Food and Drugs Act | |
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Parliament of Canada | |
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Citation | R.S.C. 1985, c. F-27 |
Amended by | |
Budget Implementation Act, 2023 | |
Status: In force (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 ]
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 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:
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.
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]
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.
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:
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.
The selection of the front-of-package nutrition symbol was informed by feedback from Canadian residents and consumer research, ensuring its relevance and comprehensibility.
For uniformity and ease of identification, the nutrition symbol must adhere to specific requirements concerning size, location, and language:
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.
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.
Cosmetics are composed of mixtures of chemical compounds derived from either natural sources or synthetically created ones. Cosmetics have various purposes, including personal and skin care. They can also be used to conceal blemishes and enhance natural features. Makeup can also add colour to a person's face, enhance a person's features or change the appearance of the face entirely to resemble a different person, creature, or object.
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, such as Canada.
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.
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.
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.
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.
Cranberry juice is the liquid juice of the cranberry – a fruit recognized for its bright red color, tart taste, and versatility for product manufacturing. Major cranberry products include cranberry juice, dried cranberry, cranberry sauce, frozen cranberry, cranberry powder, and dietary supplements containing cranberry extracts.
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.
A health claim found on a food labels and in food marketing is a claim by a food manufacturer that their product will reduce the risk of developing a disease or condition.
Federal responsibility for Canadian food labelling requirements is shared between two departments, Health Canada and the Canadian Food Inspection Agency (CFIA).
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.
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."
Trans fat, also called trans-unsaturated fatty acids, or trans fatty acids, is a type of unsaturated fat that occurs in foods. Small amounts 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) had set a goal to make the world free from industrially produced trans fat by the end of 2023. The goal was not met, and the WHO announced another goal "for accelerated action till 2025 to complete this effort" along with associated support on 1 February 2024.