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Healthy Canadians > Food and Product Safety > Proposed Bill C-51 Amendments

Proposed Bill C-51 Amendments

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Table of Contents

Preamble - Page 1

That Bill C-51, in the preamble, be amended by adding after line 19 on page 1 the following:

  • Whereas the Parliament of Canada recognizes the value of traditional knowledge and of the history of use of natural health products in the assessment of their benefits and risks;
  • Whereas the Parliament of Canada recognizes that the type and amount of information required to establish that the benefits associated with a therapeutic product outweigh the risks depend on the nature of the therapeutic product and its intended use;
  • Whereas the Parliament of Canada recognizes that risk of injury to health is a factor relevant to the taking of administrative and enforcement measures;

Clause 3 - Page 6

That Bill C-51, in Clause 3, be amended by adding after line 22 on page 6 the following:

"natural health product"

« produit de santé naturel »

"natural health product" means, subject to regulations made under paragraph 30(1)(c.1), any of the following that 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 or for use in restoring, correcting or modifying organic functions in human beings:

  1. (a) a homeopathic medicine,
  2. (b) a plant, any plant material, an alga, a bacterium, a fungus or any non-human animal material,
  3. (c) any substance that is extracted or isolated from a thing referred to in paragraph (b) if the primary molecular structure of the substance is identical to the primary molecular structure of the substance before being extracted or isolated from the thing,
  4. (d) a vitamin,
  5. (e) an amino acid,
  6. (f) an essential fatty acid,
  7. (g) a synthetic duplicate of any thing referred to in any of paragraphs (c) to (f),
  8. (h) a mineral,
  9. (i) a probiotic, and
  10. (j) any product whose medicinal ingredients consist entirely of things referred to in any of paragraphs (b) to (i);

Clause 3 - Pages 6 and 7

That Bill C-51, in Clause 3, be amended by replacing line 36 on page 6 to line 12 on page 7 with the following:

  1. (b) a natural health product,
  2. (c) a device,
  3. (d) cells, tissues or organs that are distributed or represented for use in
    1. (i) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals, or
    2. (ii) restoring, correcting or modifying the body structure of human beings or animals or the functioning of parts of the bodies of human beings or animals, or
  4. (e) a combination of two or more of the things referred to in paragraphs (a) to (d);

Clause 8 - Page 15

That Bill C-51, in Clause 8, be amended by adding after line 37 on page 15 the following:

Type and amount of information required

(1.1) For greater certainty, the type and amount of information required to establish that the benefits associated with a therapeutic product outweigh the risks depends on the nature of the therapeutic product and its intended use.

Clause 8 - Page 20

That Bill C-51, in Clause 8, be amended by replacing lines 4 and 5 on page 20 with the following:

Committees

20.4 (1) The Minister shall establish one or more committees for the purpose of providing advice to the Minister concerning the development of guidelines that relate to the interpretation of this Act or the regulations and may establish other committees for the purpose of providing advice to the Minister concerning any other matter.

Membership

(1.1) The membership of each committee established for the purpose of providing advice to the Minister concerning the development of guidelines that relate to the interpretation of this Act or the regulations must reflect a range of experience or expertise relevant to the committee's mandate including, but not limited to,

  1. (a) experience or expertise in consumer issues;
  2. (b) experience or expertise in patient or caregiver issues;
  3. (c) specialized knowledge, such as the knowledge possessed by scientists and academics;
  4. (d) practical or clinical experience as a health professional; and
  5. (e) experience or expertise in industry issues.

