Health Canada and the FDA: Key Regulatory Bodies in North America

Cosmetics, nutritional supplements, drugs and even medical devices have existed in one form or another throughout history, but the greatest scientific progress has occurred in the last 100 years. With the constant development of science, new challenges have been presented to governments for the regulation of new products. Much of the evolutionary change in North American regulators have been to properly protect consumers and still allow innovation in various industries. There has been a need to regulate ingredients, labeling, manufacturing and quality systems in order to allow the sale of new products on the market.


Health Canada is the federal department responsible for helping Canadians “maintain and improve their health, while respecting individual choices and circumstances.” The question is; what does this actually mean? Health Canada engages in various activities all throughout the country and has numerous responsibilities related to health. This agency administers numerous pieces of legislation and develops and enforces these regulations which have a direct impact on the health and safety of Canadians. This department will consult with the public, industries, non-governmental organizations (NGO) and other interested parties in the development of regulations. A very important part of the regulatory side of Health Canada is that they prepare guidelines in order to help interpret and clarify their legislation which is very helpful for manufacturers. To learn about upcoming or ongoing consultation on proposed federal regulations, you may visit the Canada Gazette and the Consulting with Canadians website.

United States

The United States Food and Drug Administration is the main department in the United States responsible for protecting “the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices and cosmetics.” This department is also responsible for advancing the health sector by helping to speed innovations that make the products consumers use more effective, safer and more affordable. The scope of the FDA is extremely broad.  Much like Health Canada, the Food and Drug Administration publishes their regulations in the Federal Register which is the government’s official publication for notifying the public of many agencies actions. The rule-making procedure is fairly long and complicated but can be found on the Office of Information and Regulatory Affairs FAQ page.

As you can see, both of these regulatory bodies play very similar roles in each of their respective countries. However, both of these agencies function differently and require knowledgeable and dedicated people to efficiently maneuver through them. Health Canada Consultants and FDA Consultants such as Focal Point Research Inc. can provide guidance and help in fully understanding what each federal agency requires along with preparing submissions and assessing new products for regulatory compliance.