By Richard Acello, Small Times contributing editor
August 6, 2007 — In the first major report of its Nanotechnology Task Force, the Food and Drug Administration has declined to require that labels inform consumers of the presence of nano-sized material in food, drug and cosmetic products.
“We have worried about that question, and this point we believe we do not have scientific evidence about nano-sized materials, merely by virtue of being nano-sized as posing safety questions,” says Randall Lutter, FDA deputy commissioner of policy.
The 38-page report had been anticipated since the FDA formed its Nanotechnology Task Force nine months ago.
Apart from declining to take action on labeling, the report sets out what the agency intends to do in the future to get its arms around what could be a sprawling marketplace for products it has jurisdiction over, such as cosmetics, drugs, medical devices, and sunscreens.
Foremost, the agency says it will offer “guidances” to industry about what kinds of information it will require to assess the risks and benefits of nanotech products. “We will offer information about how we will make distinctions about nanosized material in our product review and regulatory processes and what information we will need to have from industry to make sure products are safe and effective,” Lutter said.
The report’s recommendations fall short of what was sought by the Washington, D.C.-based International Center for Technology Assessment (ICTA), which filed a 79-page petition with the FDA in May 2006. The ICTA petition the FDA to enact new regulations directed at FDA oversight of nanomaterials, including that nanoparticles be treated as new substances, the nanomaterials be subject to health and safety testing and that “nanoproducts” be labeled to delineate all nanoparticle ingredients. The ICTA also sought a formal advisory opinion “explaining FDA’s position regarding engineered nanoparticles in products regulated by FDA” and the amendment of FDA regulations to include definitions of “nanotechnology,” “nanomaterials,” and “nanoparticle.”
In addition, the petition also sought action on sunscreen products with nanomaterials, including a declaration that all sunscreen products containing nanoengineered particles of zinc oxide and titanium oxide are to be considered an imminent health hazard.