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FDA Statement on Canola Oil
Unsaturated
Fatty Acids from Canola Oil and Reduced Risk of
Coronary Heart Disease
Docket
No. 2006Q-0091
10/06/2006 enforcement discretion letter
Claim
Statement
Limited
and not conclusive scientific evidence suggests
that eating about 1 ½ tablespoons (19 grams)
of canola oil daily may reduce the risk of coronary
heart disease due to the unsaturated fat content
in canola oil. To achieve this possible benefit,
canola 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 canola oil.
Eligible
foods
* Canola oil (see * for definitions)
* Vegetable oil spreads, dressings for salads,
shortenings, and canola oil-containing foods that
contain 4.75 g or more of canola oil per reference
amount customarily consumed (RACC), are low in
saturated fat (21 CFR 101.62(c)(2)), are low in
cholesterol (21 CFR 101.62(d)(2)), and meet the
saturated fat, cholesterol, and sodium disqualifying
levels (21 CFR 101.14(a)(4)). Vegetable oil spreads
and canola oil-containing foods must also meet
the 10% minimum nutrient content requirement (21
CFR 101.14(e)(6)).
Factors
The
claim meets the general requirements for health
claims in 21 CFR 101.14, except for: (1) the requirement
that the evidence for the claim meet the significant
scientific agreement standard and be made in accordance
with an authorizing regulation (21 CFR 101.14(c));
(2) the requirement that the food comply with
the total fat disqualifying level (21 CFR 101.14(e)(3));
(3) for canola oil, dressings for salads, and
shortenings, the requirement that the food contain
a minimum of 10 percent of the Daily Value per
RACC of at one of the following: vitamin A, vitamin
C, iron, calcium, protein, or dietary fiber per
reference amount customarily consumed (21 CFR
101.14(e)(6)).
When
the total fat disqualifying level is exceeded
in vegetable oil spreads, dressings for salads,
shortenings, or canola-oil containing foods, the
disclosure statement (i.e., See nutrition information
for total fat content) must be placed immediately
following the claim, with no intervening material,
in the same size, typeface, and contrast as the
claim itself.
*For
the purposes of this qualified health claim:
1. (1) "Canola oil" means products that
are essentially pure canola oil and are labeled
as such.
2. (2) "Vegetable oil spread" means
margarine (21 CFR 166.110) and margarine-like
products, formulated to contain canola oil.
3. (3) "Dressings for salads" means
dressings for salads formulated to contain canola
oil.
4. (4) "Shortenings" means vegetable
oil shortenings, formulated to contain canola
oil.
5. (5) "Canola oil-containing foods"
means all other foods, such as sauces or baked
goods, formulated to contain canola oil, excluding
canola oil, vegetable oil spreads, dressings for
salads, and shortenings.
The study used resulting in
the FDA's announcement also concluded the following
observations in diets containing 4.75g Canola
Oil per serving.
Helps
to reduce the LDL (Bad Cholesterol)
Does
not reducethe HDL (Good Cholesterol)
Does
not reduce the Triglycerides
Contains
Omega 3 Polyunstaturates at high levels
Contains
Plant Sterols offering increased Vitamin E
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