How to Comply with the FDAâs NDI Notification Process
Learn how to meet FDAâs new dietary ingredient notification requirements for dietary supplements with new educational tools.
... Read more June 13, 2025
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[blog_list]
Class II NHP submissions: What Health Canada’s new workload rules mean for you
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.
... Read more June 9, 2025
FDA Approves Natural Food Colors for Safer Use
FDA approves three food colors from natural sources, offering safer alternatives to petroleum-based dyes. Learn how this impacts your food products.
... Read more May 12, 2025
FDA Unannounced Inspections: What Foreign Manufacturers Need To Know
FDA expands unannounced inspections for foreign sites. Learn what this means and how to stay compliant.
... Read more May 12, 2025
FDA Front-of-Package Labeling Deadline Extended
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.
... Read more May 11, 2025
Health Canada electronic filing updates: Key changes in 2025
Health Canadaâs update changes how drug product submissions must be filed. Learn whatâs new and how to stay compliant.
... Read more May 9, 2025
April 2025 Updates to Medical Device Shortage Reporting
Medical device shortage reporting requirements have recently changed, and it is essential for manufacturers and importers to stay informed.
... Read more April 29, 2025
Why The FDA Is Phasing Out Petroleum-based Synthetic Dyes
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.
... Read more April 27, 2025
FDA announces ESG NextGen launch for industry submissions
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.
... Read more April 17, 2025
EFSA Opens 2025 Call for Novel Food Advice to SMEs
EFSA is offering early advice to SMEs preparing novel food applications in 2025. Apply before the June 12 deadline to get guidance.
... Read more April 13, 2025
Health Canada Releases Consultation on Co-Packaged Drug Products
Health Canada is asking for your input on new draft guidance for co-packaged drug products. Participate now to help shape future compliance expectations.
... Read more March 29, 2025
FDA Releases Cosmetic Facility & Product Registration Summary
FDA releases registration and listing data for cosmetic facilities and products under MoCRA. Learn what this means for your compliance.
... Read more March 26, 2025
Canadian Agent Now Mandatory for Cosmetic Notifications
Starting March 2025, Health Canada requires all cosmetic notifications to include a Canadian Agent. Learn what this means for your business.
... Read more March 23, 2025
FDA to Extend Food Traceability Rule: What You Need to Know
The FDA plans to extend the Food Traceability Rule compliance date by 30 months. Find out how this impacts your compliance strategy.
... Read more March 22, 2025
Health Canada Announces Amendments to Cannabis Regulations
Health Canada updated cannabis regulations on March 12, 2025. Learn about compliance, cost-saving benefits, and industry impact.
... Read more March 16, 2025
Health Canada’s Latest Front-of-Package Labelling Updates
Stay compliant with the latest Health Canada FOP labelling updates affecting fresh coconut and breakfast cereals. Learn key policy changes here.
... Read more March 13, 2025
Health Canada Proposes Changes to Caffeine as a Supplemental Ingredient
Health Canada proposes modifications to caffeine use in supplemented foods. Learn how this impacts compliance and product formulation.
... Read more March 13, 2025
Self-Affirmed GRAS May End – What It Means for You
The FDA may eliminate self-affirmed GRAS. Learn how this change could affect food ingredient approvals and what steps you should take now.
... Read more March 12, 2025
Health Canada Reviews CBD as an NHP in New Consultation
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.
... Read more March 7, 2025
FDAâs New AI Rules for Medical Devices: Whatâs Changing?
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.
... Read more March 5, 2025
Health Canada to Prioritize Canadian-Made Class III NHPs
Health Canada is prioritizing Class III NHPs made or sold in Canada. Learn what this means for your application and how to stay compliant.
... Read more March 4, 2025
Canada Updates Supplemental Ingredients Compliance Rules
Stay compliant with Canadaâs updated rules for supplemental ingredients in supplemented foods. Learn key factors and avoid regulatory risks.
