9/24/2012. Science Symposium FDA, Nanotechnology and Cosmetics Jay Ansell, PhD., DABT AGENDA

Transcription

1 Science Symposium FDA, Nanotechnology and Cosmetics Jay Ansell, PhD., DABT October 3, 2012 Newark NJ AGENDA FDA Guidance and Council Response Current State of Science Conclusions Guidance for Industry Safety of Nanomaterials in Cosmetic Products Food and Drug Administration Center for Food Safety and Applied Nutrition April

2 FDA Guidance Provides guidance on FDA s current thinking on the safety assessment of nanomaterials in cosmetic products. Intended to assist in identifying the potential safety issues and developing a framework for evaluating them. Consistent with Task Force recommendation that FDA issue guidance describing safety issues that manufacturers should consider to ensure that cosmetic products made with nanomaterials are safe and not adulterated. Guidance does not establish legally enforceable responsibilities. FDA Guidance: Support FDA emphasizing it does not categorically judge all products containing nanomaterials or otherwise involving application of nanotechnology as intrinsically benign or harmful; FDA determining that adopting of a formal definition of nanotechnology, nanoscale, or related terms is not appropriate; FDA confirming that the safety of the product should be substantiated under the intended conditions of use. FDA Guidance: Support Acknowledging a tiered or staged approach for evaluating the safety of cosmetics is appropriate for those products containing nanoscale ingredients; and Affirming its risk-based approach recognizing current general framework for safety assessments are adequately robust and flexible enough for nanomaterials: hazard identification, dose-response assessment, exposure assessment, and risk characterization 2

3 FDA Guidance: Clarify Safety assessment undertaken for cosmetics containing nanoscale ingredients are not be fundamentally different from that for all ingredients and finished products; characterization of both the test substances and the test formulations is a universal "must have for properly conducted safety/toxicity studies and thus is not unique to nanomaterials. All testing, whether nano or not needs to account for appropriate solvents, dosing formulations, purity and stability conditions, and other variables. Suggesting these considerations are somehow unique to nanomaterials or are modifications to traditional approaches to safety assessment is confusing and potentially misleading. Guidance: Clarify Characterization of nanomaterials for safety assessment should strive to be accurate and relevant to their usage in cosmetic products; Testing recommendations for nanomaterials should remain flexible, taking into account alternative approaches to satisfy the requirements of the applicable statutes and regulations. Guidance: Revise Dermal penetration testing for nanomaterials should not be routinely conducted on impaired skin; Impaired skin models generally do not provide reproducible conditions; The bulk of research, including studies conducted by FDA, have failed to confirm altered dermal absorption in any model using either intact or impaired skin relevant to cosmetic products. Only stable and insoluble nanomaterials should fall within the scope of the Guidance. 3

4 Guidance: Reiterated Previous Objections Incorporates 2011 Guidance Considering Whether an FDA Regulated Product Involves the Application of Nanotechnology; Points to Consider. Describes FDA s current thinking on whether FDA-regulated products contain nanomaterials. Supports FDA affirming its risk-based assessment of products containing nanomaterials. Being designated a nanomaterial does not categorically imply any conclusion on a materials safety Nanomaterial should be the result deliberate manipulation and control of particle size, excluding those products that contain incidental or background levels. Guidance: Points to Consider 1. Size: Acknowledge that a size range of approximately 1 nm to 100 nm is commonly used in various working definitions or descriptions proposed by the regulatory and scientific community. 2. Altered Properties or Phenomena: Size range of approximately 1 to 100 nanometers, or having any properties that are attributable to its dimension up to a limit of 1 micrometer. Requested Changes Eliminate the one micrometer upper limit; Unreasonably expands the scope of nanomaterials Departure from Other International Scientific and Regulatory Authorities Identify Unique characteristics of (the) nanoscale materials not normally observed in their larger counterparts Clarifying that properties or phenomenon...attributable to its dimension includes only those which are distinguishable and not extrapolations from the chemical or physical properties of individual atoms, individual molecules and bulk material; Add to the rationale that only stable and insoluble materials fall within the scope of the Guidance. 4

5 State Of Science Recent Nano Guidance Most Relevant References FDA Guidance for Industry: Safety of Nanomaterials in Cosmetic Products; April 20, 2012 EU Scientific Committee on Consumer Safety; Guidance on the Safety Assessment of Nanomaterials in Cosmetics; June 2012 ICCR Report Of The Joint Regulator -Industry Working Group, Safety Approaches to Nanomaterials in Cosmetics. July 2012 Letter from FDA to International Center for Technology Assessment, et. Al., dated April 20, FDA Guidance: Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology; June 2011 FDA: A Report of the U.S. FDA Nanotechnology Task Force; July 2007 Reports of the ICCR Working Group: Characterization of Nanomaterials I & II July 2011, July 2012 Converging Science Current general framework for safety assessments are adequately robust and flexible enough for nanomaterials Guidance are not suggesting significant revisions in the approaches taken but rather highlight areas where greater attention needs to be paid. Characterization Metrology However in many instances there is nothing particularly nano about that. Reactive material Volatile 5

6 Diverging Regulation The greatest challenge isn t in the science but how to apply the science within differing regulatory environments. Precise definitions EU non-sectorial v. Recast v. FDA v. Health Canada Insoluble, Stable, Unique Properties, 1 to 100 nm Divergence of the Science and Regulation can lead to precise scientific measurement of questionable relevance to assessing safety or informing the consumer. A nanomaterial with no nanoparticles A Nano enabled product but only in some regions Conclusion Differences between perception and reality present tremendous challenges in such a high-profile subject area. We know how to do this! Our Products are Safe! ansellj@personalcarecouncil.org 6