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FDA Sued On Nano

by Gwyneth K. Shaw | Dec 21, 2011 4:16 pm

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Posted to: Environment, Nanotech, Science/ Medical

Gwyneth K. Shaw file photo A coalition of consumer advocacy groups filed suit against the U.S. Food and Drug Administration Wednesday, the latest move in a long effort to force the agency to regulate sunscreens, cosmetics and other products containing super-small particles.

The suit, filed in federal court in California, accuses the agency of failing to answer a petition filed by the same groups in 2006. The petition called on the FDA to enact new rules on products using nanotechnology, amid questions about the safety of people, animals and the environment.

The International Center for Technology Assessment, or CTA, is the leader of an assortment of not-for-profit groups, including Friends of the Earth, the Center for Environmental Health and Food and Water Watch.

While the suit filed Wednesday is a procedural one, the ultimate goal is to force the government’s hand on an issue that’s fraught with uncertainty.

“We’ve brought this case because, in our view, they have a duty to respond to us, and they haven’t,” said George Kimbrell, senior attorney for the CTA. “This lawsuit ... will require the agency to respond to our petition, which they have failed to do for five and a half years.”

A spokesperson for the FDA did not respond to a request for comment. The agency has 60 days to file its initial response to the lawsuit.

Products that use nanotechnology are proliferating, and evidence is growing that at least some of them might be harmful to people, animals and the environment. Yet, as with so many other issues involving ongoing research, the federal government has been reluctant to weigh in without overwhelming scientific proof, instead funding efforts to get at these difficult questions.

By leveraging the often-amazing properties of these ultra-tiny materials, nanotechnology can make airplane wings stronger and help cancer treatments ruthlessly target the bad cells. As nano-enabled products proliferate, however, there’s a big gap between what’s possible and what’s been tested for safety. Growing evidence suggests that shrinking these materials can sometimes change the way they interact with the world around them, raising serious questions about their impact on health and the environment.

Take sunscreens, for example. Many creams and lotions now contain nano-sized titanium dioxide or zinc oxide (and sometimes both) and are marketed as “mineral-based” or “chemical-free.” The ingredients are mainstays of the sunblock industry, but the ultra-tiny size allows the formulations to go on clear, instead of showing up as a white blaze.

The smaller size, however, raises questions about whether the nano-sunscreens can penetrate the skin, or cause problems once humans wash it off. The result is a fairly fierce debate about safety—an increasingly common battle when it comes to nano-enabled products.

FDA researchers found that nano-sized titanium dioxide didn’t get into the bloodstream of laboratory pigs when they were slathered with sunscreen. A scientist in Australia, however, found that mini-particles of zinc oxide did get into the blood, albeit at minuscule levels.

“The science has shown that there are some specific red flags” that the agency needs to address, Kimbrell said.

When the FDA released long-awaited changes to its sunscreen guidelines last summer, however, the agency basically sidestepped the debate, which frustrated advocates.

“That gave them a golden opportunity to address this pressing issue of nano-sunscreens ... and they took no action whatsoever,” Kimbrell said. “They didn’t even address the issue, which underscores their failure more broadly on this issue of nanomaterials.”

“If they had addressed this on their own, we wouldn’t have filed this suit,” he said.

The goal is to get the agency to respond to the concerns addressed in the 2006 petition, then go on from there. But the silence is unacceptable. Kimbrell said.

The CTA, along with several of the groups in this coalition, is also pressuring the U.S. Environmental Protection Agency to tighten restrictions on the use of nanosilver as an antimicrobial agent. While the EPA recently gave conditional approval to the first nanopesticide that contains nanosilver—and has hinted that stricter rules may be coming—the number of consumer products containing the material continues to grow.

The EPA won’t touch a company that’s not explicitly claiming to kill germs. But even a quick Amazon search turns up products from humidifiers to hair dryers touting their nanosilver advantage.

It’s time, KImbrell said, for the FDA and other federal agencies to deal with the questions nano-enabled products raise.

“Nanomaterials are in so many things now,” he said. “There are a number of things the agency can do that we call on them to do more generally with regard to nanomaterials.”

 

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