... Read more March 3, 2025
NHP Labelling: Ministerial Exemption Order Announced
Health Canada announces a Ministerial Exemption Order for NHP labelling regulations, delaying new compliance requirements until June 21, 2028.
... Read more February 28, 2025
Is Your Cosmetic Ready for Canada’s New Allergen Rules?
Health Canadaâs fragrance allergen rules take effect April 12, 2026. Ensure your cosmetic products comply with new labelling regulations.
... Read more February 27, 2025
Health Canadaâs New Front-of-Package Label Rules Explained
Health Canada’s new front-of-package label rules take effect on January 1, 2026. Learn how to comply and avoid penalties.
... Read more February 19, 2025
How to Make âMade in Canadaâ Claims Amid Trade Tensions
Learn how to navigate âMade in Canadaâ claims to stay compliant and competitive amid changing trade regulations.
... Read more February 14, 2025
New Organic Product Import Rules Coming to Canada
Learn about CFIAâs new import requirements for organic products, effective May 26, 2025, to ensure compliance and avoid shipment rejections.
... Read more February 6, 2025
Whatâs New in the EFSA QPS Update for Food Safety?
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.
... Read more January 22, 2025
Understanding Health Canadaâs Approval on Grape Seed Extract in Foods
Discover Health Canada’s decision to allow grape seed extract in foods and how it impacts the industry.
... Read more January 20, 2025
FDA to Revoke Use of Red No. 3: What You Need to Know
Find out why the FDA is banning Red No. 3 in food and ingested drugs. Understand the impact and compliance updates.
... Read more January 17, 2025
Whatâs Behind the FDAâs New Front-of-Package Labeling Proposal?
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.
... Read more January 16, 2025
Canada Simplifies Pet Food Imports from the US
Learn how Health Canadaâs new rules make importing pet food from the US to Canada easier in 2025. Stay compliant with updated requirements.
... Read more January 12, 2025
Understanding the FDAâs Updated âHealthyâ Nutrient Content Claim
Discover how the FDAâs updated âHealthyâ nutrient content claim could affect food labeling and your compliance strategy.
... Read more January 11, 2025
FDA Sets 2028 Compliance Date for Food Labels
The U.S. Food and Drug Administration (FDA) recently announced a uniform compliance date for food labeling regulations. This update establishes
... Read more January 10, 2025
Why Are FDA Food Contact Notifications No Longer Effective?
Learn why some FDA Food Contact Notifications are no longer effective and how to ensure compliance with updated regulations.
... Read more January 6, 2025
What Causes Foodborne Illness? Updates from the IFSAC Report
Discover key insights from the 2022 IFSAC report on foodborne illness sources, including Salmonella, E. coli, and Listeria.
... Read more December 31, 2024
MoCRA GMP Delayed Until October 2025: What You Need to Know
Learn about the FDAâs delay of MoCRA GMP to October 2025 and discover how cosmetic companies can prepare for compliance with MoCRA regulations.
... Read more December 18, 2024
FDA Updates Guidance on Genome-Edited Foods
Discover the FDA’s latest update on voluntary premarket engagement for genome-edited foods and its implications for developers.
... Read more December 16, 2024
Health Canada Infant Formula Policy Transition
Learn about Health Canada’s transition strategy for infant formula regulations and ensure compliance before the December 31, 2024, deadline.
... Read more December 12, 2024
Health Canada Fees 2025 Guide
Understand Health Canada’s 2025 fees for NHPs, drugs, medical devices, and cannabis. Stay compliant with Quality Smart Solutions.
... Read more December 5, 2024
Health Canadaâs New Nicotine Rules: Whatâs Changing in 2024
If youâre in the business of nicotine replacement therapies, major regulatory changes are now in place.
