Will FDA Get New Authority to Regulate Cosmetics?

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1 July 3, 2012 Authors: Mark N. Duvall 1350 I Street, NW Suite 700 Washington, DC (202) mduvall@bdlaw.com Introduction Will FDA Get New Authority to Regulate Cosmetics? 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 For more information about our firm, please visit If you do not wish to receive future Client Alerts, please send an to: jmilitano@bdlaw.com Since 1938, FDA has regulated the safety and effectiveness of cosmetic products through the Federal Food, Drug, and Cosmetic Act[1] ( 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. [2] 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"). [3] However, currently only about a third of cosmetics companies participate in VCRP. [4] 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[5] or misbranded[6] from the marketplace. In general, cosmetics manufacturers, and not FDA, are responsible for ensuring that the safety of their products is adequately substantiated. [7] 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

2 chemical identified as causing cancer or reproductive toxicity, including chemicals used for fragrance or flavoring, regardless of the concentration of the chemical.[8] 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.[9] 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 [10] 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[11] (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: Establishment Registration Domestic and foreign establishments that manufacture, package, or distribute cosmetics would have to register annually with FDA. Registration requirements would include the submission of general information about the establishment and its cosmetic products. FDA would be required to make the registration list publicly available, but registration documents would not be disclosed.[12] Full Ingredient Disclosure Within one year of enactment, labels on each package of cosmetics would be required to bear a declaration of the name of each ingredient in descending order of prominence, regardless of trade secret claims. Internet vendors of cosmetics would also be required to display product ingredient lists on their websites. Current law does not require complete ingredient disclosure for cosmetic products.[13] Submission of Publicly Available Test Data Within one year of enactment, manufacturers and distributors of cosmetics and cosmetic ingredients would be required to submit to FDA (in electronic format) all reasonably available information in the possession or control of the manufacturer or distributor that has not previously been submitted to FDA regarding the physical, chemical, and toxicological properties of the chemicals listed on the cosmetic labels. Ingredient Listing and Safety Assessments Within two years of enactment, FDA would have to issue a list of ingredients identified by FDA as either prohibited, restricted, or safe without limits. Prohibited ingredients would include those which FDA determines are unsafe for use in cosmetics in any amount, while restricted ingredients would be those which must be limited in use or concentration to ensure safety. FDA would also have to develop a priority assessment list of not less than 300 ingredients for which a lack of authoritative information precludes FDA from designating the ingredient as prohibited, restricted or safe without limits. FDA would then have to make safety determinations pursuant to administrative rulemaking procedures (i.e., providing public notice and comment) for the ingredients on the assessment list, and would have to continue to add at least 100 ingredients to the list each year until all ingredients used in cosmetic products have been added to the assessment list, the safe without limits list, or the prohibited and restricted list. Notification and Recall of Adulterated or Misbranded Cosmetics The bill would require responsible parties to notify FDA if they have reason to believe that a cosmetic is adulterated or misbranded in a manner that presents a reasonable probability that the use or exposure to the cosmetic will cause a threat of serious adverse health consequences or death to humans. Depending on the circumstances, FDA would have authority to request a voluntary recall, issue an order for the company to cease distribution, or issue an emergency recall order.

