Guidance on distinction between advertising and other activities for health products: Relevant legislative and regulatory sections

Stakeholders are advised to consult the full text of the relevant Acts and associated regulations. For convenience, some relevant sections are reproduced below:

Sections of the Food and Drugs Act

Section 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.

Exemption: Refer to sections A.01.067 and A.01.068 of the Food and Drug Regulations (FDR) and sections 103.2 and 103.3 of the Natural Health Products Regulations (NHPR).

Section 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.

Section 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.

Sections of the Food and Drug Regulations under the Food and Drugs Act

Section A.01.067: A drug is exempt from subsection 3(1) of the Act with respect to its advertisement to the general public as a preventative, but not as a treatment or cure, for any of the diseases, disorders or abnormal physical states referred to in Schedule A to the Act.

Section A.01.068: A drug is exempt from subsection 3(2) of the Act with respect to its sale by a person where the drug is represented by label or is advertised by that person to the general public as a preventative, but not as a treatment or cure, for any of the diseases, disorders or abnormal physical states referred to in Schedule A to the Act.

Section C.01.007: No reference, direct or indirect, to the Act or to these regulations shall be made upon any label of or in any advertisement for a drug unless such reference is a specific requirement of the Act or these regulations.

Section C.01.044: If a person advertises a prescription drug to the general public, the person shall not make any representation other than with respect to the brand name, the proper name, the common name and the price and quantity of the drug.

Section C.08.002: No person shall sell or advertise a new drug unless:

1. the manufacturer of the new drug has filed with the Minister a new drug submission, an extraordinary use new drug submission, an abbreviated new drug submission or an abbreviated extraordinary use new drug submission relating to the new drug that is satisfactory to the Minister
2. the Minister has issued, under section C.08.004.01, a notice of compliance to the manufacturer of the new drug in respect of the submission and
3. the notice of compliance in respect of the submission has not been suspended under section C.08.006

Section G.01.007: No person shall

1. advertise a controlled drug to the general public or
2. issue or publish any other written advertisement respecting a controlled drug unless that advertisement carries the symbol in a clear and conspicuous colour and size in the upper left quarter of the first page of the advertisement

Alt text:

Symbol consisting of a diamond shape outline in which an uppercase letter C is centred.

Sections of the Medical Device Regulations under the Food and Drugs Act

Section 24 (1): For the purposes of subsections 3(1) and (2) of the Act and subject to section 27, a condom may be advertised and sold to the general public for the purpose of preventing the transmission of sexually transmitted diseases if the advertisement and the label of the condom claim only that the condom reduces the risk of transmitting sexually transmitted diseases.

Section 24(2): For the purpose of subsection 3(3) of the Act and subject to section 27, contraceptive devices, other than intrauterine devices, may be advertised to the general public by any means other than by the distribution of samples of the devices door-to-door or through the mail.

Section 27: No person shall advertise a Class II, III or IV medical device for the purpose of sale unless:

1. the manufacturer of the device holds a licence in respect of that device or, if the device has been subjected to a change described in section 34, an amended medical device licence or
2. the advertisement is placed only in a catalogue that includes a clear and visible warning that the devices advertised in the catalogue may not have been licensed in accordance with Canadian law

Sections of the Natural Health Products Regulations under the Food and Drugs Act

Section 92: No reference, direct or indirect, to the Act, the Food and Drug Regulations or to these regulations shall be made on any label of or in any advertisement for a natural health product unless the reference is specifically required by law.

Section 103.2: A natural health product is exempt from subsection 3(1) of the Act with respect to its advertisement to the general public as a preventative, but not as a treatment or cure, for any of the diseases, disorders or abnormal physical states referred to in Schedule A to the Act.

Section 103.3: A natural health product is exempt from subsection 3(2) of the Act with respect to its sale by a person where the drug is represented by label or is advertised by that person to the general public as a preventative, but not as a treatment or cure, for any of the diseases, disorders or abnormal physical states referred to in Schedule A to the Act.

Section of the Controlled Drugs and Substances Act

Section 55 (1) (l): The Governor in Council may make regulations for carrying out the purposes and provisions of this Act, including the regulation of the medical, scientific and industrial applications and distribution of controlled substances and precursors and the enforcement of this Act, as well as the regulation of designated devices and, without restricting the generality of the foregoing, may make regulations controlling and limiting the advertising for sale of any controlled substance or precursor or any class thereof

Sections of the Narcotic Control Regulations under Controlled Drugs and Substances Act

Section 70: No person shall:

1. publish or cause to be published or furnish any advertisement respecting a narcotic unless the symbol "N" is clearly and conspicuously displayed in the upper left-hand quarter thereof or, if the advertisement consists of more than 1 page, on the first page thereof
2. publish or cause to be published or furnish any advertisement to the general public respecting a narcotic or
3. advertise in a pharmacy a preparation referred to in section 36

Section of the Benzodiazepines and Other Targeted Substances Regulations under Controlled Drugs and Substances Act

Section 78: A person must not:

1. advertise a targeted substance to the general public or
2. issue or publish an advertisement for a targeted substance unless the advertisement:
   
   1. is published in literature distributed to, or in a trade publication for, licensed dealers, pharmacists, practitioners or hospitals and
   2. displays in the upper left quarter of its first page, in a clear manner and in a conspicuous colour and size, the following symbol:

Alt text:

Symbol consisting of a square outline divided in half from top left corner to bottom right corner. The top right half has an uppercase letter C inside and lower left half has an uppercase letter T inside.