Appendix - Qualified Health Claims for Canola Oil, October 2009
Guidance for Industry: A Food Labeling Guide

Qualified Health Claims
Unsaturated Fatty Acids from Canola Oil and Reduced Risk of Coronary Heart Disease
Docket No. 2006Q-0091 10/06/2006 enforcement discretion letter

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 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 for Exercising Enforcement Discretion
Canola oil, vegetable oil spreads, dressings for salads, shortenings and canola-oil containing foods do not need to
comply with the total fat disqualifying level in 21 CFR 101.14(a)(4).

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 RACC (21 CFR 101.14(e)(6)) does not apply to canola
oil, dressings for salads, and shortenings.

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.

Claim Statements
Limited and not conclusive scientific evidence suggests that eating about 1 1/2 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.

For the purposes of this qualified health claim:

(1) "Canola oil" means products that are essentially pure canola oil and are labeled as such.

(2) "Vegetable oil spread" means margarine (21 CFR 166.110) and margarine-like products, formulated to contain
canola oil.

(3) "Dressings for salads" means dressings for salads formulated to contain canola oil.

(4) "Shortenings" means vegetable oil shortenings, formulated to contain canola oil.

(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.
Canola oil side effects, dangers, facts, ingredients, nutrition and benefits
November 23, 2011 ZHION@ZHION.COM
Canola oil facts and Canola oil nutrition
Canola oil is marketed as vegetable oil for cooking and use in salads. It is one of the most widely consumed food oil in
Canada, and has been considered as GRAS (Generally Recognized as Safe) material by the US FDA. Canola oil
ingredients are: 55% of the monounsaturated fatty acid; oleic acid, 25% linoleic acid and 10% alpha-linolenate
[polyunsaturated fatty acid (PUFA)], and only 4% of the saturated fatty acids (SFAs). Many health associations
recommended the dietary goals for an average diet containing about 30% of calories as fat made up of less than 10%
saturated fatty acids, and they consider canola oil having benefits on health in general. [1]

According to
Wikipedia.com, canola was bred naturally from rapeseed in the early 1970s, it has much less erucic acid.
Thus, it is different from rapeseed oil. Experiments on animals have suggested that erucic acid, consumed in large
quantities, may cause heart damage, however, this observation is questionable. Canola oil is made by crushing the
rapeseed. Approximately 43% of a seed is oil. The canola oil is used for industrial lubricants, biofuels, candles, lipsticks,
and newspaper inks.

Canola oil is among the healthiest of cooking oils. The oil has the lowest saturated fat content (7%) of any oil commonly
consumed in the U.S. While, sunflower oil has 12% saturated fat, corn oil has 13%, and olive oil has 15%.Canola oil has
been given a qualified health claim from the U.S. Food and Drug Administration based on the theory that the absence
of saturated fats (consumption of which may cause coronary heart disease) in the oil content makes it a healthy food.
Here is the health benefit claim:

"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."

The totality of the scientific evidence in this case includes eight intervention studies (Baudet et al., 1988; Lichtenstein et
al., 1993; Sundram et al., 1995; Wardlaw et al., 1991; Sarkkinen et al., 1998; Uusitupa et al., 1994; Matheson et al.,
1996; Noakes et al., 1998).  Four of the intervention studies strictly controlled the dietary intervention of subjects
(Baudet et al., 1988, Lichtenstein et al., 1993, Sundram et al., 1995, Wardlaw et al., 1991) and three of these studies
reported that UFAs from canola oil reduced serum total- and LDL-cholesterol levels compared to diets containing high
levels of SFAs (Baudet et al., 1988, Lichtenstein et al., 1993; Wardlaw et al., 1991).  The fourth strictly controlled study
by Sundram et al. (1995) found no effect of UFAs from canola oil on serum total- and LDL-cholesterol levels compared
to diets containing high levels of SFAs.  The four intervention studies that allowed the subjects to prepare their own
meals reported similar results to the strictly controlled trials in that three studies reported a beneficial relationship
(Uusitupa et al., 1994; Matheson et al., 1996; Noakes et al., 1998) while one found no relationship (Sarkkinen et al.,
1998) between a diet containing UFAs from canola oil and a diets containing high levels of SFAs.

Based on FDA's review of the strength of the total body of scientific evidence for the proposed claim, FDA concludes
that the scientific evidence is credible and supports the substance/disease relationship.  However, due to the small
number of subjects in the six intervention studies that showed a beneficial relationship and the fact that three of these
six studies did not strictly control the diets, FDA believes that the scientific evidence represents a low level of comfort
among qualified scientists that the claimed relationship is scientifically valid.  Therefore, FDA intends to consider the
exercise of its enforcement discretion for a qualified health claim about UFAs from canola oil on the label or in labeling
of canola oil that includes a truthful and non-misleading description of the strength of the body of scientific evidence,
e.g., "limited and not conclusive scientific evidence suggests."  (See Appendix)

[Qualified Health Claims: Letter of Enforcement Discretion - Unsaturated Fatty Acids from Canola Oil and Reduced Risk of Coronary Heart Disease (Docket No.
2006Q-0091); October 6, 2006]
______________________________________________________________________________________

Research Highlights - Benefits of Canola Oil

2011

Replacing dairy fat with rapeseed oil causes rapid improvement of hyperlipidaemia: a randomized controlled
study. J Intern Med. 2011 Apr 5.
Conclusion  In a diet moderately high in total fat, replacing dairy fat with RO causes
a rapid and clinically relevant improvement in serum lipoprotein profile including lowering of triglycerides in
hyperlipidaemic individuals.

