The
U.S. Food and Drug Administration (FDA) just hit a new low in its
obeisance to giant food companies.
FDA
issued the decision late last month, in response to a petition from
Associated British Foods: the $8-billion-per-year food giant that
makes Mazola® corn oil, Karo® corn syrup and Argo® corn
starch.
The
ruling permits the following health claim on the labels of corn
oil products, which includes the bizarre little scientific
evidence qualifier underlined below, which echoed in
the language of the agencys decision:
Very limited and preliminary scientific evidence suggests
that eating about 1 tablespoon (16 grams) of corn oil daily may
reduce the risk of heart disease due to the unsaturated fat content
in corn oil.
FDA
concludes that there is little scientific evidence supporting
this claim. To achieve this possible benefit, corn oil is to replace
a similar amount of saturated fat and not increase the total number
of calories you eat in a day. One serving of this product contains
[x] grams of corn oil.
As
the agency says in its ruling, due to the small number
of subjects in the two intervention studies that showed a beneficial
relationship and the fact that not all of the studies reported a
benefit, FDA believes that the scientific evidence represents a
very low level of comfort among qualified scientists that the claimed
relationship is scientifically valid.
Compared
with saturated fats, omega-6 fatty acids are clearly beneficial
for heart health.
However,
the FDAs decision to allow the new corn-oil claim seems irresponsible
in light of four things:
1. Mainstream medicine considers chronic, silent inflammation
a key risk factor for heart disease.
2. Corn oil is very high in omega-6 fatty acid, which, compared
with omega-3s, are relatively pro-inflammatory.
3. Americans consume five to 10 times more omega-6s than experts
believe is optimal.
4. Countries with higher ratios of omega-3s to omega-6s enjoy
lower rates of depression and cardiovascular disease.
New
qualified-claims category facilitates industry influence
Before
2002, the FDA only allowed unqualified health claims
for foods, which require so-called significant scientific
agreement: i.e., a general consensus among experts that the
claim is valid and supported by all publicly available evidence.
The
best known example of an unqualified claim is the one permitted
on low-sodium foods: Diets low in sodium may reduce the risk
of high blood pressure, a disease associated with many factors.
This
new label claim for corn oil is similar to the qualified claims
that were previously allowed for olive oil and canola oil, for which
the evidence was described as limited and not conclusive,
instead of the weaker very limited and preliminary standard
that the agency decided corn oil meets.
Because
a qualified claim does not require significant scientific
agreement, it invariably includes a disclaimer that describes
the strength of the supporting evidence.
The
FDA now issues permits for three levels of qualified health claims,
which meet the varying levels of evidence:
Strongest
Qualified Claim -- Although there is scientific evidence
supporting the claim, the evidence is not conclusive.
Medium-Level
Qualified Claim -- Some scientific evidence suggests However,
FDA has determined that this evidence is limited and not conclusive.
Weakest
Qualified Claim -- Very limited and preliminary scientific
research suggests . FDA concludes that there is little scientific
evidence supporting this claim.
The
FDA determined that the evidence backing the new corn oil claim
met only the weakest claim standard: one so low as to invite bad
decisions in response to political pressures from big food.
Last
year, we heard Marion Nestle -- professor of nutrition at NYU and
a widely respected advocate for public health -- speak about the
nutritional sins of the food industry and its ability to bend public
policy to its will.
Her
comment to the Los Angeles Times regarding the new corn oil claim
reflects the disdain with which anyone knowledgeable about nutrition
and health should hold the agencys decision: Its
hilarious. They get funnier and funnier. This one is at the far
end of hilarity. (Ravn K 2007)
Dr.
Nestle also voiced a cautionary note in her LA Times interview:
There's a tendency to put the good parts in big print and
the bad parts in small print, because FDA sets no limits on
how health claims must appear on labels or in ads.
Further,
in a 2005 report the FDA acknowledged that few consumers read or
understand the disclaimers attached to qualified health-benefit
statements like the new corn oil claim. Consequently, the disclaimer
attached to new corn oil claim wont impede its misleading
implications.
Compared
with corn oil, olive oil enjoys much more evidence in favor of its
ability to enhance heart health, but the FDA has only allowed olive
oil labels to bear this slightly stronger label claim:
Limited
and not conclusive scientific evidence suggests that eating about
2 tablespoons (23 grams) of olive oil daily may reduce the risk
of coronary heart disease due to the monounsaturated fat in olive
oil. To achieve this possible benefit, olive oil is to replace
a similar amount of saturated fat and not increase the total number
of calories you eat in a day. One serving of this product contains
[x] grams of olive oil."
And
the olive oil claim approved by the FDA ignores the fact that extra
virgin grade olive oil likely adds substantial additional benefits,
thanks to its potent antioxidants.
Sadly,
the FDAs risible corn-oil-claim ruling supports the increasingly
credible suspicion that corporate money and the political influence
it buys plays a powerful role in the FDAs decisions.
Editor's
note:
We
consider organic whole foods from both plant and animal kingdoms
to be a major key to superior health. We also think it's terribly
important to eat fish at least twice a week to get the essential
fatty acids. Here at our house, we only eat wild Alaskan salmon
and other wild seafoods from our friends at Vital Choice.
Click
here to visit Vital Choice Seafood.
8-18-08
UPDATE
Letter from a reader:
I thought
you might like to know that on April 15th of this year, UCLA researchers
at both the UCLA Jonsson Cancer Center and the UCLA department of
urology demonstrated a definitive link between consumption of large
amounts of omega-6 fatty acids -specifically, corn oil -
and increased incidence and rate of progression in prostate cancer.
The
initial findings were using the standard mouse model used for almist
all modern prostate cancer research, and they are currently involved
in a followup volunteer human study.
- Terry
L
Sources:
*
U.S. FDA. Qualified Health Claims: Letter of Enforcement Discretion
- Corn Oil and Corn Oil-Containing Products and a Reduced Risk of
Heart Disease (Docket No. 2006P-0243). Accessed online April 13,
2007 at http://www.cfsan.fda.gov/~dms/qhccorno.html
* Ravn K. Corn oil's qualified health claim raises eyebrows.
Accessed online April 13, 2007 at http://www.latimes.com/features/health/la-he-cornoil16apr16,1,4611891.story?coll=la-headlines-health
* U.S. FDA. Letter Responding to Health Claim Petition dated August
28, 2003: Monounsaturated Fatty Acids from Olive Oil and Coronary
Heart Disease
* (Docket No 2003Q-0559). Accessed online April 13, 2007 at http://www.cfsan.fda.gov/~dms/qhcolive.html
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