FDA & Health Canada (CFIA) Requirements to Sell Foods in North America
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This food compliance webinar focuses on food labelling requirements, TMAL, requirements to import or export food. U.S Agent, FSVP agent and more. Visit: https://qualitysmartsolutions.com/food-beverage-regulatory-compliance-canada/ https://qualitysmartsolutions.com/food-beverage-regulatory-compliance-canada/
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FDA & Health Canada (CFIA) Requirements to Sell Foods in North America
- 1. FDA & Health Canada/CFIA requirements to sell foods in North America
- 2. About Quality Smart Solutions A Canadian regulatory compliance agency established in 2007 Served over 1400 clients, completing over 120,000 services Our team of 25+ experts include former government agency employees, regulatory and quality assurance personnel from North America’s top companies Offering regulatory and quality assurance solutions in Consumer Packaged Goods, Pharmaceutical and Cannabis Three companies cover these solutions Quality Smart Solutions – Natural Health Products, Dietary Supplements, Homeopathics, Veterinary Health Products, Conventional and Supplemented Foods, Cosmetics, OTC Drugs and Medical Devices Regulatory and Quality Assurance solutions Quality IMPORT Solutions – Health Canada Licensed Import Agent for Natural Health Products, Conventional and Supplemented Foods Cannabis License Experts – Federal and Provincial cannabis licensing covering cultivation, processing, medical sales, research, analytical testing, dispensary retail store licensing. Post License Support including auditing, cultivation and grow consulting, EU-GMP readiness, standard operating procedures writing
- 3. Regulations - Canada • Food In Canada is regulated by Health Canada and the Canadian Food Inspection Agency. • Imports are regulated primarily by Canada Border Services Agency. • Applicable regulations such as: • Food and Drugs Regulations. • Safe Food For Canadians Regulations. • Many articles are incorporated by Reference to the SFCRs. • Customs Act.
- 4. Food Labelling - Canada • To ensure a label is compliant, it must show: • Bilingual labelling • Common name • Country of origin • Date markings and storage instructions • Name and principal place of business • Legibility and location • List of ingredients and allergens • Product Specific requirements • Review of Label Claims. • Content must be truthful and not misleading. • New requirements for NFT and Ingredients listing. • Food Labeling Tool for Industry.
- 5. Temporary Market Authorization (TMAL) & Supplemented Foods Conventional foods examples are cereal, orange juice frozen foods and many more. Supplemented Foods are traditional foods that contain added herbal ingredients, vitamins, minerals, amino acids and caffeine (eg. RedBull, Awake Chocolate). These require a Temporary Market Authorization (TMAL) approval by Health Canada. Licensing can take 6 to 9 months. 12+ in some cases. Annual reports must be filed with Health Canada, based on agreement with the regulator. Health Canada will be releasing new Supplemented Foods Regulations to replace the TMAL program. Where permitted ingredients will be allowed to be added with restrictions to certain categories. (~Spring 2022) Such as caffeine within chewing gums.
- 6. Requirements to Export Food to Canada To manufacture, package, label, import or export foods you must obtain a SFCR Food Import License. This is renewed every 2 years. You must have a food safety plan (PCP or HACCP) prior to obtaining a food license. Quality IMPORT Solutions holds a SFCR Food Import License, can help with these requirements and can act as your importer for foods into Canada Foods must have a bilingual, compliant label with a nutrition facts table. We recommend a label review. Product Testing. Keep in Mind! Additional freight and broker arrangements are required for the commercial side of importing foods to Canada.
- 7. Regulations - USA The regulatory bodies that have oversight of foods in the USA are: US Food and Drugs Administration US Department of Agriculture Customs and Border Protection There are multiple sets of regulations that may apply to your food. Bioterrorism Act (site registration) FSMA (Food Safety Modernization Act) improves regulations on the way foods are grown, harvested and processed (site renewal) US and Canada have developed the FSSRA (Food Safety Systems Recognition Arrangement). The FDA FSVP applies a revised set of regulations for US importers when they import food that is covered under the FSSRA from Canadian manufacturers in compliance with the CFIA. This makes it easier for US and Canadian imports and exports.
- 8. What are the labeling requirements to sell food in the USA? Required Elements for a compliant label are: Common Name Net Quantity Ingredients Listing Nutrition Labeling Claims This helps explain the location and required verbiage for each label item. Tip: Avoid intervening material US Departments of Health and Human Services has published a guide to help label US foods.
- 9. How do I register my food facility with the FDA? What is a US Agent? Bioterrorism Act and FSMA (2011) requires facilities that are involved in manufacturing, processing, packing, or holding food for consumption in the United States to register their operations and renew. This is in effort to ensure: Food facilities are on file with FDA. FDA can revoke privileges in case of safety concern. Food Facility registration must be renewed every two years. FDA must also be given advance notice on shipments of imported food. Food Facilities can submit their registration package to register by e- submission, mail or fax US Agent is a person or company located in the US that communicates on behalf of your company with the FDA.
