Authorized food products

Health Canada has determined, in accordance with its guidance document on "Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats", that certain products sitting at the Food-Natural Health Product (NHP) interface fit the regulatory definition of a food and will be transitioned to the Food Regulatory Framework over a period of time through the issuance of Temporary Marketing Authorization Letters (TMALs).

Transition Criteria

Food products sitting at the Food-NHP interface that are deemed to be safe (i.e., pose no immediate health and safety concern) will be transitioned to the food regulatory framework through the issuance of a TMAL.

For those food products where a category-specific guidance document has been developed, such as for caffeinated energy drinks, transitioning products will have to meet specific compositional requirements, which include conditions on ingredients such as the total level of caffeine from all sources, levels of added vitamins, minerals, and amino acids, novel ingredients, and food additives. For more information, please visit Transition process for foods marketed as Natural Health Products.

Health Canada has recently made available a General Guidance Document for Temporary Marketing Authorization for Foods. The purpose of this guidance document is to help explain when a Temporary Marketing Authorization (TMA) may be granted by Health Canada for a food and how to prepare a complete submission that fulfills TMA requirements.

The department has committed to provide regular updates, additional guidance, and continued engagement of industry to ensure that impacted parties are fully aware of the overall transition process for eligible products at the Food-NHP interface.

Transition of products from the Food-NHP Interface to the Food Regulatory Framework

Foods that will be transitioned fall under the four broad categories listed below. The transition of caffeinated energy drinks was considered as a first step.

  • Pre-packaged, ready-to-consume drinks (for example, juices and waters)
  • Conventional foods (for example, yogourt and bars)
  • Granulated and powdered products added to food or drinks (for example, drink mixes and meal replacements)
  • Other products

The Lists of foods that have received Temporary Marketing Authorization Letters provide the most current list of products that have transitioned from the Food-NHP interface to the Food Regulatory Framework through the issuance of TMALs.

Classification criteria

The Classification for Products at the Food-NHP Interface Guide: Products in Food Formats explains the four basic principles used in determining the classification for products at the interface: product format product, public perception and history of use, product representation and product composition. The Department has determined, in general, that products at the food-NHP interface embodying the following criteria fit the definition of a food:

  • Product format: These products are packaged in a format typical of foods. Such formats are consistent with the ad libitum consumption of foods.
  • Public perception and history of use: It is the Department's position that Canadians tend to perceive and consume these products as foods rather than as therapeutic products because they provide nourishment, nutrition, hydration, satisfaction of hunger/thirst, or desire for taste, texture or flavour irrespective of any associated health claim. This history of consumption, in spite of any specific directions of use, promotes consumer perception that they can be consumed ad libitum.
  • Product representation to consumers: These products have been represented and advertised in a manner that makes them appear as a food: they are found in grocery and convenience stores. Regardless of any specific health claims, they are normally regarded as foods, as part of the regular diet, with the intent to provide nourishment, nutrition, hydration, satisfaction of hunger/thirst, or desire for taste, texture or flavour.
  • Product composition: In general, products containing ingredients which are expected to provide nourishment, nutrition, hydration, satisfaction of hunger/thirst, or desire for taste, texture or flavour support classification as a food.

More specific classification criteria for the three main product categories:

These criteria were used by the Department to notify manufacturers and distributors of the intent to classify specific products as foods. Final classification decisions will be issued in a coordinated manner with the issuance of TMALs and the revocation of NHP status for eligible products.

Pre-packaged, ready to consume drink products

The Department has determined that "pre-packaged, ready to consume drink products" embodying the following criteria fit the definition of a food:

  • Product format: The product is a drink product that is packaged in a container typical of beverages including, but not limited to cups, tetra paks, bottles, canettes or cans such as those in which soda, bottled water, fruit juices or teas are sold. Such formats are consistent with the ad libitum consumption of beverages.
  • Public perception and history of use: It is the Department's position that Canadians tend to perceive and drink products as beverages rather than as therapeutic products because they are expected to provide nourishment, nutrition, hydration, satisfaction of hunger/thirst, or desire for taste, texture or flavour irrespective of any associated health claim. Drink products, such as sodas, juices, waters, teas, milks, and fruit drinks have a long history of being consumed as foods. This history of consumption, in spite of any specific directions of use, promotes consumer perception that they can be consumed ad libitum.
  • Product representation to consumers: "Representation" includes indications of use, claims presented as a word, sentence, a picture, a symbol, a paragraph or an implication on product labels, package inserts or advertisement, placement and location of sale. Drink products that use terms including but not limited to "drink", "beverage", "water", "juice", "punch", "cocktail", "milk" or similar descriptors in the product name, trade name or elsewhere on the product label, and are found in retail food establishments (e.g. grocery, convenience stores, etc.), amongst soft drinks, juices and other beverages are typically represented to consumers as foods. Regardless of any specific health claims, they are normally regarded as foods, as part of the regular diet, with the intent to provide nourishment, nutrition, hydration, satisfaction of hunger/thirst, or desire for taste, texture or flavour.
  • Product composition: In general, products containing ingredients which are expected to provide nourishment, nutrition, hydration, satisfaction of hunger/thirst, or desire for taste, texture or flavour support classification as a food.

