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By Amy Kosowski, M.S., LDN, May 8, 2009
Much excitement has been generated recently regarding the use of nanotechnology in the nutritional supplements industry. Nanotechnology deals with materials that are smaller than 100 nanometers. It is the art and science of manipulating matter at the nanoscale to create new and unique materials and products (For more information, see Nanotechnology – Opportunities and Risks, December 2006.)
Nanotechnology is already being sought as a major source of innovation for both food products and dietary supplements, in spite of the poor understanding of the implications of its widespread use. As of last year, there were 44 nutraceutical products on the market claiming to have nano-sized particles, and this number is growing. Use of nanoparticles in food packaging has also been an area of rapid development. There is no question that the applications of nanotechnology are potentially beneficial and far-reaching. However, numerous questions are being raised regarding the safety of this technology, as well as how these products are to be regulated by the FDA.
In light of the increasing use of nanotech in foods, supplements, and cosmetics, the FDA formed a task force on nanotechnology in order to address safety and regulatory concerns. A report on the findings of the task force (posted July 2007)1 has outlined the challenges the agency faces and calls for FDA guidance on nanotechnology in order to clarify the manufacturers’ responsibilities, as well as what conditions regarding the use of nanoscale materials would change the regulatory status of particular products. The task force report recommends that the agency should assess the available information regarding biological effects and interactions of nanoparticles. In addition, the report recommends that the agency should evaluate current testing approaches to assess the safety, effectiveness, and quality of nanoscale materials.
As yet, no FDA guidance document has been issued and there are no special procedures for introducing these products into the marketplace. Currently, most nanotech products are being treated as New Dietary Ingredients (NDI’s) by the FDA. The term NDI refers to a dietary ingredient that was not marketed in the U.S. prior to October 15, 1994, before DSHEA came into effect2. Manufacturers are required to notify the FDA of any NDI they intend to market and provide evidence of the product’s safety. However, there is no requirement that dietary supplements be approved by FDA prior to marketing and the manufacturer assumes the responsibility for ensuring its safety. NDI notifications are posted on the FDA website along with the agency’s comments on their safety data2. Unfortunately, some manufacturers do not submit NDI notifications for their new ingredients, so the FDA is not aware of their existence nor does it have any way to evaluate the safety of these products. In these cases, the consumer is also unaware that the product ingredients are new to the marketplace.
Another issue is that of labeling. There are no specific requirements for labeling products containing nanoscale ingredients. Moreover, there is no requirement for nanomaterials to be labeled as such. Because these ingredients are treated like any other NDI, and because no safety assessments are necessary for pre-market approval, the lack of labeling guidelines means that consumers are often not given the opportunity to make informed choices regarding whether or not they want to use these products. Consequently, consumers are forced to rely on adverse event reporting systems to point out the problems that might arise from using these products only after they have already been in general use. Furthermore, some products are labeled to imply that they include nano-sized materials that the products do not in fact contain. It is the ambiguity in the labeling of these products that makes it difficult for the consumer to determine the true nature of their ingredients and no rules have been forthcoming.
Some organizations, such as PEN (Project on Emerging Nanotechnologies), have questioned the FDA’s regulatory capacity in the case of nanotechnology, stating that the agency is ill-equipped and lacking information, adequate personnel, and the statutory authority to deal with this matter effectively3. Other groups like CRN (Council for Responsible Nutrition) agree that FDA is understaffed and could use more resources, but they see no specific safety issues associated with the use of nanotechnology and argue that “reasonable regulation” can be implemented by the industry itself, while cooperating with FDA efforts4.
The FDA is requesting budgetary increases to deal with this and many other issues, but it has not yet fully investigated the implications of nanotech in consumable products. While this issue remains in limbo, consumers must be made aware of developments within the field of nanotechnology so they can make informed choice regarding the use of products produced via this technology. Unfortunately the science behind nanotech is very complex, and consumers are therefore more vulnerable to misinformation both for and against the use of these products.
NOW Foods is striving to maintain a balanced view of this issue. There is no doubt that nanotech products promise untold benefits in the area of personal care and nutrition. However, there are still too many unanswered questions regarding the safety of this new technology. Even the most enthusiastic proponents for the development of nanotechnology agree there are unknown risks involved in the widespread use of nanomaterials. NOW Foods is primarily concerned with the health and well-being of its customers. Employing a safety-based agenda, we are watching the development of nanotechnology and its use in nutritional products. NOW Foods continues to take a conservative approach to the use of nanomaterials. We have no line of products marketed as “nano” nor do we include nanoparticles in our products. NOW Foods seeks to “Empower People to Live Healthier Lives” and we want to ensure that all of our products are consistent with that mission.
1 FDA Nanotechnology Task Force. U.S. FDA website: http://www.fda.gov/nanotechnology/nano_tf.html. Accessed 07 May 2009.
2 New Dietary Ingredients in Dietary Supplements. U.S. FDA website: http://www.cfsan.fda.gov/~dms/ds-ingrd.html. Accessed 07 May 2009.
3 A Hard Pill to Swallow: Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplments. Shultz WB, Barclay L. Project on Emerging Nanotechnologies. January, 2009. http://www.nanotechproject.org/process/assets/files/7056/pen17_final.pdf.
4 Report Sheds No New Light on Nanotechnology says CRN. CRN website: http://www.crnusa.org/prpdfs/CRNPR09_Nanonotnew011509.pdf. Accessed 08 May, 2009.