 |
Un groupe de travail du FDA recommande de ne pas exiger l'affichage des nano-ingrédients dans les médicaments, les produits médicaux, les aliments et les cosmétiques. Cette recommandation soulève des débats et ne mettra pas un terme à la polémique entre tenants et opposants à une réglementation plus sévère. À priori, il semble qu'il n'y ait pas d'éléments justifiant un étiquetage détaillé selon le comité. Les industriels n'auront donc pas besoin de spécifier cet aspect pour commercialiser des produits respectant les normes actuelles. Toutefois, plusieurs opposants cherchent d'autres moyens pour obtenir l'imposition de mesures plus sévères ou d'un moratoire sur la commercialisation de tels produits. Au delà des résumés rapides, qui semblent donner la «victoire» à l'industrie, le rapport du comité est beaucoup plus pondéré. Les points positifs, soulevés par la presse grand public, sont assortis d'importantes conditions et le comité suggère une série de mesures pour encadrer le développement et la commercialisation de tels nanoproduits. Voici quelques extraits du sommaire du rapport : A general finding of the report is that nanoscale materials present regulatory challenges similar to those posed by products using other emerging technologies. However, these challenges may be magnified both because nanotechnology can be used in, or to make, any FDA-regulated product, and because, at this scale, properties of a material relevant to the safety and (as applicable) effectiveness of FDA-regulated products might change repeatedly as size enters into or varies within the nanoscale range. In addition, the emerging and uncertain nature of the science and potential for rapid development of applications for FDA-regulated products highlights the need for timely development of a transparent, consistent, and predictable regulatory pathway. (…) The Task Force concluded that the agency's authorities are generally comprehensive for products subject to premarket authorization requirements, such as drugs, biological products, devices, and food and color additives, and that these authorities give FDA the ability to obtain detailed scientific information needed to review the safety and, as appropriate, effectiveness of products. For products not subject to premarket authorization requirements, such as dietary supplements, cosmetics, and food ingredients that are generally recognized as safe (GRAS), manufacturers are generally not required to submit data to FDA prior to marketing, and the agency's oversight capacity is less comprehensive. (…) A number of recommendations deal with requesting data and other information about effects of nanoscale materials on safety and, as appropriate, effectiveness of products. Other recommendations suggest that FDA provide guidance to manufacturers about when the use of nanoscale ingredients may require submission of additional data, change the product's regulatory status or pathway, or merit taking additional or special steps to address potential safety or product quality issues. The Task Force also recommends seeking public input on the adequacy of FDA's policies and procedures for products that combine drugs, biological products, and/or devices containing nanoscale materials to serve multiple uses, such as both a diagnostic and a therapeutic intended use. The Task Force also recommends encouraging manufacturers to communicate with the agency early in the development process for products using nanoscale materials, particularly with regard to such highly integrated combination products.
Pour se faire une idée juste de ce sujet complexe, il faut lire le document source (21 pages) et se méfier des résumés qui sont «tout blanc ou tout noir», car ce n'est pas l'essence du rapport. |
Abonnement à la veille commerciale