Cosmetics Safety Bill Would Incorporate TSCA Bill Provisions

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1 Beveridge & Diamond, P.C., August 2, 2010 Regulation of cosmetics by the Food and Drug Administration ( FDA ) would be thoroughly overhauled under a bill introduced on July 20, 2010, the Safe Cosmetics Act of 2010, H.R ( SCA ). The bill would be a substantial change to the Federal Food, Drug, and Cosmetic Act ( FFDCA ).[1] It is also noteworthy in that it would extend to cosmetics many of the provisions of another bill introduced two days later to amend the Toxic Substances Control Act ( TSCA ). In many ways, the Safe Cosmetics Act is an extension of the Toxic Chemicals Safety Act, H.R ( TCSA ), introduced on July 22, Both were sponsored by Rep. Jan Schakowsky (D-IL). Background on Existing Regulation of Cosmetics FDA regulates the safety and effectiveness of cosmetic products through the FFDCA and its implementing regulations. Cosmetic is defined in the FFDCA 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] By this definition, cosmetics encompass a broad range of products.[3] As compared to FDA s other regulated products, cosmetics are governed relatively lightly, and (except for color additives used in cosmetics) only after introduction to the market. The current regulatory framework does not require advance approval by FDA before a cosmetic is marketed. Cosmetic manufacturers, not a regulatory agency, bear the responsibility of ensuring that the safety of their product is adequately substantiated. The industry standard for substantiation is through an independent ingredient safety assessment conducted by the Cosmetic Ingredient Review, an industry-funded but independent expert panel founded in While the FFDCA does not authorize FDA to require affirmative proof from a manufacturer that any cosmetic or ingredient is safe, FDA is empowered to take regulatory action to remove cosmetic products deemed adulterated[4] or misbranded[5] from the marketplace. In sum, industry-initiated assessments and voluntary reporting largely supplant FDA oversight of cosmetics under the current regulatory framework.

2 Safe Cosmetics Act of 2010 Introduced by Reps. Jan Schakowsky (D-IL), Ed Markey (D-MA), and Tammy Baldwin (D-WI), the Safe Cosmetics Act would transform FDA s role in the oversight of cosmetics. The bill would preserve FDA s authority to take action against adulterated and misbranded products, but it would also amend the FFDCA by adding a new subchapter on cosmetics. Provisions in the bill include: Establishment Registration Domestic and foreign establishments that manufacture, package, or distribute cosmetics must register annually with FDA. Registration requirements 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.[6] 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. 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.[7] Submission of Publicly Available Test Data Within one year of enactment, manufacturers and distributors of cosmetics and 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 are 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

3 make safety determinations pursuant to administrative rulemaking procedures (i.e., providing public notice and comment) for the ingredients on the assessment list, and must 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. Market Restrictions The bill would prohibit companies from manufacturing, importing, distributing, or marketing cosmetics which contain non-permitted ingredients (i.e., in reference to the prohibited and restricted ingredients lists).[8] Additionally, the bill would prohibit any ingredient for which FDA has not made a safety determination within five years from the time the ingredient is first listed on the priority assessment list. The prohibition would lift if FDA subsequently determines the ingredient to be safe. Finally, companies that fail to provide information to FDA as required by the bill would also be prohibited from manufacturing, importing, distributing or marketing cosmetics. 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. 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. Fees The bill would require FDA to establish a schedule of fees to provide oversight and enforcement of the new cosmetic regulation. Fees would be prorated based on each establishment s gross receipts or sales, and would only be assessed on companies with annual gross

4 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. Relationship to the TSCA Bill Rep. Schakowsky and her co-sponsors introduced the Safe Chemicals Act only two days before she co-sponsored the Toxic Chemicals Safety Act, which would similarly overhaul how EPA regulates industrial chemicals under TSCA. Many of the Safe Chemicals Act provisions are very similar to those in the Toxic Chemicals Safety Act, including the following: The safety standard of reasonable certainty of no harm. Both bills would require consideration of aggregate exposure to a chemical, including impacts on vulnerable populations. Both bills also require protection of the public welfare from adverse effects.[9] Unlike the TSCA bill, however, the cosmetics bill would define reasonable certainty as either a one-in-a-million risk of an adverse effect or a level of exposure producing no adverse effects, incorporating an uncertainty factor of 1,000.[10] Disclosure of trade secret chemical identities. The cosmetics bill would require public listing of ingredient identities even if trade secret and prohibit confidentiality protection for chemical identities. The TSCA bill would prohibit confidentiality protection for chemical identities in certain circumstances.[11] Public database of health and safety studies. Like the cosmetics bill, the TSCA bill would require companies to submit health and safety studies to the agency, which would then make the information available on a public-accessible Internet database.[12] Safety standard determinations. Both bills would require the agency to determine whether chemicals are safe without restrictions, require certain restrictions in order to be safe, or are not safe even with additional restrictions.[13] Priority list. Both bills would require the agency to compile a list of at least 300 chemicals that are a priority for safety determinations.[14] Burden of proof. Both bills would require a manufacturer to provide

