UFAs are fat components that occur naturally in many foods. Under 21 CFR 101.14(b)(3)(ii), if the substance is to be consumed at other than decreased dietary levels, the substance must be a food or a food ingredient or a component of a food ingredient whose use at the levels necessary to justify the claim must be demonstrated by the proponent of the claim, to FDA's satisfaction, to be safe and lawful under the applicable food safety provisions of the Act. a week of canola oil. (3) See guidance entitled "Interim Evidence-based Ranking System for Scientific Data," July 10, 2003. google_ad_width = 468; Uusitupa, M., Schwab, U., Mukimattila, S., Karhapaa, P., Sarkkinen, E., Maliranta, H., Agren, J., Penttila, I. FDA focuses its review on reports of human intervention and observational studies. //-->. The main source of trans fat is partially hydrogenated vegetable oil used to make hard margarines, shortenings "The environment and disease: association or causation?" It has roughly 70 percent monounsaturated fat and a high smoke point (475 °F/246 °C) – slightly higher than regular canola oil. must be included on the label and comply with 21 CFR 101.13(h). A. A disease or health-related condition means damage to an organ, part, structure, or system of the body such that it does not function properly, or a state of health leading to such dysfunctioning (21 CFR 101.14(a)(5)). 3. Kratz et al., 2002 The plant varieties are those producing oil-bearing seeds with a low erucic acid content. (1990). As a result, high-oleic canola oil is becoming popular among U.S. restaurants and food service operations, including universities, state fairs, resorts and supermarket delis, as they continue to strive to eliminate artificial trans fat from their menus.”. "Dietary fats and lecithin-cholesterol acyltranserase activity in healthy humans." V. Conclusions I started to work with her and I told her to get rid of the canola oil, which she completely did. * Three studies (see Appendix 1) were a republication of another study and therefore these studies provided no new scientific evidence to support the substance and disease relationship. The comment supported the claim unconditionally. Republication Gylling et al., 1999 C. Safety However, the four studies that strictly controlled the subject's dietary intakes provide stronger evidence for the substance/ disease relationship since compliance was strictly monitored. As compared to other vegetable oils, it contains lower amounts of trans- and saturated fats. Notify me of follow-up comments by email. (17) FDA recognizes that margarine-like products do not have to meet the fat criteria as defined in the standards of identity for margarine (21 CFR 166.110). (4) For brevity, "disease" will be used as shorthand for "disease or health-related condition" in the rest of the section. § 343(r)(4)). Next, FDA rates the remaining human intervention and observational studies for methodological quality. Canola oil, which is extracted from the seeds of the canola plant, is generally recognized as safe by the Food and Drug Administration. Based on its review of available scientific evidence, the FDA now permits manufacturers of high-oleic edible oils to use the following claim and a variation of it on labels and in promotional materials: “Supportive but not conclusive scientific evidence suggests that daily consumption of about 1½ tablespoons (20 grams) of oils containing high levels of oleic acid, when replaced for fats and oils higher in saturated fat, may reduce the risk of coronary heart disease. The appropriate disclosure statement "See nutrition information for total fat content." USDA Nutrient Database for Standard Reference, Release 18. 2006Q-0091) (5) In an intervention study, subjects similar to each other are randomly assigned to either receive the intervention or not to receive the intervention, whereas in an observational study, the subjects (or their medical records) are observed for a certain outcome (i.e., disease). FDA also uses animal studies as background information regarding mechanisms of action that might be involved in any relationship between the substance and the disease, and they can also be used to generate hypotheses or to explore a mechanism of action, but they cannot adequately support a relationship between the substance and the disease in humans. At present, canola oil sold within the United States is regulated by the FDA and must contain no more than 2% erucic acid by weight. This letter responds to the health claim petition dated January 7, 2006, submitted to the Food and Drug Administration (FDA or the agency) by the U.S. Canola Association pursuant to Section 403(r)(4) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. Metcalf et al., 2003 ... FDA Everything Added to Food: Designated as safe for general or specific, limited use in food: FDA Food Additive Status: Data gaps. According to the European Food Safety Authority (EFSA), rapeseed oil for sale as food generally contains less than 0.5% erucic acid ( 2 ). Therefore, the determination of the qualifying level of UFAs from canola oil for a food to bear the claim will be based on four eating occasions per day. (c) Low erucic acid rapeseed oil. The petition has identified CHD as the disease that is the subject of the proposed qualified health claim. FDA intends to consider exercising enforcement for the above qualified health claim when all other factors for enforcement discretion identified in Section IV of this letter are met. Guiesserian et al., 2002 Please note that scientific information is subject to change, as are consumer consumption patterns. For example, scientific evidence may become available that will support significant scientific agreement or that will no longer support the use of a qualified health claim, or that raises safety concerns about that substance that is the subject of the claim. Because the 99th percentile of intake was used to set the upper boundary of the AMDR for n-6 PUFAs, consuming 19 g of canola oil per day falls well within the boundaries of the AMDR for n-6 PUFA intake. With the new health claim consumers now have two soybean oils, conventional or commodity