Food and Drugs Act

Last updated
Food and Drugs Act
Parliament-Ottawa.jpg
Parliament of Canada
  • An Act respecting food, drugs, cosmetics and therapeutic devices
    Loi concernant les aliments, drogues, cosmétiques et instruments thérapeutiques
Citation R.S.C. 1985, c. F-27
Amended by
Budget Implementation Act, 2023
Status: Amended

The Food and Drugs Act (French : Loi sur les aliments et drogues) 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 disease listed in Schedule A [1] (including cancer, obesity, anxiety, asthma, depression, appendicitis, and sexually transmitted diseases), cannot be advertised to the general public.[ citation needed ]

Contents

Background

After the launch of the Federal Department of Health in 1919, the Food and Drugs Act was presented in late 1920. Rules and regulations developed under the Act established the requirements for licensing and creating drugs in Canada. The law granted the Minister of Health the right to cancel or suspend licenses of companies failing to comply with the requirements. [2]

The Food and Drugs Act was not significantly modified until 1947 when the foundations were laid for the current market today. In 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, which had been approved to enter the market, resulted in the deaths of thousands of infants and severe birth defects in others when the drug was taken by women in early stages of pregnancy.

As a result of the problems caused by the drug thalidomide, the Act was revisited and strengthened by Health Canada. The revised version placed new requirements on manufacturers to provide evidence for efficacy in seeking a Notice of Compliance, which must be obtained before any drug could be sold. The manufacturer must meet all the requirements before making any drug available to the public, but once the drug passes with no adverse reactions and without any changes needed to the drug's formula, it may never be subjected to review by Health Canada again.[ citation needed ] Some health advocates[ who? ] want post-approval surveillance to watch for unexpected problems.

Part I

Part I provides general interpretations of the terms, and provides details of each of the topics discussed on what the Act entails:

Part II

Part II of the Act focuses the administration and the Enforcement that allows the government to intervene with the manufacturer. It entails:

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

In 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. [3] Some of the proposed amendments are as follows:

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. [4] Natural health products in Canada have been regulated as a subset of 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. [5]

In spite of this claim, The Natural Health Industry remained skeptical. A watchdog group was employed to investigate the concerns and a number of hidden camera videos surfaced that further aggravated the NHP industry concerns. [6]

Regulations Amending the Food and Drug Regulations (Nutrition Symbols, Other Labelling Provisions, Vitamin D and Hydrogenated Fats or Oils)

Overview

Example of Canada's nutritional labelling Canada, example of nutritional summary of labeling.jpg
Example of Canada's nutritional labelling

Frequent consumption of foods rich in sodium, sugars, or saturated fats is associated with elevated health risks, including but not limited to:

To address this concern, a front-of-package nutrition symbol has been introduced. This symbol serves the dual purpose of aiding consumers in making informed choices while grocery shopping and assisting health professionals in educating the public about the nutritional content of foods high in sodium, sugars, and saturated fat.

Front-of-Package Nutrition Labelling

The front-of-package nutrition symbol is mandatory for prepackaged foods that meet or exceed specified levels for sodium, sugars, or saturated fat. However, certain foods are exempt from displaying this symbol, including:

Appearance of the Front-of-Package Nutrition Symbol

The front-of-package nutrition symbol is depicted in black and white and features a magnifying glass, emphasizing whether the food product is high in sodium, sugars, saturated fat, or a combination of these components.

Symbol Selection Process

The selection of the front-of-package nutrition symbol was informed by feedback from Canadian residents and consumer research, ensuring its relevance and comprehensibility.

Placement Requirements

For uniformity and ease of identification, the nutrition symbol must adhere to specific requirements concerning size, location, and language:

See also

Related Research Articles

<span class="mw-page-title-main">Cream</span> Dairy product

Cream is a dairy product composed of the higher-fat layer skimmed from the top of milk before homogenization. In un-homogenized milk, the fat, which is less dense, eventually rises to the top. In the industrial production of cream, this process is accelerated by using centrifuges called "separators". In many countries, it is sold in several grades depending on the total butterfat content. It can be dried to a powder for shipment to distant markets, and contains high levels of saturated fat.

<span class="mw-page-title-main">Food and Drug Administration</span> United States federal agency

The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

<span class="mw-page-title-main">Margarine</span> Semi-solid oily spread often used as a butter substitute

Margarine is a spread used for flavoring, baking, and cooking. It is most often used as a substitute for butter. Although originally made from animal fats, most margarine consumed today is made from vegetable oil. The spread was originally named oleomargarine from Latin for oleum and Greek margarite. The name was later shortened to margarine.

In the U.S. and Canada, the Reference Daily Intake (RDI) is used in nutrition labeling on food and dietary supplement products to indicate the daily intake level of a nutrient that is considered to be sufficient to meet the requirements of 97–98% of healthy individuals in every demographic in the United States. While developed for the US population, it has been adopted by other countries, though not universally.

<span class="mw-page-title-main">Good manufacturing practice</span> Manufacturing quality standards

Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).

<span class="mw-page-title-main">Evaporated milk</span> Unsweetened milk product derived from cows milk

Evaporated milk, known in some countries as "unsweetened condensed milk", is a shelf-stable canned cow’s milk product for which approximately 60% of the water has been removed from fresh milk. It differs from sweetened condensed milk, which contains added sugar and requires less processing to preserve, as the added sugar inhibits bacterial growth. The production process involves the evaporation of 60% of the water from the milk, followed by homogenization, canning and heat sterilization.

<span class="mw-page-title-main">Regulation of therapeutic goods</span> Legal management of drugs and restricted substances

The regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.

<span class="mw-page-title-main">Federal Food, Drug, and Cosmetic Act</span> Acts of the United States Congress

The United States Federal Food, Drug, and Cosmetic Act is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was Charles W. Crawford. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.

