WASHINGTON (AP) — Regulators are proposing that food
companies that want to use tiny engineered particles in their packaging
may have to provide extra testing data to show the products are safe.
The
Food and Drug Administration issued tentative guidelines Friday for
food and cosmetic companies interested in using nanoparticles, which 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.
The
submicroscopic particles are increasingly showing up in FDA-regulated
products like sunscreens, skin lotions and glare-reducing eyeglass
coatings. Some scientists believe the technology will one day be used in
medicine, but the FDA’s announcement did not address that use.
The
draft guidance suggests the FDA may require food companies to provide
data establishing the safety of any packaging using nanotechnology.
Under
longstanding regulations, companies aren’t required to seek regulatory
approval before launching products containing established ingredients
and materials, such as caffeine, spices and various preservatives.
But FDA officials said Friday that foods and packaging containing nanoparticles may require more
scrutiny.
"At
this point, in terms of the science, we think it’s likely the exemption
does not apply and we would encourage folks to come in and talk to us,"
said Dennis Keefe, director of FDA’s office of food additive safety.
Keefe
said companies are studying whether nanoparticles can reduce the risk
of bacterial contamination in certain foods. He said the agency is aware
of just one food package currently on the market that uses
nanoparticles but did not identify it. He said more are expected in
coming years.
The FDA has previously stated its position that
nanotechnology is not inherently unsafe; however, materials at the nano
scale can pose different safety issues than do things that are far
larger.
"This is an emerging, evolving technology and we’re trying
to get ahead of the curb to ensure the ingredients and substances are
safe," Keefe said.
In a separate guidance, the FDA laid out
suggestions for the use of nanotechnology in cosmetics, a practice which
has been in use since the 1990s. Nanoparticles are used in skin
moisturizer, mineral make up and other cosmetics.
The FDA has less
authority over cosmetics than food additives. Generally, the FDA does
not review cosmetics before they launch, and companies are responsible
for assuring the safety of their products.
The FDA will take comments on both proposals for 90 days. There is no deadline for finalizing the
documents.
Copyright 2012 The Associated Press.