FDA Removes Key Barrier to Real-World Evidence for Drugs and Medical Devices
The U.S. Food and Drug Administration has announced a change to how it evaluates real world evidence in regulatory reviews. In
... Read more December 17, 2025
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FDA Proposal Signals Major Changes for Sunscreen Active Ingredients
Recent regulatory activity in the United States is drawing renewed attention to sunscreen compliance. In a new announcement, the FDA
... Read more December 17, 2025
FDA Strengthens Infant Formula Recall Oversight After Botulism Case
The U.S. Food and Drug Administration has announced new actions aimed at improving recall effectiveness following an investigation into an
... Read more December 17, 2025
U.S. Congress Introduces Bill Requiring Warning Labels And Ad Limits For “Junk Food”
Members of the U.S. House of Representatives have introduced the Childhood Diabetes Reduction Act of 2025, a bill that would
... Read more December 17, 2025
CFIA Releases Notice on Final Implementation of the Feeds Regulations
The Canadian Food Inspection Agency (CFIA) has issued a new industry notice outlining the final steps required before the Feeds Regulations 2024 becomes fully
... Read more December 11, 2025
CFIA Advances Red Tape Reduction With Major Regulatory Repeals
Red tape continues to create challenges for companies working within Canada’s food, agriculture, and plant industries. While strong safeguards remain essential, many
... Read more December 5, 2025
Health Canada Revises Permitted Caffeine Levels for Food Additives
Health Canada has lowered the permitted level of caffeine and caffeine citrate in cola type beverages from 200 ppm to
... Read more December 3, 2025
Health Canada Expands the Use of Caffeine in Supplemental Ingredients
Health Canada released a new modification to the List of Permitted Supplemental Ingredients that expands when and how caffeine can be used
... Read more November 29, 2025
Health Canada Seeks Input on New Risk-Based Framework for Infant Food Authorization
Health Canada has launched a new national consultation that could reshape how infant foods for special dietary purposes are assessed
... Read more November 27, 2025
NNHPD Update: New Tools for Monograph Combinations and Interchangeable Terms
NNHPD has introduced two new regulatory tools designed to simplify the natural health product submission process and give you more
... Read more November 27, 2025
New 2025 Senate Bill Would Mandate FDA Notification for All GRAS Ingredients
A new proposal in the U.S. Senate could bring mandatory GRAS notification to the forefront of food regulation, changing how
... Read more November 20, 2025
EFSA’s Novel Foods Transparency Rules Explained for EU Compliance
EFSA’s transparency rules for novel foods are reshaping how businesses approach regulatory compliance in the European Union. If you’re planning to introduce
... Read more November 19, 2025
Health Canada Delays Implementation of NHP Cost Recovery Fees
Health Canada has officially postponed the implementation of its proposed NHP cost recovery fees, which were initially expected to take
... Read more November 3, 2025
Time to Renew: FDA Drug Establishment and Listing Deadline Is Coming Up
If your company manufactures, repacks, relabels, or imports drugs for distribution in the U.S., it’s time to prepare for the
... Read more October 23, 2025
FDA Declares Nicotinamide Mononucleotide Lawful in Dietary Supplements
After years of uncertainty and legal disputes, the U.S. Food and Drug Administration (FDA) declared on September 29, 2025, that
... Read more October 3, 2025
FDA Self-Affirmed GRAS Pathway May Soon End
The self-affirmed GRAS pathway is closer than ever to being eliminated. On March 10, 2025, U.S. Health and Human Services
... Read more September 26, 2025
FDA Launches Real Time Adverse Event Reporting Dashboard for Cosmetic Products
The FDA adverse event reporting dashboard for cosmetic products is now live, offering businesses and consumers real time access to
... Read more September 18, 2025
Health Canada Releases Version 4.0 of the GMP Guide for Natural Health Products
On September 4, 2025, Health Canada released Version 4.0 of the Good Manufacturing Practices (GMP) Guide for Natural Health Products
... Read more September 16, 2025
Health Canada to Reduce Red Tape: What It Means for Your Business
Businesses in Canada have long raised concerns about red tape in Health Canada regulations, from outdated rules to lengthy approval
... Read more September 11, 2025
De Minimis Rule Ending: What Businesses Must Know
The de minimis rule has long been a key part of U.S. customs policy. It allowed companies to import low-value
... Read more August 30, 2025
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... Read more July 14, 2025