The International Nomenclature of Cosmetic Ingredients (INCI) are the unique identifiers for cosmetic ingredients such as waxes, oils, pigments, and other chemicals that are assigned in accordance with rules established by the Personal Care Products Council (PCPC), previously the Cosmetic, Toiletry, and Fragrance Association (CTFA). INCI names often differ greatly from systematic chemical nomenclature or from more common trivial names and is a mixture of conventional scientific names, Latin and English words. INCI nomenclature conventions "are continually reviewed and modified when necessary to reflect changes in the industry, technology, and new ingredient developments".

<span class="mw-page-title-main">Standard for the Uniform Scheduling of Medicines and Poisons</span> Australian legal instrument

The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), also known as the Poisons Standard for short, is an Australian legislative instrument produced by the Therapeutic Goods Administration (TGA). Before 2010, it was known as the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP). The SUSMP classifies drugs and poisons into different Schedules signifying the degree of control recommended to be exercised over their availability to the public. As of 2023, the most recent version is the Therapeutic Goods Instrument 2023.

<span class="mw-page-title-main">Nutrition facts label</span> Table of nutrition facts on food labels

The nutrition facts label is a label required on most packaged food in many countries, showing what nutrients and other ingredients are in the food. Labels are usually based on official nutritional rating systems. Most countries also release overall nutrition guides for general educational purposes. In some cases, the guides are based on different dietary targets for various nutrients than the labels on specific foods.

Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP).

The Health Products and Food Branch (HPFB) of Health Canada manages the health-related risks and benefits of health products and food by minimizing risk factors while maximizing the safety provided by the regulatory system and providing information to Canadians so they can make healthy, informed decisions about their health.

Nutritional rating systems are used to communicate the nutritional value of food in a more-simplified manner, with a ranking, than nutrition facts labels. A system may be targeted at a specific audience. Rating systems have been developed by governments, non-profit organizations, private institutions, and companies. Common methods include point systems to rank foods based on general nutritional value or ratings for specific food attributes, such as cholesterol content. Graphics and symbols may be used to communicate the nutritional values to the target audience.

Canadian health claims by Health Canada, the department of the Government of Canada responsible for national health, has allowed five scientifically verified disease risk reduction claims to be used on food labels and on food advertising. Other countries, including the United States and Great Britain, have approved similar health claims on food labels.

Federal responsibility for Canadian food labelling requirements is shared between two departments, Health Canada and the Canadian Food Inspection Agency (CFIA). All labelling information that is provided on food labels or in advertisements, as required by legislation, must be accurate, truthful and not misleading. Ingredient lists must accurately reflect the contents and their relative proportions in a food. Nutrition facts tables must accurately reflect the amount of a nutrient present in a food. Net quantity declarations must accurately reflect the amount of food in the package. Certain claims, such as those relating to nutrient content, organic, kosher, halal and certain disease-risk reduction claims, are subject to specific regulatory requirements in addition to the prohibitions in the various acts. For claims that are not subject to specific regulatory requirements, the Canadian Food Inspection Agency (CFIA) and/or Health Canada provide interpretive guidance that assist industry in compliance.

Consumer Health Laws are laws that ensure that health products are safe and effective and that health professionals are competent; that government agencies enforce the laws and keep the public informed; professional, voluntary, and business organizations that serve as consumer advocates, monitor government agencies that issue safety regulations, and provide trustworthy information about health products and services; education of the consumer to permit freedom of choice based on an understanding of scientific data rather than misleading information; action by individuals to register complaints when they have been deceived, misled, overcharged, or victimized by frauds.

<span class="mw-page-title-main">Food labelling and advertising law (Chile)</span> Food labeling and advertising law in Chile (2016)

Chile's food labelling and advertising law, formally titled Ley 20.606, sobre la composición de los alimentos y su publicidad establishes a regulatory framework on food security and healthy food with the intention of guiding consumers towards behaviour patterns that promote public health. After the 2012 law was enacted, its accompanying regulations came into full force on June 27, 2016. Andrew Jacobs, writing for The New York Times, has characterized this measure as "the world’s most ambitious attempt to remake a country’s food culture" and suggests it "could be a model for how to turn the tide on a global obesity epidemic that researchers say contributes to four million premature deaths a year."

<span class="mw-page-title-main">Trans fat</span> Type of unsaturated fat

Trans fat, also called trans-unsaturated fatty acids, or trans fatty acids, is a type of unsaturated fat that occurs in foods. Trace concentrations of trans fats occur naturally, but large amounts are found in some processed foods. Since consumption of trans fats is unhealthy, artificial trans fats are highly regulated or banned in many nations. However, they are still widely consumed in developing nations, resulting in hundreds of thousands of deaths each year. The World Health Organization (WHO) has set a goal to make the world free from industrially produced trans fat by the end of 2023.

References

  1. Branch, Legislative Services (6 May 2021). "Consolidated federal laws of canada, Food and Drugs Act". laws-lois.justice.gc.ca.
  2. "Brief History of Drug Regulation in Canada". hc-sc.gc.ca.
  3. "Government Bill (House of Commons) C-51 (39-2) - First Reading - An Act to amend the Food and Drugs Act and to make consequential amendments to other Acts - Parliament of Canada". www2.parl.gc.ca.
  4. "Critical legal analysis of Bill C-51". avivahealth.com.
  5. "C-51 and the Regulation of Natural Health Products - Fast Facts". healthycanadians.ca.
  6. "C-51 hidden camera video". youtube.com. Archived from the original on 2013-12-17.
  7. Canada, Health (2022-05-25). "Nutrition labelling: Front-of-package nutrition symbol". www.canada.ca. Retrieved 2024-01-17.