Dietary supplement industry groups say an FDA panel's report citing the lack of information about working with nanotechnology should prompt the agency to be cautious about acting on the panel's recommendation to issue a guidance on using nano-materials in new dietary ingredients.

In a July 25 report, the Nanotechnology Task Force outlines the scientific and regulatory challenges related to the field of nanotechnology and recommends the agency develop guidances and take other steps to determine the risks and benefits of nanotechnology's potential applications to FDA-regulated products.

Because "FDA's authority is more limited with regard to products that are not subject to pre-market authorization," it could be difficult for the agency to assemble data to gauge the safety of a nano-engineered product as well as to determine its structural makeup, according to the report.

However, noting that manufacturers are still responsible for assuring product safety, the task force recommends FDA issue a Federal Register notice requesting firms to submit data and other information "addressing the effects on product safety of nano-scale materials in products not subject to pre-market authorization."

The task force recommends FDA "work with manufacturers of these products and assist them in identifying data to substantiate the safety of products containing nano-scale materials, including chronic toxicity and other long-term toxicity data as appropriate."

The report says FDA also should issue guidances or amend existing guidances to "describe what additional or distinct information" the agency should require concerning the use of nano-scale materials in new dietary ingredients.

The task force makes the same recommendation concerning the use of nano-scale materials in food ingredients when a generally recognized as safe notification is submitted, or the reduction of particle size to nano-scale for food ingredients for which an earlier notification had been submitted and not objected to by FDA.

The task force's recommendations include the agency issuing a call for data to identify OTC products that may contain nano-scale versions of monographed ingredients and nano-scale versions of previously approved food and color additives.

The report also summarizes the state of the science for biological interactions of nanomaterials, an analysis of and recommendations for science issues, and an analysis of recommendations for regulatory issues, FDA Deputy Commissioner for Policy Randall Lutter said during a same-day conference call with media.

"Over the next few months, FDA will take steps to begin drafting guidances and developing calls for data," Lutter said.

FDA has not yet developed a schedule for the release of guidances on specific product categories, but plans to begin to publish them in the coming months, the agency says.

FDA Commissioner Andrew von Eschenbach appointed the task force in August 2006 to identify policy gaps related to nanotechnology and to identify potential adverse effects from products that incorporate nano-materials (¹ Also see "Task Force To Develop Approaches To Nanotechnology In Drugs, Foods" - Pink Sheet, 14 August, 2006., p. 7).

A report released in October 2006 said FDA's budget constraints and gaps in its legal authority hinder its ability to understand and manage nanotechnology's potential risks (² Also see "Nanotech Experts Question Whether Regulatory “Gaps” Affect Consumers" - Pink Sheet, 16 October, 2006., p. 4).

Recommendations Could Challenge Industry

Andrew Maynard, chief science advisor for the Woodrow Wilson International Center for Scholars' Project on Emerging Nanotechnologies, said the task force's report comes at the right time for FDA and industries.

"FDA's recommendations will go a long way towards providing responsible companies with the information they need to develop nanotechnology-based products safely," Maynard wrote in an e-mail to "The Tan Sheet."

"But these recommendations need to be acted on - and fast: there are already over 500 manufacturer- identified nanotechnology consumer products on the market, and many more that are close to production, or just not identified as nano," Maynard said.

However, the Natural Products Association and the Council for Responsible Nutrition recommend FDA conduct extensive information gathering before it issues any nanotechnology guidances or publishes Federal Register notices asking for information.

NPA Vice President Scientific and Regulatory Affairs Daniel Fabricant said the first step should be involving industry in the data-collecting process.

"This is one area where FDA really ... needs some help and is really looking to industry to help out. It's interesting because they don't have much industry involved on the task force," Fabricant told "The Tan Sheet."

"Industry involvement is important because it will help fill FDA's knowledge gaps on nanotechnology, which should be done before the agency issues a guidance as recommended by the task force," he said.

Fabricant added FDA should place a higher priority on issuing other guidance affecting the supplement industry, such as labelling and new ingredient issues.

"I don't see how you can issue a guidance that is worthwhile in any way, shape or form, so I think there has to be some dialogue. Without a doubt, there has to be some back and forth," he said.

CRN's Vice President for scientific and international affairs, John Hathcock, said the task force report is valuable for setting the stage for FDA and industries to develop greater knowledge of nanotechnology's impact on how products are manufactured and on their chemical and material structures.

"I think they generally take the right stance, one that's compatible with current state of knowledge on nanotechnology, and that is to decide things on a case-by-case basis," Hathcock told "The Tan Sheet."

The report also acknowledges FDA needs to conduct extensive and comprehensive information gathering before determining its standards and definitions for evaluating nano-engineered for nano-scaled products, he added.

"The definitions would be partly a size definition or maybe it ought to be a functional definition. They recognize these complexities," Hathcock said.

However, it is most important that FDA recognize too little is known about nanotechnology to ask firms in the supplement industry to provide such information.

"The biggest problem with their notice recommenddation is how do you determine which ingredient comes under this notice? If there is not a size definition or a functional definition and if there are not feasible assays to determine whether a particular ingredient meets that size or functional definition, then who is it that's going to fill out the pre-market information and send it in? How does a company know, or for that matter how does the FDA know if a company is not in compliance?" Hathcock said.

"They've got to not issue that notice too soon or they've got to have the definitions and the assays in place," he said, adding, "Nobody should want the industry to be subjected to a notice that demands or suggests something that can't be done."

FDA also should approach with caution issuing a guidance about information it should require from firms applying to market nanotech products.

"I think guidance is OK if they've got the substance to make the guidance technically and scientifically logical and defensible. In some cases I think they recognize guidance would be needed but we don't have the state of the science and technology ready to support it," Hathcock said.

While Maynard agrees about making a priority of filling in the gaps of information FDA needs to set its nanotechnology standards and definitions, he said industries should be ready to supply the information and ensure they manufacture safe and effective products.

"Of course, many industries act responsibly and fill in the gaps themselves, by making sure that their products are as safe as possible," he said.

"However, one of the big challenges of nanotechnology is asking the right questions about product safety, and taking appropriate actions. Because engineered nano-materials are often designed to behave in new and unusual ways, it is possible that well-meaning but conventional approaches to ensuring their safety will miss something, and potentially harmful products will unintentionally slip out into the market," Maynard added.

- Jessica Lake (j.lake@elsevier.com) and Malcolm Spicer (m.spicer@elsevier.com)

Nanotech Report’s Recommendations Unsettling To Supplement Industry

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