Food and Drugs Act

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

In this Act,

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

that is not publicly available,

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

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 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 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 means the Department of Health; (ministère)

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 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)

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

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,

diagnosing pregnancy in human beings or animals,

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

preventing conception in human beings or animals;

drug includes any substance or mixture of substances 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 or animals,

restoring, correcting or modifying organic functions in human beings or animals, or

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

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 means a food that has been specially processed or formulated

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

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

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

Minister means the Minister of Health; (ministre)

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

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

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

sell includes

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

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

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

therapeutic product authorization means

an authorization, including a licence, that

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

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

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 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)

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

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

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.

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.

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.

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.

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:

the risk of injury that the thing or things present to human health;

the protection and promotion of health;

the possibility of a person being deceived or misled;

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

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

the prescribed factors, if any.

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

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);

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);

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

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).

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

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

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.

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

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

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.

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.

No person shall conduct a clinical trial in respect of a drug, device or prescribed food for a special dietary purpose unless the person holds an authorization issued under the regulations that authorizes the conduct of the clinical trial.

The holder of an authorization referred to in section 3.1 shall comply with any terms and conditions of the authorization that are imposed by the Minister under regulations made under paragraph 30(1)(b.3).

The holder of an authorization referred to in section 3.1 shall ensure that prescribed information concerning the clinical trial is made public within the prescribed time and in the prescribed manner.

No person shall sell an article of food that

has in or on it any poisonous or harmful substance;

is unfit for human consumption;

consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance;

is adulterated; or

was manufactured, prepared, preserved, packaged or stored under unsanitary conditions.

A food does not have a poisonous or harmful substance in or on it for the purposes of paragraph (1)(a) — or is not adulterated for the purposes of paragraph (1)(d) — by reason only that it has in or on it a pest control product as defined in subsection 2(1) of the Pest Control Products Act, or any of its components or derivatives, if the amount of the pest control product or the components or derivatives in or on the food being sold does not exceed the maximum residue limit specified under section 9 or 10 of that Act.

No person shall label, package, treat, process, sell or advertise any food in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.

An article of food that is not labelled or packaged as required by, or is labelled or packaged contrary to, the regulations shall be deemed to be labelled or packaged contrary to subsection (1).

Where a standard for a food has been prescribed, no person shall any article that is intended for sale and that is likely to be mistaken for that food unless the article complies with the prescribed standard.

import into Canada,

send, convey or receive for conveyance from one province to another, or

have in possession for the purpose of sending or conveying from one province to another

Paragraphs (1)(b) and (c) do not apply to an operator of a conveyance that is used to carry an article or to a carrier of an article whose sole concern, in respect of the article, is the conveyance of the article unless the operator or carrier could, with reasonable diligence, have ascertained that the conveying or receiving for conveyance of the article or the possession of the article for the purpose of conveyance would be in contravention of subsection (1).

Where a standard for a food has been prescribed, no person shall label, package, sell or advertise any article that in such a manner that it is likely to be mistaken for that food unless the article complies with the prescribed standard.

has been imported into Canada,

has been sent or conveyed from one province to another, or

is intended to be sent or conveyed from one province to another

The Governor in Council may, by regulation, identify a standard prescribed for a food, or any portion of the standard, as being necessary to prevent injury to the health of the consumer or purchaser of the food.

Where a standard or any portion of a standard prescribed for a food is identified by the Governor in Council pursuant to subsection (1), no person shall label, package, sell or advertise any article in such a manner that it is likely to be mistaken for that food unless the article complies with the standard or portion of a standard so identified.

No person shall manufacture, prepare, preserve, package or store for sale any food under unsanitary conditions.

No person shall sell any drug that

was manufactured, prepared, preserved, packaged or stored under unsanitary conditions; or

is adulterated.

No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety.

A drug that is not labelled or packaged as required by, or is labelled or packaged contrary to, the regulations shall be deemed to be labelled or packaged contrary to subsection (1).

Where a standard has been prescribed for a drug, no person shall label, package, sell or advertise any substance in such a manner that it is likely to be mistaken for that drug, unless the substance complies with the prescribed standard.

Where a standard has not been prescribed for a drug, but a standard for the drug is contained in any publication referred to in Schedule B, no person shall label, package, sell or advertise any substance in such a manner that it is likely to be mistaken for that drug, unless the substance complies with the standard.

