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

Transcript for: Watchdog Report: FDA's Oversight of Food Labeling

Audio interview by GAO staff with Lisa Shames, Director, Natural
Resources & Environment

Related GAO Work: GAO-11-102: Food Labeling: FDA Needs to Reassess Its
Approach to Protecting Consumers from False or Misleading Claims

Released on: January 14, 2011

[ Background Music ]

[ Narrator: ] Welcome to GAO's Watchdog Report, your source for news and
information from the Government Accountability Office. It's January 14,
2011. The Food and Drug Administration, or FDA, oversees the federal
requirements that prohibit false or misleading food labels. While
companies need scientific evidence to make health claims on their
products, they can also make qualified health claims which require less
support. A group led by Lisa Shames, a director in GAO's Natural
Resources and Environment team, recently reviewed FDA's oversight of
qualified health claims and the extent to which consumers understand
these claims. GAO's Jeremy Cluchey sat down with Lisa to learn more.

[ Jeremy Cluchey: ] Companies can make a lot of different kinds of
claims on food labels. What's the difference between health claims,
qualified health claims, and structure function claims?

[ Lisa Shames: ] Yes, there are real differences across those claims in
terms of the level of scientific support as well as the level of FDA
review. Health claims for example are supported by significant
scientific agreement or by some authoritative source. An example of such
a claim is diets low in sodium may reduce the risk of high blood
pressure. There are also qualified health claims, they have a lower
level of scientific support and FDA prescribes the exact wording of the
qualifying language to characterize the strengths and the limitations.
An example of a qualified health claim is scientific evidence suggests
but does not prove that eating one and one half ounces of nuts may
reduce the risk of heart disease, and FDA has allowed the use of 12 such
claims. There are also these so called structure function claims; an
example of one is calcium helps build strong bones. These structure
function claims describe how a nutrient affects the body. Companies are
not required to submit any scientific support for these structure
function claims, nor has FDA provided any sort of guidance in terms of
what would be sufficient support.

[ Jeremy Cluchey: ] An FDA decision in 2002 helped change the status of
the use of qualified health claims. Can you provide some background
about this decision?

[ Lisa Shames: ] Yes, it's interesting that qualified health claims came
about through a ruling dealing with dietary supplements. In that
hearing, in that ruling, the court held that FDA can't prohibit a
potentially misleading health claim unless it also considers whether
qualifying language could negate the claim's misleading nature. So as a
result of that ruling FDA announced that companies could petition for
qualified claims on dietary supplements and eventually FDA expanded that
approach to include conventional foods.

[ Jeremy Cluchey: ] Your team looked at some of the outcomes of this
decision. What did you find?

[ Lisa Shames: ] We found that FDA's oversight of qualified health
claims is limited. FDA has issued only two warning letters, those were
last year. FDA found that the companies had not used the prescribed
language that FDA allows and also had added information that didn't have
sufficient scientific support. We also found that FDA had limited
oversight of these structure function claims, and this limitation is
actually more problematic because FDA's data show that the structure
function claims are used more often than the qualified health claims.

[ Jeremy Cluchey: ] Your team also looked at consumer's understanding of
these claims. How did you assess this?

[ Lisa Shames: ] We reviewed numerous scientific reports that looked at
consumer's perceptions and understanding of these health claims, and the
research showed that consumers don't really understand the differences
in scientific support between health claims and qualified health claims.
And, it's because of this consumer confusion that governments, like
Canada and the European Union, disallowed the use of qualified health
claims.

[ Jeremy Cluchey: ] One of your primary recommendations has to do with
the information that FDA can require from companies in support of their
claims. Can you expand on this?

[ Lisa Shames: ] We found that FDA bears the burden of proof to
demonstrate that a structure function claim may be false or misleading.
So for FDA to prove that, it would require extensive work on their part
that could take time or be labor intensive. Instead, what we recommended
is that FDA seek the statutory authority that it would need to access
the evidence from the companies themselves and to review the evidence to
see if there's sufficient support. We know that the Federal Trade
Commission had similar statutory authority that allows it to access the
evidence if companies may be falsely advertising their product. FDA
generally agreed with our recommendation and said that it would
re-examine its approach for examining structure function claims.

[ Background Music ]

[ 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.