5 the information needed by the agency to determine whether a chemical meets the safety standard.[15] Minimum data set. Both bills would require manufacturers to submit a minimum data set for their chemicals.[16] CEO certification. The cosmetics bill would incorporate a provision absent from the Toxic Chemicals Safety Act, but present in the 2008 TSCA bill, requiring the chief executive officer of a manufacturer to certify, after a good faith inquiry, that the chemical meets the safety standard or there are insufficient data to determine whether it meets the safety standard.[17] Special provisions for nanomaterials. The cosmetics bill would authorize FDA to require labeling of ingredients as nano-scale, while the TSCA bill would authorize EPA to require reporting of substance characteristics, which could include size considerations.[18] Animal testing. Both bills have provisions intended to minimize the use of animal testing.[19] Reaction to the Safe Cosmetics Act One of the most contentious issues in the debate over consumer product regulatory reform is how to balance the competing interests of consumer insistence on full ingredient disclosure with product manufacturers expressed need to protect confidential business information and trade secrets. The Safe Cosmetics Act cuts more in favor of the consumer interest in disclosure, providing that the name, identity, and structure of a chemical substance, contaminant, or impurity that is an ingredient and all information concerning function, exposure, health hazards, and environmental hazards, and the functions of ingredients in cosmetics shall not be considered to be confidential business information. Moreover, fragrances, flavors and colorants would not be considered confidential. The bill would, however, protect as confidential the concentration of ingredients used in finished products. The bill is likely to face opposition from the cosmetics industry due in part to the safety assessment framework, market restrictions, and mandatory disclosure requirements. The Personal Care Products Council ( PCPC ) has already lodged its opposition to the bill, arguing that it would put an

6 enormous if not impossible burden on FDA, and would create a mammoth new regulatory structure for cosmetics, parts of which would far exceed that of any other FDA-regulated product category including food or drugs. Only days before the introduction of the Safe Cosmetics Act, that group sent a letter to health policy legislators outlining the trade association s proposed regulatory changes to strengthen the effective FDA regulation of personal care products such as cosmetics. The industry group s five-point plan calls for more moderate measures including the following: 1. Enhanced FDA Regulation: Manufacturers who market their products in the U.S. would have to: Register with FDA all facilities where those products are manufactured; File with FDA product ingredient reports disclosing all ingredients used in those products; and Report to FDA any serious unexpected adverse event experienced by consumers with a product. (Note: these requirements are similar to those in the Safe Cosmetics Act, but the PCPC plan requires ingredient disclosure only to FDA whereas the bill requires ingredients be listed on the package labels.) 2. FDA Ingredient Review Process: Upon request of any party or on its own initiative, FDA would be required to review the safety of any ingredient intended for use in a personal care product and set safety levels for such ingredient on a specified timetable. (Note: this proposal would give FDA authority to conduct ingredient safety assessments, but unlike the bill, it would not obligate FDA to assess each ingredient.) 3. Processes to Set Safety Levels for Trace Contaminants: Upon request of any party or on its own initiative, FDA would be required to establish safe levels for trace constituents in cosmetic ingredients and products. 4. FDA Oversight of CIR Findings: FDA would be required to review current and future findings on the safety of cosmetic ingredients by the CIR Expert Panel and determine if the findings are correct.