soybean oil, which is high in polyunsaturated fat, and high oleic soybean oil, which is high in oleic acid, that, according to the FDA, lower blood cholesterol levels and risk of coronary heart disease. "Canola oil (19 grams – about 1 ½ tablespoons per day) may reduce the risk of coronary heart disease due to its unsaturated fat content, according to supportive but not conclusive research. Mutanen et al., 1992 Therefore, the agency concludes that UFAs from canola oil, identified in the petition, are a component of food and thus meets the definition of substance in the health claim regulation (21 CFR 101.14(a)(2)). (12) See supra, note 3. FDA considered the comment in its evaluation of this petition. By Although useful for background information, these materials do not contain sufficient information on the individual studies that they reviewed and, therefore, FDA could not draw any scientific conclusions from this information. UFAs are ubiquitous, natural components of the food supply that provide nutritive value to the diet, certain individual UFA components have been approved as direct food additives or authorized for use in foods, and the level of UFAs from canola oil necessary to justify the claim should not increase an individual's total fat intake due to the replacement of SFAs in the diet. In addition to individual reports of human studies, the agency also considers other types of data and information in its review, such as meta-analyses,(6) review articles,(7) and animal and in vitro studies. Not only is it highly concerning to feed developing infants a GMO oil, but it’s also highly questionable to give them unhealthy fats. Dear Dr. Johnson: 2005. (FDA), canola oil does not contain trans fat. An intake of 19 g of canola oil provides approximately 171 calories but because the qualified health claim specifies that canola oil is to replace saturated fat in the diet while not increasing caloric intake, an individual's total fat intake should not increase based on the recommendations in the claim. Unsaturated fatty acids, particularly polyunsaturated fatty acids can be decomposed forming toxic substances when subjected to high temperature during food processing. Canada paid the US FDA $50 million to have Canola oil added to the safe additive list. (9) See supra, note 3. Wardlaw, GM., Snook, JT., Lin, M., Puangco, MA., Kwon, JS. A health claim characterizes the relationship between a substance and a disease or health-related condition (21 CFR 101.14(a)(1)). The general requirements for health claims require that, if the claim is about the effects of consuming the substance at other than decreased dietary levels, the level of the substance must be sufficiently high and in the appropriate form to justify the claim. FDA identified 42 intervention studies for its evaluation of the relationship between consumption of UFAs from canola oil and risk of CHD. The Continuing Survey of Food Intakes by Individuals, 1994-1996, 1998, which represents a wide range in the amount of foods consumed in the U.S., showed that the 99th percentile of n-6 PUFAs intake for all individuals (31.3 g/day) would exceed the sum of the median intake of PUFAs (12 g/day) plus the PUFAs from 19 g of canola oil (5.6 g/day). The diets were six weeks in duration and all meals were provided to the subjects. Assessment of Animal Studies Nielsen et al., 2002 It began appearing on food labels by 1988[*]. Hill A.B. Raven Press, New York, New York, 1991, pp. Proc R Soc Med, 58:295-300, 1965. Notes (1) Low erucic acid rapeseed oil, also known as canola oil, is the fully refined, bleached, and deodorized edible oil obtained from certain varieties of Brassica Napus or B. Campestris of the family Cruciferae. The agency received one comment on this petition. The primary concerns with canola oil are the trans fat content, which depends to some extent on the processing techniques used to extract the canola oil from the rapeseed plant. Health claims characterize the relationship between the substance and a reduction in risk of contracting a particular disease. Duration of intervention period to short (less than 3 weeks) The agency determined the minimum effective amount of UFAs from canola oil necessary to substitute in place of SFAs by first calculating the difference in the amount of UFAs, in grams,(18) between the high-UFA and high-SFA diets in the three strictly controlled intervention studies that demonstrated a reduction in serum total- and LDL-cholesterol levels. FDA evaluates the individual reports of human studies to determine whether any scientific conclusions can be drawn from each study. Your email address will not be published. Canola oil, also known as low erucic acid rapeseed (LEAR) oil, is the fully refined, bleached, and deodorized edible oil obtained from certain varieties of Brassica Napus or B. Campestris of the family Cruciferae. Where no definition of high has been established, the claim must specify the daily dietary intake necessary to achieve the claimed effect (see 21 CFR 101.14(d)(2)(vii)). google_ad_client = "pub-1225973934413646"; "Serum lipid and apolipoprotein concentrations in healthy men on diets enriched in either canola oil or safflower oil." [http://www.ahrq.gov/clinic/epcsums/strengthsum.htm#Contents] FDA has identified the following disease endpoints to use in identifying CHD risk reduction for purposes of a health claim evaluation: the incidence of coronary events (myocardial infarction (MI), ischemia), cardiovascular death, coronary artery disease, atherosclerosis. Jenkins et al., 1997 The petition also asserts, under 21 CFR 101.14(b)(3)(i), that UFAs provide nutritive value to the diet by serving as a source of energy and, furthermore, certain individual UFAs contribute technical effects. Four of these studies provided all of the meals and snacks to the subjects and thoroughly controlled for all aspects of the dietary intervention (Baudet et al., 1988; Lichtenstein et al., 1993; Sundram et al., 1995; Wardlaw et al., 1991). Metabolism, 47: 744-750, 1998. The resulting oil is a reliable land-based source of long-chain omega-3s that will help address the limitations of fish oil. McDonald et al., 1989