- 10. What is an FSVP Agent? What are their responsibilities? If you are a foreign company without a US owner, importer, or consignee at the time of importing. You must appoint a representative in the US to act on your behalf as an FSVP agent. FSVP Agent has the responsibility of maintaining food safety-related documentation that proves you meet the foreign supplier verification process (FSVP) Risk Based review of sites, documents and products to ensure foods are made to US standards, are not adulterated and are not misbranded. FDA may inspect the FSVP agent for verification of compliance with FSVP rule. FSVP agent will assist your company in case of audit or questioning from the FDA. Work with our US/FSVP Agent!
- 11. Can Help! Help with formula review, product labelling and nutrition facts creation (For Canada and USA) Register your supplemented foods with TMALs or ensure you comply with the new Supplemented Food Regulations when they are released. Ensure you meet the Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing). Ensure you meet US Food Safety requirements (HARPC, HACCP, FSVP) Register your facility and act as your US Agent. Act as your FSVP Agent. Help with importation and market entry for Canada and the USA.
- 12. We are here to serve you • www.qualitysmartsolutions.com • www.qualityIMPORTsolutions.com • www.NHPLicenseExperts.com Websites • info@qualitysmartsolutions.com Email: • 1-800-396-5144 Phone:
Editor's Notes
- Food Labelling For Canada A compliant label is important to reduce or eliminate potential enforcement action on your product. Health Canada has published and posted a great tool to help industry label foods: The Food Labelling for Industry tool. The Label must be bilingual to comply with Health Canada requirements. There are also several foods that have specific labelling requirements such as honey and maple products. It is important to review that all label claims are in alignment with applicable regulations. Also, to ensure that the content on your label are truthful and not misleading. We recommend using an experienced consultant to review your label prior to sale or importation.
- Food Labelling For Canada A compliant label is important to reduce or eliminate potential enforcement action on your product. Health Canada has published and posted a great tool to help industry label foods: The Food Labelling for Industry tool. The Label must be bilingual to comply with Health Canada requirements. There are also several foods that have specific labelling requirements such as honey and maple products. It is important to review that all label claims are in alignment with applicable regulations. Also, to ensure that the content on your label are truthful and not misleading. We recommend using an experienced consultant to review your label prior to sale or importation.
- TMALs and Supplemented Foods A traditional food is something common we consume like bread, milk, eggs. A Supplemented food is when a new ingredient or manufacturing process is added or applied to a food. Such as adding caffeine into a beverage aka an Energy drink. A Traditional food must have a compliant label. A supplemented food must also be approved through a review process called a TMAL or temporary market authorization letter. This allows the sale of your supplemented food. New regulations are set to be published spring 2022 to allow and set out several categories of foods for which certain ingredients can be supplemented. Such as caffeine to chewing gum.
- Import Requirements When shipping a food from another country into Canada you must have or use a Safe Foods for Canadians Food Import License. This requires a preventative control plan and a HACCP (hazard analysis critical control points) to be set up for your manufacturing site. Quality Import Solutions holds an SFCR food import license, can help draft these requirements for your manufacturing sites, and can help with bringing your products into Canada. Again, part of these requirements is a compliant bilingual label and sufficient product testing. (Organoleptic, allergen, micro, heavy metals, packaging, stability, etc.)
- Import Requirements When shipping a food from another country into Canada you must have or use a Safe Foods for Canadians Food Import License. This requires a preventative control plan and a HACCP (hazard analysis critical control points) to be set up for your manufacturing site. Quality Import Solutions holds an SFCR food import license, can help draft these requirements for your manufacturing sites, and can help with bringing your products into Canada. Again, part of these requirements is a compliant bilingual label and sufficient product testing. (Organoleptic, allergen, micro, heavy metals, packaging, stability, etc.)
- Import Requirements When shipping a food from another country into Canada you must have or use a Safe Foods for Canadians Food Import License. This requires a preventative control plan and a HACCP (hazard analysis critical control points) to be set up for your manufacturing site. Quality Import Solutions holds an SFCR food import license, can help draft these requirements for your manufacturing sites, and can help with bringing your products into Canada. Again, part of these requirements is a compliant bilingual label and sufficient product testing. (Organoleptic, allergen, micro, heavy metals, packaging, stability, etc.)
- Import Requirements When shipping a food from another country into Canada you must have or use a Safe Foods for Canadians Food Import License. This requires a preventative control plan and a HACCP (hazard analysis critical control points) to be set up for your manufacturing site. Quality Import Solutions holds an SFCR food import license, can help draft these requirements for your manufacturing sites, and can help with bringing your products into Canada. Again, part of these requirements is a compliant bilingual label and sufficient product testing. (Organoleptic, allergen, micro, heavy metals, packaging, stability, etc.)
- Import Requirements When shipping a food from another country into Canada you must have or use a Safe Foods for Canadians Food Import License. This requires a preventative control plan and a HACCP (hazard analysis critical control points) to be set up for your manufacturing site. Quality Import Solutions holds an SFCR food import license, can help draft these requirements for your manufacturing sites, and can help with bringing your products into Canada. Again, part of these requirements is a compliant bilingual label and sufficient product testing. (Organoleptic, allergen, micro, heavy metals, packaging, stability, etc.)
- In Summary Quality Smart Solutions can help with formula review, product labelling and nutrition facts creation (For Canada and the USA) Help with registering supplemented foods with TMALs or review when the new Supplemented Food Regulations are published. Help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing). Help with facility registration and US Agent. Act as FSVP Agent. Help with importation and market entry for Canada and the USA.