Bill C-307

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First Reading

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	1st Session, 36th Parliament, 46 Elizabeth II, 1997-98
	The House of Commons of Canada
	BILL C-307
	An Act to amend the Food and Drugs Act
R.S., c. F-27; R.S., cc. 27, 31 (1st Supp.), c. 27 (3rd Supp.), c. 42 (4th Supp.); 1992, c. 1; 1993, cc. 34, 37, 44; 1994, cc. 26, 38, 47; 1995, c. 1; 1996, cc. 8, 16, 19; 1997, cc. 6, 18	Her Majesty, by and with the advice and consent of the Senate and House of Commons of Canada, enacts as follows:
	*1. (1) Section 2 of the Food and Drugs Act* is amended by adding the following in alphabetical order:**
``determined'' « déclaré »	``determined'' means determined in accordance with section 2.2;
``harmful to human beings'' « nocif pour les êtres humains »	``harmful to human beings'', in respect of a food or drug, means harmful to human beings when the food or drug is used by human beings as indicated, suggested or recommended by the manufacturer, seller or advertiser, as the case may be, of the food or drug;
	(2) The Act is amended by adding the following after section 2:
Interpreta- tion	2.1 Where a thing is both a food and a drug, that thing shall be deemed to be a food until such time as it has been determined to be harmful or potentially harmful to human beings, in which case it shall then be both a food and a drug and may be dealt with as either under this Act.
	*2. The Act is amended by adding the following immediately after the heading ``General'' before section 3*:
Determi- nation by Minister	2.2 (1) Where a determination is made
	(a) for the purposes of section 2.1, 4.1, 4.2, 8.1 or 14,
	(b) for the purposes of subsection 3(1), (1.1) or (2), or
	(c) for the purposes of a regulation made under paragraph 30(1)(a), (b), (c), (d), (e), (f), (l), (n) or (o) or subsection 30(2)
	that any food or drug or class of food or drugs, as the case may be, is harmful or potentially harmful, as the case may be, to human beings, or that the adulteration of any food or drug or the addition, extraction or omission of any prescribed substance or class of substances to or from any food or drug or class of food or drugs, as the case may be, is harmful to human beings, that determination shall be made by the Minister and shall be made on the basis of a preponderance of scientic evidence.
Publication in Canada Gazette	(2) The name of every food or drug and class of food or drugs determined to be harmful or potentially harmful to human beings shall be published forthwith in the Canada Gazette.
Public registry	(3) The Minister shall maintain a current list of every food or drug and class of food or drugs determined to be harmful or potentially harmful to human beings and provide a copy free of charge to any person who makes a written request to the Minister for the list.
Definition	(4) In subsection (1), ``scientific evidence'' means a conclusion or judgment reached through the principles and empirical processes of the scientific method.
	3. (1) Subsection 3(1) of the Act is replaced by the following:
Prohibited advertising	3. (1) No person shall advertise to the general public any food or drug that has been determined to be potentially harmful to human beings, or any cosmetic or device, as a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states referred to in Schedule A.
Prohibited advertising	(1.1) No person shall advertise any food or drug that has been determined to be harmful to human beings or that the person knows is harmful to human beings.
	(2) The portion of subsection 3(2) of the Act before paragraph (a) is replaced by the following:
Prohibited label or advertise- ment where sale made	(2) No person shall sell any food or drug that has been determined to be potentially harmful to human beings, or any cosmetic or device,
	4. (1) Paragraph 4(d) of the Act is repealed.
	(2) The Act is amended by adding the following after section 4:
Prohibited sale of adulterated food	4.1 No person shall sell an article of food that is adulterated where it has been determined that the adulteration makes the article of food harmful to human beings or where the person knows that the adulteration makes the drug harmful to human beings.
Prohibited sale, etc. of harmful food	4.2 No person shall sell an article of food that has been determined to be harmful to human beings or that the person knows is harmful to human beings.
	5. Section 8 of the Act is replaced by the following:
Prohibited sale of drugs	8. No person shall sell any drug that was manufactured, prepared, preserved, packed or stored under unsanitary conditions.
Prohibited sale of adulterated drugs	8.1 No person shall sell any drug that is adulterated where it has been determined that the adulteration makes the drug harmful to human beings or where the person knows that the adulteration makes the drug harmful to human beings.
	6. Section 14 of the Act is replaced by the following:
Samples	14. (1) No person shall distribute or cause to be distributed, as a sample, any drug that has been determined to be harmful or potentially harmful to human beings or that the person knows is harmful or potentially harmful to human beings or any drug described in subsection 30.1(3).
Exception	(2) Subsection (1) does not apply to the distribution, under prescribed conditions, of samples of drugs to physicians, dentists, veterinary surgeons or pharmacists where those drugs have been determined to be potentially harmful to human beings or where those drugs are drugs described in subsection 30.1(3).
	7. Section 15 of the Act is replaced by the following:
Schedule F drugs not to be sold	15. No person shall sell any drug described in Schedule F or that the person knows is harmful to human beings.
	8. (1) Paragraph 30(1)(m) of the Act is replaced by the following:
	(m) adding any publication to Schedule B , in the interest of, or for the prevention of injury to, the health of the purchaser or consumer, or deleting any publication therefrom;
	(m.1) adding any drug to Schedule C. D or E, in the interest of, or for the prevention of injury to, the health of the purchaser or consumer, provided that the addition is approved by a resolution of such committee of the House of Commons as is designated or established by the House for that pur pose, or deleting any such drug therefrom;
	(m.2) adding any drug to Schedule F for the prevention of injury to the health of the purchaser or consumer, provided that the drug has been determined to be harmful to human beings, or deleting any such drug therefrom;
	(2) The Act is amended by adding the following after subsection 30(1):
Saving provision	(1.1) Where any drug was, immediately before the coming into force of this Act, listed in any schedule referred to in paragraph 30(1)(m.1), that drug shall, on the coming into force of this Act, be deemed to have been approved by a resolution of a committee referred to in that paragraph for addition to that schedule.
	9. The Act is amended by adding the following after section 30:
Exception	30.1 (1) No regulation may be made under paragraph 30(1) (a), (b), (c), (d), (e), (f), (l), (n) or (o) in respect of a food or class of food unless that food or class of food has been determined to be harmful or potentially harmful, as the case may be, to human beings.
Exception	(2) No regulation may be made under paragraph 30(1) (a), (b), (c), (d), (e), (f), (l), (n) or (o) or subsection 30(2) in respect of a drug or class of drugs unless that drug or class of drugs has been determined to be harmful or potentially harmful, as the case may be, to human beings.
Interpreta- tion	(3) For the purposes of subsection (2), ``drug'' does not include a drug that is manufactured, sold or represented solely for use with animals.

Bill C-307

BILL C-307