Consumer Groups Uneasy, FDA Cautious Over Nanotech In Supplements

Nanotechnology applications in dietary supplements and food additives demand FDA's immediate attention and guidance, consumer advocates say. Agency officials and industry groups, however, tend to support a more measured approach and show fewer signs of concern about nano products.

At FDA's public meeting on nanotechnology Sept. 8 in Rockville, Md., speakers acknowledged the agency's minimal resources for focusing on the nascent field, but also pointed to questions looming over the behaviors of nanoscale materials in the human body.

At a session on food and color additives and dietary supplements, food and drug attorney William Schultz said the enhanced bioavailability of nanoparticles could make supplements as biologically potent as drugs, though absorption data remain scant.

"There's no basis for concluding that the industry is doing the testing to figure out what this means," said Schultz, a partner with Washington-based firm Zuckerman Spaeder. "The agency has no basis for concluding that these products are safe, and consumers are left at risk."

Schultz added that 44 dietary supplement products using nanoparticles have been identified on the market, 26 more than were found at the time of FDA's initial nanotechnology meeting in October 2006.

The Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars, which tracks the nano consumer goods, has raised concerns that no regulatory scheme exists to protect consumers from nano products or regulate their labeling (¹ (Also see "Nanotech Experts Question Whether Regulatory “Gaps” Affect Consumers" - Pink Sheet, 16 Oct, 2006.), p. 4).

Ian Illuminato, a health and environment campaigner for Friends of the Earth, said estimates show nano foods could be a $6 billion industry by 2010, even as companies are less than forthcoming about the nano-ingredients in their products.

Robin Guy, a toxicology consultant, said the concept of "stealth nano" products - which omit mention of their use of nanoparticles on the label - has spread because companies fear consumer backlash and "don't want to take it to that level comparable to the genetically modified or irradiated foods."

Guy encouraged FDA to pursue nanoparticle research that employs certified good laboratory practices and to offer revised, nano-specific guidance on food additive toxicology. For example, current acceptable daily intake expressions are based on mass, which could prove irrelevant when considering nanoscale versions of a substance.

Michael Hansen, a senior scientist with Consumers Union, cited a possible example of nano-encapsulated lycopene dietary supplements potentially reaching toxic levels by accumulating in the bloodstream. He said he hoped that FDA would not automatically allow nanoscale lycopene under an already approved lycopene-extract color additive petition.

Hansen also repeated a general theme of the meeting, advising that nanoparticles in food substances generally recognized as safe are different enough to warrant a separate pre-market approval process (see sidebar: " ² (Also see "Nano-Engineered Products Are Not GRAS-Ready - Experts" - Pink Sheet, 15 Sep, 2008.) ").

Schultz made several recommendations on how FDA could handle nanoparticles in dietary supplements, prefaced by his perception that budget cuts have left the agency's supplements program "barely alive."

PEN has noted the Center for Food Safety and Applied Nutrition lost 100 staffers and almost $18 million in operating funds between 2003 and 2006, severely limiting its readiness to respond to the use of nanotechnology in products (³ (Also see "FDA Nanotechnology Oversight Limited By Budget Constraints – Report" - Pink Sheet, 9 Oct, 2006.), p. 4).

FDA said Sept. 11 it is has added 91 staff positions to CFSAN in fiscal 2008, increasing the center's employment by 10 percent.

Schultz said FDA in the near term should shift existing resources into the nanotech area of supplements and begin developing guidance or a regulation declaring nanoparticles to be new dietary ingredients.

He admitted that Congress would ultimately have to grant the agency more authority and resources to adequately police nanomaterials in supplements.

Additionally, he raised the example of ephedra, which was banned by FDA in 2004 after years of safety concerns, "just to show how difficult this can be." Schultz pointed out it would be easier to issue pre-emptive guidance on nanoscale products rather than wait to receive adverse event reports, as happened with ephedra-containing supplements (⁴ (Also see "FDA Defends Ephedra Ban Procedures In Nutraceutical Case Filing" - Pink Sheet, 29 Jan, 2007.), p. 9).

Brad Williams, a manager in the Division of Dietary Supplement Programs in CFSAN's Office of Nutrition, Labeling and Dietary Supplements, took issue with Schultz's characterization of FDA taking a backseat on supplement oversight.

"Let's separate the political statements ... from reality, where we do what we can with what we've got," Williams said. "We do push very hard with that new dietary ingredient program when we don't have satisfactory evidence of safety."

Under its NDI notification system, firms must give FDA notice 75 days before bringing a new ingredient to market. However, industry groups say the agency has left unclear the line between new and old ingredients (⁵ (Also see "Request For NDI Input May Portend Much Anticipated Guidance – Industry" - Pink Sheet, 31 Mar, 2008.), p. 6).

While Williams explained generating a new guidance on nanoparticles could be just as onerous as developing a regulation, Schultz said a regulation was mainly necessary "if the industry resists," and suggested FDA could start with an announcement about its concerns on nanoingredients.

The agency's Nanotechnology Task Force July 2007 report recommended a guidance that would describe information to be required in evaluating nanoscale NDIs (⁶ (Also see "Nanotech Report’s Recommendations Unsettling To Supplement Industry" - Pink Sheet, 30 Jul, 2007.), p. 12).

The same report also noted nanoscale materials exhibit no more inherent hazard than any other group of materials, a point echoed by Natural Products Association executive Dan Fabricant.

Fabricant, NPA's scientific and regulatory affairs VP, said while FDA is unlikely to act on nanotech issues soon, with food safety issues a more pressing concern, consumer groups are "fear-mongering" with questionable data.

He added it is likely that no dietary supplement firm currently uses true nanoscale ingredients, due to the unattractive economics of the new technology.

- Dan Schiff ([email protected])