Food and Drugs Act (Project 1539) — Regulations Amending Certain Regulations Made under

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Food and Drugs Act (Project 1539) — Regulations Amending Certain Regulations Made under

Vol. 141, No. 26 — December 26, 2007

Registration SOR/2007-288 December 13, 2007

FOOD AND DRUGS ACT

Regulations Amending Certain Regulations Made under the Food and Drugs Act (Project 1539)

P.C. 2007-1916 December 13, 2007

Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) of the Food and Drugs Act, hereby makes the annexed Regulations Amending Certain Regulations Made under the Food and Drugs Act (Project 1539).

REGULATIONS AMENDING CERTAIN REGULATIONSMADE UNDER THE FOOD AND DRUGS ACT (PROJECT 1539)

FOOD AND DRUG REGULATIONS

1. The Food and Drug Regulations are amended by adding the following after section A.01.065:

EXEMPTIONS

Application

A.01.066. Sections A.01.067 and A.01.068 do not apply to

(a) a drug included in Schedule I, II, III, IV or V to the Controlled Drugs and Substances Act; or

(b) a drug that is listed or described in Schedule F, other than a drug that is listed or described in Part II of that Schedule and that is

(i) in a form not suitable for human use, or

(ii) labelled in the manner prescribed by paragraph C.01.046(b).

Advertising

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.

Sale

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.

NATURAL HEALTH PRODUCTS REGULATIONS

2. The Natural Health Products Regulations are amended by adding the following after section 103.1:

EXEMPTIONS

Advertising

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.

Sale

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 natural health product 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.

COMING INTO FORCE

3. These Regulations come into force on June 1, 2008.

REGULATORY IMPACTANALYSIS STATEMENT

(This statement is not part of the Regulations.)

Description

I. Overview of the regulatory proposal

This regulatory amendment amends the Food and Drug Regulations (FDR), the Natural Health Products Regulations (NHPR), and the Medical Devices Regulations (MDR). The amendment

(1) revises the list of Schedule A diseases;

(2) exempts natural health products (NHPs) and certain drugs from the prohibition of preventative claims for the diseases listed in Schedule A; and

(3) revises section 24(1) to replace the term "venereal disease" with "sexually transmitted diseases."

All other provisions of the Food and Drugs Act (FDA), the Controlled Drugs and Substances Act (CDSA), and their regulations continue to apply.

(1) Revising the list of Schedule A diseases

Schedule A to the FDA is a list ...

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