... Read more November 22, 2024
Health Canada Opens 75-Day Consultation on Batch 4b â Share Your Input
Health Canada Opens 75-Day Consultation on Batch 4b â Share Your Input The Natural and Non-Prescription Health Products Directorate (NNHPD)
... Read more November 1, 2024
FDA Fees Summary for 2025
FDA User Fees for Fiscal Year 2025 (FY2025) The FDAâs user fees for FY2025, which runs from October 1, 2024,
... Read more October 29, 2024
Quality Smart Solutions Launches GRAS Experts to Protect Against Food Safety Risks
GRAS Experts, a new division aimed at tackling ingredient safety concerns and helping businesses stay ahead of regulatory changes and
... Read more October 25, 2024
New Hydration Product Monographs Launched
The NNHPD Opens Consultation on Batch 4 Through new guidelines, stakeholders are invited to shape the future of homeopathic and
... Read more October 23, 2024
New Update on FDA Sodium Reduction Efforts
The FDA has taken a significant step forward in its ongoing sodium reduction initiative by issuing new, voluntary sodium reduction
... Read more August 17, 2024
GRAS Notice vs. Self-Affirmed GRAS: Which Is Best?
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.
... Read more October 31, 2023
Health Canada’s Notice Enables the Use of L-alpha Glycerylphosphorylcholine in Supplemented Food
Health Canada Approves Alpha GPC in Foods On September 20, 2023, Health Canada approved the use of L-alpha-glycerylphosphorylcholine (alpha GPC)
... Read more September 21, 2023
Navigating Cosmetic Product Regulations through FDA Recent MoCRA Update
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,
... Read more September 20, 2023
How to prepare and submit an eStar 510k Submission as of October 1st
Introduction: Staying up-to-date with the latest regulations and tools is crucial in medical device submissions. As of June 9, 2023,
... Read more September 15, 2023
AAFCO Membership Approves New Pet Food Regulations for Enhanced Transparency and Consistency
Introduction In a groundbreaking move, the Association of American Feed Control Officials (AAFCO) has given the green light to an extensive overhaul
... Read more August 24, 2023
New CFIA regulatory responsibilities regarding caffeinated energy drinks
The Canadian Food Inspection Agency (CFIA) has regulated food products for many years, with a particular focus on the safety
... Read more August 18, 2023
US Cosmetic Regulatory Requirements for Manufacturers (MoCRA Regulations)
https://youtu.be/uuXA8yHrrZc Introduction: Behold the âModernization of Cosmetic Regulation Act of 2022â that President Biden signed on December 29, 2022. This
... Read more August 9, 2023
Everything you should know about the registration and listing of Cosmetic Product Facilities and Products
This guidance provides suggestions and instructions to assist in submitting cosmetic product facility registrations and product listings to the FDA.
... Read more August 8, 2023
NHPs considered a therapeutic drug product under Vanessa’s Law
Introduction: Health Canada’s new dietary supplement regulations, which are intended to revamp an already successful system, are unintentionally harming both
... Read more July 17, 2023
FDA Toxicological Testing guidance for food additives Clinical Trials
The safety evaluation of direct food additives and color additives used in food will be evaluated in this blog post
... Read more June 21, 2023
FDA guidance for EUA medical devices transition under PHE policies
The U.S. Food and Drug Administration (FDA) published two final guidelines on March 24, 2023, to help manufacturers of medical devices transition
... Read more June 13, 2023
Health Canada interim policy extension on importing and selling infant formula
Introduction: By extending the interim policy on the importation and sale of infant formulas, human milk fortifiers, and dietary products
... Read more May 18, 2023
NNHPD Improvements to support NHP site licensing
What improvements are being made to support NHP site licensing? Internal template updates support: consistency between reviews-Fall 2023 Increased efficiencies
... Read more May 12, 2023
FTC puts nearly 700 companies on notice of product claim civil penalties
Introduction: On April 13th, the Federal Trade Commission sent letters to warn hundreds of marketers to refrain from misleading customers with product
... Read more April 21, 2023
FDA to close VCRP to prepare for MOCRA registration in 2023
Introduction: In a recent update released on March 27, 2023, the FDA announced it has stopped accepting and processing VCRP submissions to
... Read more April 4, 2023
FDA Registration Renewals: FDA Increases Facility Enforcement
As a business owner, keeping up with regulatory requirements is a top priority. One such requirement is the FDA’s renewal
... Read more March 22, 2023
Health Canada Medical Device License Renewals (MDL or MDEL) in 2023
As a Canadian medical device license (MDL) holder, you are subject to an annual license renewal procedure. The renewal process
... Read more March 22, 2023
FDA Fees for Medical Device Establishment Registration in 2023
The cost to register an FDA Medical Device Establishment is USD $6,493 for 2023. The FDA’s fiscal year 2023
... Read more March 16, 2023
MDEL, DEL, DIN & PRMA Application Fee Amendments for 2023
PMRA Annual Fees reduced for Reporting and Applications: Health Canada is implementing a new approach beginning April 1, 2023.
