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

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.

• Marginal note:Exemption

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

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).

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.

• Marginal note:Not applicable to carriers

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

• Marginal note:Labelling, etc., of food that is imported or moved interprovincially

  (3) Where a standard for a food has been prescribed, no person shall label, package, sell or advertise any article that

  • (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.

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.

Marginal note:Unsanitary manufacture, etc., of food

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

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.

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).

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.

Marginal note:Unsanitary manufacture, etc., of drug

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

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.

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.

Marginal note:Samples

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

Marginal note:Schedule F drugs not to be sold

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

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;

• (b) consists in whole or in part of any filthy or decomposed substance or of any foreign matter; or

• (c) was manufactured, prepared, preserved, packaged or stored under unsanitary conditions.

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.

Marginal note:Unsanitary conditions

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

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.

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).

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.

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.

• Definition of government

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

  • (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.

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.

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.

• Marginal note:Recall order — corrective action

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

• Marginal note:Prohibition — selling

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

• Marginal note:Power to authorize sale

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

• Marginal note:Exception

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

• Marginal note:Contravention of unpublished order

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