amount of volatile organic compounds, which may be included as ingredients in cosmetics.12

The Safe Cosmetics Act of 2011: Background

On June 24, 2011, U.S. Representatives introduced the Safe Cosmetics Act of 2011, H.R. 2359, to "ensure the safe use of cosmetics."13 The Act's provisions include:

Annual registration requirements for companies with more than $2 million in sales, accompanied by fees for companies manufacturing or packaging cosmetics that have annual gross receipts or sales exceeding $10 million;14 Disclosure requirements that obligate cosmetics manufacturers to submit to the U.S. Department of Health and Human Services ("HHS"): ingredient lists; product...