The FDA Food labeling compliance program has just been updated to help food manufacturers and importers meet U.S. labeling requirements more effectively. On June 20, 2025, the U.S. Food and Drug Administration (FDA) announced a revised Compliance Program Manual (CPM) for general food labeling.
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Learn how to meet FDAâs new dietary ingredient notification requirements for dietary supplements with new educational tools.
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Starting June 9, 2025, Class II NHP submissions will no longer be reviewed just based on the date you filed them. Health Canada is updating how it handles licensing applications by applying a new workload management approach, prioritizing submissions based on intent to sell or manufacture in Canada.
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FDA approves three food colors from natural sources, offering safer alternatives to petroleum-based dyes. Learn how this impacts your food products.
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FDA expands unannounced inspections for foreign sites. Learn what this means and how to stay compliant.
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The FDA has extended the comment period for the front-of-package labeling rule. Learn how this affects your business and how to submit feedback.
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Health Canadaâs update changes how drug product submissions must be filed. Learn whatâs new and how to stay compliant.
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Medical device shortage reporting requirements have recently changed, and it is essential for manufacturers and importers to stay informed.
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Learn how the FDA’s plan to phase out petroleum-based synthetic dyes could impact your food products and what steps you should take now.
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FDA ESG NextGen is now officially live. If your company needs to submit regulatory documents to the FDA, youâll now use this updated system instead of the retired WebTrader platform.
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EFSA is offering early advice to SMEs preparing novel food applications in 2025. Apply before the June 12 deadline to get guidance.
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Health Canada is asking for your input on new draft guidance for co-packaged drug products. Participate now to help shape future compliance expectations.
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FDA releases registration and listing data for cosmetic facilities and products under MoCRA. Learn what this means for your compliance.
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Starting March 2025, Health Canada requires all cosmetic notifications to include a Canadian Agent. Learn what this means for your business.
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The FDA plans to extend the Food Traceability Rule compliance date by 30 months. Find out how this impacts your compliance strategy.
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Health Canada updated cannabis regulations on March 12, 2025. Learn about compliance, cost-saving benefits, and industry impact.
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Stay compliant with the latest Health Canada FOP labelling updates affecting fresh coconut and breakfast cereals. Learn key policy changes here.
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Health Canada proposes modifications to caffeine use in supplemented foods. Learn how this impacts compliance and product formulation.
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The FDA may eliminate self-affirmed GRAS. Learn how this change could affect food ingredient approvals and what steps you should take now.
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Health Canada is conducting a public consultation on CBD regulations for NHPs, exploring a pathway to allow non-prescription CBD products under the NHPR. This consultation opened on March 7, 2025, and will close on June 5, 2025.
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The FDA just updated its AI rules for medical devices. Learn whatâs changing, how it will impact your business, and stay ahead of compliance updates.
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Health Canada is prioritizing Class III NHPs made or sold in Canada. Learn what this means for your application and how to stay compliant.
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Stay compliant with Canadaâs updated rules for supplemental ingredients in supplemented foods. Learn key factors and avoid regulatory risks.
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Health Canada announces a Ministerial Exemption Order for NHP labelling regulations, delaying new compliance requirements until June 21, 2028.
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Health Canadaâs fragrance allergen rules take effect April 12, 2026. Ensure your cosmetic products comply with new labelling regulations.
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Health Canada’s new front-of-package label rules take effect on January 1, 2026. Learn how to comply and avoid penalties.
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Learn how to navigate âMade in Canadaâ claims to stay compliant and competitive amid changing trade regulations.
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Learn about CFIAâs new import requirements for organic products, effective May 26, 2025, to ensure compliance and avoid shipment rejections.
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Learn about the latest updates in the EFSA QPS list, including new microbiological agents for food and feed safety and what this means for your business.
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Discover Health Canada’s decision to allow grape seed extract in foods and how it impacts the industry.
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Find out why the FDA is banning Red No. 3 in food and ingested drugs. Understand the impact and compliance updates.
