The Boston Globe recently ran an article that nanotechnology is about to be the next big thing in bioscience. Although nanotechnology has had a lot of ups and downs in its enthusiam in the marketplace, it’s still remains mostly a laboratory study subject. Now, nanotech seems staged to make huge leaps in medical treatment, so some say.

Nanotechnology is the understanding and control of matter at dimensions of roughly 1 to 100 nanometers, where unique phenomena enable novel applications. Encompassing nanoscale science, engineering and technology, nanotechnology involves imaging, measuring, modeling, and manipulating matter at this length scale. At the nanoscale, the physical, chemical, and biological properties of materials differ in fundamental and valuable ways from the properties of individual atoms and molecules or bulk matter.

Nanotechnology could introduce whole new classes of materials and products but could also present tough challenges to regulatory agencies. The National Science Foundation predicts that the global marketplace for goods and services using nanotechnologies will grow to $1 trillion by 2015, and there are already over 500 products being sold that claim they are made with nanoscale or engineered nanomaterials. These include products like self-cleaning windows, automobile paint, sunscreens, and tennis rackets. In the future, a marriage of nano and biotechnology will likely create a whole new generation of drugs, biomedical devices, and other products.

Nanomedicine has been defined as the monitoring, repair, construction and control of human biological systems at the molecular level, using engineered nanodevices and nanostructures. Current applications of nanotechnology in medicine involve engineered molecules to develop drugs, drug delivery techniques, diagnostics, medical devices and enhanced gene therapy and tissue engineering procedures. “Nanosizing” is a term developed in the pharmaceutical industry to describe how some previously approved products with particle sizes greater than 100 nm are being produced with smaller particle sizes, in order to change certain physical and performance characteristics, such as pharmacokinetic profile (i.e. the rate and extent of absorption and clearance from the body). To date, the FDA has no knowledge of reports of adverse reactions related to the “nano” size of resorbable drug or medical device products.

Not everyone is thrilled. A coalition of consumer and environmental groups petitioned the FDA to increase its regulation of nanoparticle-containing sunscreens and cosmetics and recall some products. Among the FDA-regulated products being sold are sunscreens containing titanium dioxide or zinc oxide nanoparticles (which offer strong ultraviolet protection while remaining colorless) and cosmetics with nanoscale liposomes. A number of animal studies have shown that at least some nanoparticles can penetrate cells and tissues, migrate through the body and brain and cause biochemical damage. But whether these pose health risks remains largely unknown, pending completion of long-range studies recently begun by the FDA and other agencies. The FDA has six months to respond to the petition.

The FDA has not established its own formal definition for nanotech, though the agency participated in the development of the NNI definition of “nanotechnology.” Using that definition, nanotechnology relevant to the FDA might include research and technology development that both satisfies the NNI definition and relates to a product regulated by FDA.

However, the FDA only regulates certain categories of products. Though existing requirements may be adequate for most nanotechnology products, many of the nanotechnology products will be Combination Products (i.e., drug-device, drug-biologic, or device-biologic products). The current policy regarding combination products helps prevent duplication of effort and a protracted approval process. If the product meets the definition of a combination product, it will be assigned to an Agency center that will have primary jurisdiction for its regulation. The assignment of a lead center is based upon a determination of the primary mode of action (PMOA) of the combination product. For example, if the PMOA of a combination product is that of a biological product, then the combination product would be assigned to the Agency component responsible for premarket review of that biological product.

FDA published a proposed rule defining the primary mode of action of a combination product. The proposed rule defines primary mode of action as “the single mode of action of a combination product that provides the most important therapeutic action of the combination product.” In some cases, neither the FDA nor the sponsor can determine the most important therapeutic action at the time a request is submitted. A combination product may also have two independent modes of action, neither of which is subordinate to the other. Depending upon the type of combination product, approval, clearance or licensure may be obtained through submission of a single marketing application, or through separate marketing applications for the individual constituent parts of the combination product. For most combination products, a single marketing applicition is sufficient for the product’s approval, clearance or licensure.

However, nanotech is better known to the public for its potential to run amuck like in the the “gray goo” (or “global ecophagy“) scenario developed by an early nanotech theorist, which holds that a tiny, self-replicating device could end up consuming all the organic material on earth, turning the world into a sterile mush.

Granted, there are genuine toxicity questions raised by the use of nanomaterials in consumer products, such as sunscreens and cosmetics, in which ultrafine particles are incorporated into the formulations. The dilemma, of course, is that the growing concerns over the use of nanoparticles in consumer products could outweigh the benefits that can be had in medicine and technology. Every new technology brings a new set of benefits and fears that are dealt with as they arise but public perception means a lot in both the marketplace and in the world of regulation where the FDA rules are often driven by politics.

Although the safety of nanoparticles and nanomaterials deserves careful consideration, what the public thinks about gray goo is critical. If they’re not careful, nanotech companies will lose the battle over public opinion and suffer the backlash felt by companies like Monsanto over biotech foods.

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