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

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

R.S., c. F-27, s. 1

Interpretation and Application

Marginal note: Definitions

2 In this Act,

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 )

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 )

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 )

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 )

, 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 )

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 )

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 )

means the Department of Health; ( ministère )

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 )

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 )

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 )

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 )

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 )

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 )

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

means the Minister of Health; ( ministre )

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

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

means prescribed by the regulations; ( Version anglaise seulement )

(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 )

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

(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

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 )

R.S., 1985, c. F-27, s. 2
R.S., 1985, c. 27 (1st Supp.), s. 191
1992, c. 1, s. 145(F)
1993, c. 34, s. 71
1994, c. 26, s. 32(F), c. 38, s. 18
1995, c. 1, s. 63
1996, c. 8, ss. 23.1, 32, 34
1997, c. 6, s. 62
2014, c. 24, s. 2
2016, c. 9, s. 1
2019, c. 29, s. 163
2023, c. 26, s. 500
2024, c. 17, s. 322

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.

2012, c. 25, s. 1

Marginal note: Tobacco products

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

2018, c. 9, s. 72

Marginal note: Vaping products

2.3 (1) Despite the definition in section 2, this Act does not apply to a 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 in section 2, this Act does not apply to a 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.

2018, c. 9, s. 72

Marginal note: Classification — thing

2.4 (1) If the Minister believes that a thing falls within two or more of the definitions , , and 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 , , and 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.

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

PART I Foods, 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.

R.S., 1985, c. F-27, s. 3
1993, c. 34, s. 72(F)
2019, c. 29, s. 165

Marginal note: Prohibition — clinical trials

3.1 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.

Marginal note: Terms and conditions — clinical trial authorizations

3.2 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).

Marginal note: Duty to publicize clinical trial information

3.3 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.

Food

Marginal note: Prohibited sales of food

4 (1) No person shall sell an article of food that

(a) has in or on it any poisonous or harmful substance;
(b) is unfit for human consumption;
(c) consists in whole or in part of any filthy, putrid, disgusting, rotten, decomposed or diseased animal or vegetable substance;
(d) is adulterated; or
(e) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions.

R.S., 1985, c. F-27, s. 4
2005, c. 42, s. 1
2012, c. 19, s. 412

Marginal note: Deception, etc., regarding food

5 (1) 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.
Marginal note: Food labelled or packaged in contravention of regulations (2) 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).

R.S., c. F-27, s. 5

Marginal note: Importation and interprovincial movement of food

6 (1) Where a standard for a food has been prescribed, no person shall

(a) import into Canada,
(b) send, convey or receive for conveyance from one province to another, or
(c) have in possession for the purpose of sending or conveying from one province to another

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.

(a) has been imported into Canada,
(b) has been sent or conveyed from one province to another, or
(c) is intended to be sent or conveyed from one province to another

in such a manner that it is likely to be mistaken for that food unless the article complies with the prescribed standard.

R.S., 1985, c. F-27, s. 6
R.S., 1985, c. 27 (3rd Supp.), s. 1

Marginal note: Governor in Council may identify standard or portion thereof

6.1 (1) 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.
Marginal note: Where standard or portion thereof is identified (2) 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.

R.S., 1985, c. 27 (3rd Supp.), s. 1

Marginal note: Unsanitary manufacture, etc., of food

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

R.S., c. F-27, s. 7

Drugs

Marginal note: Prohibited sales of drugs

8 No person shall sell any drug that

(a) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions; or
(b) is adulterated.

R.S., c. F-27, s. 8

Marginal note: Deception, etc., regarding drugs

9 (1) 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.
Marginal note: Drugs labelled or packaged in contravention of regulations (2) 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).

R.S., c. F-27, s. 9

Marginal note: Where standard prescribed for drug

10 (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.
Marginal note: Trade standards (2) 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.

Marginal note: Where no prescribed or trade standard (3) 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

(a) it is in accordance with the professed standard under which it is sold; and
(b) 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.

R.S., c. F-27, s. 10

Marginal note: Unsanitary manufacture, etc., of drug

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

R.S., c. F-27, s. 11

Marginal note: Drugs not to be sold unless safe manufacture indicated

12 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.

R.S., c. F-27, s. 12

Marginal note: Drugs not to be sold unless safe batch indicated

13 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.

R.S., c. F-27, s. 13

Marginal note: Samples

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

R.S., 1985, c. F-27, s. 14
2020, c. 1, s. 57

Marginal note: Schedule F drugs not to be sold

15 No person shall sell any drug described in Schedule F.

R.S., c. F-27, s. 15

Cosmetics

Marginal note: Prohibited sales of cosmetics

16 No person shall sell any cosmetic that

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

(i) according to the directions on the label or accompanying the cosmetic, or
(ii) for such purposes and by such methods of use as are customary or usual therefor;

R.S., 1985, c. F-27, s. 16
2016, c. 9, s. 2(F)

Marginal note: Prohibited sales — animal testing

16.1 (1) 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.

Marginal note: Exceptions (2) The prohibition in subsection (1) does not apply if

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

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

(A) 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
(B) 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,

Marginal note: Prohibition — animal testing

16.2 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.

Marginal note: Prohibited claims — animal testing

16.3 (1) 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.
Marginal note: Provision of evidence (2) 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.

Marginal note: Where standard prescribed for cosmetic

17 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.

R.S., c. F-27, s. 17

Marginal note: Unsanitary conditions

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

R.S., c. F-27, s. 18

Devices

Marginal note: Prohibited sales of devices

19 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.

R.S., c. F-27, s. 19

Marginal note: Deception, etc., regarding devices

20 (1) 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.
Marginal note: Devices labelled or packaged in contravention of regulations (2) 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).

R.S., c. F-27, s. 20
1976-77, c. 28, s. 16

Marginal note: Where standard prescribed for device

21 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.

R.S., c. F-27, s. 21

Therapeutic Products

Marginal note: Power to require information — serious risk

21.1 (1) 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.
Marginal note: Disclosure — serious risk (2) 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.

Marginal note: Disclosure — health or safety (3) 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) a government;
(b) a person from whom the Minister seeks advice; or
(c) a person who carries out functions relating to the protection or promotion of human health or the safety of the public.

(a) the federal government;
(b) a corporation named in Schedule III to the Financial Administration Act ;
(c) a provincial government or a public body established under an Act of the legislature of a province;
(d) an aboriginal government as defined in subsection 13(3) of the Access to Information Act ;
(e) a government of a foreign state or of a subdivision of a foreign state; or
(f) an international organization of states.

2014, c. 24, s. 3

Marginal note: Modification or replacement — labelling or packaging

21.2 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.

2014, c. 24, s. 3

Marginal note: Minister’s powers — risk of injury to health

21.3 (1) 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

(a) recall the product; or
(b) send the product, or cause it to be sent, to a place specified in the order.

2014, c. 24, s. 3

Marginal note: Information — serious environmental risk

21.301 (1) 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.
Marginal note: Disclosure — serious environmental risk (2) 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.

Marginal note: Disclosure — protection of the environment (3) 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) a government;
(b) a person from whom the Minister seeks advice; or
(c) a person who carries out functions relating to the protection of the environment, including the assessment and management of risks to the environment.

Marginal note: Labelling or packaging — serious risk to environment

21.302 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.

Marginal note: Minister’s powers — serious risk to environment

21.303 (1) 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

(a) recall the product; or
(b) send the product, or cause it to be sent, to a place specified in the order.

Marginal note: Power to require assessment

21.31 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.

2014, c. 24, s. 4

Marginal note: Power to require tests, studies, etc.

21.32 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

(a) compile information, conduct tests or studies or monitor experience in respect of the therapeutic product; and
(b) provide the Minister with the information or the results of the tests, studies or monitoring.

