Exposure to engineered nanoparticles is growing—especially in cosmetics and dietary supplements—yet we know very little about their safety. At the same time, the U.S. Food and Drug Administration’s ability to regulate the safety of over-the-counter products using nanomaterials is severely limited by lack of information, lack of resources, and the agency’s lack of statutory authority in certain critical areas, according to a new expert report released by the Project on Emerging Nanotechnologies.

 

The report, A Hard Pill To Swallow: Barriers to Effective FDA Regulation of Nanotechnology-Based Dietary Supplements, details the main problems at FDA in regulating nano-enabled dietary supplements and offers some recommendations for improving oversight of such products. The Project on Emerging Nanotechnologies is a partnership between the Woodrow Wilson International Center for Scholars and the Pew Charitable Trusts. It seeks to identify gaps in knowledge and regulation around nanotechnology and works with researchers, government, industry, and policy makers to devise ways to close them.

 

“Historically, the regulation of dietary supplements has been a significant challenge for FDA, and the fact that some of those products are now being manufactured using nanotechnology creates an additional layer of complexity,” says William Schultz, a co-author of the report and a former FDA official.

 

Dietary supplements are governed by the Dietary Supplement Health and Education Act under a very broad definition. They could could include nearly any product labeled as a dietary supplement that is ingested that is not “represented for use as a conventional food or as a sole item of a meal or the diet.”. Products making certain claims of effectiveness against diseases are regulated as drugs. Unlike drugs, which must get FDA review and approval before they are marketed, dietary supplements may be marketed to the public without FDA review. Nor do they need any determination as to whether these products have met a statutory safety standard. In fact, in order to remove a dietary supplement from the market, FDA must demonstrate that the product presents “a significant or unreasonable risk of illness or injury.” Even then, the final decision on whether or not to remove the product from the market rests with the court, not the FDA.

 

Most of the information about nanotechnology in products comes from the manufacturers themselves in the form of marketing materials touting the benefits. According to an inventory of federal environmental, health and safety research on nanotechnology maintained by the Project on Emerging Nanotechnologies, the U.S. government is spending less than $1 million annually to study the direct impact of nanoscale materials on the gastrointestinal tract.

 

The use of nanoparticles in food is growing, yet little is known about their safety and regulatory oversight is almost non-existent. According to the report, in the past two years, the number of manufacturer identified dietary supplement products claiming to use nanoscale ingredients has more than tripled, to more than 40 products from 11.

 

“While it is not possible to precisely determine the prevalence of dietary supplements using engineered nanoparticles, it is likely that the public’s exposure to these products will grow significantly in the next several years,” says Lisa Barclay, also a co-author of the report.

 

Nanotechnology is the ability to measure, see, manipulate, and manufacture things that are between 1 and 100 nanometers in length. A nanometer is one billionth of a meter; a human hair is roughly 100,000 nanometers wide. Their tiny size makes it much more likely that nanoparticles can get through natural barriers—skin and the lining of the gastro-intestinal tract.

 

Improving FDA’s capacity to provide oversight of new dietary supplements based on new science will require increased regulatory authority, better information and more resources to support scientific analysis.

 

“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,” says David Rejeski, director of the Project on Emerging Nanotechnologies. “This means that consumers are potentially exposed to unknown risks that should be balanced with the possible benefits of taking these supplements.”