Summary of Health Canada's Assessment of a Health Claim about Vegetables and Fruit and Heart Disease
Bureau of Nutritional Sciences
Food Directorate, Health Products and Food Branch
In 1993, a health claim about vegetables and fruit and heart disease was accepted by the U.S. Food and Drug Administration.Footnote 1 In 2006, Health Canada posted its Position Paper on Five U.S. Health Claims for Use in Canada (Position Paper) for online consultation.Footnote 2 This paper included a proposal for a claim about vegetables and fruit and the risk of heart disease in Canada. Stakeholders from all sectors generally supported the decision to accept the claim. Certain stakeholders questioned the eligibility of juices to use the claim, citing a lack of evidence for heart disease risk reduction.
Scientific Evidence Supporting the Claim
The Position Paper proposal was based on the U.S. Food and Drug Administration decision and an assessment of the scientific evidence published since the U.S. claim was accepted through to the year 2000. Four of 8 controlled trials selected for inclusion reported positive effects on blood lipids. Two of the four positive trials included participants with elevated lipids and/or blood pressure. Ten of 13 prospective cohort studies selected for inclusion supported an effect of vegetables and fruit on coronary heart disease (CHD) risk reduction. Corn, legumes, potatoes (and other starchy roots and tubers such as yams, cassava and plantain) were generally not included in the estimate of vegetables and fruit intake. Condiments, preserves and powders made with vegetables or fruit were also not typically included as vegetables and fruit. In the largest and best-controlled study, CHD mortality reductions ranged from 15 to 37%, with a 20% reduction in risk reported for individuals consuming more than 8 servings/day compared with those consuming less than 3 servings/day (Joshipura et al, 2001).
In 2011, Health Canada assessed 3 systematic reviews published since 2000 to ensure that the scientific evidence still supported the claim. Dauchet et al (2006) found that the risk of CHD was decreased by 4% [RR (95% CI): 0.96 (0.93–0.99), P=0.0027] for each additional portion per day of vegetables and fruit. He et al (2007) found that risk of CHD was decreased by 17% [0.83 (0.77-0.89), P<0.0001)] for individuals with more than 5 servings/day compared with those who had less than 3 servings/day. Mente et al (2009) concluded that there is strong evidence for a causal association between vegetables and CHD risk reduction and moderate evidence for a causal association between fruits and CHD risk reduction.
Health Canada also assessed the evidence to see whether there was support for juice and CHD risk reduction. Three of the 8 controlled trials specifically tested the effects of juice on CHD biomarkers. Two of the 3 reported no effect; the third found that 4 weeks of 8 servings/day of orange juice (but not 2 or 4 servings/day) improved high-density lipoprotein (HDL) cholesterol levels as well as the ratio of HDL to low-density lipoprotein (LDL) cholesterol in individuals with hypercholesterolemia (Kurowska et al, 2000). This amount of juice is not consistent with the pattern for healthy eating recommended in Eating Well with Canada’s Food Guide.Footnote 3 Canada’s Food Guide recommends 7-10 servings of vegetables and fruit per day for adults aged 19-50. Canadians are also advised to “have vegetables and fruit more often than juice”.
Health Canada’s Conclusion
Health Canada has concluded that sufficient scientific evidence exists to support a health claim about vegetables and fruit consumption and a reduced risk of heart disease. The evidence is not sufficient to support a beneficial effect of fruit or vegetable juice on heart disease risk.
The claim is relevant and generally applicable to the Canadian population. Heart disease is a major public health concern in Canada. In 2011, heart disease was the second leading cause of death in Canada, accounting for 20% of all deaths.Footnote 4
Section 3 of the Food and Drugs Act prohibits the labelling and advertising of products that refer to the treatment, prevention or cure of diseases listed in Schedule A, including arteriosclerosis, to the general public. Since CHD, the most common type of heart disease, is often used as a synonym for arteriosclerosisFootnote 5, claims about heart disease are prohibited. Therefore, a regulatory amendment is required before foods are permitted to carry the claim. On June 13 2015, Health Canada published proposed regulatory amendments in Canada Gazette, Part IFootnote 6. The following wording is proposed:
A healthy diet rich in a variety of vegetables and fruits may help reduce the risk of heart disease.Footnote 7
Conditions for Foods to Carry the Claim
- is one of the following vegetables or fruits and may contain only food additives that are subject to section 2 of a marketing authorization, salt, herbs, spices, seasonings, water:
- a fresh, frozen, canned or dried vegetable,
- a fresh, frozen, canned or dried fruit, or
- a combination of the foods set out in subparagraphs (i) and (ii);
- is not one of the following:
- potatoes, yams, cassava, plantain, corn, mature legumes and their juices,
- vegetables or fruit used as condiments, garnishes or flavourings, including maraschino cherries, glacé fruit, candied fruit and onion flakes,
- jams or jam-type spreads, marmalades, preserves and jellies,
- a fruit or vegetable juice, a fruit or vegetable drink or any mixture of these foods, or
- powdered vegetables or fruit; and
- contains 0.5% or less alcohol; and
- contains less than 15% of the Daily Value of sodium per reference amount and per serving of stated size, and per 50 g if the reference amount is 30 g or 30 mL or less.
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