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Discover the FDAâs proposed rule on front-of-package nutrition labeling, how it impacts your products, and what you need to do to stay compliant.
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Learn how Health Canadaâs new rules make importing pet food from the US to Canada easier in 2025. Stay compliant with updated requirements.
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Discover how the FDAâs updated âHealthyâ nutrient content claim could affect food labeling and your compliance strategy.
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The U.S. Food and Drug Administration (FDA) recently announced a uniform compliance date for food labeling regulations. This update establishes
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Learn why some FDA Food Contact Notifications are no longer effective and how to ensure compliance with updated regulations.
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Discover key insights from the 2022 IFSAC report on foodborne illness sources, including Salmonella, E. coli, and Listeria.
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Learn about the FDAâs delay of MoCRA GMP to October 2025 and discover how cosmetic companies can prepare for compliance with MoCRA regulations.
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Discover the FDA’s latest update on voluntary premarket engagement for genome-edited foods and its implications for developers.
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Learn about Health Canada’s transition strategy for infant formula regulations and ensure compliance before the December 31, 2024, deadline.
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Understand Health Canada’s 2025 fees for NHPs, drugs, medical devices, and cannabis. Stay compliant with Quality Smart Solutions.
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If youâre in the business of nicotine replacement therapies, major regulatory changes are now in place.
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Health Canada Opens 75-Day Consultation on Batch 4b â Share Your Input The Natural and Non-Prescription Health Products Directorate (NNHPD)
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FDA User Fees for Fiscal Year 2025 (FY2025) The FDAâs user fees for FY2025, which runs from October 1, 2024,
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GRAS Experts, a new division aimed at tackling ingredient safety concerns and helping businesses stay ahead of regulatory changes and
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The NNHPD Opens Consultation on Batch 4 Through new guidelines, stakeholders are invited to shape the future of homeopathic and
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The FDA has taken a significant step forward in its ongoing sodium reduction initiative by issuing new, voluntary sodium reduction
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Learn the key differences between GRAS Notice and Self-Affirmed GRAS to ensure FDA compliance and food safety. Find the best approach for your product.
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Health Canada Approves Alpha GPC in Foods On September 20, 2023, Health Canada approved the use of L-alpha-glycerylphosphorylcholine (alpha GPC)
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https://youtu.be/uuXA8yHrrZc Introduction: In response to the FDA’s recent draft guidance on the Registration and Listing of Cosmetic Product Facilities and Products,
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Introduction: Staying up-to-date with the latest regulations and tools is crucial in medical device submissions. As of June 9, 2023,
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Introduction In a groundbreaking move, the Association of American Feed Control Officials (AAFCO) has given the green light to an extensive overhaul
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The Canadian Food Inspection Agency (CFIA) has regulated food products for many years, with a particular focus on the safety
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https://youtu.be/uuXA8yHrrZc Introduction: Behold the âModernization of Cosmetic Regulation Act of 2022â that President Biden signed on December 29, 2022. This
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This guidance provides suggestions and instructions to assist in submitting cosmetic product facility registrations and product listings to the FDA.
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Introduction: Health Canada’s new dietary supplement regulations, which are intended to revamp an already successful system, are unintentionally harming both
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The safety evaluation of direct food additives and color additives used in food will be evaluated in this blog post
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The U.S. Food and Drug Administration (FDA) published two final guidelines on March 24, 2023, to help manufacturers of medical devices transition
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Introduction: By extending the interim policy on the importation and sale of infant formulas, human milk fortifiers, and dietary products
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What improvements are being made to support NHP site licensing? Internal template updates support: consistency between reviews-Fall 2023 Increased efficiencies
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Introduction: On April 13th, the Federal Trade Commission sent letters to warn hundreds of marketers to refrain from misleading customers with product
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Introduction: In a recent update released on March 27, 2023, the FDA announced it has stopped accepting and processing VCRP submissions to
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As a business owner, keeping up with regulatory requirements is a top priority. One such requirement is the FDA’s renewal
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As a Canadian medical device license (MDL) holder, you are subject to an annual license renewal procedure. The renewal process
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The cost to register an FDA Medical Device Establishment is USD $6,493 for 2023. The FDA’s fiscal year 2023
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PMRA Annual Fees reduced for Reporting and Applications: Health Canada is implementing a new approach beginning April 1, 2023.
