SILVER SPRING, Md.—FDA is reaching out to consumers for their comments on nanotechnology use in food, drugs, supplements and cosmetics. Last week, the agency issued a press release to indutsry on its proposed guidelines on using nanomaterials in FDA-regulated products; today FDA issued a consumer alert showing it is seeking to add consumers to the dialogue.
Last week, FDA said it wanted industry consultation and will offer technical advice and guidance to manufacturers, as needed, to enhance product development, benefit, and safety.
The guidelines list things that might be considered when deciding if nanotechnology can used on a product regulated by FDA—including the size of the nanomaterials that were used, and what their properties are. FDA said nanotechnology could have a broad range of applications, such as increasing the effectiveness of a particular drug or improving the packaging of food or cosmetics.
“Nanotechnology is an emerging technology that has the potential to be used in a broad array of FDA-regulated medical products, foods, and cosmetics," said Carlos Peña, director of FDA’s emerging technology programs. “But because materials in the nanoscale dimension may have different chemical, physical, or biological properties from their larger counterparts, FDA is monitoring the technology to assure such use is beneficial."
Agency experts haven’t identified specific safety concerns involving nanotechnology in FDA-regulated products, but nanomaterials can, in some cases, raise safety issues, according to the consumer alert. Because of this, FDA scientists continue to examine data to decide if and when additional studies are needed.
In 2006, FDA formed the Nanotechnology Task Force with an eye toward identifying and addressing ways to evaluate the potential effects on health from FDA-regulated nanotechnology products. A year later, the task force recommended FDA issue guidelines to industry and take steps to address the potential risks and benefits of drugs, medical devices, cosmetics, and other FDA-regulated products that incorporate nanotechnology.
The proposed guidelines are the first step toward developing policies that guide regulation of products using nanotechnology. The agency plans to develop additional guidelines for specific products in the future.