2014, c. 24, s. 4

Marginal note: Definition of

21.321 Despite the definition in section 2, in sections 21.31 and 21.32 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 .

Marginal note: Power — information relating to environmental effects

21.33 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

(a) compile information or conduct tests, studies or monitoring in respect of the therapeutic product; and
(b) provide the Minister with the information or the results of the tests, studies or monitoring.

21.4 (1) For greater certainty, orders made under any of sections 21.1 to 21.33 are not statutory instruments within the meaning of the Statutory Instruments Act .
Marginal note: Availability of orders (2) The Minister shall ensure that any order made under any of sections 21.1 to 21.33 is publicly available.

2014, c. 24, ss. 3, 4
2023, c. 12, s. 66

Marginal note: Injunction

21.5 (1) If, on the application of the Minister, it appears to a court of competent jurisdiction that a person has done, is about to do or is likely to do anything that constitutes or is directed toward the commission of an offence under this Act in respect of a therapeutic product, the court may issue an injunction ordering the person, who is to be named in the application, to

(a) refrain from doing anything that it appears to the court may constitute or be directed toward the commission of the offence; or
(b) do anything that it appears to the court may prevent the commission of the offence.

2014, c. 24, s. 3

Marginal note: False or misleading information — therapeutic products

21.6 No person shall knowingly make a false or misleading statement to the Minister — or knowingly provide him or her with false or misleading information — in connection with any matter under this Act concerning a therapeutic product.

2014, c. 24, s. 3

Marginal note: Terms and conditions of authorizations

21.7 The holder of a therapeutic product authorization shall comply with any terms and conditions of the authorization that are imposed by the Minister under subsection 21.92(3) or under regulations made under paragraph 30(1.2)(b).

2014, c. 24, s. 3
2019, c. 29, s. 167

Marginal note: Duty to publicize clinical trial information

21.71 The holder of a therapeutic product authorization referred to in paragraph 30(1.2)(c) shall ensure that prescribed information concerning the clinical trial is made public within the prescribed time and in the prescribed manner.

2014, c. 24, s. 3
2019, c. 29, s. 168

Marginal note: Health care institutions to provide information

21.8 (1) A prescribed health care institution shall provide the Minister, within the prescribed time and in the prescribed manner, with prescribed information that is in its control about a serious adverse drug reaction that involves a therapeutic product or a medical device incident that involves a therapeutic product.
Marginal note: Definition of (2) Despite the definition in section 2, in subsection (1) 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 .

2014, c. 24, s. 5
2023, c. 26, s. 502

Advanced Therapeutic Products

Marginal note: Prohibited activities

21.9 (1) No person shall import, sell, advertise, manufacture, prepare, preserve, package, label, store or test an advanced therapeutic product unless the person

(a) holds a licence in respect of that product that was issued under subsection 21.92(1) and that authorizes the activity in question;
(b) is authorized under an order made under subsection 21.95(1) to conduct the activity in question in respect of the product; or
(c) conducts the activity in question in accordance with the regulations.

Marginal note: Additions to Schedule G

21.91 (1) For the purpose of preventing injury to health or preventing a person from being deceived or misled, the Minister may, by order, add a description of a therapeutic product or a class of therapeutic products to Schedule G if the Minister believes that the therapeutic product or products represent an emerging or innovative technological, scientific or medical development.

Marginal note: Factors (2) Before adding a description of a therapeutic product or a class of therapeutic products to Schedule G, the Minister shall consider the following factors:

(a) the degree of uncertainty respecting the risks and benefits associated with the therapeutic product or products and the measures that are available to adequately manage and control those risks;
(b) the extent to which the therapeutic product or products are different from therapeutic products for which therapeutic product authorizations have been issued under the regulations;
(c) the extent to which existing legal frameworks are adequate to prevent injury to health or to prevent persons from being deceived or misled; and
(d) the prescribed factors, if any.

Marginal note: Advanced therapeutic product licence

21.92 (1) Subject to the regulations, the Minister may, on application, issue or amend an advanced therapeutic product licence that authorizes a person to import, sell, advertise, manufacture, prepare, preserve, package, label, store or test an advanced therapeutic product if the Minister believes that the applicant has provided sufficient evidence to support the conclusion that

(a) the benefits associated with the product outweigh the risks; and
(b) the risks associated with the product and the activity will be adequately managed and controlled.

Marginal note: Suspension and revocation

21.93 (1) Subject to the regulations, the Minister may suspend or revoke an advanced therapeutic product licence, in whole or in part, if

(a) the Minister believes that the risks that are associated with the advanced therapeutic product outweigh the benefits;
(b) the Minister believes that the risks associated with the product or any authorized activity are not being adequately managed or controlled;
(c) in the case of a suspension, any prescribed circumstance exists; or
(d) in the case of a revocation, any prescribed circumstance exists.

Marginal note: Exemption

21.94 The holder of an advanced therapeutic product licence is, in respect of the activities authorized under the licence, exempt from the provisions of the regulations other than any provisions that are specified in regulations made under paragraph 30(1.2)(b.2).

Marginal note: Order — advanced therapeutic products

21.95 (1) The Minister may make an order, with or without terms and conditions, that authorizes any person within a class of persons that is specified in the order to import, sell, advertise, manufacture, prepare, preserve, package, label, store or test an advanced therapeutic product.

Marginal note: Additional content (2) The Minister may, in the order,

(a) specify provisions of the regulations that are excluded from the scope of the exemption provided for in section 21.96; and
(b) establish classes and distinguish among those classes.

Marginal note: Exemption

21.96 A person that conducts an activity under an order made under subsection 21.95(1) is, in respect of the activity, exempt from the provisions of the regulations other than any provisions that are specified in the order or in regulations made under paragraph 30(1.2)(b.2).

PART II Administration and Enforcement

Inspection, Seizure and Forfeiture

Marginal note: Inspectors

22 (1) For the purposes of the administration and enforcement of this Act, the Minister may designate individuals or classes of individuals as inspectors to exercise powers or perform duties or functions in relation to any matter referred to in the designation.
Marginal note: Certificate to be produced (2) An inspector shall be given a certificate in a form established by the Minister or the President of the Canadian Food Inspection Agency attesting to the inspector’s designation and, on entering any place pursuant to subsection 23(1), an inspector shall, if so required, produce the certificate to the person in charge of that place.

R.S., 1985, c. F-27, s. 22
1997, c. 6, s. 63
2016, c. 9, s. 4

Marginal note: Provision of documents, information or samples

22.1 (1) An inspector may, for a purpose related to verifying compliance or preventing non-compliance with the provisions of this Act or the regulations, order a person to provide, on or before the date and time specified by the inspector and at the place and in the manner specified by the inspector, any document, information or sample specified by the inspector.
Marginal note: Duty to provide (2) A person that is ordered by an inspector to provide a document, information or a sample shall do so on or before the date and time, and at the place and in the manner, specified by the inspector.

Marginal note: Powers of inspectors

23 (1) Subject to subsection (9), an inspector may, for a purpose related to verifying compliance or preventing non-compliance with the provisions of this Act or the regulations, enter any place, including a conveyance, in which they believe on reasonable grounds

(a) an activity that may be regulated under this Act is being conducted;
(b) any article to which this Act or the regulations apply is located;
(c) an activity could be conducted under an authorization, including a licence, for which an application is under consideration by the Minister; or
(d) an activity could be conducted as a result of an exemption that is under consideration by the Minister.

