Food and Drug Regulations (C.R.C., c. 870)

Regulations are current to 2017-05-11 and last amended on 2017-05-05. Previous Versions

[B.01.514 to B.01.599 reserved]

Health Claims

Languages

 A statement or claim set out in column 1 of the table following section B.01.603 that appears on the label of a food shall be

  • (a) in English and French; or

  • (b) in one of those languages, if in accordance with subsection B.01.012(3) or (7) the information that is required by these Regulations to be shown on the label of the food may be shown in that language only and is shown on the label in that language.

  • SOR/2003-11, s. 20.

Statements or Claims

  •  (1) A food with a label or advertisement that carries a statement or claim set out in column 1 of the table following section B.01.603 is exempt from the provisions of the Act and its Regulations with respect to drugs, and from subsections 3(1) and (2) of the Act, if

    • (a) the food meets the applicable conditions set out in column 2;

    • (b) the label of or the advertisement for the food meets the applicable conditions set out in column 3; and

    • (c) the food is not

      • (i) intended solely for children under two years of age, or

      • (ii) a food represented for use in a very low energy diet.

  • (2) Subsection (1) does not apply to a food that comes within the definition of drug as defined in section 2 of the Act for a reason other than the fact that its label or advertisement carries a statement or claim referred to in that subsection.

  • (3) Subsection (1) applies even if the word “graisses” in the French version of the statement or claim is replaced by the word “lipides”.

  • SOR/2003-11, s. 20.
  •  (1) The information required under the conditions set out in column 3 of the table following section B.01.603 that appears in an advertisement for a food that is not a prepackaged product, or in an advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, shall,

    • (a) in the case of an advertisement, other than a radio or television advertisement, be

      • (i) adjacent to, without any intervening printed, written or graphic material, the statement or claim set out in column 1, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once, and

      • (ii) shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once;

    • (b) in the case of a radio advertisement or the audio portion of a television advertisement, immediately precede or follow the statement or claim set out in column 1; or

    • (c) in the case of a television advertisement, be communicated

      • (i) in the audio mode, if the statement or claim set out in column 1 is made only in the audio portion of the advertisement or in both the audio and visual portions, or

      • (ii) in the audio or visual mode, if the statement or claim set out in column 1 is made only in the visual portion of the advertisement.

  • (2) The information that is communicated in the visual mode of a television advertisement in accordance with subparagraph (1)(c)(ii) shall

    • (a) appear concurrently with and for at least the same amount of time as the statement or claim;

    • (b) be adjacent to, without any intervening printed, written or graphic material, the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once; and

    • (c) be shown in letters of at least the same size and prominence as those of the statement or claim, if the statement or claim is made only once, or the most prominent statement or claim, if the statement or claim is made more than once.

  • SOR/2003-11, s. 20.
  •  (1) For greater certainty, a statement or claim set out in column 1 of the table following this section that is made on the label of or in any advertisement for a food may be preceded or followed by other words, numbers, signs or symbols, but none of those shall be interposed between the words, numbers, signs or symbols of the statement or claim.

  • (2) If a food meets the conditions set out in column 2 of the table following this section for more than one item of that table, it is not necessary to repeat the common element of the statements or claims set out in column 1 that are used on the label of or in the advertisement for the food, and the remaining elements may be joined by means of a conjunction or punctuation, as appropriate.

    TABLE

    ItemColumn 1Column 2Column 3
    Statement or ClaimConditions — FoodConditions — Label or Advertisement
    1
    • (1) “A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is sodium-free.”

    • (2) “A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is low in sodium.”

    • (3) “A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is a good source of potassium and is sodium-free.”

    • (4) “A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is a good source of potassium and is low in sodium.”

    • (5) “A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is high in potassium and is sodium-free.”

    • (6) “A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease. (Naming the food) is high in potassium and is low in sodium.”

    The food

    • (a) other than a vegetable or fruit, does not meet the conditions set out in column 2 of item 2 of the table following section B.01.513 for the subject “low in energy” set out in column 1;

    • (b) contains at least 10% of the weighted recommended nutrient intake of a vitamin or a mineral nutrient

      • (i) per reference amount and per serving of stated size, or

      • (ii) per serving of stated size, if the food is a prepackaged meal;

    • (c) meets the conditions set out in column 2 of item 19 of the table following section B.01.513 for the subject “low in saturated fatty acids” set out in column 1;

    • (d) contains 0.5% or less alcohol;

    • (e) meets the conditions set out in column 2 of item 31 of the table following section B.01.513 for the subject “free of sodium or salt” set out in column 1, if the label of or advertisement for the food carries statement or claim (1), (3) or (5) set out in column 1 of this item;

    • (f) meets the conditions set out in column 2 of item 32 of the table following section B.01.513 for the subject “low in sodium or salt” set out in column 1, if the label of or advertisement for the food carries statement or claim (2), (4) or (6) set out in column 1 of this item; and

    • (g) contains 350 mg or more of potassium, if the label of or advertisement for the food carries statement or claim (3), (4), (5) or (6) set out in column 1 of this item,

      • (i) per reference amount and per serving of stated size, or

      • (ii) per serving of stated size, if the food is a prepackaged meal.

