News & Events / Will FDA Get New Authority to Regulate Cosmetics?
Will FDA Get New Authority to Regulate Cosmetics?
Beveridge & Diamond, P.C., July 5, 2012
Drug and medical device manufacturers must receive advance approval from the U.S. Food and Drug Administration (“FDA”) before marketing their products to the public. In contrast, cosmetic companies are individually responsible for substantiating the safety of their products before they go to market. Despite the cosmetics industry having experienced significant change with the inclusion of more complex ingredients in products, FDA’s authority to regulate cosmetics has not changed in decades. Several bills have been introduced in Congress to change that, but cosmetics reform remains uncertain. This Client Alert discusses the current regulatory framework for cosmetics and provides an overview on the various cosmetics reform bills proposed in Congress.
Existing Regulation of Cosmetics
Since 1938, FDA has regulated the safety and effectiveness of cosmetic products through the Federal Food, Drug, and Cosmetic Act (“FFDCA”), as amended, and its implementing regulations. Under the FFDCA, the term “cosmetic” is broadly defined as “(1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.” Common examples of cosmetics include makeup, face and body lotions, nail polishes, shampoos and conditioners, some toothpastes, mouthwashes, deodorants, perfumes, and baby powders.
Cosmetics are regulated relatively lightly in comparison to other products FDA regulates. FDA has adopted regulations for the voluntary registration of cosmetics product establishments and disclosure of ingredients in cosmetics through FDA’s Voluntary Cosmetic Registration Program ("VCRP"). However, currently only about a third of cosmetics companies participate in VCRP. Additionally, the FFDCA does not subject cosmetics products to advance approval by FDA prior to their introduction into the marketplace, nor does it authorize FDA to require affirmative proof from a manufacturer that any cosmetic or ingredient is safe. However, the FFDCA does allow FDA to take action to remove cosmetic products deemed adulterated or misbranded from the marketplace.
In general, cosmetics manufacturers, and not FDA, are responsible for ensuring that the safety of their products is “adequately substantiated.” The industry standard for substantiation is through an independent, industry-funded, ingredient safety assessment conducted by the Cosmetic Ingredient Review (“CIR”). Founded in 1976, CIR is an independent expert panel that assesses the safety of ingredients in cosmetics and publishes the results in peer-reviewed scientific literature. Ingredients reviewed by CIR are generally considered by FDA to meet the adequate substantiation requirement. In sum, the current regulatory framework for cosmetics consists of industry-initiated reviews as well as voluntary reporting.
State Regulation of Cosmetics
Some states have acted to supplement this limited federal regulation of cosmetics by passing their own more restrictive legislation. California enacted the California Safe Cosmetics Act of 2005 (“CSCA”), requiring manufacturers to tell state officials about cosmetics that “contain any ingredient that is a chemical identified as causing cancer or reproductive toxicity,” including chemicals used for fragrance or flavoring, regardless of the concentration of the chemical. CSCA grants authority to the state’s Safe Cosmetics Program to conduct audits, investigations, and health-based studies. It also requires manufacturers to submit any additional information on their products as deemed necessary by the program for conducting these assessments.
Other states have followed California in passing more restrictive legislation as well. In 2008, Washington passed the Children's Safe Products Act. It directs the Department of Ecology to require manufacturers of children’s products, specifically including children’s cosmetics, to generate reports about their products containing “high priority” chemicals. In 2009, Minnesota adopted the Toxic Free Kids Act, which directs the Minnesota Department of Health (“MDH”) to create two lists of chemicals, i.e., “chemicals of high concern” and “priority chemicals” present in children’s products, a term which specifically includes personal care products (i.e., cosmetics).
Safe Cosmetics Act of 2011
Congress itself is considering beefing up FDA’s authority to regulate cosmetics. On June 24, 2011, Reps. Jan Schakowsky (D-IL), Ed Markey (D-MA), and Tammy Baldwin (D-WI) introduced the Safe Cosmetics Act of 2011, H.R. 2359 (the “Schakowsky Bill”). This bill is designed to overhaul the cosmetics provisions of the FFDCA and strengthen FDA’s role in the regulation of cosmetics. Under this bill, cosmetic manufacturers would be required to submit extensive information to FDA on the safety of their product ingredients. Of the various proposals introduced in Congress, the Schakowsky Bill represents the most restrictive regulation of cosmetics. Provisions in the bill include:
The President’s Proposal for Cosmetics Reform
In 2012, the Obama Administration proposed its own, more modest reforms for cosmetic regulation. Similar to the FDA registration program for drug manufacturers, the Administration has proposed legislation authorizing a cosmetic manufacturers user fee to help fund the establishment of a mandatory cosmetic registration program. A mandatory cosmetic registration program would require cosmetics companies to register their products by submitting product, ingredient, and facility information to FDA, essentially making the VCRP mandatory. The information and data acquired from the mandatory cosmetic registration program would also enable FDA to better develop cosmetic regulations and monitoring approaches of cosmetic products.