Effects of canola and corn oil mimetic on Jurkat cells. Lipids Health Dis. 2011 Jun 1;10:90. Conclusion Use of
canola oil in the diet instead of corn oil might be beneficial for diseases promoted by inflammation.

Chemopreventive effects of dietary canola oil on colon cancer development. Nutr Cancer. 2011;63(2):242-7.
Conclusion: Dietary canola oil significantly (P<0.05) decreased colonic tumor incidence and tumor multiplicity as
compared to dietary corn oil in rats. Fatty acid analysis showed that corn oil group had higher levels of ω-6 fatty acid
levels, whereas the canola oil groups exhibited higher levels of ω-3 fatty acids from the colon and serum samples of
rats. For the mechanistic study, COX-2 expression in the colon samples from the canola oil group was significantly lower
(P<0.05) as compared to the corn oil group. Taken together, dietary canola oil may be chemopreventive for colon tumor
development in Fischer rats as compared to possibly by increasing ω-3 fatty acid levels and decreasing COX-2 levels.

_____________________________________________________________________________________________________________

REFERENCES
[1] Dupont J et al, Food safety and health effects of canola oil. J Am Coll Nutr. 1989 Oct;8(5):360-75. [2] Wakamatsu D et al, Isolation,
identification, and structure of a potent alkyl-peroxyl radical scavenger in crude canola oil, canolol. Biosci Biotechnol Biochem. 2005 Aug;69
(8):1568-74. [3] Chisholm A et al, Cholesterol lowering effects of nuts compared with a Canola oil enriched cereal of similar fat
composition. Nutr Metab Cardiovasc Dis. 2005 Aug;15(4):284-92. [4] Bierenbaum ML et al, Effects of canola oil on serum lipids in humans.
J Am Coll Nutr. 1991 Jun;10(3):228-33. [5] Kuwahara H et al, Antioxidative and antimutagenic activities of 4-vinyl-2,6-dimethoxyphenol
(canolol) isolated from canola oil. J Agric Food Chem. 2004 Jul 14;52(14):4380-7. [6] Clark C et al, Toxic effects in dairy cattle following the
ingestion of a large volume of canola oil. Can Vet J. 2001 Sep;42(9):721-3. [7] Shackelford DD et al, Determination of ethalfluralin in canola
seed, meal, and refined oil by capillary gas chromatography with mass selective detection. J Agric Food Chem. 2000 Sep;48(9):4422-7. [8]
Green TJ et al, Low erucic acid canola oil does not induce heart triglyceride accumulation in neonatal pigs fed formula. Lipids. 2000 Jun;35
(6):607-12. [9] Kwon JS et al, Effects of diets high in saturated fatty acids, canola oil, or safflower oil on platelet function, thromboxane B2
formation, and fatty acid composition of platelet phospholipids. Am J Clin Nutr. 1991 Aug;54(2):351-8. [10] McLennan PL et al Dietary canola
oil modifies myocardial fatty acids and inhibits cardiac arrhythmias in rats. J Nutr. 1995 Apr;125(4):1003-9 [11] Aguila MB et al Numerical
density of cardiac myocytes in aged rats fed a cholesterol-rich diet and a canola oil diet (n-3 fatty acid rich). Virchows Arch. 1999 May;434(5):
451-3. [12] Nydahl M et al, Similar effects of rapeseed oil (canola oil) and olive oil in a lipid-lowering diet for patients with
hyperlipoproteinemia. J Am Coll Nutr. 1995 Dec;14(6):643-51. [13] Aguila MB et al, Morphological and biochemical comparison among
aged rats fed with hyperlipidic and canola oil diet Arq Bras Cardiol. 1997 Mar;68(3):155-61.
_____________________________________________________________________________________________________________________________________________________________________________________
Benefits of canola oil

Canola oil benefit - anti-oxidant activities
Canolol (4-vinyl-2,6-dimethoxyphenol ) is a highly potent ROO(*) scavenger, isolated from crude canola oil (rapeseed). After roasting the seed, the
canolol content increases but it content is low in highly purified canola oil.  Researcher found its potency was much greater than that of well-known
antioxidants, including alpha-tocopherol, vitamin C, beta-carotene, rutin, and quercetin. [2]

