Source Nutraceutical, Inc. E-Newsletter
Welcome to our E-Newsletter, your “one-stop” for the information you need to ensure success in the Canadian market. Learn about current issues and how they may affect your business, what’s new at Source Nutraceutical, Inc., how we can help you and where you can find us.
Last month’s e-newsletter looked at the similarities and differences in the regulation of supplements in Canada and the USA. This month we are looking at the regulation of foods in Canada and the USA.
The following is a primer on some of the similarities and differences in the way foods are regulated in Canada and in the United States.
In general, foods are defined in a similar manner in Canada as they are in the United States. The one major difference being that dietary supplements are considered to be a subset of foods in the United Sates while natural health products are regulated as a subset of drugs in Canada.
Foods are typically considered to be products that are consumed for their taste, nutritional benefits, and/or ability to satisfy hunger. As science continues to confirm the role of diet in health and chronic disease the category of functional foods and/or foods with health benefits (beyond that of basic nutrition) continues to develop and grow as well.
In Canada, foods fall under the provisions of the federal Food & Drugs Act and Regulations, the Consumer Packaging & Labelling Act & Regulations and commodity specific acts & regulations such as the Meat Inspection Act & Regulations. The latter are soon to be repealed and incorporated under the new Safe Food for Canadians Act.
In the United States the primary food laws are the Federal Food, Drug & Cosmetic Act, the Fair Packaging & Labeling Act and other relevant FDA regulations. However, the US, similar to Canada, is overhauling its food safety legislation and in 2011 signed the FDA Food Safety & Modernization Act (FSMA) into law. This law aims to increase food safety by shifting the focus from responding to food contamination to preventing it.
Although by definition, foods are similar commodities north and south of the 49th parallel, there are significant differences in permitted ingredients and/or their levels of use.
In Canada, the addition of vitamins, minerals and amino acids is limited to specific foods, at specific levels and for specific purposes. In the United States there is much more flexibility in the ability to fortify a much broader range of foods at varying levels of nutrient addition.
- Food Additives
There are also differences in the permitted food additives, their uses and levels of use. For example, monkfruit extract is a permitted sweetening agent in all foods (except meat and poultry products), at levels consistent with Good Manufacturing Practices in the United States. In Canada, monkfruit extract is only permitted as a tabletop sweetener at a maximum level of use 0.8% calculated as mogroside V.
Although policies surrounding fibres and novel fibres are changing in Canada there are still differences in permitted fibre sources and the calculation of energy between Canada and the United States.
- Novel Ingredients
Canada has regulations requiring premarket notification and approval of novel foods, that is foods that have been produced through new processes, that do not have a history of safe use as a food, or that have been modified by genetic manipulation.The FDA only recently (January 2014) issued Guidance for Industry Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements which essentially deals with the issues of ingredients not traditionally used in foods and/or at levels not typically associated with foods. The FDA also has regulations in place to ensure the safety of foods from genetically engineered plants and animals.
Although the basic information required on a food label is similar in Canada and the United States (common name, net contents, nutrition information, name and address of legal agent, ingredients, etc.) there are some unique differences. In Canada, mandatory label information must be in both French and in English, and metric units must come before Imperial units (if the latter is used). There are also some differences in the presentation of nutrition information and reference values, as well as what the priority allergens are that require label declaration.
Although there are differences in regulatory pathways and requirements, nutrient content claims, structure function claims and some disease risk reduction claims are allowed for foods in both Canada and the USA.
GMPs for foods have been founded in regulation in the United States since 1969. They are overarching and general in nature, and applicable to all food commodities. In Canada, GMPs are not based in regulations. In both Canada and the United States HACCP requirements are mandatory for some higher risk commodities.
The FDA Food Safety and Modernization Act is introducing a rule for preventive controls for foods which has been described as ‘enhanced HACCP’. The Safe Food for Canadians Act is also looking at regulating preventive control programs for all food manufacturers, importers, and exporters as a prerequisite to licensing.
As new technologies, new products and new safety issues emerge, rules and regulations will continue to change to protect consumer health and safety. It is important to keep abreast of the changes and to be aware of differences, big or small, between different regulatory environments.
Our experts at Source Nutraceutical are in the know regarding American and Canadian food law and can help you enter the Canadian and/or US markets quickly, efficiently and compliantly. Contact us today at email@example.com to find out how we can assist you.
The preceding is a high level overview of the Canadian and American laws for foods and does not cover all of the requirements. For more information on marketing your food product in Canada and the USA contact Source Nutraceutical, Inc. today.
Did You Know?
According to a recent TD Economics Report, Canadians spend almost US$1,200 more on food and beverage per capita than Americans do. (http://www.td.com/document/PDF/economics/special/ComparingCanadianAndAmericanConsumers.pdf)
Whatever your regulatory, packaging and/or fulfillment needs are – contact Source Nutraceutical today to learn how we can help you achieve brand success and market penetration in 2014/2015 (firstname.lastname@example.org).
Source Nutraceutical, Inc. is your “one-stop-solution” for regulatory compliance, graphic design, mandatory bilingual (English & French translation) labeling and importation and fulfillment services for foods, natural health products, cosmetics, medical devices and pharmaceutical products in Canada. Contact us today to learn more about how we can help you get your products to market quickly, compliantly and cost effectively.
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