(a) examine any article to which this Act or the regulations apply or anything that the inspector believes on reasonable grounds is used or is capable of being used for an activity regulated under this Act;
(b) open and examine any receptacle or package that the inspector believes on reasonable grounds contains any article to which this Act or the regulations apply;
(c) examine — and make copies of or take extracts from — any record, report, electronic data or other document that is found at the place and that the inspector believes on reasonable grounds includes information relevant to the administration of this Act or the regulations;
(d) cause to be reproduced any electronic data referred to in paragraph (c);
(e) use, or cause to be used, any computer system or telecommunication system at the place;
(f) examine — and reproduce or cause to be reproduced — any electronic data that is contained in or available to a system referred to in paragraph (e) and that the inspector believes on reasonable grounds includes information relevant to the administration of this Act or the regulations;
(g) remove, for examination or copying, any copies made or extracts taken under paragraph (c), (d) or (f);
(h) test anything that the inspector believes on reasonable grounds is an article to which this Act or the regulations apply;
(i) take samples of any food, drug, cosmetic, device or anything used for an activity regulated under this Act;
(j) take photographs and make recordings and sketches;
(k) remove anything from the place for the purpose of examination, conducting tests or taking samples; and
(l) seize and detain for the time that may be necessary any article that the inspector believes on reasonable grounds is an article by means of, or in relation to which, any provision of this Act or the regulations has been contravened.

(a) the dwelling-house is a place referred to in subsection (1);
(b) entry to the dwelling-house is necessary for a purpose referred to in that subsection; and
(c) entry to the dwelling-house has been refused or there are reasonable grounds to believe that it will be refused.

(a) give the inspector all reasonable assistance; and
(b) provide the inspector with any information that the inspector may reasonably require, including information that is necessary to establish their identity to the inspector’s satisfaction.

(a) any food, drug, cosmetic or device;
(b) anything used for an activity regulated under this Act; and
(c) any record, report, electronic data or other document — including any labelling or advertising material — relating to the administration of this Act or the regulations.

R.S., 1985, c. F-27, s. 23
R.S., 1985, c. 31 (1st Supp.), s. 11, c. 27 (3rd Supp.), s. 2
2019, c. 29, s. 170
2022, c. 17, s. 63
2024, c. 17, s. 323

Marginal note: Obstruction and false statements

24 (1) No person shall obstruct or hinder, or knowingly make any false or misleading statement either orally or in writing to, an inspector while the inspector is engaged in carrying out his duties or functions under this Act or the regulations.
Marginal note: Interference (2) Except with the authority of an inspector, no person shall remove, alter or interfere in any way with anything seized under this Part.

R.S., c. F-27, ss. 22, 37

Marginal note: Storage, movement and disposal

25 An inspector may, in respect of any article seized under this Part,

(a) on notice to its owner or the person having possession, care or control of it at the time of its seizure, store it or move it at the expense of the person to whom the notice is given;
(b) order its owner or the person having possession, care or control of it at the time of its seizure to store it or move it at the expense of the person being so ordered; or

(c) order its owner or the person having possession, care or control of it at the time of its seizure to dispose of it at the expense of the person being so ordered — or, on notice to its owner or the person having possession, care or control of it at the time of its seizure, dispose of it at the expense of the person to whom the notice is given — if

(i) the article is perishable, or
(ii) the inspector is of the opinion that the article presents a risk of injury to health or safety and that its disposal is necessary to respond to the risk.

R.S., 1985, c. F-27, s. 25
2016, c. 9, s. 5

Marginal note: Release of seized articles

26 An inspector who has seized any article under this Part shall release it when he is satisfied that all the provisions of this Act and the regulations with respect thereto have been complied with.

R.S., c. F-27, ss. 23, 37

Marginal note: Unclaimed seized articles

26.1 (1) An article seized under this Part is, at the election of the Minister or the Minister of Agriculture and Agri-Food, forfeited to Her Majesty in right of Canada if

(a) within 60 days after the seizure, no person is identified in accordance with the regulations, if any, as its owner or as the person entitled to possess it; or
(b) its owner or the person having possession, care or control of it at the time of its seizure does not claim it within 60 days after the day on which they are notified that an inspector has released it.

2016, c. 9, s. 6

Marginal note: Forfeiture with consent

27 (1) If an inspector has seized an article under this Part and its owner or the person having possession, care or control of it at the time of its seizure consents to its forfeiture, the article is forfeited to Her Majesty in right of Canada and may be disposed of as the Minister or the Minister of Agriculture and Agri-Food may direct, at the expense of its owner or the person having possession, care or control of the article at the time of its seizure.
Marginal note: Forfeiture — offence (2) If a person has been convicted of a contravention of this Act or the regulations, the court or judge may, in addition to any punishment imposed, order that any article by means of or in relation to which the offence was committed, and any thing of a similar nature belonging to or in the possession, care or control of the person or found with the article, be forfeited. On the making of the order, the article and thing are forfeited to Her Majesty in right of Canada and may be disposed of as the Minister or the Minister of Agriculture and Agri-Food may direct, at the expense of the person who has been convicted.
Marginal note: Order for forfeiture on application of inspector (3) Without prejudice to subsection (2), a judge of a superior court of the province in which any article is seized under this Part may, on the application of an inspector and on any notice to those persons that the judge directs, order that the article and any thing of a similar nature found with it be forfeited to Her Majesty in right of Canada, if the judge finds, after making any inquiry that the judge considers necessary, that the article is one by means of or in relation to which a provision of this Act or the regulations has been contravened. On the making of the order, the article or thing may be disposed of as the Minister or the Minister of Agriculture and Agri-Food may direct, at the expense of the owner of the article or the person having possession, care or control of it at the time of its seizure.

R.S., 1985, c. F-27, s. 27
1992, c. 1, s. 145(F)
1994, c. 38, s. 19
1995, c. 1, s. 62
1996, c. 8, s. 23.2
1997, c. 6, s. 64
2016, c. 9, s. 6

Removal, Forfeiture or Destruction of Unlawful Imports

Marginal note: Unlawful imports

27.1 (1) An inspector who has reasonable grounds to believe that an imported food, drug, cosmetic or device does not meet the requirements of the regulations or was imported in contravention of a provision of this Act or the regulations may decide whether to give the owner or importer, or the person having possession, care or control of the food, drug, cosmetic or device, the opportunity to take a measure in respect of it.

Marginal note: Factors (2) In making a decision under subsection (1), the inspector shall consider, among other factors:

(a) whether the food, drug, cosmetic or device presents a risk of injury to health or safety; and
(b) any other prescribed factors.

2016, c. 9, s. 6

Marginal note: Removal or destruction

27.2 (1) An inspector who has reasonable grounds to believe that an imported food, drug, cosmetic or device does not meet the requirements of the regulations or was imported in contravention of a provision of this Act or the regulations may, by notice, whether the food, drug, cosmetic or device is seized or not, order its owner or importer, or the person having possession, care or control of it, to remove it from Canada at their expense or, if removal is not possible, to destroy it at their expense.
Marginal note: Notice (2) The notice must be delivered personally to the owner or importer of the food, drug, cosmetic or device, or the person having possession, care or control of it, or sent to the owner, importer or person by any method that provides proof of delivery or by any prescribed method.
Marginal note: Forfeiture (3) If the food, drug, cosmetic or device is not removed from Canada, or destroyed, within the period specified in the notice — or, if no period is specified, within 90 days after the day on which the notice was delivered or sent — it is, despite section 26, forfeited to Her Majesty in right of Canada and may be disposed of, as the Minister may direct, at the expense of the person to whom the notice was delivered or sent.

Marginal note: Suspension of application of subsection (3) (4) An inspector may, for the period specified by the inspector, suspend the application of subsection (3) if the inspector is satisfied that

(a) the food, drug, cosmetic or device does not present a risk of injury to health;
(b) the food, drug, cosmetic or device will not be sold within that period;
(c) the measures that should have been taken for the food, drug, cosmetic or device not to have been imported in contravention of a provision of this Act or the regulations will be taken within that period; and
(d) if the food, drug, cosmetic or device does not meet the requirements of the regulations, it will be brought into compliance with those requirements within that period.

