Nanotech task force advises FDA collect data

By Clarisse Douaud

- Last updated on GMT

Related tags: Task force, Dietary supplement

A US Food & Drug Administration (FDA) task force on
nanotechnology has presented its findings in a report calling for
the creation of an official guidance and in-house data on the

FDA formed the task force on nanotechnology in 2006 to address concerns surrounding its use in an increasing number of products. The task force solicited comments and also held a public meeting in October to this effect. The issue of dietary supplements surfaces in the report pertaining to the federal agency's weaker jurisdiction over the products and how this potentially challenges its ability to govern nanotechnology applications. "When dealing with products not subject to premarket authorization, the agency has less ability to obtain information about the presence of nanoscale materials,"​ states the report, Nanotechnology: a report of the US Food & Drug Administration Nanotechnology Task Force​. Nanotechnology is the ability to control things at an atomic and molecular scale of between one and 100 nanometers. While it has been met with enthusiasm across a variety of industries, critics highlight unknown factors relating to how nanoparticles affect toxicity. They say the particles should be treated as new, potentially harmful materials and tested for safety accordingly. Some comments submitted to the task force suggested products be required to state on their label whether or not they contain ingredients making use of nanotechnology. But the task force highlights in the report that, due to the fact consumers may not understand the nature of this science, it could actually become a marketing tactic to increase sales. However, with regards to dietary supplements and labeling, the task force points out that this may in fact be the only way the agency can become aware of any nanotechnology used in production. "Because FDA's regulation of dietary supplements is generally post-market, the agency may not know whether the particle size or material features used in dietary supplement products are in the nanoscale range, unless the agency becomes aware of the use of such sizes and features, for example, from information submitted in a notification or from the product labeling,"​ states the report. The task force calls for an FDA guidance on nanotechnology in order to clarify what information manufacturers should submit to the authority, and whether or not the presence of nanotechnology materials changes the regulatory status of a product. Such a guidance would then be made available in draft form and subject to public comment, as has been the procedure with other guidances issued by the agency. The data that the task force proposes FDA gather pertain to the biological effects of the technology, possible interactions of nanoscale materials, as well as whether or not product safety and effectiveness may change with different nanoscale sizes. With this goal in mind, the task force calls on FDA to develop in-house expertise so as to be ready for new information on nanotechnology as it becomes available. The report also suggests the federal agency should evaluate current testing approaches for the purpose of assessing safety and quality of nanoscale materials. In the case of regulating dietary supplements, New Adverse Events reporting (AER) legislation will likely give FDA more oversight leeway, according to the report. Starting December 22, 2007, any serious adverse events associated with a dietary supplement will have to be submitted to FDA. Companies will be required to keep records of all dietary supplement adverse events, serious or non-serious, and FDA will have access to these records during inspections.

Related topics: Regulation

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