    If the statement or claim is made on the label of or in the advertisement for a food that is not a prepackaged product, or in the advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, the label or advertisement shall include the amount of sodium and potassium per serving of stated size, in accordance with section B.01.602, if applicable. However, this requirement does not apply if the statement or claim is made on the label of or in the advertisement for a fresh vegetable or fruit or any combination of fresh vegetables or fruits without any added ingredients, an orange with added food colour or a fresh vegetable or fruit coated with mineral oil, paraffin wax, petrolatum or any other protective coating.

    2
    • (1) “A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is a good source of calcium.”

    • (2) “A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is high in calcium.”

    • (3) “A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is an excellent source of calcium.”

    • (4) “A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is very high in calcium.”

    • (5) “A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is an excellent source of calcium and vitamin D.”

    • (6) “A healthy diet with adequate calcium and vitamin D, and regular physical activity, help to achieve strong bones and may reduce the risk of osteoporosis. (Naming the food) is very high in calcium and vitamin D.”

    The food

    • (a) other than a vegetable or fruit, does not meet the conditions set out in column 2 of item 2 of the table following section B.01.513 for the subject “low in energy” set out in column 1;

    • (b) contains no more phosphorus, excluding that provided by phytate, than calcium;

    • (c) contains 0.5% or less alcohol;

    • (d) contains, if the label of or advertisement for the food carries statement or claim (1) or (2) set out in column 1 of this item,

      • (i) 200 mg or more of calcium per reference amount and per serving of stated size, or

      • (ii) 300 mg or more of calcium per serving of stated size, if the food is a prepackaged meal;

    • (e) contains, if the label of or advertisement for the food carries statement or claim (3), (4), (5) or (6) set out in column 1 of this item,

      • (i) 275 mg or more of calcium per reference amount and per serving of stated size, or

      • (ii) 400 mg or more of calcium per serving of stated size, if the food is a prepackaged meal; and

    • (f) contains 1.25 µg or more of vitamin D, if the label of or advertisement for the food carries statement or claim (5) or (6) set out in column 1 of this item,

      • (i) per reference amount and per serving of stated size, or

      • (ii) per serving of stated size, if the food is a prepackaged meal.

    • (1) If the statement or claim is made on the label of or in the advertisement for a prepackaged product, by or on the direction of the manufacturer of the product, the nutrition facts table shall include the amount of vitamin D and phosphorus, in accordance with subsection B.01.402(2).

    • (2) If the statement or claim is made on the label of or in the advertisement for a food that is not a prepackaged product, or in the advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, the label or advertisement shall include the amount of vitamin D, calcium and phosphorus per serving of stated size, in accordance with section B.01.602, if applicable. However, this requirement does not apply if the statement or claim is made on the label of or in the advertisement for a fresh vegetable or fruit or any combination of fresh vegetables or fruits without any added ingredients, an orange with added food colour or a fresh vegetable or fruit coated with mineral oil, paraffin wax, petrolatum or any other protective coating.

    3
    • (1) “A healthy diet low in saturated and trans fats may reduce the risk of heart disease. (Naming the food) is free of saturated and trans fats.”

    • (2) “A healthy diet low in saturated and trans fats may reduce the risk of heart disease. (Naming the food) is low in saturated and trans fats.”

    The food

    • (a) other than a vegetable or fruit, does not meet the conditions set out in column 2 of item 2 of the table following section B.01.513 for the subject “low in energy” set out in column 1;

    • (b) contains at least 10% of the weighted recommended nutrient intake of a vitamin or a mineral nutrient

      • (i) per reference amount and per serving of stated size, or

      • (ii) per serving of stated size, if the food is a prepackaged meal;

    • (c) contains 100 mg or less of cholesterol per 100 g of food;

    • (d) contains 0.5% or less alcohol;

    • (e) if it is a fat or an oil, meets the conditions set out in

      • (i) column 2 of item 25 of the table following section B.01.513 for the subject “source of omega-3 polyunsaturated fatty acids” set out in column 1,

      • (ii) column 2 of item 26 of the table following section B.01.513 for the subject “source of omega-6 polyunsaturated fatty acids” set out in column 1, or

