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From: The eUpdate, 5.8.2012

Proposed FDA Guidance on Nanomaterials Seen As Flawed

Tentative parameters give industry ultimate say in use of such materials

The FDA’s proposed guidance document for the use of nanomaterials as food additives is “a step in the right direction,” said a leading nanotechnology expert, but ultimately leaves the decision about whether or not to consult with the FDA in the hands of industry.

The FDA’s approach seems excessively narrow to many consumer groups and academics.

On April 23, the FDA issued tentative guidelines titled “Assessing the Effects of Significant Manufacturing Process Changes, Including Emerging Technologies, on the Safety and Regulatory Status of Food Ingredients and Food Contact Substances, Including Food Ingredients that are Color Additives.”

“Understanding nanotechnology remains a top FDA priority,” said FDA Commissioner Margaret A. Hamburg, MD, in a release. “FDA is strengthening the scientific tools and methods for evaluating food products, cosmetics, drugs and medical devices. We are taking a prudent scientific approach to assess each product on its own merits and to not make broad, general assumptions about the safety of nanotechnology products.”

The FDA’s approach seems excessively narrow to many consumer groups and academics. “The guidance is entirely voluntary, nonbinding, and manufacturers putting nanomaterials [in food products] are not legally bound to report to the FDA about them,” said Jennifer Kuzma, PhD, associate professor of science, technology, and environmental policy at the Humphrey School of Public Affairs at the University of Minnesota in Minneapolis. “They essentially say that if a manufacturer changes the process for what’s used in the food, please come to us.”

Interestingly, the document focuses on the manufacturing process rather than on the nanomaterials themselves. It also mentions the general term “emerging technologies,” which isn’t clearly defined in the guidance. “Perhaps they’re trying to avoid covering the nanomaterials that arise naturally in foods by processes we’ve been using for decades,” Dr. Kuzma speculated.

She praised the FDA for taking a step toward a more careful approach to the manufacturing process intended to produce nanomaterials in foods, and compared the nanofoods document to similar FDA guidelines issued in 2009 for genetically modified foods. “There, too, the manufacturers were not legally bound to comply, but to our knowledge, industry has complied with that guidance. But I think it would have been to the benefit of all for the FDA to make a clearer statement and make it mandatory for manufacturers to consult with them if they are changing their process to put nanomaterials in their foods.”

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