New FDA Guidelines for Nano Particles
The Food and Drug Administration has announced new voluntary guidelines for the use of nano technology in food packaging and cosmetics. Dennis Keefe, director of FDA's office of food additive safety, tells host Bruce Gellerman that the guidelines reflect the FDA's best understanding of the emerging technology.
GELLERMAN: Now, let’s get small, very small - nano size. Nano means billionth. It’s hard to picture but consider this: there are a billion seconds in 32 years. That’s small. But when it comes to making products using nano materials, companies are thinking big. It’s estimated the nano-market could soon be worth hundreds of billions of dollars a year -maybe even a trillion or two.
And while you can’t see nano particles, unless you had an electron microscope, you can already find products that use them: they’re in everything from non-schmear sunscreens and lip-gloss to hi-tech textiles and mobile phones. Recently, the U.S. FDA announced the first voluntary guidelines for companies that want to use nano-particles in their foods, drugs and packaging materials.
Dennis Keefe is Director of the FDA’s Office of Food Additive Safety. Welcome to the show, Mr. Keefe.
KEEFE: Hello, thanks for having me today
GELLERMAN: So, why voluntary guidelines?
KEEFE: Well, guidance by definition under our system are voluntary. They’re designed to represent the agency’s best thinking on particular issues.
GELLERMAN: What about regulations? Why not make real rules?
KEEFE: Well, if in a specific situation, with a particular nano material, we could indeed develop specific regulations to establish safe conditions of use for nano materials.
GELLERMAN: So, in terms of guidelines, does that have the force of law?
KEEFE: It does not have the force of law, no.
GELLERMAN: So, you’re basically saying to companies is kind of “let us know how these things turn out for you.”
KEEFE: What it’s doing is, under the law, the companies have an obligation to market foods that are safe and including the ingredients that they put into those foods are safe. Now, what this guidance is doing or the intent of it, is to provide manufactures with guidance on what we think they should be considering as they make manufacturing changes.
GELLERMAN: So, let's say I’m a company that produces a food that has a nano particle or incorporates a nano particle in the wrapper, what do I have to do?
KEEFE: Okay, if it’s a brand new ingredient that hasn’t been used in the food supply before, we would encourage them to look at the guidance and consider the points we’ve made in the guidance that they should be looking at, and if they do indeed have questions, they should come in and talk to us, and we can give them guidance and perhaps if they do have concerns about the safety of the ingredient, we would require additional testing.
GELLERMAN: So, what if a company didn’t come and meet with you?
KEEFE: If they didn’t come in and meet with us and we had a safety issue, we would take an enforcement action. This might be a warning letter, depending on the severity of the public health risk, we might seize the product to get it off the market, we might ask for a recall of the product, depending on what our authorities are in terms of the regulated industry.
GELLERMAN: What if you didn’t know if you had a safety issue and this stuff was being sold and used?
KEEFE: What if we didn't know we had a safety issue?
GELLERMAN: Yeah, I mean, it was being used for five, six or seven years and then, you know, all of a sudden, people start developing, you know, nano disease, or...
KEEFE: Well, then we would have an identified safety concern and we would take action.
GELLERMAN: I’m reminded, back many years ago when there were so many chemicals being developed, and the U.S. Government’s attitude towards the explosion of chemicals was, you know, they’re innocent until proven guilty, that the companies could basically produce these things until someone said that they weren’t safe. Is that what’s going on here?
KEEFE: No, actually, under the way the statute is organized, if an ingredient falls under the definition of a food additive or a color additive, they must undergo a pre-market approval and review by the FDA. They can’t just go to market.
GELLERMAN: What about food supplements?
KEEFE: Food supplements, there are new dietary ingredients they are exempt from the legal definition of a food additive. And so, they’re not subject to the pre-market approval authority for food additives.
GELLERMAN: So, how well understood are the health effects of nano-particles.
KEEFE: Well, you know, this is an emerging technology. In addition to this guidance, we have research that the FDA and others are funding to examine the safety of these nano materials. You know, we understand it’s an emerging technology and we have to move slowly on this.
GELLERMAN: If you applied a nano material to your skin, which is your largest organ- I would assume it would go right through, right?
KEEFE: There are tests that have been done to measure, you know, transmission through the skin for cosmetic application and also for drug applications. So there is an assay that has been developed to measure that and that is something that would be looked at under a pre-market approval process.
GELLERMAN: So a manufacture might say: Well, I know what the assay of this test is - but they don’t have the submit the data to you…
KEEFE: Well, if, you know, it is a drug application, they would.
GELLERMAN: But not a food?
KEEFE: Because of the legal authority under for cosmetics we don’t have pre-market approval authority for cosmetics.
GELLERMAN: So, if somebody put a nano particle in a cosmetic they can do that, and they don’t need your seal of approval.
KEEFE: They don’t have to come and get an approval before they go to market, yes. And this is one of the importances of the cosmetic guidance in indicating to industry what we think they should be doing in terms of due diligence to ensure that their products are indeed safe.
GELLERMAN: This nano-biz can get really big, what’s industry’s response been to these two guidelines?
KEEFE: Well, the guidelines are just becoming available on the web.We have a 90-day comment period, and we’ll just have to see what the response will be from the industry.
GELLERMAN: Well, Mr. Keefe, thanks very much!
KEEFE: My pleasure, thank you!
GELERMAN: Dennis Keefe is Director of the FDA's Office of Food Additive Safety.
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