Over-the-counter nano

09/01/2007

The FDA’s Nanotechnology Task Force has declined to require labeling for the growing list of drugstore products containing nanoparticles. While the reasoning may be sound, the move has only added fuel to the fiery regulation debate

By Richard Acelo

In the first major report of its Nanotechnology Task Force, the Food and Drug Administration (FDA) 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 at 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 in August 2006.

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 “guidance” 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,” says Lutter.

A thorny issue

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, whose members include labor unions and environmental concerns such as Greenpeace, petitioned the FDA to enact new regulations directed at FDA oversight of nanomaterials, including that nanoparticles be treated as new substances, that 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 “nanoparticles.”

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 be considered an imminent health hazard.

Meanwhile, products such as sunscreens and cosmetics with nano-sized particles are not new to store shelves; the Wilson Center Project on Emerging Technologies lists about 70 such products on its nanotech products inventory. Some observers noted that the FDA’s actions reflect a go-slow approach on regulation.

“It’s important to look at all sectors of the federal government, because everything has to be viewed through federal government research and development initiatives that are under the auspices of the National Nanotechnology Initiative,” says Lynn Bergeson, a partner in the Washington law firm of Bergeson and Campbell. “All initiatives need to be viewed more broadly, which tempers any one agency’s ability to move briskly forward because it has to be mindful of what other members of the federal family are up to.”

One part of the ICTA petition that Bergeson says she finds intriguing is its request that currently existing or future FDA regulatory programs for nano-materials comply with the requirements of the National Environmental Policy Act (NEPA). NEPA requires federal agencies to assess the environmental impacts of “major federal actions” and to ensure the interested and affected public is informed of environmental analyses.

ICTA’s request to apply NEPA to nanotech is a novel and potentially far-reaching position, Bergeson says, that could require FDA to conduct a Programmatic Environmental Impact Statement (PEIS) to review the impact of nanomaterials on human health and the environment.

“If I were the commissioner of the FDA and I saw this, I wouldn’t cavalierly dismiss it because it is an interesting and innovative application of NEPA,” she adds.

In its report, the task force declined to apply NEPA to nanosized material. “As knowledge of nanoscale materials increases, it may be productive for the agency to develop or amend agency NEPA guidance to address expressly nanoscale materials or certain types of nanoscale materials,” the agency says. “In light of the current, evolving state of scientific knowledge regarding nanoscale materials, however, the task force recommends a case-by-case approach at this time to assessing NEPA requirements for products using these materials, and coordination across the agency to enable consistent determinations informed by the most current science.”