Food and Drugs Act (R.S.C., 1985, c. F-27)

Short Title

Marginal note:Short title

1 This Act may be cited as the Food and Drugs Act.

Interpretation and Application

Marginal note:Definitions

2 In this Act,

advanced therapeutic product

advanced therapeutic product means a therapeutic product that is described in Schedule G or that belongs to a class of therapeutic products that is described in that Schedule; (produit thérapeutique innovant)

advertisement

advertisement includes any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any food, drug, cosmetic or device; (publicité ou annonce)

analyst

analyst means an individual designated as an analyst for the purposes of this Act under section 28 or under section 13 of the Canadian Food Inspection Agency Act; (analyste)

clinical trial

clinical trial means a study, involving human subjects, for the purpose of discovering or verifying the effects of a drug, a device or a food for a special dietary purpose; (essai clinique)

confidential business information

confidential business information, in respect of a person to whose business or affairs the information relates, means — subject to the regulations — business information

• (a) that is not publicly available,

• (b) in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available, and

• (c) that has actual or potential economic value to the person or their competitors because it is not publicly available and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors; (renseignements commerciaux confidentiels)

contraceptive device

contraceptive device means any instrument, apparatus, contrivance or substance other than a drug, that is manufactured, sold or represented for use in the prevention of conception; (moyen anticonceptionnel)

cosmetic

cosmetic includes any substance or mixture of substances manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes; (cosmétique)

Department

Department means the Department of Health; (ministère)

device

device means an instrument, apparatus, contrivance or other similar article, or an in vitro reagent, including a component, part or accessory of any of them, that is manufactured, sold or represented for use in

• (a) diagnosing, treating, mitigating or preventing a disease, disorder or abnormal physical state, or any of their symptoms, in human beings or animals,

• (b) restoring, modifying or correcting the body structure of human beings or animals or the functioning of any part of the bodies of human beings or animals,

• (c) diagnosing pregnancy in human beings or animals,

• (d) caring for human beings or animals during pregnancy or at or after the birth of the offspring, including caring for the offspring, or

• (e) preventing conception in human beings or animals;

however, it does not include such an instrument, apparatus, contrivance or article, or a component, part or accessory of any of them, that does any of the actions referred to in paragraphs (a) to (e) solely by pharmacological, immunological or metabolic means or solely by chemical means in or on the body of a human being or animal; (instrument)

drug

drug includes any substance or mixture of substances manufactured, sold or represented for use in

• (a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals,

• (b) restoring, correcting or modifying organic functions in human beings or animals, or

• (c) disinfection in premises in which food is manufactured, prepared or kept; (drogue)

food

food includes any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever; (aliment)

food for a special dietary purpose

food for a special dietary purpose means a food that has been specially processed or formulated

• (a) to meet the particular requirements of an individual in whom a physical or physiological condition exists as a result of a disease, disorder or abnormal physical state, or

• (b) to be the sole or primary source of nutrition for an individual; (aliment à des fins diététiques spéciales)

foreign regulatory authority

foreign regulatory authority means a government agency or other entity outside Canada that controls the manufacture, use or sale of therapeutic products or foods within its jurisdiction; (autorité réglementaire étrangère)

inspector

inspector means an individual designated as an inspector for the purposes of this Act under subsection 22(1) or under section 13 of the Canadian Food Inspection Agency Act; (inspecteur)

label

label includes any legend, word or mark attached to, included in, belonging to or accompanying any food, drug, cosmetic, device or package; (étiquette)

Minister

Minister means the Minister of Health; (ministre)

package

package includes any thing in which any food, drug, cosmetic or device is wholly or partly contained, placed or packed; (emballage)

person

person means an individual or an organization as defined in section 2 of the Criminal Code; (personne)

prescribed

prescribed means prescribed by the regulations; (Version anglaise seulement)

sell

sell includes

• (a) offer for sale, expose for sale or have in possession for sale — or distribute to one or more persons, whether or not the distribution is made for consideration, and

• (b) lease, offer for lease, expose for lease or have in possession for lease; (vente)

therapeutic product

therapeutic product means a drug or device or any combination of drugs and devices; (produit thérapeutique)

therapeutic product authorization

therapeutic product authorization means

• (a) an authorization, including a licence, that

  • (i) authorizes the conduct of a clinical trial in respect of a therapeutic product and is issued under the regulations, or