(a) the food, drug, cosmetic or device does not present a risk of injury to health;
(b) the food, drug, cosmetic or device has not been sold within the period referred to in subsection (6);
(c) the measures referred to in paragraph (4)(c) were taken within that period; and
(d) if the food, drug, cosmetic or device did not meet the requirements of the regulations when it was imported, it was brought into compliance with those requirements within that period.

(a) if the application of subsection (3) was suspended under subsection (4), the period of the suspension; and
(b) if the application of subsection (3) was not suspended, the period specified in the notice or, if no period was specified, the period of 90 days after the day on which the notice was delivered or sent.

2016, c. 9, s. 6

Preventive and Remedial Measures

Marginal note: Measures

27.3 (1) If the Minister has reasonable grounds to believe that a person has contravened, or is likely to contravene, this Act or the regulations, the Minister may order the person to take any measures that the Minister considers necessary to remedy the contravention or prevent it.
Marginal note: Duty to take measures (2) A person that is ordered to take measures shall take them.

Analysis

Marginal note: Analysts

28 The Minister may designate any individual as an analyst for the purposes of the administration and enforcement of this Act.

R.S., 1985, c. F-27, s. 28
2016, c. 9, s. 6

Marginal note: Analysis and examination

29 (1) An inspector may submit to an analyst, for analysis or examination, any article seized by the inspector, any sample therefrom or any sample taken by the inspector.

Marginal note: Costs (1.1) The analysis or examination of any article seized, or of any sample, shall be at the expense of

(a) in respect of an article seized or a sample taken from it, the owner of the article or the person having possession, care or control of the article at the time of its seizure; or
(b) in respect of a sample taken by the inspector, the owner of the article from which the sample was taken or the person having possession, care or control of it at the time the sample was taken.

R.S., 1985, c. F-27, s. 29
2016, c. 9, s. 7

Power of the Minister

Marginal note: List

29.1 (1) Subject to the regulations, the Minister may establish a list that sets out prescription drugs, classes of prescription drugs or both.
Marginal note: Statutory Instruments Act (2) The list is not a regulation within the meaning of the Statutory Instruments Act .

2012, c. 19, s. 413

29.2 [Repealed, 2024, c. 17, s. 324]

Regulations

Marginal note: Regulations

30 (1) The Governor in Council may make regulations for carrying the purposes and provisions of this Act into effect, and, in particular, but without restricting the generality of the foregoing, may make regulations

(a) declaring that any food or drug or class of food or drugs is adulterated if any prescribed substance or class of substances is present therein or has been added thereto or extracted or omitted therefrom;
(a.01) declaring that any drug is adulterated if the Minister believes that a prescribed substance contained in that drug presents a serious risk to the environment;
(a.1) respecting consultations in respect of orders referred to in section 2.4;

(b) respecting

(i) the labelling and packaging and the offering, exposing and advertising for sale of food, drugs, cosmetics and devices,
(ii) the size, dimensions, fill and other specifications of packages of food, drugs, cosmetics and devices,
(iii) the sale or the conditions of sale of any food, drug, cosmetic or device, and
(iv) the use of any substance as an ingredient in any food, drug, cosmetic or device,

to prevent the purchaser or consumer thereof from being deceived or misled in respect of the design, construction, performance, intended use, quantity, character, value, composition, merit or safety thereof, or to prevent injury to the health of the purchaser or consumer;

(i) the labelling and packaging and the offering, exposing and advertising for sale of food, drugs, cosmetics and devices,
(ii) the size, dimensions, fill and other specifications of packages of food, drugs, cosmetics and devices,
(iii) the sale or the conditions of sale of any food, drug, cosmetic or device, and
(iv) the use of any substance as an ingredient in any food, drug, cosmetic or device;

(i) the method of manufacture, preparation, preserving, packing, labelling, storing and testing of any new drug, and
(ii) the sale or the conditions of sale of any new drug,

and defining for the purposes of this Act the expression ;

(a) respecting the issuance of authorizations — including licences — that authorize, as the case may be, the import, sale, advertisement, manufacture, preparation, preservation, packaging, labelling, storage or testing of a therapeutic product, and the amendment, suspension and revocation of such authorizations;
(b) authorizing the Minister to impose terms and conditions on authorizations referred to in paragraph (a), including existing authorizations, and to amend those terms and conditions;
(b.1) requiring the Minister to ensure that decisions with regard to the issuance, amendment, suspension and revocation of authorizations referred to in paragraph (a), and to the imposition and amendment of terms and conditions in respect of those authorizations, along with the reasons for those decisions, are publicly available;
(b.2) specifying provisions of the regulations that are excluded from the exemption provided for in section 21.94 or 21.96;
(c) requiring holders of a therapeutic product authorization that authorizes the import or sale of a therapeutic product for a clinical trial, or former holders of such an authorization, to provide the Minister, after the trial is completed or discontinued, or, if the authorization is suspended or revoked, after the suspension or revocation, with safety information that the holders or former holders receive or become aware of about the therapeutic product;
(c.1) [Repealed, 2019, c. 29, s. 172]

(d) requiring holders of a therapeutic product authorization to provide the Minister with information, in respect of any serious risk of injury to human health, that the holders receive or become aware of and that is relevant to the safety of the therapeutic product to which the authorization relates, regarding

(i) risks that have been communicated outside Canada, and the manner of the communication,
(ii) changes that have taken place to labelling outside Canada, and
(iii) recalls, reassessments and suspensions or revocations of authorizations, including licences, in respect of a therapeutic product, that have taken place outside Canada;

(i) risks that have been communicated outside Canada, and the manner of the communication,
(ii) changes that have taken place to labelling outside Canada, and
(iii) recalls, reassessments and suspensions or revocations of authorizations, including licences, in respect of a therapeutic product, that have taken place outside Canada;

(i) is not confidential business information, or
(ii) has ceased to be confidential business information;

(a) the importation into Canada of any drug or class of drugs manufactured outside Canada, or
(b) the distribution or sale in Canada, or the offering, exposing or having in possession for sale in Canada, of any drug or class of drugs manufactured outside Canada,

as the Governor in Council deems necessary for the protection of the public in relation to the safety and quality of any such drug or class of drugs.

R.S., 1985, c. F-27, s. 30
1993, c. 44, s. 158
1994, c. 47, s. 117
1999, c. 33, s. 347
2004, c. 23, s. 2
2005, c. 42, s. 2
2012, c. 19, ss. 414, 415
2014, c. 24, ss. 6, 14(E)
2016, c. 9, s. 8
2019, c. 29, s. 172
2020, c. 1, s. 58
2020, c. 5, s. 33
2021, c. 7, s. 9
2023, c. 12, s. 67
2023, c. 26, s. 506
2024, c. 17, s. 325

Supplementary Rules

Marginal note: Supplementary rules — therapeutic product

30.01 (1) Subject to any regulations made under paragraph 30(1)(j.1) and if the Minister believes on reasonable grounds that the use of a therapeutic product, other than the intended use, may present a risk of injury to health, the Minister may, by order, establish rules in respect of the importation, sale, conditions of sale, advertising, manufacture, preparation, preservation, packaging, labelling, storage or testing of the therapeutic product for the purpose of preventing, managing or controlling the risk of injury to health.
Marginal note: Promotion (2) For greater certainty, the Minister may, in the order, establish rules for the purpose of preventing the therapeutic product from being promoted for a use, other than the intended use, of a therapeutic product or preventing a use, other than the intended use, of a therapeutic product from being appealing.
Marginal note: Uncertainty (3) The Minister may make the order despite any uncertainty respecting the risk of injury to health that the use of the therapeutic product, other than the intended use, may present.