... Read more March 7, 2023
MDR Amendments COVID-19 Medical Devices Importing & Sales
Background: Health Canada issued three interim orders to allow the importation and sale of medical devices used to diagnose,
... Read more March 7, 2023
Health Canada Labelling & Cosmetic Notification changes in 2023
Introduction: The sections relating to the disclosure of fragrance allergens because of the regulations go into effect two years following
... Read more March 3, 2023
FDA Draft Guidance Labeling Plant Based Milk Alternatives in 2023
Introduction: The US Food and Drug Administration (FDA) issued draft guidance for comment today to help ensure appropriate labelling of
... Read more February 22, 2023
Health Canada Latest Draft Guidance (Biologic Regulations, Drug Labelling, NDS/ANDS & Drug Submissions Rolling Reviews)
Introduction: Submitting a new drug to Health Canada can be a complex and time-consuming process. This post will provide
... Read more February 22, 2023
FDA to tighten regulatory process around CBD food & supplements
Introduction: The FDA may have turned a blind eye to companies like Bio Steel in the past whoâve been selling
... Read more January 27, 2023
Health Canada Medical Device Regulations (MDL, MDEL, SaMD)
Introduction: Medical devices are an important part of healthcare and play a critical role in the treatment of patients. Medical
... Read more December 8, 2022
5 FDA Warning Letters: Food Manufacturers of CBD Food Products
Introduction On November 21, 2022, the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition issued warning
... Read more November 30, 2022
FDA UDI Labeling Requirements for FDA Class 1 Medical Device in 2023
Introduction: FDA regulations for Class 1 medical devices can be daunting and confusing to navigate. However, with this easier-to-understand
... Read more November 16, 2022
CFIA Enforcement of Nutrition Facts Table & CFIA Labeling Requirements
The Canadian Food Inspection Agency (CFIA) protects Canadians’ health and safety by ensuring food that reaches customers is safe, nutritious, and
... Read more November 9, 2022
FSVP Compliance: Regulatory Assessment Record Keeping 2023
U.S.A RRA FDA Draft Guidance: In a recent U.S. Food and Drug Administration (FDA) draft guidance detailing its implementation
... Read more November 7, 2022
Food Labelling & Health Canada Packaging Update for 2023
Health Canada Announcement: The Minister of Health has introduced new front-of-package nutrition labeling laws for prepackaged food products, and
... Read more November 3, 2022
Inside Scoop FDA Medical Device User Fees (MDUFA) for 2023
The FDA or U.S. Food and Drug Administration recently announced the Fiscal Year Medical Device User Fee (MDUFA) amendments. The
... Read more November 1, 2022
Health Canada’s Regulatory Enrollment Process (REP): Top 4 things to know
Industry people and experts considering working with a company not registered with Health Canada should be aware of the regulatory
... Read more September 9, 2022
Regulatory & Market Landscapes of CBD as a NHP
https://youtu.be/veCBMkYUWEU Market Analysis and Overview of CPG Market: Will CBD Products be considered an NHP? The consumer packaged goods (CPG)
... Read more August 5, 2022
FDA Releases Draft Guidance on Enforcement Discretion for Certain NAC Products
Navigating the FDA and NAC regulations can be intimidating, but with the right information and guidance, you’ll be able to
... Read more August 4, 2022
Supplemented Foods: Food & Drug Regulations Unlocked in 2023
Have you been anticipating the Food and Drug Regulations (FDR) adding supplemented foods as an official category of food?