  • (ii) authorizes, as the case may be, the import, sale, advertisement, manufacture, preparation, preservation, packaging, labelling, storage or testing of a therapeutic product and is issued under subsection 21.92(1) or the regulations, or

• (b) an authorization, including a licence, that would fall within paragraph (a) if the authorization were not suspended; (autorisation relative à un produit thérapeutique)

unsanitary conditions

unsanitary conditions means such conditions or circumstances as might contaminate with dirt or filth, or render injurious to health, a food, drug or cosmetic. (conditions non hygiéniques)

Marginal note:Non-corrective contact lenses

2.1 For the purposes of this Act, a non-corrective contact lens is deemed to be a device.

Marginal note:Tobacco products

2.2 This Act does not apply to a tobacco product as defined in section 2 of the Tobacco and Vaping Products Act.

Marginal note:Vaping products

• 2.3 (1) Despite the definition drug in section 2, this Act does not apply to a vaping product as defined in section 2 of the Tobacco and Vaping Products Act by reason that it contains nicotine, unless the vaping product is manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings.

• Marginal note:Vaping products

  (2) Despite the definition device in section 2, this Act does not apply to a vaping product as defined in section 2 of the Tobacco and Vaping Products Act by reason that it is manufactured, sold or represented for use with a substance or mixture of substances that contains nicotine, unless the vaping product is manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings.

Marginal note:Classification — thing

• 2.4 (1) If the Minister believes that a thing falls within two or more of the definitions food, drug, cosmetic and device in section 2, the Minister may, by order, add a description of the thing to a single part of Schedule A that corresponds to one of the definitions in which the thing is believed to fall.

• Marginal note:Classification — class of things

  (2) If the Minister believes that every thing in a class of things falls within the same two or more definitions food, drug, cosmetic and device in section 2, the Minister may, by order, add a description of the class to a single part of Schedule A that corresponds to one of the definitions in which the things in the class are believed to fall.

• Marginal note:Factors

  (3) Before adding a description of a thing or a class of things to a part of Schedule A, the Minister shall consider the following factors:

  • (a) the risk of injury that the thing or things present to human health;

  • (b) the protection and promotion of health;

  • (c) the possibility of a person being deceived or misled;

  • (d) the purposes for which the thing or things are sold, represented or used and the history of use of the thing or things;

  • (e) the treatment of similar things that have been regulated as foods, drugs, cosmetics or devices under this Act; and

  • (f) the prescribed factors, if any.

• Marginal note:Effect of addition

  (4) A thing that either is described in or belongs to a class of things that is described in

  • (a) Part 1 of Schedule A falls within the definition food in section 2 and does not fall within any of the other definitions referred to in subsections (1) and (2);

  • (b) Part 2 of Schedule A falls within the definition drug in section 2 and does not fall within any of the other definitions referred to in subsections (1) and (2);

  • (c) Part 3 of Schedule A falls within the definition cosmetic in section 2 and does not fall within any of the other definitions referred to in subsections (1) and (2); and

  • (d) Part 4 of Schedule A falls within the definition device in section 2 and does not fall within any of the other definitions referred to in subsections (1) and (2).

• Marginal note:Deletion from Schedule A

  (5) The Minister may, by order, delete the description of a thing or a class of things from Schedule A.

• Marginal note:Interpretation — definitions food, drug, cosmetic and device

  (6) For greater certainty, the definitions food, drug, cosmetic and device in section 2 are subject to subsection (4).

PART IFoods, Drugs, Cosmetics and Devices

General

Marginal note:Prohibited advertising

• 3 (1) No person shall advertise any food, drug, cosmetic or device to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.1.

• Marginal note:Prohibited sales

  (2) No person shall sell any food, drug, cosmetic or device if

  • (a) it is represented by label as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.1; or

  • (b) the person advertises it to the general public as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.1.

• Marginal note:Unauthorized advertising of contraceptive device prohibited

  (3) Except as authorized by regulation, no person shall advertise to the general public any contraceptive device or any drug manufactured, sold or represented for use in the prevention of conception.