Cosmetics Safety Enhancement Act of 2012
On March 26, 2012, Reps. Pallone (D-NJ) and Dingell (D-MI) introduced the Cosmetics Safety Enhancement Act of 2012, H.R. 4262 (the “Pallone Bill”), a more limited bill than the Schakowsky Bill but which nevertheless would go beyond the Obama Administration’s request. In addition to establishing a mandatory cosmetics registration program, the Pallone Bill would require cosmetics companies to compile scientific evidence demonstrating the safety of their products. However, cosmetics companies would have no obligation to submit the scientific evidence to FDA unless FDA specifically requested the information. Provisions of the bill include:
Cosmetics Safety Amendments Act of 2012
One of the most contentious issues in the debate over cosmetics reform is how to balance the competing interests of the insistence of some for full ingredient disclosure for cosmetics with cosmetic manufacturers’ expressed need to protect confidential business information and trade secrets. One proposed bill has the full support of the Personal Care Products Council, the leading national trade association representing the cosmetics and personal care industry. Introduced by Rep. Leonard Lance (R-NJ) on April 18, 2012, the Cosmetic Safety Amendments Act of 2012, H.R. 4395 (the “Lance Bill”), aims to create national uniform standards for cosmetics regulation, while affording cosmetics companies trade secret protections of product ingredients. Provisions of the bill include:
Prospects for Passage
At this point, it is not likely that any of the four proposals for cosmetics reform will pass. None has yet made it out of committee. In particular, the Schakowsky Bill, which received little traction in the previous Democratic-controlled Congress, shows no sign of moving forward in the current Republican-controlled House. Both the House and Senate have approved the Food and Drug Administration Safety and Innovation Act, S. 3187, a FDA user fee bill now before President Obama for signature. That legislation does not address cosmetics. Rep. Lance had hoped to include his cosmetics reform bill within the House version of an earlier FDA user-fee bill, but his provisions were not accepted during the House Energy and Commerce Committee mark-up of the bill.
The Senate has yet to consider any proposals in regard to cosmetics reform, although it has passed legislation increasing regulatory oversight of sunscreens. In an election year, the prospect of passing any cosmetics reform remains uncertain at best.
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 21 U.S.C. §§ 301-399.
 Id. at § 321.
 21 C.F.R. Parts 710, 720.
 See Statement of Michael Landa, Director, Center for Food Safety and Applied Nutrition, FDA, Examining the Current State of Cosmetics: Hearing Before the Subcomm. On Health of the H. Comm. on Energy & Commerce, 112th Cong. (March 27, 2012), http://energycommerce.house.gov/hearings/hearingdetail.aspx?NewsID=9394.
 Adulterated cosmetics are those which (1) contain poisonous or deleterious substances rendering the cosmetics injurious, (2) contain filthy, putrid, or decomposed substances, (3) have containers made, formed, or filled as to be misleading. FFDCA § 602, 21 U.S.C. § 362.
 Misbranded cosmetics generally are those which (1) have false or misleading labeling, (2) have labels without all required information displayed prominently and conspicuously, or (3) have containers made, formed, or filled as to be misleading. FFDCA § 602, 21 U.S.C. § 362.
 21 C.F.R. § 740.10
 Cal. Health & Safety Code § 111792(a)
 Wash. Rev. Code Ann. § 70.240
 Minn. Stat. § 116.9401. According to the statute, a “priority chemical” is one that “(1) has been identified as a high-production volume chemical by the United States Environmental Protection Agency; and (2) meets any of the following criteria: (i) the chemical has been found through biomonitoring to be present in human blood, including umbilical cord blood, breast milk, urine, or other bodily tissues or fluids; (ii) the chemical has been found through sampling and analysis to be present in household dust, indoor air, drinking water, or elsewhere in the home environment; or (iii) the chemical has been found through monitoring to be present in fish, wildlife, or the natural environment.”
 The Safe Cosmetics Act of 2011 was an update to the Safe Cosmetics Act of 2010, H.R. 5786 (111th Congress). In many ways, the Safe Cosmetics Act of 2011 is similar to legislation introduced to amend the Toxic Substances Control Act (“TSCA”) in 2010 and 2011. For more information about the Safe Cosmetics Act of 2010 and its relationship to TSCA legislation, see “Cosmetics Safety Bill Would Incorporate TSCA Bill Provisions” (August 2, 2010), http://www.bdlaw.com/news-935.html.
 FDA currently has a voluntary program for registration of cosmetic product establishments, 21 C.F.R. Part 710.
 FDA currently requires ingredient disclosure on cosmetic labels, except for trade secret ingredients. 21 C.F.R. Part 701.
 For an analysis of how FDA handles nanoscale ingredients in cosmetics today, see "FDA Regulation of Nanomaterials" (Mark Duvall, ed., 2012), http://www.bdlaw.com/assets/attachments/FDA%20REGULATION%20OF%20NANOTECHNOLOGY.pdf.
 21 C.F.R. Part 207 (establishing registration requirements for drug manufacturers).
 U.S. Department of Health and Human Services, Food and Drug Administration, Budget in Brief: Strengthening Health and Opportunity for All Americans, Fiscal Year 2013 (2012), www.hhs.gov/budget/budget-brief-fy2013.pdf.
 The bill would define “safe” to mean “that evidence in the file . . . demonstrates that there is a reasonable certainty that no harm will result from the use of the cosmetic product under the intended conditions of use for such cosmetic product.”
 FDA currently has voluntary GMP regulations, see http://www.fda.gov/cosmetics/guidancecomplianceregulatoryinformation/
 “Serious adverse event” would include any event resulting in “death, a life threatening experience, inpatient hospitalization, disability, disfigurement, incapacity, or a congenital anomaly or birth defect.”
 “Serious adverse event” would be defined as one that results in death, a life-threatening experience, inpatient hospitalization, a persistent and significant disability, or a birth defect. An “unexpected adverse event” would be defined as “one that is not identified in the current labeling for the cosmetic.”
 The Sunscreen Labeling and Protection Act of 2011, S. 1064.