Where a standard for a drug has not been prescribed and no standard for the drug is contained in any publication referred to in Schedule B, no person shall sell the drug unless

it is in accordance with the professed standard under which it is sold; and

it does not resemble, in a manner likely to deceive, any drug for which a standard has been prescribed or is contained in any publication referred to in Schedule B.

No person shall manufacture, prepare, preserve, package or store for sale any drug under unsanitary conditions.

No person shall sell any drug described in Schedule C or D unless the Minister has, in prescribed form and manner, indicated that the premises in which the drug was manufactured and the process and conditions of manufacture therein are suitable to ensure that the drug will not be unsafe for use.

No person shall sell any drug described in Schedule E unless the Minister has, in prescribed form and manner, indicated that the batch from which the drug was taken is not unsafe for use.

No person shall distribute or cause to be distributed any drug as a sample except in accordance with the regulations.

No person shall sell any drug described in Schedule F.

No person shall sell any cosmetic that

has in or on it any substance that may cause injury to the health of the user when the cosmetic is used,

according to the directions on the label or accompanying the cosmetic, or

for such purposes and by such methods of use as are customary or usual therefor;

consists in whole or in part of any filthy or decomposed substance or of any foreign matter; or

was manufactured, prepared, preserved, packaged or stored under unsanitary conditions.

No person shall sell a cosmetic unless the person can establish the safety of the cosmetic without relying on data derived from a test conducted on an animal that could cause pain, suffering or injury, whether physical or mental, to the animal.

The prohibition in subsection (1) does not apply if

the Government of Canada has published the data in a scientific journal or on a Government of Canada website;

the data is publicly available and is derived from a test that was not sponsored by or conducted by or on behalf of a person who manufactures, imports or sells the cosmetic;

the following conditions are met:

the data is derived from a test that was conducted on a substance in order to meet

a requirement under a provision of an Act of Parliament or any of its regulations that applied at the time that the test was conducted, except a requirement that relates only to cosmetics under a provision of this Act or the regulations, or

a requirement that does not relate to cosmetics under the law that applied in a foreign state at the time that the test was conducted,

the substance is or has been used in a product that is not a cosmetic and that is or has been legally sold in the country where the requirement in question applied, and

the test was necessary to meet the requirement in order to sell the product in that country;

the data is derived from a test that was conducted before the day on which this section comes into force;

the cosmetic was sold in Canada at any time before the day on which this section comes into force; or

any prescribed circumstance applies.

No person shall conduct a test on an animal that could cause pain, suffering or injury, whether physical or mental, to the animal if the purpose of the test is to meet, with respect to a cosmetic, a requirement under a provision of this Act or the regulations or to meet a requirement that relates to the safety of cosmetics under the law that applies in a foreign state.

No person shall make a claim on the label of or in an advertisement for a cosmetic that is likely to create an impression that the cosmetic was not tested on animals after the day on which this section comes into force unless the person has evidence that no such testing occurred after that day.

A person who makes a claim described in subsection (1) shall, on the request of the Minister, provide the Minister with the evidence referred to in that subsection.

Where a standard has been prescribed for a cosmetic, no person shall label, package, sell or advertise any article in such a manner that it is likely to be mistaken for that cosmetic, unless the article complies with the prescribed standard.

No person shall manufacture, prepare, preserve, package or store for sale any cosmetic under unsanitary conditions.

No person shall sell any device that, when used according to directions or under such conditions as are customary or usual, may cause injury to the health of the purchaser or user thereof.

No person shall label, package, treat, process, sell or advertise any device in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its design, construction, performance, intended use, quantity, character, value, composition, merit or safety.

A device that is not labelled or packaged as required by, or is labelled or packaged contrary to, the regulations shall be deemed to be labelled or packaged contrary to subsection (1).

Where a standard has been prescribed for a device, no person shall label, package, sell or advertise any article in such a manner that it is likely to be mistaken for that device, unless the article complies with the prescribed standard.

If the Minister believes that a therapeutic product may present a serious risk of injury to human health, the Minister may order a person to provide the Minister with information that is in the person’s control and that the Minister believes is necessary to determine whether the product presents such a risk.