3 Mandatory Reporting of Adverse Health Effects The bill would require cosmetic manufacturers, packagers, or distributors to report any information they receive concerning serious adverse health effects associated with the use of their cosmetics. Labeling of Nano-scale Materials FDA would have authority to require that products containing nano-scale materials be labeled as such.[14] Fees The bill would require FDA to establish a schedule of fees to provide for oversight and enforcement of the new cosmetic regulations. Fees would be prorated based on each establishment s gross receipts or sales, and would only be assessed on companies with annual gross receipts or sales of more than $1,000,000. Animal Testing Alternatives The bill would require FDA to publish alternative testing methods to minimize the use of animal testing. 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,[15] the Administration has proposed legislation authorizing a cosmetic manufacturers user fee to help fund the establishment of a mandatory cosmetic registration program.[16] 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 (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: Establishment Registration The bill would require cosmetics companies to register with FDA and disclose where a product is made, all brand names of the product, the product category, and ingredients contained in the product. Safety Substantiation The bill would require companies to maintain for no less than five years, a file on each product it makes containing studies, tests, data, or other information known that relates to the cosmetic product s safety and demonstrate that such cosmetic product is safe. [17] Good Manufacturing Practices The bill would require FDA to promulgate mandatory good manufacturing practice ( GMP ) regulations, and to review international GMPs for cosmetics. [18] Serious Adverse Events Reporting The bill would require cosmetics companies to report any serious adverse event [19] regarding use of a product within 15 days of learning of the event. Fees The bill would require cosmetics companies to pay an annual fee of $500 beginning Fees for 2014 and years following would be set according to a formula contained in the bill. Mandatory Recall The bill would authorize FDA to request that a company voluntarily recall products the agency believes will have serious adverse health consequences. If the company fails to do so, FDA would have the authority to recall such products on its own.

4 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 (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: Establishment Registration Domestic and foreign establishments that manufacture, package, or distribute cosmetics would have to register annually with FDA. Registration requirements would include the submission of general information about the establishment and its cosmetic products. Trade Secret Protections The bill would authorize FDA to accept CIR s determination on safety substantiation of cosmetics ingredients. However, the bill provides that CIR s determination does not apply to companies that have demonstrated the safety of their ingredients and have provided that substantiation as confidential business information to FDA. The bill would also provide that confidential business information is not subject to publication in an electronic National Cosmetic Regulatory Databank available for use by regulators and the general public. Serious and Unexpected Adverse Events Reporting The bill would require cosmetics companies to report any serious and unexpected adverse event [20] regarding use of a product within 15 days of learning of the event. Good Manufacturing Practices The bill would require FDA to promulgate mandatory GMP regulations and to review international GMPs for cosmetics. Regulation of Tolerance Levels of Nonfunctional Constituents The bill would authorize FDA to establish tolerance levels for nonfunctional constituents, i.e., ancillary ingredients in cosmetics products that serve no cosmetics function in products. 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.[21] In an election year, the prospect of passing any cosmetics reform remains uncertain at best. For more information, please contact Mark Duvall (mduvall@bdlaw.com), (202) [1] 21 U.S.C

5 [2] Id. at 321. [3] 21 C.F.R. Parts 710, 720. [4] 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), hearingdetail.aspx?newsid=9394. [5] 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 [6] 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 [7] 21 C.F.R [8] Cal. Health & Safety Code (a) [9] Wash. Rev. Code Ann [10] Minn. Stat 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. [11] The Safe Cosmetics Act of 2011 was an update to the Safe Cosmetics Act of 2010, H.R (111 th 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 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), [12] FDA currently has a voluntary program for registration of cosmetic product establishments, 21 C.F.R. Part 710. [13] FDA currently requires ingredient disclosure on cosmetic labels, except for trade secret ingredients. 21 C.F.R. Part 701. [14] For an analysis of how FDA handles nanoscale ingredients in cosmetics today, see "FDA Regulation of Nanomaterials" (Mark Duvall, ed., 2012), FDA%20REGULATION%20OF%20NANOTECHNOLOGY.pdf. [15] 21 C.F.R. Part 207 (establishing registration requirements for drug manufacturers). [16] 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), budget/budget-brief-fy2013.pdf. [17] 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.

6 [18] FDA currently has voluntary GMP regulations, see guidancecomplianceregulatoryinformationgoodmanufacturingpracticegmpguidelinesinspection checklist/default.htm. [19] 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. [20] 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. [21] The Sunscreen Labeling and Protection Act of 2011, S Office Locations: Washington, DC Maryland New York New Jersey Massachusetts Texas California Copyright 2012 Beveridge & Diamond, P.C. All rights reserved This Client Alert is not intended as, nor is it a substitute for, legal advice. You should consult with legal counsel for advice specific to your circumstances. This communication may be considered advertising under applicable laws regarding electronic communications

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