Marginal note: Supplementary rules — drug intended for animal

30.02 (1) Subject to any regulations made under paragraph 30(1)(j.1) and if the Minister believes on reasonable grounds that the use of a drug intended for an animal of a particular species, including a use other than the intended use, may present a risk of adverse effects to human beings, animals of a different species or the environment, the Minister may, by order, establish rules in respect of the importation, sale, conditions of sale, advertising, manufacture, preparation, preservation, packaging, labelling, storage or testing of the drug for the purpose of preventing, managing or controlling the risk of adverse effects.
Marginal note: Uncertainty (2) The Minister may make the order despite any uncertainty respecting the risk of adverse effects that the use of the drug, including a use other than the intended use, may present.

30.03 An order made under subsection 30.01(1) or 30.02(1) that applies to only one person is not a statutory instrument within the meaning of the Statutory Instruments Act .

Marginal note: Availability — person-specific orders

30.04 The Minister must ensure that any order made under subsection 30.01(1) or 30.02(1) that applies to only one person is publicly available but may exclude personal information and confidential business information from the order.

Exemption

Marginal note: Exemption — foods and therapeutic products

30.05 (1) Subject to subsection (2) and any regulations made under paragraph 30(1)(j.1), the Minister may, by order, on any conditions that the Minister considers necessary, exempt — other than in relation to cosmetics — a class of foods, therapeutic products, persons or activities from the application of all or any of the provisions of Part I, section 37 or the regulations.

Marginal note: Preconditions (2) The Minister may make an order only if the Minister believes on reasonable grounds that

(a) it is necessary for a health or safety purpose or is otherwise in the public interest; and

(b) having regard to its benefits and conditions, it is unlikely to result in

(i) unacceptable health, safety or, if applicable, environmental risks, or
(ii) an unacceptable degree of uncertainty respecting health, safety or, if applicable, environmental risks.

Decision of Foreign Regulatory Authority

Marginal note: Deeming order

30.06 (1) Subject to subsection (2) and any regulations made under paragraph 30(1)(j.1), the Minister may, by order, deem that specified requirements of this Act or the regulations are met — in respect of a therapeutic product or food that belongs to a class specified in the order — on the basis of a decision of, or any information or document produced by, a foreign regulatory authority in respect of that therapeutic product or food.

Marginal note: Preconditions (2) The Minister may make the order only if the Minister believes on reasonable grounds that

(a) it is necessary for a health or safety purpose or is otherwise in the public interest; and

(b) having regard to its benefits and conditions, it is unlikely to result in

(i) unacceptable health, safety or, if applicable, environmental risks, or
(ii) an unacceptable degree of uncertainty respecting health, safety or, if applicable, environmental risks.

(a) the requirements referred to in subsection (1) include requirements imposed on the Minister;
(b) the Minister may rely on a portion of a decision of, or a portion of any document or information produced by, a foreign regulatory authority; and
(c) nothing in this section is intended to limit the Minister’s ability to consider information, documents or other material obtained, directly or indirectly, from a foreign regulatory authority.

Reference to Regulations

Marginal note: Deeming

30.07 For the purposes of any provision of this Act, other than sections 30.01, 30.02, 30.05 and 30.06, any reference to regulations made under this Act is deemed to include orders made under section 30.01, 30.02, 30.05 or 30.06.

Interim Orders

Marginal note: Interim orders

30.1 (1) The Minister may make an interim order that contains any provision that may be contained in a regulation made under this Act if the Minister believes that immediate action is required to deal with a significant risk, direct or indirect, to health, safety or the environment.

Marginal note: Cessation of effect (2) An interim order has effect from the time that it is made but ceases to have effect on the earliest of

(a) 14 days after it is made, unless it is approved by the Governor in Council,
(b) the day on which it is repealed,
(c) the day on which a regulation made under this Act, that has the same effect as the interim order, comes into force, and
(d) one year after the interim order is made or any shorter period that may be specified in the interim order.

(a) is exempt from the application of sections 3, 5 and 11 of the Statutory Instruments Act ; and
(b) shall be published in the Canada Gazette within 23 days after it is made.

2004, c. 15, s. 66
2024, c. 17, s. 329

Marketing Authorizations

Marginal note: Marketing authorization — representation

30.2 (1) Subject to regulations made under paragraph 30(1)(r), the Minister may issue a marketing authorization that exempts — if the conditions, if any, to which the marketing authorization is subject are met — an advertisement, or a representation on a label, with respect to a food from the application, in whole or in part, of subsection 3(1) or (2) or any provision of the regulations specified in the marketing authorization.
Marginal note: Condition (2) The marketing authorization may be subject to any condition that the Minister considers appropriate.

2005, c. 42, s. 3
2012, c. 19, s. 416

Marginal note: Marketing authorization — food

30.3 (1) Subject to regulations made under paragraph 30(1)(r), the Minister may issue a marketing authorization that exempts — if the conditions to which the marketing authorization is subject are met — a food from the application, in whole or in part, of paragraph 4(1)(a) or (d) or section 6 or 6.1 or any provision of the regulations specified in the marketing authorization.

Marginal note: Condition — amount (2) The marketing authorization may be subject to any condition relating to the amount of any substance that may or must be in or on the food, including

(a) the maximum residue limit of an agricultural chemical and its components or derivatives, singly or in any combination;
(b) the maximum residue limit of a veterinary drug and its metabolites, singly or in any combination;
(c) the maximum level of use for a food additive; and
(d) the minimum or maximum level, or both, of a vitamin, a mineral nutrient or an amino acid.

2012, c. 19, s. 416

Marginal note: Classes

30.4 A marketing authorization may establish classes and distinguish among those classes.

2012, c. 19, s. 416

Incorporation by Reference

Marginal note: Incorporation by reference

30.5 (1) The following instruments may incorporate by reference any document, regardless of its source, either as it exists on a particular date or as it is amended from time to time:

(a) a regulation made under this Act with respect to a food or therapeutic product;
(b) a marketing authorization; and
(c) an order made under subsection 30.63(1).

2012, c. 19, s. 416
2014, c. 24, s. 7
2024, c. 17, s. 331

Marginal note: Existing power not limited

30.6 For greater certainty, an express power in this Act to incorporate a document by reference does not limit the power that otherwise exists to incorporate a document by reference in a regulation made under this Act.

2012, c. 19, s. 416

Fees

Marginal note: Fees

30.61 (1) The Minister may, by order, fix the following fees in relation to a drug, device, food or cosmetic:

(a) fees to be paid for a service, or the use of a facility, provided under this Act;
(b) fees to be paid in respect of regulatory processes or approvals provided under this Act; and
(c) fees to be paid in respect of products, rights and privileges provided under this Act.

2017, c. 20, s. 317

Marginal note: Consultation

30.62 Before making an order under subsection 30.61(1), the Minister shall consult with any persons that the Minister considers to be interested in the matter.

2017, c. 20, s. 317

Marginal note: Remission of fees

30.63 (1) The Minister may, by order, remit all or part of any fee fixed under subsection 30.61(1) and the interest on it.
Marginal note: Remission may be conditional (2) A remission granted under subsection (1) may be conditional.
Marginal note: Conditional remission (3) If a remission granted under subsection (1) is conditional and the condition is not fulfilled, then the remission is cancelled and is deemed never to have been granted.

2017, c. 20, s. 317

Marginal note: Non-payment of fees

30.64 The Minister may withdraw or withhold a service, the use of a facility, a regulatory process or approval or a product, right or privilege under this Act from any person who fails to pay the fee fixed for it under subsection 30.61(1).

2017, c. 20, s. 317

Marginal note: Adjustment of amounts

30.65 (1) An order made under subsection 30.61(1) may prescribe rules for the adjustment of the amount of the fee by any amounts or ratios that are referred to in the order, for the period that is specified in the order.
Marginal note: Notice of adjusted amount (2) The amount of a fee that is subject to an adjustment rule remains unadjusted for the specified period unless, before the beginning of that period, the Minister publishes a notice in the Canada Gazette that specifies the adjusted amount and the manner in which it was determined.