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Background: Health Canada issued three interim orders to allow the importation and sale of medical devices used to diagnose,
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Introduction: The sections relating to the disclosure of fragrance allergens because of the regulations go into effect two years following
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Introduction: The US Food and Drug Administration (FDA) issued draft guidance for comment today to help ensure appropriate labelling of
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Introduction: Submitting a new drug to Health Canada can be a complex and time-consuming process. This post will provide
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Introduction: The FDA may have turned a blind eye to companies like Bio Steel in the past whoâve been selling
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Introduction: Medical devices are an important part of healthcare and play a critical role in the treatment of patients. Medical
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Introduction On November 21, 2022, the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition issued warning
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Introduction: FDA regulations for Class 1 medical devices can be daunting and confusing to navigate. However, with this easier-to-understand
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The Canadian Food Inspection Agency (CFIA) protects Canadians’ health and safety by ensuring food that reaches customers is safe, nutritious, and
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U.S.A RRA FDA Draft Guidance: In a recent U.S. Food and Drug Administration (FDA) draft guidance detailing its implementation
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Health Canada Announcement: The Minister of Health has introduced new front-of-package nutrition labeling laws for prepackaged food products, and
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The FDA or U.S. Food and Drug Administration recently announced the Fiscal Year Medical Device User Fee (MDUFA) amendments. The
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Industry people and experts considering working with a company not registered with Health Canada should be aware of the regulatory
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https://youtu.be/veCBMkYUWEU Market Analysis and Overview of CPG Market: Will CBD Products be considered an NHP? The consumer packaged goods (CPG)
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Navigating the FDA and NAC regulations can be intimidating, but with the right information and guidance, you’ll be able to
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Have you been anticipating the Food and Drug Regulations (FDR) adding supplemented foods as an official category of food?
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What are the latest Natural Health Product Amendments (NHPR) Health Canada will be amending the Natural Health Products Regulations (NHPR)
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Health Canada recently announced that Front-of-package labelling changes for foods are set to come into effect on July 20, 2022,
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Background On April 22, 2022, Health Canada issued a notice to the industry on the interim implementation of electronic
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Have you ever looked at a food label and wondered why all that information is there? Labels do more than
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COVID had significantly impacted the processing of NHP product license applications with delays in the processing of all classes of
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In response to the COVID-19 public health emergency, FDA issued a declaration regarding the appropriateness of utilizing emergency use authorizations
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Health Canada Announced a Marketing Authorization (MA) to Permit Increase in the Amount of Vitamin D in Cowâs Milk, Goatâs Milk and Margarine.
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On December 11, 2021, Health Canada issued a notice regarding the annual adjustment of fees for drugs and medical devices
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Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (the third interim
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What is a cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as âany substance
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Manufacturers and companies exporting medical devices from Canada may be asked by foreign customers or foreign governments to supply certification
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The U.S. Food and Drug Administration (FDA) has communicated via Letter of Enforcement Discretion that it will not oppose or
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Summary of Health Canada Licensing and Update Reports Product Licensing A combined 1390/5045 (28%) of NHP product license application submissions
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On November 24, 2021, The Food and Drug Administration (FDA) sent correspondence to industry requesting information on the past use
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On October 13, 2021, the U.S. Food and Drug Administration (FDA) issued final guidance for the food industry that provides
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In the wake of the COVID-19 pandemic, preventive measures and a healthy lifestyle with an efficient immune system were suggested
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Itâs that time of year again! Any domestic and foreign establishments registered with US FDA must renew their registration annually
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The âSunshineâ vitamin, Vitamin D, Vitamin D3 or Vitamin D2 as it is more commonly known. The term âsunshineâ was
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