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Consumers Union Requests FDA Safety Assessment on Use of Nanoparticles in Cosmetics and Sunscreens

Beveridge & Diamond, P.C. - Client Alert, December 11, 2008

On October 30, 2008, Consumers Union, publisher of Consumer Reports, submitted a letter to the Food and Drug Administration (FDA) requesting a “full safety assessment on the use of engineered nanoparticles, particularly in cosmetics, sunscreens, and sunblocks, and to investigate possible enforcement action to ensure accurate labeling as to the presence or absence of nanoparticles.”  

The letter reported that Consumers Union had tested five sunscreens from manufacturers who claimed that their products did not contain nanoparticles.  The test results showed four of the five sunscreens contained nanoparticles of titanium dioxide and/or zinc oxide.  The December 2008 issue of Consumer Reports stated that the “risks these nanoparticles might pose and how they compare with the risks of other sunscreen ingredients remain unestablished.”

The letter cited opinions by the European Commission’s Scientific Committee on Consumer Products and the Scientific Committee on Emerging and Newly-Identified Health Risks that identified issues related to assessing the safety of cosmetics containing nanoparticles.  As a result of these opinions, the European Commission requested that companies submit safety data “with regard to all substances used at nano-scale and the final [cosmetic] products in which they are used” by December 31, 2008.  (Public Consultation Notice, Directorate-General Enterprise and Industry).  The European Commission plans to use the data to establish guidance and methodology for assessing the safety of nanoparticles in cosmetics.

Consumers Union requested the FDA to (1) follow the European Commission’s lead by requiring all manufacturers to submit safety assessment data on nanoparticles used in sunscreens; (2) conduct a full safety assessment for cosmetic products using nanoparticles; (3) require manufacturers to disclose the presence of nanoparticles on the label of any cosmetic or over-the-counter drug product that contain such particles; (4) investigate misstatements by manufacturers to Consumer Reports about the absence of these nanoparticles in sunscreen products; and (5) investigate whether the failure to disclose the presence of nanoparticles renders these sunscreen products misbranded and in violation of Section 301(b) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 331(b).  Because the letter was not a formal citizen petition pursuant to 21 C.F.R. § 10.30, the FDA is not required to respond to the letter.

Previous Petition and the FDA’s Response

In May 2006, the International Center for Technology Assessment (ICTA) and a coalition of consumer, health, and environmental groups filed a citizen petition with FDA pursuant to 21 C.F.R. § 10.30.  The petition requested, among other things, that the FDA regulate nano-products by requiring nanomaterial toxicity testing and mandatory nano-product labeling.  In addition, the petition called for regulations classifying sunscreens that contain nanoparticles such as zinc oxide and titanium dioxide as new drug products which require pre-market approval and review of health and safety evidence.  The FDA issued an interim response on November 2, 2006 that was not published in the Federal Register.

The FDA has responded to the increasing concern of nanoparticles in cosmetics, sunscreens, and other regulated products by convening a Nanotechnology Task Force and holding two public meetings.  In July 2007, the FDA issued the Nanotechnology Task Force Report that recommended that the FDA coordinate with other federal agencies and the private sector in research and other activities to increase general scientific understanding and facilitate assessment of data needs for regulated products through the development of safety assessment guidance materials.  The Task Force did not recommend requiring product labeling to include information regarding nanoparticles.  While not directly referring to the ICTA petition, the Nanotechnology Task Force Report was widely regarded as at least an interim response to the petition because it addressed many of the issues raised therein.

On August 27, 2007, the FDA published a proposed rule that would set standards for formulating, testing, and labeling over-the-counter sunscreen products and expand the sunscreen labeling to provide a four-star rating system for ultraviolet A and ultraviolet B protection (72 Fed. Reg. 49070).  Although labeling of nanoparticles used in sunscreens was not required by the proposed rule, the FDA asked for comments regarding the safety and effectiveness of sunscreen ingredients formulated with nanoparticles “because of the potential risk of nanoparticle ingredients penetrating consumers’ skin.”  (72 Fed. Reg. 49110).  After extending the comment period to December 26, 2007, the FDA has not yet issued the final rule.

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For more information, please contact Mark Duvall at (202) 789-6090 (mduvall@bdlaw.com); or Phil Moffat at (202) 789-6027 (pmoffat@bdlaw.com). This alert was written with the assistance of Linda Tsang.

Key documents are available below.

  • Opinion on the Appropriateness of the Risk Assessment Methodology in Accordance with the Technical Guidance Documents for New and Existing Substances for Assessing the Risks of Nanomaterials.  Scientific Committee on Emerging and Newly-Identified Health Risks, Health & Consumer Protection Directorate-General, European Commission (June 21-22, 2007): http://ec.europa.eu/health/ph_risk/committees/04_
    scenihr/docs/scenihr_o_010.pdf

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