2017, c. 20, s. 317

30.66 The Service Fees Act does not apply to a fee fixed under subsection 30.61(1).

2017, c. 20, s. 317

Costs

Marginal note: Recovery

30.7 (1) Her Majesty in right of Canada may recover, as a debt due to Her Majesty in right of Canada, any costs incurred by Her Majesty in right of Canada in relation to anything required or authorized under this Act, including the inspection of a place or the analysis, examination, storage, movement, seizure, detention, forfeiture, disposal or release of an article.
Marginal note: Time limit (2) Proceedings to recover a debt due to Her Majesty in right of Canada under subsection (1) shall not be commenced later than five years after the debt became payable.

2016, c. 9, s. 9

Marginal note: Certificate of default

30.8 (1) Any debt that may be recovered under subsection 30.7(1) in respect of which there is a default of payment, or the part of any such debt that has not been paid, may be certified by the Minister.
Marginal note: Judgment (2) On production to the Federal Court, a certificate made under subsection (1) shall be registered in that Court and, when registered, has the same force and effect, and all proceedings may be taken on the certificate, as if it were a judgment obtained in that Court for a debt of the amount specified in the certificate and all reasonable costs and charges attendant in the registration of the certificate.

2016, c. 9, s. 9

Offences and Punishment

Marginal note: Contravention of Act or regulations

31 Subject to sections 31.1, 31.2 and 31.4, every person who contravenes any of the provisions of this Act or of the regulations, or fails to do anything the person was ordered to do by an inspector under section 25 or 27.2, is guilty of an offence and liable

(a) on summary conviction for a first offence to a fine not exceeding five hundred dollars or to imprisonment for a term not exceeding three months or to both and, for a subsequent offence, to a fine not exceeding one thousand dollars or to imprisonment for a term not exceeding six months or to both; and
(b) on conviction on indictment to a fine not exceeding five thousand dollars or to imprisonment for a term not exceeding three years or to both.

R.S., 1985, c. F-27, s. 31
1996, c. 19, s. 77
1997, c. 6, ss. 65, 91
2014, c. 24, s. 8
2016, c. 9, s. 10

Marginal note: Offences relating to food

31.1 (1) Every person who contravenes any provision of this Act or the regulations, as it relates to food, is guilty of an offence and liable

(a) on summary conviction, to a fine not exceeding $50,000 or to imprisonment for a term not exceeding six months or to both; or
(b) on conviction by indictment, to a fine not exceeding $250,000 or to imprisonment for a term not exceeding three years or to both.

(a) section 3, if the contravention of that section involves food;
(a.1) section 3.1 or 3.3, if the contravention of that section involves a clinical trial that relates to food;
(a.2) section 3.2, if the contravention of that section involves the terms and conditions of an authorization that authorizes the conduct of a clinical trial that relates to food;
(b) subsection 22.1(2), if the contravention of that subsection involves any document or information that relates to food or a sample that is or relates to food;
(c) subsection 23(6), if the contravention of that subsection involves a conveyance in respect of which an inspector is exercising powers or performing duties or functions in relation to food;
(d) subsection 23(13), if the contravention of that subsection involves a place in which an inspector is exercising powers or performing duties or functions in relation to food;
(e) subsection 24(1), if the contravention of that subsection involves the obstruction or hindering of — or the making of a false or misleading statement to — an inspector who is carrying out duties or functions in relation to food;
(f) subsection 24(2), if the contravention of that subsection involves anything seized that is or relates to food; and
(g) subsection 27.3(2), if the contravention of that subsection involves measures that were ordered to be taken in relation to food.

1997, c. 6, s. 66
2019, c. 29, s. 173

Marginal note: Offences relating to therapeutic products

31.2 (1) Subject to section 31.4, every person who contravenes any provision of this Act or the regulations, as it relates to a therapeutic product, or an order made under any of sections 21.1 to 21.32 is guilty of an offence and liable

(a) on conviction by indictment, to a fine not exceeding $5,000,000 or to imprisonment for a term not exceeding two years or to both; and
(b) on summary conviction, for a first offence, to a fine not exceeding $250,000 or to imprisonment for a term not exceeding six months or to both and, for a subsequent offence, to a fine not exceeding $500,000 or to imprisonment for a term not exceeding 18 months or to both.

(a) section 3, if the contravention of that section involves a therapeutic product;
(a.1) section 3.1 or 3.3, if the contravention of that section involves a clinical trial that relates to a therapeutic product;
(a.2) section 3.2, if the contravention of that section involves the terms and conditions of an authorization that authorizes the conduct of a clinical trial that relates to a therapeutic product;
(b) subsection 22.1(2), if the contravention of that subsection involves any document or information that relates to a therapeutic product or a sample that is or relates to a therapeutic product;
(c) subsection 23(6), if the contravention of that subsection involves a conveyance in respect of which an inspector is exercising powers or performing duties or functions in relation to a therapeutic product;
(d) subsection 23(13), if the contravention of that subsection involves a place in which an inspector is exercising powers or performing duties or functions in relation to a therapeutic product;
(e) subsection 24(1), if the contravention of that subsection involves the obstruction or hindering of — or the making of a false or misleading statement to — an inspector who is carrying out duties or functions in relation to a therapeutic product;
(f) subsection 24(2), if the contravention of that subsection involves anything seized that is or relates to a therapeutic product; and
(g) subsection 27.3(2), if the contravention of that subsection involves measures that were ordered to be taken in relation to a therapeutic product.

2014, c. 24, ss. 9, 10
2019, c. 29, s. 174

Marginal note: Due diligence

31.3 Due diligence is a defence in a prosecution for an offence under this Act, other than an offence under section 31.4.

2014, c. 24, s. 9

Marginal note: Offences — section 21.6 and serious risk

31.4 (1) A person who contravenes section 21.6, or who knowingly or recklessly causes a serious risk of injury to human health in contravening another provision of this Act or the regulations, as it relates to a therapeutic product, or an order made under any of sections 21.1 to 21.32 is guilty of an offence and liable

(a) on conviction on indictment, to a fine the amount of which is at the discretion of the court or to imprisonment for a term not exceeding five years or to both; and
(b) on summary conviction, for a first offence, to a fine not exceeding $500,000 or to imprisonment for a term not exceeding 18 months or to both and, for a subsequent offence, to a fine not exceeding $1,000,000 or to imprisonment for a term not exceeding two years or to both.

(a) section 3, if the contravention of that section involves a therapeutic product;
(a.1) section 3.1, if the contravention of that section involves a clinical trial that relates to a therapeutic product;
(a.2) section 3.2, if the contravention of that section involves the terms and conditions of an authorization that authorizes the conduct of a clinical trial that relates to a therapeutic product;
(b) subsection 22.1(2), if the contravention of that subsection involves any document or information that relates to a therapeutic product or a sample that is or relates to a therapeutic product;
(c) subsection 23(6), if the contravention of that subsection involves a conveyance in respect of which an inspector is exercising powers or performing duties or functions in relation to a therapeutic product;
(d) subsection 23(13), if the contravention of that subsection involves a place in which an inspector is exercising powers or performing duties or functions in relation to a therapeutic product;
(e) subsection 24(1), if the contravention of that subsection involves the obstruction or hindering of — or the making of a false or misleading statement to — an inspector who is carrying out duties or functions in relation to a therapeutic product;
(f) subsection 24(2), if the contravention of that subsection involves anything seized that is or relates to a therapeutic product; and
(g) subsection 27.3(2), if the contravention of that subsection involves measures that were ordered to be taken in relation to a therapeutic product.