      • (iii) subparagraphs (i) and (ii);

    • (f) contains

      • (i) 480 mg or less 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, or

      • (ii) 960 mg or less of sodium per serving of stated size, if the food is a prepackaged meal;

    • (g) meets the conditions set out in column 2 of item 18 of the table following section B.01.513 for the subject “free of saturated fatty acids” set out in column 1, if the label of or advertisement for the food carries statement or claim (1) set out in column 1 of this item; and

    • (h) meets the conditions set out in column 2 of item 19 of the table following section B.01.513 for the subject “low in saturated fatty acids” set out in column 1, if the label of or advertisement for the food carries statement or claim (2) set out in column 1 of this item.

    If the statement or claim is made on the label of or in the advertisement for a food that is not a prepackaged product, or in the advertisement for a prepackaged product that is not made or placed by or on the direction of the manufacturer of the product, the label or advertisement shall include the amount of saturated fatty acids and trans fatty acids per serving of stated size, in accordance with section B.01.602, if applicable. However, this requirement does not apply if the statement or claim is made on the label of or in the advertisement for a fresh vegetable or fruit or any combination of fresh vegetables or fruits without any added ingredients, an orange with added food colour or a fresh vegetable or fruit coated with mineral oil, paraffin wax, petrolatum or any other protective coating.

    4

    “A healthy diet rich in a variety of vegetables and fruit may help reduce the risk of some types of cancer.”

    The food

    • (a) is one of the following vegetables, fruits or juices and may contain only food additives that are referred to in section 2 of a marketing authorization, sweetening agents, salt, herbs, spices, seasonings and water:

      • (i) a fresh, frozen, canned or dried vegetable,

      • (ii) a fresh, frozen, canned or dried fruit,

      • (iii) a vegetable or fruit juice, or

      • (iv) a combination of the foods set out in subparagraphs (i) to (iii);

    • (b) is not one of the following:

      • (i) potatoes, yams, cassava, plantain, corn, mushrooms, mature legumes and their juices,

      • (ii) vegetables or fruit used as condiments, garnishes or flavourings, including maraschino cherries, glacé fruit, candied fruit and onion flakes,

      • (iii) jams or jam-type spreads, marmalades, preserves and jellies,

      • (iv) olives, or

      • (v) powdered vegetables or fruit; and

    • (c) contains 0.5% or less alcohol.

    4.1

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

    The food

    • (a) is one of the following vegetables or fruits and may contain only food additives that are referred to in section 2 of a marketing authorization, salt, herbs, spices, seasonings and water:

      • (i) a fresh, frozen, canned or dried vegetable,

      • (ii) a fresh, frozen, canned or dried fruit,

      • (iii) a vegetable juice or vegetable drink, or

      • (iv) a combination of the foods set out in any of subparagraphs (i) to (iii);

    • (b) is not one of or does not contain any of the following:

      • (i) potatoes, yams, cassava, plantain, mature legumes and their juices,

      • (ii) vegetables or fruit used as condiments, garnishes or flavourings, including maraschino cherries, glacé fruit, candied fruit and onion flakes,

      • (iii) jams or jam-type spreads, marmalades, preserves and jellies,

      • (iv) olives,

      • (v) a fruit juice or fruit drink,

      • (vi) powdered vegetables or fruit, or

      • (vii) the seed of a fruit known as a drupe, including almonds, cashews and coconuts;

    • (c) contains 0.5% or less alcohol; and

    • (d) 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.

    5
    • (1) “Won’t cause cavities.”

    • (2) “Does not promote tooth decay.”

    • (3) “Does not promote dental caries.”

    • (4) “Non-cariogenic.”

    The food is a chewing gum, hard candy or breath freshener product that

    • (a) contains 0.25% or less starch, dextrins, mono-, di- and oligosaccharides or other fermentable carbohydrates combined; or

    • (b) does not, if it contains more than 0.25% fermentable carbohydrates, lower plaque pH below 5.7 by bacterial fermentation during 30 minutes after consumption as measured by the indwelling plaque pH test, referred to in “Identification of Low Caries Risk Dietary Components” by T.N. Imfeld, Volume 11, Monographs in Oral Science, 1983.

    If the statement or claim is made on the label of or in the advertisement for a prepackaged product, by or on the direction of the manufacturer of the product, the nutrition facts table shall include the amount of sugar alcohols, if present, in accordance with subsection B.01.402(2).

  • SOR/2003-11, s. 20;
  • err.(F), Vol. 137, No. 5;
  • SOR/2010-142, s. 2;
  • SOR/2016-305, ss. 47, 48, 75(F).
 
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