The Minister may disclose confidential business information about a therapeutic prod­uct without notifying the person to whose business or affairs the information relates or obtaining their consent, if the Minister believes that the product may present a serious risk of injury to human health.

The Minister may disclose confidential business information about a therapeutic prod­uct without notifying the person to whose business or affairs the information relates or obtaining their consent, if the purpose of the disclosure is related to the protection or promotion of human health or the safety of the public and the disclosure is to

a government;

a person from whom the Minister seeks advice; or

a person who carries out functions relating to the protection or promotion of human health or the safety of the public.

In this section, government means any of the following or their institutions:

the federal government;

a corporation named in Schedule III to the Financial Administration Act;

a provincial government or a public body established under an Act of the legislature of a province;

an aboriginal government as defined in subsection 13(3) of the Access to Information Act;

a government of a foreign state or of a subdivision of a foreign state; or

an international organization of states.

The Minister may, if he or she believes that doing so is necessary to prevent injury to health, order the holder of a therapeutic product authorization that authorizes the import or sale of a therapeutic product to modify the product’s label or to modify or replace its package.

If the Minister believes that a therapeutic product presents a serious or imminent risk of injury to health, he or she may order a person who sells the product to

recall the product; or

send the product, or cause it to be sent, to a place specified in the order.

For greater certainty, if the Minister makes an order under paragraph (1)(a) and believes that corrective action is an effective means of dealing with the risk, the order may require the person who sells the product to, instead of requesting the product’s return, request the product’s owner or user to allow corrective action to be taken in respect of the product and then take that corrective action, or cause it to be taken, if the request is accepted.

Subject to subsection (5), no person shall sell a therapeutic product that the Minister orders them, or another person, to recall.

The Minister may authorize a person to sell a therapeutic product, with or without conditions, even if the Minister has ordered them, or another person, to recall it.

A person does not contravene subsection (3) if they sell a therapeutic product that they have been authorized under subsection (4) to sell, provided that they sell it in accordance with any conditions that the Minister establishes.

No person shall be convicted of an offence for the contravention of subsection (3) unless it is proved that, at the time of the alleged contravention, the person had been notified of the recall order or reasonable steps had been taken to bring the purport of the recall order to the notice of those persons likely to be affected by it.

If the Minister believes that a therapeutic product may present a serious risk to the environment, the Minister may order a person to provide the Minister with information that is in the person’s control and that the Minister believes is necessary to determine whether the product presents such a risk.

The Minister may disclose confidential business information about a therapeutic product without notifying the person to whose business or affairs the information relates or obtaining their consent, if the Minister believes that the product may present a serious risk to the environment.

The Minister may disclose confidential business information about a therapeutic product without notifying the person to whose business or affairs the information relates or obtaining their consent, if the purpose of the disclosure is related to the protection of the environment and the disclosure is to

a government;

a person from whom the Minister seeks advice; or

a person who carries out functions relating to the protection of the environment, including the assessment and management of risks to the environment.

In this section, government has the same meaning as in subsection 21.1(4).

The Minister may, if he or she believes that doing so is necessary to prevent a serious risk to the environment, order the holder of a therapeutic product authorization that authorizes the import or sale of a therapeutic product to modify the product’s label or to modify or replace its package.

If the Minister believes that a therapeutic product presents a serious or imminent risk to the environment, he or she may order a person who sells the product to

recall the product; or

send the product, or cause it to be sent, to a place specified in the order.

Subsections 21.3(2) to (6) apply, with any modifications that the circumstances require, in respect of any order made under subsection (1).

Subject to the regulations, the Minister may order the holder of a therapeutic product authorization to conduct an assessment of the therapeutic product to which the authorization relates and provide the Minister with the results of the assessment.

Subject to the regulations, the Minister may, for the purpose of obtaining additional information about a therapeutic product’s effects on health or safety, order the holder of a therapeutic product authorization to

compile information, conduct tests or studies or monitor experience in respect of the therapeutic product; and

provide the Minister with the information or the results of the tests, studies or monitoring.

Despite the definition therapeutic product in section 2, in sections 21.31 and 21.32 therapeutic product means a drug or device or any combination of drugs and devices, but does not include a natural health product within the meaning of the Natural Health Products Regulations.

Subject to the regulations, the Minister may, for the purpose of obtaining additional information about a therapeutic product’s effects on the environment, order the holder of a therapeutic product authorization to