2014, c. 24, ss. 9, 11
2019, c. 29, s. 175

Marginal note: Sentencing considerations

31.5 A court that imposes a sentence for an offence under section 31.2 or 31.4 shall take into account, in addition to any other principles that it is required to consider, the following factors:

(a) the harm or risk of harm caused by the commission of the offence; and
(b) the vulnerability of consumers of the therapeutic product.

2014, c. 24, s. 9

Marginal note: Parties to offence

31.6 If a person other than an individual commits an offence under section 31.2, or commits an offence under section 31.4 by reason of contravening section 21.6, then any of the person’s directors, officers or agents or mandataries who directs, authorizes, assents to or acquiesces or participates in the commission of the offence is a party to the offence and is liable on conviction to the punishment provided for by this Act, even if the person is not prosecuted for the offence.

2014, c. 24, s. 9

Marginal note: Continuing offence

31.7 If an offence under section 31.2 or 31.4 is committed or continued on more than one day, it constitutes a separate offence for each day on which it is committed or continued.

2014, c. 24, s. 9

Marginal note: Limitation period

32 (1) A prosecution for a summary conviction offence under this Act may be instituted at any time within two years after the time the subject-matter of the prosecution becomes known to the Minister or, in the case of a contravention of a provision of the Act that relates to food, to the Minister of Agriculture and Agri-Food.
Marginal note: Minister’s certificate (2) A document purporting to have been issued by the Minister referred to in subsection (1), certifying the day on which the subject-matter of any prosecution became known to the Minister, is admissible in evidence without proof of the signature or official character of the person appearing to have signed the document and is evidence of the matters asserted in it.

R.S., 1985, c. F-27, s. 32
1997, c. 6, s. 66

Marginal note: Venue

33 A prosecution for a contravention of this Act or the regulations may be instituted, heard, tried or determined in the place in which the offence was committed or the subject-matter of the prosecution arose or in any place in which the accused is apprehended or happens to be.

R.S., c. F-27, s. 28

Marginal note: Want of knowledge

34 (1) Subject to subsection (2), in a prosecution for the sale of any article in contravention of this Act, except Parts III and IV, or of the regulations made under this Part, if the accused proves to the satisfaction of the court or judge that

(a) the accused purchased the article from another person in packaged form and sold it in the same package and in the same condition the article was in at the time it was so purchased, and
(b) that the accused could not with reasonable diligence have ascertained that the sale of the article would be in contravention of this Act or the regulations,

the accused shall be acquitted.

R.S., c. F-27, ss. 29, 39, 46

Marginal note: Certificate of analyst

35 (1) Subject to this section, in any prosecution for an offence under any of sections 31 to 31.2 and 31.4, a certificate purporting to be signed by an analyst and stating that an article, sample or substance has been submitted to, and analysed or examined by, the analyst and stating the results of the analysis or examination is admissible in evidence and, in the absence of evidence to the contrary, is proof of the statements contained in the certificate without proof of the signature or official character of the person appearing to have signed it.
Marginal note: Requiring attendance of analyst (2) The party against whom a certificate of an analyst is produced pursuant to subsection (1) may, with leave of the court, require the attendance of the analyst for the purposes of cross-examination.
Marginal note: Notice of intention to produce certificate (3) No certificate shall be admitted in evidence pursuant to subsection (1) unless, before the trial, the party intending to produce the certificate has given reasonable notice of that intention, together with a copy of the certificate, to the party against whom it is intended to be produced.
Marginal note: Proof of service (4) For the purposes of this Act, service of any certificate referred to in subsection (1) may be proved by oral evidence given under oath by, or by the affidavit or solemn declaration of, the person claiming to have served it.
Marginal note: Attendance for examination (5) Notwithstanding subsection (4), the court may require the person who appears to have signed an affidavit or solemn declaration referred to in that subsection to appear before it for examination or cross-examination in respect of the issue of proof of service.

R.S., 1985, c. F-27, s. 35
R.S., 1985, c. 27 (1st Supp.), s. 192
1996, c. 19, s. 78
2014, c. 24, s. 12

Marginal note: Proof as to manufacturer or packager

36 (1) In a prosecution for a contravention of this Act or of the regulations made under this Part, proof that a package containing any article to which this Act or the regulations apply bore a name or address purporting to be the name or address of the person by whom it was manufactured or packaged is, in the absence of evidence to the contrary, proof that the article was manufactured or packaged, as the case may be, by the person whose name or address appeared on the package.
Marginal note: Offence by employee or agent (2) In a prosecution for a contravention described in subsection (1), it is sufficient proof of the offence to establish that it was committed by an employee or agent of the accused whether or not the employee or agent is identified or has been prosecuted for the offence.
Marginal note: Certified copies (3) In a prosecution for a contravention described in subsection (1), a copy of or extract from a document, including electronic data, that is certified to be a true copy by the inspector who made or took it under paragraph 23(2)(c), (d) or (f), as the case may be, is admissible in evidence and is, in the absence of evidence to the contrary, proof of its contents.
Marginal note: Where accused had adulterating substances (4) Where a person is prosecuted under this Part for having manufactured an adulterated food or drug for sale, and it is established that the person had in his possession or on his premises any substance the addition of which to that food or drug has been declared by regulation to cause the adulteration of the food or drug, the onus of proving that the food or drug was not adulterated by the addition of that substance lies on the accused.

R.S., 1985, c. F-27, s. 36
1996, c. 19, s. 79
2019, c. 29, s. 176

Exports

Marginal note: Conditions under which exports exempt

37 (1) This Act does not apply to any packaged food, drug, cosmetic or device if

(a) it is manufactured or prepared in Canada;
(b) it is intended for export and is not manufactured or prepared for consumption or use in Canada nor sold for consumption or use in Canada;
(c) a certificate that the package and its contents do not contravene any known requirement of the law of the country to which it is or is about to be consigned has been issued in respect of the package and its contents in prescribed form and manner; and
(d) the packaged food, drug, cosmetic or device meets any other prescribed requirement.

(a) section 4, subsection 5(1) and section 7 apply to any food;
(b) section 8, subsection 9(1) and section 11 apply to any drug that is not a within the meaning of the Natural Health Products Regulations ;
(c) sections 16 and 18 apply to any cosmetic; and
(d) section 19 and subsection 20(1) apply to any device.

R.S., 1985, c. F-27, s. 37
1993, c. 34, s. 73
1996, c. 19, s. 80
2004, c. 23, s. 3
2016, c. 9, s. 11
2020, c. 5, s. 34
2021, c. 7, s. 10

Marginal note: Conditions under which transhipment exempt

38 This Act does not apply to any packaged food, drug, cosmetic or device if

(a) it is manufactured or prepared outside Canada;
(b) it is imported solely for the purpose of export and is not sold for consumption or use in Canada; and
(c) it meets any other prescribed requirement.