... Read more July 26, 2022
Regulations amending the Natural Health Products Regulations (NHPR) | What you should know!
What are the latest Natural Health Product Amendments (NHPR) Health Canada will be amending the Natural Health Products Regulations (NHPR)
... Read more July 11, 2022
Nutrition Symbol Front-of-Food-Package Label Regulations
Health Canada recently announced that Front-of-package labelling changes for foods are set to come into effect on July 20, 2022,
... Read more July 5, 2022
Prescription Drugs: Interim Implementation of Electronic Labelling
Background On April 22, 2022, Health Canada issued a notice to the industry on the interim implementation of electronic
... Read more June 8, 2022
5 Reasons Why Food Labelling Is Important for Your Business
Have you ever looked at a food label and wondered why all that information is there? Labels do more than
... Read more June 7, 2022
Update on Performance Standards and System Updates for NHP Applications
COVID had significantly impacted the processing of NHP product license applications with delays in the processing of all classes of
... Read more May 10, 2022
EUA FDA Transition Plan for Medical Devices in 2022
In response to the COVID-19 public health emergency, FDA issued a declaration regarding the appropriateness of utilizing emergency use authorizations
... Read more April 29, 2022
Health Canada Marketing Authorization Update – Increased Vitamin D
Health Canada Announced a Marketing Authorization (MA) to Permit Increase in the Amount of Vitamin D in Cowâs Milk, Goatâs Milk and Margarine.
... Read more March 22, 2022
Health Canada’s Annual Adjustment of Fees for Drugs & Medical Devices
On December 11, 2021, Health Canada issued a notice regarding the annual adjustment of fees for drugs and medical devices
... Read more March 11, 2022
Interim Order No. 3 The Sale of Medical Devices for COVID-19 use
Interim Order No. 3 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 (the third interim
... Read more March 8, 2022
Your Cosmetic Notification MAY get Qualified for processing in 24 hours!
What is a cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as âany substance
... Read more February 24, 2022
Your Health Canada eMCE Update For 2022
Manufacturers and companies exporting medical devices from Canada may be asked by foreign customers or foreign governments to supply certification
... Read more February 5, 2022
FDA Qualified Health Claim for Magnesium 2022
The U.S. Food and Drug Administration (FDA) has communicated via Letter of Enforcement Discretion that it will not oppose or
... Read more February 3, 2022
Update on Performance Standards for NHP Applications
Summary of Health Canada Licensing and Update Reports Product Licensing A combined 1390/5045 (28%) of NHP product license application submissions
... Read more January 7, 2022
FDA Requests Relevant Info to use NAC as a Dietary Supplement
On November 24, 2021, The Food and Drug Administration (FDA) sent correspondence to industry requesting information on the past use
... Read more January 4, 2022
FDA Issues Sodium Reduction Final Guidance
On October 13, 2021, the U.S. Food and Drug Administration (FDA) issued final guidance for the food industry that provides
... Read more December 4, 2021
End of DEL transition period for Hand Sanitizers
In the wake of the COVID-19 pandemic, preventive measures and a healthy lifestyle with an efficient immune system were suggested
... Read more December 1, 2021
US Establishment Registration Renewals
Itâs that time of year again! Any domestic and foreign establishments registered with US FDA must renew their registration annually
... Read more October 11, 2021
Vitamin D Limits for NHPs are now Higher
The âSunshineâ vitamin, Vitamin D, Vitamin D3 or Vitamin D2 as it is more commonly known. The term âsunshineâ was
... Read more October 4, 2021
Proposal to Amend the Cosmetic Regulations
What is a Cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as âany substance
... Read more September 27, 2021
