Food and Drugs Act
The Food and Drugs Act (formal title "An Act respecting food, drugs, cosmetics and therapeutic devices") is an act of the Parliament of Canada regarding the production, import, export, transport across provinces and sale of food, drugs, contraceptive devices and cosmetics (including personal cleaning products such as soap and toothpaste). It was first passed in 1920 and most recently revised in 1985. It attempts to ensure that these products are safe, that their ingredients are disclosed and that drugs are effective and are not sold as food or cosmetics. It also states that cures for Schedule A diseases (the most serious, including cancer), cannot be advertised to the general public.
After the launch of the Federal Department of Health in 1919, the Food and Drugs Act was later presented in late 1920.Rules and regulations developed under the Act established the requirements needed for licensing and creating drugs in Canada. The Minister of Health had the right under this Act to cancel or suspend licenses for companies failing to comply with the requirements.
The Food and Drugs Act was not significantly modified until 1947, in which the foundations were laid out for the current market today. During 1951, drug manufacturers were required to submit a file for each new drug prior to marketing their product. However during the early 1960s, the drug thalidomide surfaced into the market, which caused severe birth defects along with resulting in thousands of infant deaths.
Due to the problems caused by the drug thalidomide, the Act was revisited and strengthened by the department of Health. The revised version placed new requirements for manufacturers to fill out evidence for the efficacy in seeking a Notice of Compliance.
The current Model for drug regulation in Canada focuses on pre-market activities. Once the Notice of Compliance has been received from Health Canada and it passes, the drug can then be administered into the market. The manufacturer must meet all the required obligations before being available to the public, but once the drug passes with no adverse reaction or no changes needed to the drug's formula, it may never be subjected for review by Health Canada again. Recent social trends and Medical are putting pressure on this system to progress.
Part I provides general interpretations of the terms, and provides details of each of the topics discussed on what the Act entails:
Part II of the act focuses the administration and the Enforcement that allows the government to intervene with the manufacturer. It entails:
- Inspection, Seizure and forfeiture
- Power of the Minister
- Incorporation by Reference
- Interim Orders
- Marketing Authorization
- Offense and Punishment
Parts III and IV
Parts III (enacted in 1961) and IV (enacted in 1969) provided for implementation of controls required by the Convention on Psychotropic Substances. Part III dealt with "controlled" drugs such as amphetamine, methaqualone, and phenmetrazine, which have legitimate medical uses. Part IV focused on Schedule H "restricted drugs", those whose only legitimate use is for scientific research, such as the hallucinogens LSD, DMT, and MDMA. These Parts established eight classes of regulated substances, ranging from Schedules A to H.
The 1996 Controlled Drugs and Substances Act repealed Parts III and IV
2008 Proposed Amendment
On April 2008, an amendment to the Food and Drugs Act, Canadian Bill C-51 was tabled in the House of Commons. The purpose of this bill was to modernize the regulatory system for foods and therapeutic products, to strengthen the oversight of the benefits and risks of therapeutic products throughout their life cycle, to support effective compliance and enforcement actions and to enable a greater transparency and openness of the regulatory system. Some of the proposed amendments are as follows:
- Illegalize the sale and importation of products that have knowingly been adulterated.
- Illegalize the sale of counterfeit therapeutic products.
- Clarify in the Food and Drugs Act the requirement of therapeutic products to have market authorization, which has been required by Health Canada for many years.
The bill has been subject to criticism due to a perception that the bill would illegalize all food and Natural Health Products by categorizing them as drug products. Natural health products have not been regulated as drugs since the Natural Health Products Regulations were put into place on January 1, 2004. Health Canada has stated “The Natural Health Product Regulations, introduced in 2004, will continue to operate the same way under Bill C-51. Canadians will continue to have access to natural health products that are safe, effective and of high quality.”
- Therapeutic Products Directorate
- Food safety
- Medical device
- Food Bill 160-2 of New Zealand
- Food Safety Modernization Act
- Pledge to Africa Act
- Canada's Previous Drug Laws (before the Controlled Drugs and Substances Act came into force in May 1997), Canadian Foundation for Drug Policy.
- Cannabis Canada Issue 7.
- Co-operation between Canada and other countries and territories to promote countermeasures against illicit drug trafficking, 1987.
- Debates of the House of Commons of Canada, Oct. 30, 1995.
- Official Government of Canada webpage for information on Bill C-51
- Complete transcript of C51
- Bill C-51 and the Regulation of Natural Health Products - Fast Facts
- background of the drug act and regulations