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U.S. FDA: We can handle the safety of nanotechnology

10 June 2009 1,287 views No Comment

The Food and Drug Administration (FDA) already has sufficient authority to assess the safety of nanotechnology – but its regulation is not all to do with size, says Dr Annette McCarthy of the FDA.

Nanotechnology refers to controlling matter at an atomic or molecular scale measured in nanometers, or millionths of millimeters. In the food industry, the technology has a variety of uses including detecting bacteria in packaging, or producing stronger flavors and colorings.

Speaking at the IFT International Food Nanoscience Conference in Anaheim on Saturday, Dr McCarthy said: “We believe that the regulatory authority is sufficient to address nanotechnology but there are further questions we need to address.”

For food manufacturers looking to use nanotechnology, those questions include whether the manufacturing change impacts the identity of a component and whether the change could have any impact on safety.

McCarthy, of the office of food additive safety at the FDA’s Center for Food Safety and Applied Nutrition, said: “It’s industry’s responsibility to make sure a product is safe and part of that is making sure that product is regulated.”

In order to assist manufacturers to ensure product safety, the FDA is in the process of developing a guidance document for nanotechnology, which will become available before the end of 2010.

In the meantime, McCarthy said that nanotechnology is not as simple as just making an ingredient smaller; manufacturers looking to petition the FDA for acceptance of a nanotech food additive or coloring’s safety should examine its “impact on identity and toxicity”.

No FDA definition

So far, however, the FDA has avoided being specific about what nanotechnology is, although it is generally accepted that it refers to particles of around 100 nanometers.
“We do not have a definition about what nano size is. We tend to talk more in terms of impact,” McCarthy said.

Asked whether consumers could be concerned that the FDA lacks a nanotechnology definition, McCarthy told FoodNavigator-USA.com: “I don’t think so. There are times when 101 nanometers is just as active as 100, so if you put a cut-off on it, it could actually end up being more misleading.”


She added that FDA GRAS for nanotech ingredients in food had certainly not been ruled out, but at the moment companies would find it difficult to achieve because the current scientific knowledge is still not deep enough to conclusively prove their safety.
“For a lot of the nanotechnologies that are being designed at the moment, you would have a hard time today to come to FDA and prove that it’s generally recognized as safe. But two years down the line, it could be a slam dunk; it could be very simple.”

Introducing the discussion of the FDA’s regulatory standpoint on nanotechnology was Bob Bursey, director of regulatory and scientific affairs at Ajinomoto USA.

He said: “The regulatory system needs to evolve, not start from the beginning…In my mind, it is an evolution that has to happen as the technology develops.”
Although a fairly recent phenomenon, current estimates on the value of products using nanotechnology put it in the range of US$7bn.

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