FDA not ‘nano-ready’, says report

By Clarisse Douaud
Cosmetics Design
Oct. 08, 2006

A former FDA deputy commissioner for policy has denounced the agency's capacity to properly regulate nanotechnology products including supplements, a criticism that could inflame debate leading up to the agency’s first major public meeting on the atomic technology.

In a report commissioned by the Woodrow Wilson Center's project on emerging nanotechnologies, University of Maryland School of Medicine professor Michael Taylor concluded the US Food & Drug Administration's resource base is severely eroded. This is despite what appears to be a recent nanotechnology policy kick-start at the FDA.

The report reveals regulatory weaknesses affecting new products, such as certain dietary supplements and cosmetics, using the technology. Critics say questions over nanotechnology safety have not been answered and the FDA is not in a position to effectively police it.

“Unless the FDA addresses potential nanotechnology risks now, public confidence in a host of valuable nanotechnology-based products could be undermined," wrote Taylor, who was deputy commissioner for policy at the Food and Drug Administration from 1991 to 1994 and currently conducts research on policy, resource, and institutional issues affecting public health agencies.

Nanotechnology is the ability to control things at an atomic and molecular scale of between one and 100 nanometers and has been met with enthusiasm across a variety of industries. Critics highlight the murky area of how nanoparticles affect toxicity and say nanoparticles should be treated as new, potentially harmful materials and tested for safety accordingly.

"There are important gaps in FDA's legal authority that hamper its ability to understand and manage nanotechnology's potential risks,” wrote Taylor. “This is particularly true in the area of cosmetics and dietary supplements, and in the oversight of products after they reach the marketplace."

Unlike pharmaceuticals, which must go through a series of pre-market approvals, finished dietary supplements need no pre-market approval. Under the Dietary Supplement Health and Education Act (DSHEA), which is part of the Food and Cosmetics Act, only ingredients not marketed in the US before October 1994 must be approved by FDA before use in consumer products.

Thus, as it stands, pre-market regulation of nanotechnology in dietary supplements does not fall under FDA's regulatory umbrella, nor – according to Taylor – can fit into the agency's budget.

But Taylor points out in the report that the FDA is restricted in what it can do due to a dire lack of funding under the current administration. In order to continue activities mandated in 1996, FDA's 2006 budget would have to increase by 49 percent, according to Taylor, and under President Bush's 2007 FDA budget this funding gap will grow to 56 percent.

"But FDA's lack of 'nano-readiness' is about more than dollars," said Taylor.

"Business and health leaders alike should join in ensuring that FDA has the scientific tools and knowledge it needs to say 'yes' to safe and effective new products," said Taylor.

The market stands to benefit from nanotechnology and therefore, stands to lose a lot according to Taylor, if it is not thoroughly regulated.

In 2005, nanotechnology was incorporated into more than $30bn in manufactured goods, according to Lux Research, almost double the previous year. The market analyst projects that by 2014, 15 percent of all global manufactured goods will incorporate nanotechnology.

The Washington,DC-based Woodrow Wilson International Center for Scholars initiated its project on emerging nanotechnologies in 2005 with the aim of helping business, government and the public manage possible implications of the technology.

FDA's nanotechnology public meeting will take place October 10, 2006 in Bethesda, Maryland.

According to FDA, the purpose of the meeting is to help the agency in its understanding of developments in nanotechnology materials relating to FDA-regulated products.

“FDA is interested in learning about the kinds of new nanotechnology material products under development in the areas of foods (including dietary supplements), food and color additives, animal feeds, cosmetics, drugs and biologics, and medical devices…” states an online FDA notice for the upcoming meeting.