From the U.S. Government Accountability Office, www.gao.gov

Transcript for: Watchdog Report #7: FDA's Oversight of "Generally
Recognized As Safe" Ingredients
Audio interview by GAO staff with Lisa Shames, Director, Natural
Resources & Environment


March 5, 2010


[ Music ]

[ Narrator: ] Welcome to GAO's Watchdog Report, your source for news and
information from the Government Accountability Office. It's March 4th,
2010. The Food and Drug Administration, or FDA, is responsible for
ensuring the safety of most of America's food supply. This includes
substances that are considered to be “Generally Recognized as Safe,”
also known as GRAS. A group lead by Lisa Shames, a director in GAO's
Natural Resources and Environment team, recently examined FDA's
oversight of GRAS substances. GAO analyst Jeremy Cluchey sat down with
Lisa to learn more.

[ Jeremy Cluchey: ] What are GRAS ingredients?

[ Lisa Shames: ] GRAS ingredients include such things as spices and
artificial flavors, vitamins and minerals, and preservatives.
Manufacturers add these ingredients to enhance a food's taste,
nutrition, and shelf life. These ingredients are generally considered to
be safe among experts through scientific processes. Nevertheless, there
have been a few ingredients that have been considered generally safe but
were subsequently banned such as cyclamate salt, which is an artificial
sweetener. And now, there's concern that there are other GRAS
ingredients such as transfat and salt that should be reconsidered in
terms of their GRAS status.

[ Jeremy Cluchey: ] How does the FDA oversight process with respect to
GRAS ingredients currently work?

[ Lisa Shames: ] Well, GRAS ingredients can be added to food without FDA
approval and even without FDA's knowledge. Companies are responsible for
determining whether or not an ingredient is GRAS and that's based on an
expert panel or through a literature review. However, companies are not
required to notify FDA about these determinations. They do it on a
voluntary basis. FDA reviews the determinations and FDA can then inform
a company that it has no questions about its determination or it can
conclude that there are insufficient data, and this voluntary program
has never been formalized.

[ Jeremy Cluchey: ] To what extent do companies use this voluntary
program?

[ Lisa Shames: ] Over the last decade, FDA has received over 270
determinations for new GRAS ingredients and FDA responded that it had no
questions for nearly three-quarters of these determinations. FDA
officials told us that companies have an incentive to submit their
notifications for GRAS determinations because it then enhances the
marketability of these new ingredients. However, since companies are not
required to notify FDA of their GRAS determinations, FDA has no
information about those determinations that were not submitted to it and
they may already be included in the foods that we're eating now. Also,
GRAS ingredients can be manufactured anywhere and many, including FDA,
are concerned about other countries' food safety regulatory systems.

[ Jeremy Cluchey: ] One of GAO's concerns relates to FDA’s approach to
regulating nanotechnology or the use of tiny engineered nanomaterials in
food. Can you talk a little bit about this technology and its possible
implications for consumers?

[ Lisa Shames: ] Well, nanomaterials are manipulated at the molecular
scale and just to give you some perspective about what we're talking
about, the diameter of a human hair is 80,000 nanometers. Now,
nanomaterials have the potential to benefit food safety. For example, a
nanofilm on a food package has the potential to decrease food pathogens.
However, there are concerns about the potential risks of using
nanomaterials. FDA allows these nanomaterials to enter the food supply
as a GRAS ingredient, so companies are not required to identify the
nanomaterials in their foods. FDA has no way of knowing the extent to
which nanomaterials are included in the food supply. In contrast, we
found that many other countries do require some prenotification or a
preapproval of nanomaterials, such as in Canada and the European Union,
before they can be marketed.

[ Jeremy Cluchey: ] What steps does GAO recommend that FDA take to
improve its oversight of GRAS ingredients?

[ Lisa Shames: ] GAO made several recommendations to FDA concerning its
whole GRAS approach. First of all, for new GRAS ingredients, we
recommended that FDA develop a strategy to obtain some basic information
of the GRAS ingredients that are in the food supply. We recommended that
they monitor companies' GRAS determinations and also that it formalize
this voluntary program that it's had in place for so long. We also
recommended that FDA develop strategies for reconsidering current GRAS
ingredients and also to develop an approach for handling nanomaterials.
I have to say that FDA agreed with these recommendations and in fact
they told us that they are already starting to internally deliberate
what these strategies might be.

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[ Narrator: ] To learn more, visit GAO's Web site at GAO.gov and be sure
to tune in to the next edition of GAO's Watchdog Report for more from
the congressional watchdog, the Government Accountability Office.