2016, c. 9, s. 12

PARTS III AND IV [Repealed, 1996, c. 19, s. 81]

SCHEDULE A (Section 2.4)

Things that Fall Within Definition “Food” in Section 2

Item	Description

Things that Fall Within Definition “Drug” in Section 2

Item	Description

Things that Fall Within Definition “Cosmetic” in Section 2

Item	Description

Things that Fall Within Definition “Device” in Section 2

Item	Description

SCHEDULE A.1 (Section 3)

Acute alcoholism Alcoolisme aigu
Acute anxiety state État anxieux aigu
Acute infectious respiratory syndromes Syndromes respiratoires infectieux aigus
Acute, inflammatory and debilitating arthritis Arthrite aiguë, inflammatoire et débilitante
Acute psychotic conditions Troubles psychotiques aigus
Addiction (except nicotine addiction) Dépendance (sauf la dépendance à la nicotine)
Appendicitis Appendicite
Arteriosclerosis Artériosclérose
Asthma Asthme
Cancer Cancer
Congestive heart failure Insuffisance cardiaque congestive
Convulsions Convulsions
Dementia Démence
Depression Dépression
Diabetes Diabète
Gangrene Gangrène
Glaucoma Glaucome
Haematologic bleeding disorders Affections hématologiques hémorragiques
Hepatitis Hépatite
Hypertension Hypertension
Nausea and vomiting of pregnancy Nausées et vomissements de la grossesse
Obesity Obésité
Rheumatic fever Rhumatisme articulaire aigu
Septicemia Septicémie
Sexually transmitted diseases Maladies transmises sexuellement
Strangulated hernia Hernie étranglée
Thrombotic and Embolic disorders Maladies thrombotiques et embolies
Thyroid disease Glande thyroïdienne (affections)
Ulcer of the gastro-intestinal tract Ulcères des voies gastro-intestinales

R.S., 1985, c. F-27, Sch. A
SOR/88-252
SOR/89-503
SOR/90-655
SOR/92-198
SOR/94-287
SOR/99-413, 414
SOR/2007-289, ss. 1, 2
2019, c. 29, s. 177

SCHEDULE B (Section 10)

The most recent editions, including all errata, supplements, revisions and addenda, of the following standards:

Column I	Column II
Item	Name	Abbreviation
1	European Pharmacopoeia	(Ph.Eur.)
2	Pharmacopée française	(Ph.F.)
3	Pharmacopoeia Internationalis	(Ph.I.)
4	The British Pharmacopoeia	(B.P.)
5	The Canadian Formulary	(C.F.)
6	The National Formulary	(N.F.)
7	The Pharmaceutical Codex: Principles and Practices of Pharmaceuticals
8	The United States Pharmacopoeia	(U.S.P.)

R.S., 1985, c. F-27, Sch. B
SOR/85-276
SOR/89-315
SOR/90-160
SOR/94-288
SOR/95-530, s. 2
SOR/96-96

SCHEDULE C (Section 12)

Drugs, other than radionuclides, sold or represented for use in the preparation of radiopharmaceuticals Drogues.
Radiopharmaceuticals Produits pharmaceutiques radioactifs

R.S., c. F-27, Sch. C
SI/72-44
SI/76-1
SOR/79-237
SOR/81-195, 332
SOR/82-769

SCHEDULE D (Section 12)

Allergenic substances used for the treatment or diagnosis of allergic or immunological diseases Substances.
Anterior pituitary extracts Extraits hypophysaires (lobe antérieur)
Aprotinin Aprotinine
Cholecystokinin Cholécystokinine
Drugs obtained by recombinant DNA procedures Drogues obtenues.
Drugs, other than antibiotics, prepared from micro-organisms Drogues, sauf.
Drugs that are or are made from blood Drogue qui est.
Glucagon Glucagon
Gonadotrophins Gonadotrophines
Immunizing agents Agents immunisants
Insulin Insuline
Interferon Interféron
Monoclonal antibodies, their conjugates and derivatives Anticorps monoclonaux et leurs dérivés et conjugués
Secretin Sécrétine
Snake Venom Venin de serpent
Urokinase Urokinase

R.S., 1985, c. F-27, Sch. D
SOR/85-715, s. 1
SOR/89-177
SOR/93-64
SOR/97-560
SOR/2007-120
SOR/2013-180

SCHEDULE E (Section 13)

[There are no items in this Schedule.]

R.S., c. F-27, Sch. E
SOR/77-824
SOR/82-769

SCHEDULE F (Section 15)

[There are no items in this Schedule of the FOOD AND DRUGS ACT.]

R.S., c. F-27, Sch. F
SOR/84-566

SCHEDULE G (Sections 2 and 21.91)

Item	Description

R.S., 1985, c. F-27, Sch. G
SOR/92‑387
1996, c. 19, s. 82
2019, c. 29, s. 179

SCHEDULE H

[Repealed, 1996, c. 19, s. 82]

RELATED PROVISIONS

Writs of Assistance

Transitional

66 (2) For greater certainty, the two year limitation period provided for in subsection 32(1) of the Act, as amended by subsection (1), only applies in respect of offences committed after the coming into force of that subsection.

Deeming provision

Pest control products

5 (1) The maximum residue limit established for an agricultural chemical and its derivatives under the Food and Drug Regulations , as those regulations read immediately before the coming into force of this subsection, is deemed, if the agricultural chemical is a pest control product as defined in subsection 2(1) of the Pest Control Products Act , chapter 28 of the Statutes of Canada, 2002, to have been specified by the Minister under section 9 or 10 of that Act as the maximum residue limit for that agricultural chemical and its derivatives.

Interim marketing authorization

417 (1) An interim marketing authorization that is issued under subsection 30.2(1) of the Food and Drugs Act and in effect immediately before the day on which section 416 comes into force continues to have effect until the earliest of
- (a) the day on which the Minister of Health publishes a notice cancelling the interim marketing authorization in the Canada Gazette ;
- (b) the day on which a marketing authorization — or any part of it — that is issued under subsection 30.3(1) of the Food and Drugs Act , as enacted by section 416, has the same effect as the interim marketing authorization; and
- (c) two years after the day on which the interim marketing authorization is published in the Canada Gazette .
Exemption from Statutory Instruments Act

Therapeutic product authorizations

Clinical trials — certain drugs

Studies — positron-emitting radiopharmaceuticals

Clinical trials — natural health products

Investigational testing — certain medical devices

Clarification — immediate application

Certain applications for warrants
- 77 (2) Each of the following provisions, as it read immediately before the day on which this Act comes into force, continues to apply with respect to an application made for a warrant under the provision if the application is submitted, and no decision has been made in respect of the application, before that day:
  - (a) subsection 23(12) of the Food and Drugs Act ;
  Impact of remote proceedings
  - 78.1 (1) The Minister of Justice must, no later than three years after the day on which this Act receives royal assent, initiate one or more independent reviews on the use of remote proceedings in criminal justice matters that must include an assessment of whether remote proceedings
    - (a) enhance, preserve or adversely affect access to justice;
    - (b) maintain fundamental principles of the administration of justice; and
    - (c) adequately address the rights and obligations of participants in the criminal justice system, including accused persons.
    Report
    
    Review by committee
    Report
    
    Authorizations and licences
    - (a) an authorization, including a licence, that was issued, before the day on which this section comes into force, under the regulations made under that Act and that authorizes, as the case may be, the import, sale, manufacture, packaging or labelling of a natural health product, within the meaning of the Natural Health Products Regulations as those Regulations read immediately before that day; or
    - (b) an authorization, including a licence, that would fall within paragraph (a) if the authorization were not suspended.
    Marketing authorizations
    
    AMENDMENTS NOT IN FORCE
    - — 2023, c. 12, s. 64
      - 64 The Food and Drugs Act is amended by adding the following after section 11:
      Risk to environment
      - (a.02) prescribing the substances that are subject to an assessment under section 11.1;
      1999, c. 33, s. 347
      (5) Paragraph 30(1)(l.1) of the Act is replaced by the following:
      - (l.1) respecting the assessment of the risk to the environment or human life and health of the release into the environment of any food, drug, cosmetic or device;
      - (l.2) respecting, for the purpose of managing risks to the environment identified as part of an assessment under this Act, measures in respect of selling or importing, manufacturing, preparing, preserving, packaging or storing for sale any food, drug, cosmetic or device;
      - (l.3) authorizing the Minister to waive any requirement respecting the assessment under this Act of the risk to the environment presented by a food, drug, cosmetic or device;
      Relevant factor
      - 501 (2) Section 21.321 of the Act is repealed.
        
        502 (2) Subsection 21.8(2) of the Act is repealed.
        
        325 (2) Paragraph 30(1)(r) of the Act is repealed.