Released this week by the Project on Emerging Nanotechnologies (PEN), the report has already been fiercely criticized by the US supplements industry as presenting a “misleading picture”.
According to PEN, which aims to advance the use of nanotechnology while minimizing the potential risks, the US Food and Drug Administration (FDA) is badly equipped to regulate the safety of nanomaterials in supplements.
The agency is limited by a lack of information, resources and statutory authority in certain critical areas, claims the report.
Nanotechnology involves manipulating particles to a nanoscale in order to create new materials measuring between one and 100 nanometers. A nanometer is one billionth of a meter (a human hair is roughly 100,000 nanometers wide).
In the food and supplements industries nanotechnology is being used to create nanomaterials, which allow nutrients to be delivered to the body more effectively or be absorbed more rapidly.
In the past two years, PEN says the use of nanotechnology in dietary supplements sold in the US has tripled – from 11 to 44 products – and the public’s exposure to these types of supplements will “grow significantly” in the next few years.
No safety guarantee
However, according to the report, little is known about the use of engineered nanoparticles in the dietary supplement market, and manufacturers are not taking the necessary steps to ensure the safety of their products.
“It is not clear that the supplement industry is conducting the rigorous testing needed either to understand the effects of nanoscale ingredients in its products or to back up the product claims. This means that consumers are potentially exposed to unknown risks that should be balanced with the possible benefits of taking these supplements,” said David Rejeski, director of PEN.
The group says that the understanding of the biological impact of these materials is limited, with the US government spending less than $1m annually to study the direct impact of nanoscale particles on the gastrointestinal tract.
According to PEN, the US Food and Drug Administration is not equipped to regulate supplement products made using nanotechnology.
The report says there are three major problems that need to be addressed:
· FDA does not have the capacity to identify nano-based dietary supplements that are being developed and marketed, unless manufacturers submit to the pre-market notification process for new dietary ingredients.
· To the extent that FDA is aware of nano-based dietary supplements, it has
little regulatory authority over them.
· Even if it were granted increased regulatory authority, FDA lacks the scientific
expertise and resources to effectively regulate nanomaterials in supplements
The group recommends that Congress provide FDA with regulatory authority for product registration, the establishment of safety standards, market review, pre-market testing and the requirement of improved adverse event reporting.
Industry bites back
However, the supplements trade organization Council for Responsible Nutrition (CRN) has criticized the report as singling out the supplements industry, and providing little useful information to back up its arguments.
“We question the true motives behind this report from [PEN], which provides a very limited amount of useful information on nanotechnology and paints a misleading picture by implying that only one industry faces questions about nanotechnology,” said CRN’s vice president for scientific and regulatory affairs, Andrew Shao, Ph.D.
“This report masquerades as a legitimate review of the use of nanomaterials in dietary supplements but in reality it seems to be an attempt to explain the authors’ views on dietary supplement regulations and their suggestions for change.”
CRN said it is not aware of any specific safety issues associated with the use of nanotechnology. It said it supports efforts by FDA to examine the regulatory requirements of this emerging area of technology and welcomes “reasonable regulation” that can be implemented by industry, enforced by FDA and benefit consumers.
To view the report, A Hard Pill To Swallow: Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplements, click here.