The Food and Drug Administration (FDA) has issued its first draft of Guidance on Considering Whether an FDA-Regulated Product Involves Application of Nanotechnology, a guideline thats expected to clarify for manufacturers where they can use the new technology.
Some nanotechnology experts have pushed for more explicit guidelines in the nanotechnology field because it would help spur innovation and commercialization. The FDA guideline appears to be a step in that direction.
The draft guidance does not propose a definition of nanotechnology or nanomaterials, and it doesnt change the regulatory requirements for developing or marketing products. But does offer several points to consider, which the agency says will aid it and manufacturers understand better about whether the inclusion of nanotechnology in products has potential implications for regulatory status, safety, effectiveness or public health.
Reyad Sawafta, president and CEO of Quartek, a nanotechnology company based in High Point, N.C., says the draft guidance leaves more questions unanswered for companies like his.
What we really need is a concrete set of standards, Sawafta said. We need to know that if we pass these tests, we can effectively commercialize these products.
Right now, a lot of innovations in nanotechnology start in the United States but are manufactured overseas, he continued. Were losing the innovation race because we cant do the manufacturing here because there are no set standards.
The FDA is currently accepting public comments on its guidance and will do so until Aug. 9. To offer your comments on the guidelines, click here.
Sawafta said he hopes that public comment will help shape the future of the regulations that will push the manufacture of nanomaterials forward in this country.
The nanotechnology industry as a whole has been guilty until proven innocent when it comes to the saftey of our products, Sawafta said. I dont know on what basis thats true, but it makes it difficult to operate a commercial business in that atmosphere. Investors ask when were going to be able to commercialize our technology, and the truth is I cant answer that question until I get clarity from the regulators.
