December 20, 2014
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December 18, 2014
Safe Cosmetics and Personal Care Products Act of 2013 Mirrors Toxic Substances Control Act (TSCA) Proposals, Would Greatly Expand FDA Authority Over Cosmetics
Representative Janice Schakowsky (D-IL), with fifteen co-sponsors, has introduced legislation in the House of Representatives to dramatically increase Food and Drug Administration (FDA) oversight of chemicals in cosmetics and other personal care products. The Safe Cosmetics and Personal Care Products Act of 2013, H.R. 1385, includes a number of provisions also included in the Safe Chemicals Act of 2013, S. 696, a bill to modernize the Toxic Substances Control Act (TSCA). The bill would fundamentally transform the regulation of cosmetics and their ingredients. It expands on prior proposals in a number of respects. The bill, introduced March 21, 2013, has been referred to the House Committee on Energy and Commerce and to the Committee on Education and the Workforce.
The bill would add a major new subchapter to the Federal Food, Drug, and Cosmetic Act (FFDCA) chapter on cosmetics. This new subchapter would impose significant new obligations on FDA and on “brand owners,” the entities responsible for bringing a cosmetic to market, whether domestic or foreign establishments. Obligations would also be imposed on ingredient manufacturers and suppliers. The key provisions are as follows:
- FDA currently requires cosmetic ingredients to be listed on a label, except that a flavor or fragrance may be listed as such, and trade secret ingredients may be listed as “other ingredients.” Incidental ingredients present at insignificant levels and without technical or functional effect do not have to be listed.
- The bill would require all ingredients to be listed by name. Contaminants would have to be listed if present at more than 1 part per billion (or lower in some circumstances).
- Like the Safe Chemicals Act of 2013, there would be no trade secret protection for ingredient names. There would be trade secret protection for the concentration of cosmetic ingredients used in a finished cosmetic.
- Nanomaterials would have to be identified as “nano-scale,” using standard of 1% of particles having at least 1 dimension of 100 nanometers or less.
- Vendors of cosmetics sold over the Internet would have to include the ingredient list on their websites.
- Currently, FDA requires manufacturers to establish the safety of each ingredient and finished cosmetic prior to marketing, and to label any cosmetic whose safety has not been established with a warning. FDA itself does not routinely review cosmetics or their ingredients for safety.
- Like the Safe Chemicals Act of 2013, the bill would establish a “reasonable certainty of no harm” standard. Under this standard, FDA would have to evaluate whether a cosmetic or an ingredient in a cosmetic would be reasonably certain to cause no harm to members of the general population or any vulnerable population (including pregnant women, children, salon and spa workers, and cosmetic manufacturing plant workers) by aggregate exposure to the cosmetic or ingredient, taking into account possible harmful effects from low-dose exposures (a reference to endocrine effects), additive effects from repeated exposure over time, and cumulative exposures from all sources.
- The bill would require FDA to ensure that the likely exposure to all sources of the ingredient or cosmetic, including environmental sources, would result in either “not more than a 1 in a million risk for any adverse health effect in any vulnerable population at the lower 95th percentile confidence interval,” or exposure in a concentration “shown to produce no adverse health effects, incorporating a margin of safety of at least 1,000 and considering the impact of cumulative exposure from all sources.”
- FDA would have to review and evaluate the safety of all cosmetics and ingredients, taking into account information submitted by brand owners as well as “authoritative sources” including the Environmental Protection Agency, the International Agency for Research on Cancer, the National Toxicology Program, the California Environmental Protection Agency, and “any other authoritative international, Federal, and State entity,” as determined by FDA.
- FDA would have to place an ingredient on a list of ingredients that are prohibited or restricted in light of the safety standard, or a list of ingredients that are safe without limits or restrictions (at any concentration), or a list of priority for which additional information is needed. FDA would have to place at least 300 chemicals on one of those lists within 2 years of enactment, and at least 100 per year thereafter. Where needed, FDA would have to specify restrictions on concentration or use necessary for an ingredient to satisfy the safety standard. Manufacturers would have to comply with prohibitions or restrictions within 1 year of listing. Cosmetics containing ingredients on the prohibited list would be considered adulterated.
- For an ingredient on the list of priority chemicals, within 2 years of listing, FDA would have to determine whether the ingredient qualifies for either of the other two lists. If there were to be insufficient information, FDA would have to prescribe minimum data requirements. Brand owners would have to either supply the information or eliminate the ingredient within 18 months of the insufficient information determination. If FDA were to fail to classify a priority chemical as either meeting the safety standard or not meeting the safety standard within 5 years of listing as a priority chemical, the ingredient could not be used in cosmetics.
- FDA would have to annually publish a list of “contaminants of concern” linked to severe acute reactions or long-term adverse health effects.
- Any person could petition FDA for prioritization, listing or delisting of ingredients, or listing of contaminants of concern. FDA would have to respond within 6 months of any “reasonable” petition, as determined by FDA rules.
- A brand owner would have to submit to FDA “all data and information that the brand owner can access” regarding the safety of the cosmetic and of its ingredients. The required information would span a wide range of chemical identity, hazard, risk, and use information. The information would have to be updated annually or within 60 days of receiving information on adverse effects suspected to be caused by an ingredient or a cosmetic.
- If a brand owner were to request that a supplier or manufacturer of an ingredient provide any of the information required to be submitted to FDA, the supplier or manufacturer would have to provide it to the brand owner within 90 days of the request.
