The new frontier in technology may well be at the invisible depths of about 1000th the thickness of a human hair. Called nanotechnology, this hot research and development area is already making an impact on nutrition and food despite the infancy of supporting science. These days, technology moves quickly, and it is hard for the average businessperson, formulator, regulator and consumer to keep up with the mechanisms of action, safety, science and scope of breakthroughs such as the nanoworld.
Ask three experts to define nanotechnology, and you’ll get three slightly different answers. However, the average answer is that nanotechnology is the manipulation of particles at a size between 1 and 100 nanometers for the purposes of novel applications and benefits. A nanometer (nm) is on the level of the size of many molecules. For perspective, a molecule of gold is 0.33 nm; the head of a pin is about 1 to 2 millimeters (mm), which is 1 million times larger than a 1 to 2 nm particle.
One of the advantages of materials of this size, called nanomaterials, is when gathered in bulk, they offer more surface area¾a million 1 nm spheres have more surface area exposed than does one 1 mm sphere of the same nutrient. This theoretically increases the availability of this nutrient to the medium. The other primary advantage of nanomaterials is their small size can afford them increased access to places in the body, as membranes designed to block out naturally larger-sized particles a human typically takes in are unable to reject the nanosize nutrients.
However, these potential advantages are also potential dangers, as scientists are not yet certain just how various nanomaterials will behave when they cross membranes such as the blood-brain barrier, or when they are inhaled during production. Likewise, many nanoparticles could end up in the environment, where their impact is a similar unknown.
In life, unknown often drives fear. The mystery of nanotech may be non-threatening when used in the areas of energy, machinery and structural materials; people look at technology differently when it comes to their own well-being. While it is too early to tell whether consumers are mostly fearful of nanotechnology in food, beverages, medicines and dietary supplements, recent surveys show consumers are alarmed to ask for more information.
A late-2009 report from the Woodrow Wilson Project on Emerging Nanotechnologies (PEN) highlighted results of a national survey on adults conducted by Hart Research Associates. Public awareness of nanotechnology increased during the past year to 2006 levels, which still equates to about 7 out of 10 U.S. adults having not heard or learned a single thing about nanotechnology. They also largely feel the well-known federal agencies FDA, EPA and USDA should regulate such technologies when it comes to ingestible products. In fact, the report found the public trusts these agencies to manage risk more than the companies engaging in such technological manufacturing.
As the primary regulator of dietary supplements and food products, FDA is the agency that matters most to the natural products industry. FDA has not created its own definition of nanotechnology, but it defers to the definition (similar to the above) developed by the National Nanotechnology Initiative (NNI), a cooperative effort by FDA and 22 other federal agencies on research and development in nanoscale science, engineering and technology.
In the little guidance it has provided, FDA has noted products will be regulated according to their normal statutory category (food, drug, supplement, etc.), not according to any technology used. Despite advice from a PEN report that FDA require premarket notification for any nanotech dietary supplement ingredient¾a suggestion rebutted by the Council for Responsible Nutrition (CRN)¾the agency, at this point, has not required such notification, nor does it consider nanosized ingredients as new dietary ingredients (NDIs) requiring notification. FDA experts have indicated nanotech products under its regulation will be handled on a case-by-case basis. FDA’s Vasilios Frankos, Ph.D., CFSAN, told an audience at SupplySide West 2008, Las Vegas, FDA believes more data may be needed to demonstrate the safety and effectiveness of a material that is reduced to nano size, and the agency would determine whether a product’s regulatory status would change due to the use or presence of nanomaterials in a dietary supplement.
On foods, CFSAN’s Annette McCarthy, Ph.D., has reported the safety of a given compound in a food will not automatically apply to a nano version of the compound, due to possible novel properties and characteristics. She further noted insufficient scientific data prevents FDA from extending GRAS (generally recognized as safe) status of an ingredient to its nano-sized version. Also, any change to the chemical attributes, intended use, GMP production or quality of a nano-sized food ingredient will affect its compliance with regulations.
Nonetheless, the regulatory environment surrounding all the different types of nanomaterials in the natural products industry is in a state of flux, with nano-sized bits of info (nanoinfo?) on current and likely future considerations continuously released from the mouths of various regulators. Each month or season there is often a different outlook, so the best anyone can say is that regulation of nanomaterials and nanotechnology in foods and dietary supplements is being developed behind closed doors at FDA, EPA and other agencies. FDA has indicated a guidance document from the agency on nanotechnology will be made public in 2010. Until then, the nutshell is that nanotech food additives and colors must be tested for safety and toxicity.
However, companies need to realize the EU, Canada and the State of California have all requested information from manufacturers of nanoscale products.