May 7, 2012
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."
Discussion Questions
Discussion Questions: Are the new studies on the safety of nanotechnology likely to have a significant effect on product development and sales for manufacturers and retailers? Do you agree with the suggestion that social media is a more effective protector of consumer safety than the FDA?
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No, I don’t necessarily agree that the social media is a more effective protector than the FDA; however, the social media is a far more effective resource and tool for the FDA to use if it were so inclined.
Consumers will want to know products are safe before they use them, and plenty of people will remember the controversy over genetically modified corn, which hit the market before testing. Some additional scrutiny is a good thing.
The FDA needs to be able to support the information it provides to the public whether it is good or bad. Social media platforms allow for story telling without recourse. Social media authors may also falsely identify themselves to the extent that they appear credible or even indisputable. Anyone gathering information with a high level of integrity in content being necessary might consider resources other than social media simply to relieve the amount of verification needed to validate the sources used from social media.
It should be additionally understood that while not all information posted to social media is false, it most certainly is from a subjective perspective and thus maybe missing or embellishing the factual content.
If “The Graduate” were in theaters today, Mr. Robinson’s advice to Benjamin would be “Nanotechnology” instead of “Plastics.” Nanotechnology is emerging everywhere, not just in food. Contrary to Representative Barton’s knee jerk reaction against regulation, the fact that an unsubstantiated rumor started on Facebook or Twitter can bring down a new promising industry is the exact reason why we need regulation. The reason we have brakes on cars is so we can drive fast. If the United States is going to remain competitive, with a vibrant consumer-led economy, consumers have to believe the innovations are safe and effective. This is the role of the regulators.
This is not to say some regulators don’t go overboard. There needs to be a balance. But I think if you asked most people whether it is important to have an independent party testing the efficacy of the technology being applied to the food supply, they would support it.
I would think that mandatory regulation is necessary if there is not yet a full understanding of the short- and long-term effect of nanoparticles. Cosmetics and beauty care companies, which tend to have a strong marketing orientation, should pay the fees to make sure the products are fully and completely safe. In the end, they are the biggest benefactors. If a product turns out to be unsafe, hazardous or, worse, actually causing damage, they are the biggest losers. Another, and perhaps deeper, issue is whether or not, even with fees, the FDA actually has the capacity to regulate, monitor and enforce. Nonetheless, one thing is sure: we can’t wait for a Facebook or Twitter message to kill an unsafe product.
One challenge with social chatter is that falsehoods can have a snowball effect with the right amount of “retweets” from the right people. So, regardless of what the FDA states, people listen to the social web. Whether this study has a material effect on product development remains to be seen, however the points in the research merit more consideration.