Canola oil benefit - cholesterol and glucose conditions
Researchers found that canola oil has benefits on cholesterol. In a study, 28 human subject with mean levels of total and low density lipoprotein
cholesterol of 6.0 (1.1) mmol/L, and 4.1 (1.0)mmol/L, respectively consumed a low saturated fat diet, which included either 30g/d nuts (nut diet) or
one serving of a cereal containing Canola oil (cereal diet). Researchers found that both diets could lower the total cholesterol (TC) and low density
lipoprotein cholesterol (LDL-C) to a similar extent. Thus, foods with a similar fatty acid composition to nuts can produce comparable benefits in
lipoprotein mediated cardiovascular risk. [3]

Lipid-lowering diets containing either rapeseed oil or olive oil may have benefits on serum lipoprotein concentration and glucose tolerance in
hyperlipidemic subjects. In a study of hyperlipidemic patients, researchers found that canola oil and olive oil reduced apolipoproteins B, A-I and
Lp(a), total serum cholesterol, low-density lipoprotein and the ratio between low-density and high-density lipoprotein cholesterol to the same extent.
However, there was a slightly greater decrease in low-density lipoprotein cholesterol with the diet containing rapeseed (canola) oil than with the olive
oil diet. These two oils improved intravenous glucose tolerance to a similar extent. [12]

Canola oil benefit - blood pressure
Canola oil may have benefits on blood pressure-lowering. [4]

Canola oil benefit - anti-cancer activities
Canolol was recently reported to have benefits on lowering the risk of cell mutation.  Canolol suppressed ONOO(-)-induced bactericidal action. It
also reduced intracellular oxidative stress and apoptosis in human cancer SW480 cells when used at a concentration below 20 microM under
H(2)O(2)-induced oxidative stress. In addition, canolol suppressed plasmid DNA (pUC19) strand breakage induced by ONOO(-), as revealed by
agarose gel electrophoresis. [5]

Canola oil benefit - cardiac conditions
Regular substitution of canola oil for other dietary lipid sources may assist in reducing the likelihood of a transient ischemic event leading to
life-threatening cardiac arrhythmias. In a study, researchers randomly assigned rats to one of four experimental diet groups for 12 wk. The fat
source in the diets was 12% olive (63% oleic acid), canola (55% oleic, 8% alpha-linolenic acid), soybean [50% linoleic 18:2(n-6), 7% alpha-linolenic
acid] or sunflower seed oil (64% linoleic acid). The researchers found that the incidence of ventricular fibrillation, mortality and arrhythmia score
during reperfusion were significantly lower in rats fed the diet containing canola oil than in those fed other diets. [10]

Canola oil diet was found to have health benefits on heart tissues.  In a study, aged rats fed with canola oil diet was found to have a
well-vascularized myocardium, which is probably associated with preservation of numerical density of the myocytes in the myocardium of these
animals. [11]  In another study, aged rats fed with canola oil diet (rich in n-3 fatty acid) presented morphological cardiovascular and metabolic
changes less important in magnitude than old animals and, mainly, the same age animals under hyperlipidic diet. [13]

Canola oil has demonstrated its benefits on platelet functions in a trial. In this study, researchers supplied 30 healthy male subjects with a
controlled-saturated-fatty-acid (baseline) diet for 3 wk and then consumed either safflower oil or canola oil as a major fat source for 8 wk. The
researchers studied their platelet function and fatty acid composition. Compared with baseline, the researchers observed a 35% decrease in
arachidonic acid in platelet phospholipids of the canola-oil diet group. And, both unsaturated-fatty-acid diets reduced platelet aggregation at 3 wk of
oil-based diet feeding and only canola oil influenced platelet function (lowered ATP secretion) at 8 wk. [9]
___________________________________________________________________________________________________________________

Canola oil dangers, canola oil bad? Is canola oil healthy? Canola Oil Side Effects
Dangers of canola oil \ Canola Oil Side Effect at high dosese---> A group of 9 dairy cattle accidentally ingested large volumes of canola oil.
Consequently, four of the animals died, and 3 were necropsied. [6]

For many years, canola oil has been widely used as an ingredient in infant formula in Europe, but not in North America due to safety concerns.
Some health organizations do not recommend use of canola oil in infant formula largely because of concerns over possible accumulation of
triglyceride in heart as a result of the small amounts of erucic acid (22:1n-9) in the oil. [8] While, a few organizations in Germany compared the
safety of canola versus non-canola containing infant formula from week 4 to month 7. Absolute and standardized weight and length measures did
not differ between the formula groups with or without canola oil. They concluded that infant formula containing canola oil supports normal infant
growth as assessed by weight and length gain. [Clin Nutr. 2011 Jun;30(3):339-45.]

Ethalfluralin is a herbicide that is effective for weed control on a wide variety of crops, including canola. Researchers analyzed samples from canola
seed, meal, and refined oil and they found no detectable residue of the herbicide. [7]
---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------