FDA's New Wrinkle on Nanotech Research
Although the Food and Drug Administration (FDA) has said in the past that it doesn't believe nanotechnology is "inherently unsafe," there are still questions over potential health effects if particles used in the manufacture of such items as stain-resistant clothing, food additives, packaging and cosmetics "penetrate the skin or move between organs," according to a Reuters report.
Nanoparticles, explained The Washington Post, "are measured in billionths of a meter. Nanoscale materials are generally less than 100 nanometers in diameter. A sheet of paper, in comparison, is 100,000 nanometers thick. A human hair is 80,000 nanometers thick."
New draft guidelines from the FDA propose that companies provide additional safety studies. Dennis Keefe, director of the FDA's office of food additive safety, explained in the Post that companies hope nanoparticles "can reduce the risk of bacterial contamination in certain foods. ... We're trying to get ahead of the curve to ensure the ingredients and substances are safe."
Michael Landa, director of the FDA's Center for Food Safety and Applied Nutrition, believes technology's rate of change means tougher standards and scrutiny are necessary. Until now, the FDA has relied on voluntary guidelines; in European Union (EU) countries, proof of safety is required before products can be sold.
Mr. Landa also cited aggressive marketing claims for skin care products as a reason for increased oversight, according to Ad Age. Cosmetics companies have been using nanoparticles in a range of products including moisturizers since the 1990s.
Personal Care Products Council (PCPC) president, Lezlee Westine, stressed they are not arguing against improved regulation, in spite of having rejected calls for mandatory product and ingredient registrations or new user fees. Instead, she said, "the additional safeguards and processes proposed will provide the added transparency that consumers are seeking."
Inevitably, objections to further rules have been heard.
Rep. Joe Barton, R.-Texas, told Ad Age, "Where's the fire that we have to have these new authorities and these user fees? All it takes is one Facebook or one Twitter message and that product is deader than a doornail."