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Legal Guide

The Food and Drugs Act regulates the advertising, sale and importation of foods, drugs, cosmetics
and medical devices.

The Food and Drugs Act prohibits the advertising of foods, drugs, natural health products, cosmetics
or medical devices for the treatment, prevention or cure of certain diseases listed in a Schedule of the
Food and Drugs Act. This Schedule lists forty diseases, including alcoholism, cancer and heart disease.

The Food and Drugs Act defines “food” to include any article manufactured, sold or represented for use
as food or drink for human consumption, including chewing gum and any ingredient that may be mixed
with food for any purpose.

“Drugs” are defined to include substances or mixtures of substances manufactured, sold or represented for use in:

  • •     Diagnosing, preventing or treating a disease in man or animal;
  • •     Restoring or modifying organic functions in man or animal; or
  • •     Disinfecting premises in which food is manufactured or kept.

Any product may become a drug for the purpose of the Food and Drugs Act if therapeutic claims are made by a manufacturer through labelling or advertising. 

With respect to pre-market control, foods and drugs are treated differently by the Food and Drugs Act. There is no pre-marketing approval required for any food, although certain foods require pre-marketing notification. Drugs must be approved for importation and sale by the Therapeutic Products Directorate (“TPD”) of Health Canada and be given a Drug Identification Number (“D.I.N.”), which signifies the drug’s compliance with federal regulations. The Food and Drug Regulations set out the information that is required in the application for a D.I.N., such as the name of the manufacturer as it will appear on the label, quantitative list of the medicinal ingredients, the recommended dosage, a sample label and other information concerning testing.

Canadian drug manufacturers, packagers, distributors and wholesalers, and drug testing laboratories, must hold an establishment license that certifies that their facilities meet applicable Good Manufacturing Practices (GMP). For drugs manufactured by foreign manufacturers, the onus is on the Canadian importer to demonstrate that the drugs meet Canadian GMP standards. While not required, foreign manufacturers have the option of applying for Canadian certification of GMP compliance.

The packaging, sale and production of drugs are regulated according to their nature and purpose. Drug regulation is tailored towards the two separate and distinct markets which exist, namely, the general public and health professionals. Any over-the-counter drug which does not fall into a category of prohibited or restricted drugs set out in the Food and Drugs Act, may be advertised and sold to the general public under certain restrictive guidelines. Advertising to health professionals is governed by the Code of Marketing Practices of the Pharmaceutical Manufacturers Association of Canada. In both cases, labelling must be clearly and prominently displayed and readily discernible to the purchaser, in accordance with the Food and Drugs Act Regulations and Labelling Guide.

“Natural Health Products” are regulated as drugs but are subject to less strict controls. This category includes supplements, herbal remedies, homeopathic medicines, traditional medicines, such as traditional Chinese medicines, probiotics and other products, such as amino acids and essential fatty acids. Product and site licenses are required in order to market natural health products in Canada. These licenses are obtained from Health Canada, and require the submission of detailed information about the safety and effectiveness of a product, as well as distribution, handling, storage and delivery methods. Note that many products that classify as "cosmetics" in other jurisdictions would be regulated as natural health products (or even drugs) in Canada.

The Food and Drugs Act prohibits the sale of certain foods, unless they have been prepared according to very detailed Canadian standards. The Act also prohibits misrepresentation and deception in relation to labelling, advertising and packaging of all food and drug products.

The Food and Drugs Act establishes detailed requirements for mandatory nutrition labeling, nutrition claims and diet-related health claims. For example, most pre-packaged foods must carry a “Nutrition Facts” table, unless the food qualifies for an exemption. Exemptions include all fresh fruit and vegetables, raw meat and poultry (except when ground), raw fish and seafood, alcoholic beverages, foods served or sold in restaurants, individual servings sold for immediate consumption, pre-packaged confections sold individually, and milk sold in a refillable glass container. While the format for nutrition labelling may be similar to US requirements, companies cannot use a US label to satisfy Canadian requirements. For example, some of the elements of the Nutrition Facts table, such as servings per container and calories from fat, are mandatory in the US, but not in Canada.

The Food and Drugs Act prohibits the sale of cosmetics containing substances that may be injurious to health. Cosmetics must be manufactured, labelled, packaged, stored and advertised pursuant to prescribed standards. Notification of any new cosmetic must be made to the HPB. The Act also prohibits any misleading labelling, packaging or advertising of medical devices. Medical devices that present substantial risks, such as invasive devices, must be approved for sale in Canada.

If a food, drug, cosmetic or medical device intended for importation into Canada does not comply with Canadian standards, it may have to be relabeled or repackaged.

Canada Consumer Product Safety Act

The Canada Consumer Product Safety Act is a relatively new state which regulates the manufacture, advertising, labelling, sale and importation into Canada of “consumer products”, broadly defined as products, including their components, parts or accessories, that may reasonably be expected to be obtained by an individual to be used for non-commercial purposes, such as domestic, recreational and sports purposes, and their packaging. The Act does not apply to those consumer products identified in the Schedule 1 to the Act that are elsewhere regulated, for example: food, drugs, natural health products, cosmetics and medical devices, feeds and fertilizers.

To this end, the Act establishes consumer product safety standards, and product bans for certain identified products, many of which have been imported from the Hazardous Products Act. Examples of products which are subject to prescribed safety standards include children’s toys, cribs and car seats, and certain flammable textiles. Banned products which are set out in Schedule II to the Act include baby bottles that contain bisphenol A, and certain textiles treated with or containing flame retardant tris (2,3 dibromopropyl) phosphate. As is discussed below, the Hazardous Products Act no longer addresses consumer products, but continues to regulate controlled products for use in the workplace.

Significantly, the Canada Consumer Product Safety Act contains general prohibitions against the manufacture, importation, advertising or sale of consumer products that are deemed a danger to human health or safety, or that have been the subject of a recall (mandatory or voluntary) in Canada or other corrective measures ordered under the Act, and against misleading consumer product safety representations.

The Act further creates an obligation for persons that manufacture, import, advertise, sell or test consumer products for commercial purposes to maintain records of supply chain information. Similar record keeping and tracking measures have been in place in Canada for food, drugs and agricultural products for some time.

The Canada Consumer Product Safety Act also requires manufacturers, importers and retainers of consumer products to report any “incidents” respecting consumer products to Health Canada. An “incident” is defined as:

  • An occurrence in Canada or elsewhere that resulted or may reasonably have expected to result in an individual’s death or serious adverse effect on their health;
  • A defect or characteristic that resulted or that may reasonably have expected to result in an individual’s death or in serious adverse effect on their health;
  • Incorrect or insufficient information on a label or instruction, or lack thereof, that resulted or may reasonably have expected to result in an individual’s death or in serious adverse effects on their health; or
  • A recall or measure initiated by a foreign entity (which may include a foreign corporation), a provincial government, a provincial public body, an aboriginal government, or an institution of a provincial government, public body or aboriginal government.

While the Canada Consumer Product Safety Act largely resembles the United States Consumer Protection Act, these statutes differ in a number of respects. Notably, unlike its US counterpart, for example, the Canadian Act does not require regulatory compliance or general safety tests to be conducted as a perquisite for Canadian sales. Caution, however, that certain consumer products may be subject to testing requirements under product specific federal or provincial legislation, and, as a general rule, it is advisable for Canadian suppliers subject to express safety standards to require proof of compliance with the standards as a condition of the supply contract.

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