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
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October 23, 2025
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[blog_list]
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
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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
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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
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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
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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Businesses in Canada have long raised concerns about red tape in Health Canada regulations, from outdated rules to lengthy approval
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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
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August 30, 2025
What the New FDA PreCheck Program Means for Drug Manufacturers
Introduction Announced on August 7, 2025, the FDA PreCheck program is a new initiative aimed at strengthening the domestic pharmaceutical
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August 13, 2025
FDA Proposes Compliance Extension And Releases New Tools For Food Traceability
The FDA food traceability rule is once again in the spotlight. On August 6, 2025, the U.S. Food and Drug
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August 7, 2025
FDA Chemical Screening: What The New EDT Tool Means For Food Safety
The FDA has released a new tool called the Expanded Decision Tree (EDT), which is designed to support chemical safety
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July 31, 2025
Senators Propose Bill To Eliminate Self-affirmed GRAS Loophole
A new bill introduced in the U.S. Senate could significantly alter how food ingredient safety is assessed, especially when it
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July 24, 2025
FDA approves gardenia blue as Red No. 3 faces phase-out
The U.S. Food and Drug Administration (FDA) has approved gardenia blue, a plant-derived color additive, for limited use in certain
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July 18, 2025
How the SAFE Sunscreen Act Could Change FDA Compliance
Sunscreen compliance in the U.S. may be on the edge of its most significant update in over two decades. On
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July 18, 2025
Health Canada issues interim report on sodium targets for processed food
Introduction Sodium reduction in processed foods is no longer optional. It is a critical step for industry players to safeguard
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July 9, 2025
FDA Updates Food Labeling Compliance Program
The FDA Food Labeling Compliance Program has just been updated to help food manufacturers and importers meet U.S. labeling requirements
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June 26, 2025
How to Comply with the FDA’s NDI Notification Process
If you’re planning to introduce a new ingredient into your dietary supplement formula for the U.S. market, the FDA NDI
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June 13, 2025
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
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June 9, 2025
FDA Approves Natural Food Colors for Safer Use
The FDA has officially approved three new food color additives derived from natural sources. These offer a safer alternative to
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May 12, 2025
FDA Unannounced Inspections: What Foreign Manufacturers Need To Know
FDA unannounced inspections are no longer limited to U.S. facilities. The U.S. Food and Drug Administration (FDA) recently announced an
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May 12, 2025
FDA Front-of-Package Labeling Deadline Extended
FDA Front-Of-Package Labeling Comment Period Extended The U.S. Food and Drug Administration has extended the comment period for its proposed
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May 11, 2025
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July 14, 2025