7 (Note: this proposal reflects a preference of leaving safety assessments largely in the hands of the CIR.) 5. FDA-issued Good Manufacturing Practices ( GMP ): FDA would establish industry-wide GMP requirements. The PCPC has also expressed support for a reform bill introduced last year by Reps. John Dingell (D-MI) and Bart Stupak (D-MI). See Food and Drug Administration Globalization Act of 2009, H.R. 759 (Jan. 28, 2009) (hereinafter Dingell Bill ). The Dingell Bill would have revamped FDA s regulatory authority not only with respect to cosmetics but also with food, drugs, and medical devices. Yet like the PCPC plan, the Dingell Bill called for mandatory registration of cosmetics manufacturers and adherence to FDA-approved GMPs, but would not empower FDA to make safety determinations with respect to cosmetic ingredients. Also, while the Dingell Bill would have required manufacturers to disclose all ingredients to FDA, it would have allowed flavors and fragrances to be designated as such without specifying the individual components of those chemicals. Finally, the Dingell Bill would have limited the mandatory adverse event reporting to events resulting in death, life-threatening experience, in-patient hospitalization, persistent and significant disability or incapacity, congenital anomalies or birth defects. All three proposals would reform the way FDA regulates cosmetics. The Safe Cosmetics Act, however, incorporates the most stringent requirements, particularly with respect to FDA s obligatory safety assessments of cosmetic ingredients and full ingredient disclosure on the package labels. While the scope of reform remains undetermined, the ever-increasing pressure to strengthen regulatory oversight of chemicals in consumer products makes it possible that a legislative change is on the horizon. For more information on the Safe Cosmetics Act or other proposals discussed in this alert, please contact Mark Duvall (mduvall@bddlaw.com), (202) , or Graham St. Michel (gstmichel@bdlaw.com), (202) [1] 21 U.S.C [2] FFDCA 201(i), 21 U.S.C. 321(i). [3] Not all consumer products applied to the skin fall exclusively within the

8 definition of cosmetics. Some cosmetics also meet the definition of drugs; articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and articles (other than food) intended to affect the structure or any function of the body of man or other animals. FFDCA 201(g)(1), 21 U.S.C. 321(g)(1). While the FFDCA does not recognize the term, these so-called cosmeceuticals, which meet the definition of both a cosmetic and a drug, such as sunscreens, antiperspirants, dandruff shampoos, and acne treatments, must meet the more demanding regulatory requirements of FDA s over-the-counter drug regulation system. 21 C.F.R. Parts 347, 350, 352, 358. [4] Adulterated cosmetics are those which (1) contain poisonous or deleterious substances rendering the cosmetics injurious, (2) contain filthy, putrid, or decomposed substances, (3) have been prepared, packaged, or held under unsanitary conditions, or (4) have containers composed of poisonous or deleterious substances. FFDCA 601, 21 U.S.C [5] 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 [6] FDA currently has a voluntary program for registration of cosmetic product establishments, 21 C.F.R. Part 710. [7] FDA currently requires limited ingredient disclosure on cosmetic labels, 21 C.F.R. Part 701. [8] FDA currently restricts the use of certain chemicals in cosmetics, 21 C.F.R. Part 700, Subpart B. [9] Compare SCA 2(2), adding FFDCA 611(5), with TCSA 6(5), adding TSCA 6(b)(1)(A). [10] SCA 2(2), adding FFDCA 611(3). Those criteria may thus be relevant to interpretation of the similar standard in TCSA. [11] Compare SCA 2(2), adding FFDCA 613(c) and 620(a), with TCSA 14(5)(B), adding TSCA 14(d)(1). [12] Compare SCA 2(2), adding FFDCA 614(a), with TCSA 8(8), adding TSCA 8(d).

9 [13] Compare SCA 2(2), adding FFDCA 614(b), with TCSA 6(5), adding TSCA 6(b). [14] Compare SCA 2(2), adding FFDCA 614(b)(3), with TCSA 6(5), adding TSCA 6(a). [15] Compare SCA 2(2), adding FFDCA 613(c)(1), with TCSA 6(5), adding TSCA 6(b)(2). [16] Compare SCA 2(2), adding FFDCA 613(c)(2), with TCSA 4(1), adding TSCA 4(a). [17] Compare SCA 2(2), adding FFDCA 613(c)(3), with Kid-Safe Chemicals Act, H.R and S. 3040, 3(a), adding TSCA 502. [18] Compare SCA 2(2), adding FFDCA 618(e), with TCSA 3(a)(2)(H), adding TSCA 3(22). [19] Compare SCA 2(2), adding FFDCA Compare SCA 2(2), adding FFDCA 622, with TCSA 27(a), adding TSCA 34.