Conventional foods

The Department has determined that "products in conventional food format" embodying the following criteria fit the definition of a food:

  • Product format: Products in conventional food formats generally include pre-packaged or bulk sold products such as whole foods (e.g. nuts, seeds, fruits or vegetables), edible oils, spreads, bars, cereals (e.g. bran, oat), dairy products, condiments and seasonings, confections (e.g. sweet candy, gum, cookies and cakes), and bakery products (e.g. breads, crackers). Such formats, and any others that are consistent with ad libitum consumption, are considered conventional food formats.
  • Public perception and history of use: It is the Department's position that Canadians tend to perceive and consume pre-packaged or bulk sold, conventional food formats summarized above as foods rather than as therapeutic products because they are expected to provide nourishment, nutrition, hydration, satisfaction of hunger/thirst, or desire for taste, texture or flavour irrespective of any associated health claim. Pre-packaged or bulk sold products such as whole foods, edible oils, spreads, cereals, dairy products, condiments and seasonings, confections and bakery products have a long history of being consumed as foods. This history of consumption, in spite of any specific directions of use, promotes consumer perception that they can be consumed ad libitum.
  • Product representation to consumers: "Representation" includes indications of use, claims presented as a word, sentence, a picture, a symbol, a paragraph or an implication on product labels, package inserts or advertisement, placement and location of sale. Pre-packaged or bulk sold products that use terms, including but not limited to, "meal replacement", "yogurt", "bar", "cereal", "candy"; or terms used to describe whole foods (e.g. nuts, berries) in the product name, trade name or elsewhere on the product label; and are found in retail food establishments (e.g. grocery, convenience stores, etc.) amongst other conventional foods are typically represented to consumers as foods. Regardless of any specific health claims, they are normally regarded as foods, as part of the regular diet, with the intent to provide nourishment, nutrition, hydration, satisfaction of hunger/thirst, or desire for taste, texture or flavour. The presence of a health claim is not always a distinguishing factor for classification; however, the product's specific or implied representation for a health benefit within the context of the diet supports the classification of the product as a food.
  • Product composition: In general, products containing ingredients which are expected to provide nourishment, nutrition, hydration, satisfaction of hunger/thirst, or desire for taste, texture or flavour support classification as a food.

Granulated and powdered products

Determining the classification of products in granulated or powder formats in a fair and consistent manner is particularly challenging since these formats are consistent with classification both as foods and as natural health products. As an example, body building products in powdered formats are classified as NHPs. These products are represented to consumers as NHPs and consumers recognize that they are not to be consumed in an ad libitum manner, but according to the recommended directions of use. Drink mixes, although also in a powder format, have a history of use as foods, are typically represented to consumers as foods and are perceived by consumers as beverages consistent with ad libitum consumption. The Department has determined that "granulated and powdered products" embodying the following criteria fit the definition of a food:

  • Product format: Since both granulated and powder formats are consistent with classification both as foods and as natural health products, format is not a primary factor for classification. Characteristics of format which are supportive of a classification as food include, but are not limited to: bulk powders, resealable packaging, sachets, or any other formats consistent with the ad libitum consumption as foods.
  • Public perception and history of use: It is the Department's position that Canadians perceive and consume granulated and powdered products as foods because they contain conventional food ingredients and are mixed with or added to food. Consumers perceive these products as foods rather than as therapeutic products because they are expected to provide nourishment, nutrition, hydration, satisfaction of hunger/thirst, or desire for taste, texture or flavour irrespective of any associated health claim The majority of the ingredients contained in these products have a long history of being consumed as foods. This history of consumption, in spite of any specific directions of use, promotes the public perception that they can be consumed ad libitum.
  • Product representation to consumers: "Representation" includes indications of use, claims presented as a word, sentence, a picture, a symbol, a paragraph or an implication on product labels, package inserts or advertisement, placement and location of sale. Granulated and powdered products that use terms such as, "meal replacement", "food", "energy", "shake", "drink", "beverage", "juice", "cocktail"; feature flavour prominently on the label; are represented as part of a diet; or are marketed in retail food establishments among conventional foods are typically represented to consumers as foods. Regardless of any specific health claims, they are normally regarded as foods, as part of the regular diet, with the intent to provide nourishment, nutrition, hydration, satisfaction of hunger/thirst, or desire for taste, texture or flavour. The presence of a health claim is not always a distinguishing factor for classification; however, the product's specific or implied representation for a health benefit within the context of the diet supports the classification of the product as a food.
  • Product composition: All ingredients contained in a granulated or powdered product should be considered when making a product classification decision. Products intended for classification as food are those in which the ingredients are expected to provide nourishment, nutrition, hydration, satisfaction of hunger/thirst, or desire for taste, texture or flavour irrespective of any associated health claim.

The Department continues to refine and finalize criteria for these product categories. Once criteria have been finalized, they will be incorporated into the guidance document on the Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats.

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