- A provision would be added for mandatory reporting by brand owners of any serious adverse event associated with the use of a brand owner’s cosmetic, similar to FDA’s current reporting requirements for drugs and medical devices.
- FDA would have to maintain a database of all non-confidential information received under the above requirements.
- Brand owners would have to submit to FDA a cosmetic and ingredient statement providing product use and ingredient information and any warnings and directions for use from the cosmetic label or insert. Failure to submit this statement would render all cosmetics sold by the brand owner misbranded.
- As under the Safe Chemicals Act of 2013, chemical identity could not be claimed confidential business information.
- FDA would be authorized to require any brand owner to conduct testing to demonstrate that a cosmetic meets the safety standard.
- Suppliers could also be required to conduct testing regarding listed “contaminants of concern.”
- FDA would have to require alternative testing methods where practicable and would have to encourage other means to minimize the use of animal testing of ingredients and cosmetics. FDA would have to publish a list of the alternative testing methods every three years.
Establishment Registration and Cosmetic Listing
- FDA currently encourages voluntary registration of cosmetic manufacturing establishments and filing of finished cosmetic ingredient composition statements.
- The bill would require annual registration of domestic and foreign establishments manufacturing cosmetics for the U.S. market, along with annual fees. Microbusinesses (those with annual sales from cosmetics of less than $2 million) would be exempt from this requirement. Registration information would include the gross receipts or sales by the establishment from cosmetics, but would not be subject to the Freedom of Information Act. FDA would have to maintain a list of registered establishments.
- Each brand owner would be required to report annually to FDA information about each cosmetic that it markets, including a list of ingredients.
- New enforcement provisions would be added regarding random annual product sample audits, notification of adulterated or misbranded cosmetics, and orders to recall or cease distribution. FDA could require information about, and from, the supply chain.
- FDA would have to issue guidance prescribing good manufacturing practices for cosmetics and ingredients.
- An Interagency Council on Cosmetic Safety would be established among FDA, the National Institute of Environmental Health Sciences, the Centers for Disease Control and Prevention, the Occupational Safety and Health Administration, and EPA.
- There would be no preemption of differing state or local regulations.
- The bill would also require OSHA to promulgate an occupational safety and health standard regarding material safety data sheets for cosmetics.
Representative Schakowsky has introduced similar bills twice before, and neither got out of committee, even when the Democrats controlled the House of Representatives. In 2012, with a Republican majority in the House, more moderate cosmetic bills were introduced, but none of them got out of committee either. Thus, this bill is unlikely to be enacted. However, it does highlight the continued concerns of some legislators regarding chemicals in products and the sufficiency of information available to regulators and the public regarding such chemicals. It also illustrates the embrace by such legislators of ambitious requirements for regulatory programs as a means of dealing with large numbers of chemicals in commerce.
 Press Release, Reps. Schakowsky, Markey Statement on Introducing the Safe Cosmetics and Personal Care Products Act (Mar. 21, 2013), http://schakowsky.house.gov/index.php?option=com_content&view=article&id=3289.
 H.R. 1385, available at http://www.gpo.gov/fdsys/pkg/BILLS-113hr1385ih/pdf/BILLS-113hr1385ih.pdf.
 See Beveridge & Diamond, P.C., Safe Chemicals Act, First TSCA Reform Bill of 113th Congress, Reintroduced (Apr. 16, 2013), [link]. The bill also includes provisions similar to those in the Toxic Chemicals Safety Act of 2010, H.R. 5820, http://www.gpo.gov/fdsys/pkg/BILLS-111hr5820ih/pdf/BILLS-111hr5820ih.pdf, the House TSCA modernization bill which Representative Schakowsky co-sponsored.
 See Beveridge & Diamond, P.C., Will FDA Get New Authority to Regulate Cosmetics? (July 5, 2012), http://www.bdlaw.com/news-1386.html; Beveridge & Diamond, P.C., Cosmetics Safety Bill Would Incorporate TSCA Bill Provisions (Aug. 2, 2010), http://www.bdlaw.com/news-935.html.
 The bill would not alter the FFDCA’s definition of the term “cosmetic” 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 the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.” 21 U.S.C. § 321(i). The bill would add a new, broad definition of “ingredient.”
 21 C.F.R. Part 701.
 21 C.F.R. § 740.10.
 This standard would go beyond the somewhat similar standards in FDA’s color additive and food additive regulations, 21 C.F.R. §§ 70.3(i), 170.3(i).
 21 C.F.R. Parts 710, 720.
 FDA already has such guidance. See FDA, Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist (1997, updated 2008), http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/GoodManufacturingPracticeGMPGuidelinesInspectionChecklist/default.htm.
 See Beveridge & Diamond, P.C., States Propose to Regulate Chemicals While Congress Debates TSCA (Feb. 25, 2013),http://www.bdlaw.com/news-1446.html (noting various state proposals to regulate chemicals in cosmetics).
 See “Safe Chemicals Act of 2010,” H.R. 5786, http://www.gpo.gov/fdsys/pkg/BILLS-111hr5786ih/pdf/BILLS-111hr5786ih.pdf, and “Safe Chemicals Act of 2011,” H.R. 2359, http://www.gpo.gov/fdsys/pkg/BILLS-112hr2359ih/pdf/BILLS-112hr2359ih.pdf.