Clause 10 - Pages 22 and 23

That Bill C-51, in Clause 10, be amended by replacing line 17 on page 22 to line 33 on page 23 with the following:

Authority to enter and powers of inspectors

23. (1) For the purpose of verifying compliance or preventing non-compliance with this Act or the regulations, an inspector may, subject to subsection 23.1(1), at a reasonable time enter a place, including a conveyance, in which the inspector reasonably believes that an activity that is governed by this Act or the regulations is conducted or a document relating to the administration of this Act is located and may, in that place,

  1. (a) examine or test any article that the inspector reasonably believes is an article to which this Act or the regulations apply and take samples, free of charge, of the article and, if the article is a document, make a copy of it or take an extract from it;
  2. (b) open a receptacle or package that the inspector reasonably believes is an article to which this Act or the regulations apply or that contains such an article;
  3. (c) subject to subsections (2) and (3), seize and detain
    1. (i) an article that the inspector reasonably believes is an article to which this Act or the regulations apply, or
    2. (ii) any receptacle, package or conveyance that the inspector reasonably believes contains an article to which this Act or the regulations apply;
  4. (d) direct the owner or the person having possession, care or control of any conveyance that the inspector reasonably believes is or contains an article to which this Act or the regulations apply to move the conveyance;
  5. (e) use or cause to be used a computer or other device that is at the place to examine a document that the inspector reasonably believes is an article to which this Act or the regulations apply that is contained in or available to a computer system or reproduce it or cause it to be reproduced in the form of a printout or other intelligible output and remove the output for examination or copying;
  6. (f) use or cause to be used copying equipment that is at the place and remove the copies for examination;
  7. (g) take photographs or make recordings or sketches; and (h) direct the owner or person in charge of the place or a person who conducts an activity that is governed by this Act or the regulations at the place
    1. (i) to establish their identity to the inspector's satisfaction, or
    2. (ii) to stop or start the activity.

Grounds for detention

(2) An inspector may detain an article, a receptacle, a package or a conveyance under paragraph (1)(c) only if the inspector reasonably believes that the detention is necessary

  1. (a) to prevent a risk of injury to health;
  2. (b) to prevent inaccurate representations of the article, or an article in the receptacle, package or conveyance, as the case may be; or
  3. (c) to determine whether the article, or an article in the receptacle, package or conveyance, as the case may be, poses a risk of injury to health.

Duration of detention

(3) An article, receptacle, package or conveyance seized under paragraph (1)(c) may be detained only for so long as it is necessary to prevent a risk of injury to health or to determine whether the article, or an article in the receptacle, package or conveyance, as the case may be, poses a risk of injury to health.

Assistance and information to be given to inspector

(4) The owner or person in charge of the place and a person found in the place shall give an inspector who is carrying out their functions all reasonable assistance and provide them with the information that they may reasonably require.

Private property

(5) An inspector who is carrying out their

Clause 10 - Page 25

That Bill C-51, in Clause 10, be amended by replacing lines 5 to 7 on page 25 with the following:

  1. (c) if the inspector reasonably believes that the thing could be injurious to human health and that the thing must be disposed of to prevent injury to health,

Clause 11 - Page 29

That Bill C-51, in Clause 11, be amended by adding after line 3 on page 29 the following:

  1. (c.1) subject to subsection (1.01), specifying any thing or class of things as not being a natural health product;

Clause 11 - Page 33

That Bill C-51, in Clause 11, be amended by adding after line 19 on page 33 the following:

Restriction - exemptions from natural health products

  1. (1.01) In specifying any thing or class of things as not being a natural health product in regulations made under paragraph (1)(c.1), the Governor in Council must take into account the risk of injury to health and the intended use of the thing or of things of that class.

Clause 11 - Page 33

That Bill C-51, in Clause 11, be amended by adding after line 33 on page 33 the following:

Obligation in respect of information in applications relating to natural health products

  1. (1.3) In making regulations under paragraph (1)(y) relating to the information that is required in an application for a market authorization for natural health products, the Governor in Council shall specify that the information to be provided may include information based on
    1. (a) traditional knowledge relating to the product; or
    2. (b) the history of use of the product or any of its ingredients.

Clause 16 - Page 39

That Bill C-51, in Clause 16, be amended by replacing line 17 on page 39 with the following:

  1. under paragraph 23(1)(a) is admissible in
Date Modified: 2008-06-25

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