The Food Directorate of Health Canada has released a report “Summary of Health Canada’s Assessment of Health Claim about Vegetables and Fruit and Heart Disease”.  The report discusses the consumption of vegetables and fruits and a reduced risk of heart disease and the appropriate wording and conditions to use such a health claim in foods.

With Heart Disease a major public health concern in Canada (second leading cause of death in Canada in 2011 according to Statistics Canada¹), the Food Directorate evaluated a proposal for a claim about vegetables and fruit and the risk of heart disease in Canada.  The United States Food and Drug Administration (FDA) had already accepted a health claim about vegetable, fruit and heart disease in 1993.  After assessment of the FDA decision and the scientific evidence published since then, Health Canada concluded that sufficient scientific evidence exists to support a health claim about vegetables and fruit consumption (but not fruit or vegetable juices) and a reduced risk of heart disease.

However, the wording for the appropriate health claim relating fruit and vegetable consumption to heart disease has created issues for the Food Directorate. The term arteriosclerosis (considered synonymous to Coronary Heart Disease, the most common type of heart disease) is considered as one of the diseases that products (including food) are prohibited by the Food and Drugs Act to carry advertising or labeling for that states they can treat, prevent or cure. As a result, claims about heart disease for food products are actually prohibited.  Health Canada has therefore published the necessary proposed regulatory amendments in Canadian Gazette, Part I, with the following proposed claim:

“A healthy diet rich in a variety of vegetables and fruit may help reduce the risk of heart disease”.

In order for a food product to qualify for the above claim, the following criteria are being proposed by the Food Directorate:

1. Be one of the following vegetable or fruits preparations:
   1. A fresh, frozen, canned or dried vegetable
   2. A fresh, frozen, canned or dried fruit
   3. A combination of a. or b.

Note:  The fruit or vegetable may contain only food additives of salt, herbs, spices, seasonings, water or food additives that are subject to Section 2 (Exemptions) of a marketing authorization.

1. Exclude the following fruits and vegetables or their preparation::
   1. Potatoes, yams, cassava, plantain, corn, mature legumes and their juices,
   2. Vegetables or fruit used as condiments, garnishes or flavourings, including maraschino cherries, glacé fruit, candied fruit and onion flakes,
   3. jams or jam-type spreads, marmalades, preserves and jellies,
   4. olives
   5. a fruit or vegetable juice, a fruit or vegetable drink or any mixture of these foods, or
   6. powdered vegetables or fruit
2. Alcohol Restriction: ≤0.5% alcohol
3. Sodium Restriction: <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.Dicentra is a leading expert in food consulting and can assist in your product development by outlining the health claims considered appropriate by Health Canada or by helping substantiate novel claims that regulatory decisions have not been made on.  With our expertise in novel foods and regulatory submissions, we can assist in the proper registration of your product in the most expedient manner possible with its true compliant marketing potential.

dicentra provides regulatory and scientific solutions for accelerated business growth.  We specialize in the areas of foods, dietary supplements, natural health products, cosmetics and OTCs. We can be reached at 1-866-647-3279 or info@dicentra.com

dicentra will be keeping abreast of the development of this health claim for food products in Canada and will provide news of any updates.

Statistics Canada. The 10 leading causes of death, 2011. [Accessed on: 2015 October 16]: http://www.statcan.gc.ca/pub/82-625-x/2014001/article/11896-eng.htm