Tomatoes, Lycopene, and the FDA

The href="http://www.fda.gov/default.htm" rel="tag">FDA
just can't win.  When they restrict something or say something
negative, they are being too restrictive or complicit with big pharma.
 When they approve something too slowly they are insensitive
to the needs of patients.  When they approve something too
quickly they are not protecting the public.  



In fact, I've criticized them on all of these counts, all the while
knowing that it very difficult to know when the FDA is being fair and
balanced.



Now, we see headlines about a health claim that the FDA has denied.
 It concerns href="http://en.wikipedia.org/wiki/Lycopene" rel="tag">lycopene,
a chemical found in red fruits (note that "vegetables" with seeds are,
technically, fruits).  

class="image">

In
the USA, the FDA is responsible for monitoring health claims made about
products.  They are very picky about not allowing companies to
market products using unsubstantiated health claims, particularly with
regard to the diagnosis or treatment of specific diseases.  



If someone wants to make such a claim, they have to submit an
application with the FDA for approval of a "qualified health claim."
 



In 2004, they received a request to allow the href="http://www.cfsan.fda.gov/%7Edms/qhclyco2.html">following
health claims regarding lycopene:

#
1) "Although the evidence is not conclusive, tomato lycopene may reduce
the risk of prostate cancer."

# 2) "Although the evidence is not conclusive, tomato lycopene may
reduce the risk of prostate cancer when consumed as part of a healthy
diet."

# 3) "Although the evidence is not conclusive, tomato products, which
contain lycopene, may reduce the risk of prostate cancer."

# 4) "Although the evidence is not conclusive, tomatoes and tomato
products, which contain lycopene, may reduce the risk of prostate
cancer."

# 5) "Although the evidence is not conclusive, tomato products, which
contain lycopene, may reduce the risk of prostate cancer when consumed
as part of a healthy diet."

# 6) "Although the evidence is not conclusive, tomatoes and tomato
products, which contain lycopene, may reduce the risk of prostate
cancer when consumed as part of a healthy diet."

# 7) "Although the evidence is not conclusive, lycopene in tomato
products may reduce the risk of prostate cancer."

# 8) "Although the evidence is not conclusive, lycopene in tomatoes and
tomato products may reduce the risk of prostate cancer."

# 9) "Although the evidence is not conclusive, lycopene in tomato
products may reduce the risk of prostate cancer when consumed as part
of a healthy diet."

# 10) "Although the evidence is not conclusive, lycopene in tomatoes
and tomato products may reduce the risk of prostate cancer when
consumed as part of a healthy diet."

# 11) "Although the evidence is not conclusive, lycopene in fruits and
vegetables, including tomatoes and tomato products, may reduce the risk
of prostate cancer."

The
FDA described (link above), in agonizing detail, why they initially
rejected the claims.  However, they acknowledged that some,
but "very little credible" evidence to support the claims.
 Naturally, further research was needed.



As an aside, those of you who are interested in how the FDA evaluates
these kinds of claims might want to lead their whole statement.
 It illustrates the entire process nicely.



Now, the FDA has evaluated further evidence, as reported in an advance
publication of the rel="tag">Journal of the National Cancer Institute.

rev="review"
href="http://jnci.oxfordjournals.org/cgi/content/abstract/djm037">The
U.S. Food and Drug Administration's Evidence-Based Review for Qualified
Health Claims: Tomatoes, Lycopene, and Cancer

Claudine
J. Kavanaugh face="Helvetica, Arial, sans-serif">, face="Helvetica, Arial, sans-serif">Paula R. Trumbo face="Helvetica, Arial, sans-serif">,Kathleen C. Ellwood

Journal of the National Cancer Institute, doi:10.1093/jnci/djm037

Advance Access published online on July 10, 2007



Several studies have reported an inverse association
between tomato and/or lycopene intake and the risk of some types of
cancer. In 2004, the U.S. Food and Drug Administration (FDA) received
two petitions for qualified health claims regarding tomatoes, lycopene,
and the risk reduction for some forms of cancer. Health claims that
characterize the relationship between a food or food component and a
disease or health-related condition require premarket approval by FDA
to be included on the labels of conventional foods and dietary
supplements. Here we describe FDA's review of the scientific data for
tomato and/or lycopene intake with respect to risk reduction for
certain forms of cancer. The FDA found no credible evidence to support
an association between lycopene intake and a reduced risk of prostate,
lung, colorectal, gastric, breast, ovarian, endometrial, or pancreatic
cancer. The FDA also found no credible evidence for an association
between tomato consumption and a reduced risk of lung, colorectal,
breast, cervical, or endometrial cancer. The FDA found very limited
evidence to support an association between tomato consumption and
reduced risks of prostate, ovarian, gastric, and pancreatic cancers.

Also published was an accompanying press release, rev="review"
href="http://jnci.oxfordjournals.org/cgi/content/full/djm087v1">FDA
Finds No Strong Link between Tomatoes and Reduced Cancer Risk.



The assessment was not entirely negative.  In the press
release, the authors (Liz Savage, Andrea Widener) state:

However,
there was very limited evidence for associations between tomato
consumption and reduced risk of prostate, ovarian, gastric, and
pancreatic cancers. Based on this assessment, the FDA decided to allow
qualified health claims for a very limited association between tomatoes
and these four cancers.

In addition to the press release, the original article was also
accompanied by two editorials.  One in particular is of
interest to the general public:

href="http://jnci.oxfordjournals.org/cgi/content/full/djm049v1">

rev="review"
href="http://jnci.oxfordjournals.org/cgi/content/full/djm049v1">Evidence-Based
Reviews in Support of Health Policy Decisions

Paul M. Coates

JNCI Journal of the National Cancer Institute, doi:10.1093/jnci/djm049

The principles of evidence-based review have found broad
application, ranging from health insurance coverage decisions and
clinical practice guideline development to informing the development of
biomedical research agendas and public policy (1). For each
application, there are unique challenges, advantages, and limitations
associated with incorporating evidence-based reviews into existing
decision-making processes...



FDA's systematic review of the relevant literature followed the rules
that are crucial to evidence-based review and, as such, exemplifies the
transparency and neutrality of an evidence-based review approach in
evaluating the strength of the available evidence in an area where the
expectation of risk reduction sometimes results in a biased
interpretation of the evidence.

The author, Paul Coates, goes on to explain the challenges and
limitations of this kind of undertaking.  I think the
collection of the first FDA decision, the journal article, the
editorial, and the press release, together comprise a very good
illustration of how the FDA works.  Or at least how it is
supposed to work.  



Anyone who tried to interpret these "qualified health claims," which
means anyone who buys food supplements, complimentary, or alternative
medicines, would be well advised to gain an understanding of the
process.  Reading all of this material would take some time.
 Even so, it is the best way to understand what these
statements mean, and what they don't mean.