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

Full Document:  

Act current to 2022-07-13 and last amended on 2021-05-06. Previous Versions

PART IIAdministration and Enforcement (continued)

Interim Orders

Marginal note:Interim orders

  •  (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    • (b) the day on which it is repealed,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.

  • Marginal note:Contravention of unpublished order

    (3) No person shall be convicted of an offence consisting of a contravention of an interim order that, at the time of the alleged contravention, had not been published in the Canada Gazette unless it is proved that, at the time of the alleged contravention, the person had been notified of the interim order or reasonable steps had been taken to bring the purport of the interim order to the notice of those persons likely to be affected by it.

  • Marginal note:Exemption from Statutory Instruments Act

    (4) An interim order

  • Marginal note:Deeming

    (5) For the purpose of any provision of this Act other than this section, any reference to regulations made under this Act is deemed to include interim orders, and any reference to a regulation made under a specified provision of this Act is deemed to include a reference to the portion of an interim order containing any provision that may be contained in a regulation made under the specified provision.

  • Marginal note:Tabling of order

    (6) A copy of each interim order must be tabled in each House of Parliament within 15 days after it is made.

  • Marginal note:House not sitting

    (7) In order to comply with subsection (6), the interim order may be sent to the Clerk of the House if the House is not sitting.

  • 2004, c. 15, s. 66

Marketing Authorizations

Marginal note:Marketing authorization — representation

  •  (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

  •  (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.

  • Marginal note:Other conditions

    (3) The marketing authorization may be subject to any other condition that the Minister considers appropriate.

  • 2012, c. 19, s. 416

Marginal note:Classes

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

  • 2012, c. 19, s. 416

Incorporation by Reference

Marginal note:Incorporation by reference

  •  (1) A regulation made under this Act with respect to a food or therapeutic product and a marketing authorization 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.

  • Marginal note:Accessibility of incorporated documents

    (2) The Minister shall ensure that any document that is incorporated by reference in the regulation or marketing authorization is accessible.

  • Marginal note:Defence

    (3) A person is not liable to be found guilty of an offence for any contravention in respect of which a document that is incorporated by reference in the regulation or marketing authorization is relevant unless, at the time of the alleged contravention, the document was accessible as required by subsection (2) or it was otherwise accessible to the person.

  • Marginal note:No registration or publication

    (4) For greater certainty, a document that is incorporated by reference in the regulation or marketing authorization is not required to be transmitted for registration or published in the Canada Gazette by reason only that it is incorporated by reference.

  • 2012, c. 19, s. 416
  • 2014, c. 24, s. 7

Marginal note:Existing power not limited

 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

  •  (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.

  • Marginal note:Amount not to exceed cost

    (2) A fee fixed under paragraph (1)(a) may not exceed the cost to Her Majesty in right of Canada of providing the service or the use of the facility.

  • Marginal note:Aggregate amount not to exceed cost

    (3) Fees fixed under paragraph (1)(b) may not in the aggregate exceed the cost to Her Majesty in right of Canada in respect of providing the regulatory processes or approvals.

  • 2017, c. 20, s. 317

Marginal note:Consultation

 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

  •  (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

 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

  •  (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

Marginal note:Service Fees Act

 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

  •  (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

  •  (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

 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

  •  (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.

  • Marginal note:Clarification

    (2) For greater certainty, subsection (1) applies in respect of the following provisions of this Act:

    • (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.

Marginal note:Offences relating to therapeutic products

  •  (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.

  • Marginal note:Clarification

    (2) For greater certainty, subsection (1) applies in respect of the following provisions of this Act:

    • (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.

 
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