News
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 who’ve been selling
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Dillon Dubois
January 27, 2023
News
FDA Proposes New Rule for Investigational New Drug Applications (IND)
Introduction: The FDA recently announced a proposal to change the current regulations for Investigational New Drug (IND) applications. The proposal
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Dillon Dubois
January 24, 2023
News
FTC guidance for sellers & marketers of Health Products Unlocked
Introduction: In this blog, we’ll aim to summarize the principles that help advertisers comply with FTC laws (deceptive claims/facts) for
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Dillon Dubois
January 19, 2023
Blog
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.
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Dillon Dubois
December 8, 2022
News
FDA Determines Nicotinamide Mononucleotide (NMN) Not Permitted in Dietary Supplements for Sale
The U.S. Food and Drug Administration (FDA) recently published responses to several new dietary ingredient (NDI) notifications submitted for nicotinamide
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Dillon Dubois
December 2, 2022
News
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
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Dillon Dubois
November 30, 2022
Blog
FDA UDI Labeling Requirements for FDA Class 1 Medical Device
FDA regulations for Class 1 medical devices can be daunting and confusing to navigate. However, with this easier-to-understand overview,
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Dillon Dubois
November 16, 2022
Blog
CFIA Enforcement of Nutrition Facts Table & Food Labelling
The Canadian Food Inspection Agency (CFIA) is responsible for protecting Canadians’ health and safety by ensuring that food that reaches
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Dillon Dubois
November 9, 2022
Blog
FSVP Compliance: Regulatory Assessment Record Keeping
U.S.A RRA FDA Draft Guidance: In a recent U.S. Food and Drug Administration (FDA) draft guidance detailing its implementation of
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Dillon Dubois
November 7, 2022
News
Food Labelling & Health Canada Packaging Update 2022-12-15
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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Dillon Dubois
November 3, 2022
News
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
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Dillon Dubois
November 1, 2022
Blog
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
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Dillon Dubois
September 9, 2022
Blog
Regulatory & Market Landscapes of CBD as a NHP
Market Analysis and Overview of CPG Market: Will CBD Products be considered an NHP? The consumer packaged goods (CPG) market,
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Shahin Khazai
August 5, 2022
News
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
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Kalpna Mistry
August 4, 2022
News
Supplemented Foods: Food & Drug Regulations Unlocked
Have you been anticipating the Food and Drug Regulations (FDR) adding supplemented foods as an official category of food?
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Dillon Dubois
July 26, 2022
News
Regulations Amending the Natural Health Products Regulations (NHPR) | What you need to know!
What are the latest Natural Health Product Amendments (NHPR) Health Canada will be amending the Natural Health Products Regulations (NHPR)
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Dillon Dubois
July 11, 2022
News
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,
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Dillon Dubois
July 5, 2022
News
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 labelling
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Kalpna Mistry
June 8, 2022
News
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
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Chanpreet Juneja
May 10, 2022
News
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
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Femi Morakinyo
April 29, 2022
News
Health Canada Marketing Authorization Update – Increased Vitamin D
On January 19, 2022, Health Canada announced a marketing authorization (MA) to permit manufacturers to voluntarily increase the amount of
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Kalpna Mistry
March 22, 2022
News
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
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Jessica Koves
March 11, 2022
News
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
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Dhreeti Kapoor
March 8, 2022
News
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 “any substance
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Andrew Lau
February 24, 2022
News
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
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Femi Morakinyo
February 5, 2022
News
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
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Mitchell Kiernan
February 3, 2022
News
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
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Mitchell Kiernan
January 7, 2022
News
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
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Kalpna Mistry
January 4, 2022
News
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
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Kalpna Mistry
December 4, 2021
News
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
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Femi Morakinyo
December 1, 2021
News
US Establishment Registration Renewals
It’s that time of year again! Any domestic and foreign establishments registered with US FDA must renew their registration annually
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Kalpna Mistry
October 11, 2021
News
Vitamin D Limits for NHPs are now Higher
The “Sunshine” vitamin, Vitamin D, Vitamin D3 or Vitamin D2 as it is more commonly known. The term “sunshine” was
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Maron Daniel
October 4, 2021
News
Proposal to Amend the Cosmetic Regulations
What is a Cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance
... Read more
Andrew Lau
September 27, 2021
News
Public Consultation on Medical Devices Unique Device Identifier Initiative
On June 28, 2021, Health Canada opened a public consultation on a Unique Device Identification (UDI) system for medical devices
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Kalpna Mistry
September 14, 2021
News
CFIA & Health Canada Policy on Food Labelling
Health Canada and the CFIA (Canadian Food Inspection Agency) are teaming up to plan advancements and improvements for the timing
... Read more
Mitchell Kiernan
September 8, 2021
News
Important Notice Regarding the Transition of COVID-19 Site Licenses
In March 2020, Health Canada introduced interim measures to expedite the issuance of site licences for alcohol-based hand sanitizers, to
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Jessica Koves
September 1, 2021
News
Consultation Period Extension: Proposal to Improve Natural Health Product Labelling
On June 26, 2021, Health Canada launched a consultation on a proposal to improve natural health product labelling. Health Canada
... Read more
Jessica Koves
August 16, 2021
News
Proposal to Improve Natural Health Product Labelling
On June 25, 2021, Health Canada published a news release that announced proposed changes to the Natural Health Products Regulations.
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Jessica Koves
August 13, 2021
News
Consultation on Proposed Feeds Regulations
On June 12, 2021, the Canadian Food Inspection Agency (CFIA) opened a consultation as part of the process to modernize
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Kalpna Mistry
August 6, 2021
News
Supplemented Foods Proposed Regulatory Framework
Health Canada has been working on creating/revising the regulations with regards to Supplemented Foods for some time now. A recent
... Read more
Mitchell Kiernan
July 24, 2021
News
Public Consultation on Medical Devices Clinical Trials Modernization Initiative
Health Canada has published a consultation paper on proposed changes to the regulation and oversight of clinical trials for drug,
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Andrew Parshad
July 16, 2021
News
Cancellation of MDELs for Non-Compliance with Annual Licence Review Requirements
Cancellation of Medical Device Establishment Licence for A Non-compliance With Annual Licence Review Requirements On May 27, 2021 Health Canada
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Andrew Parshad
July 2, 2021
News
Proposed Food Safety Guidance for Novel Food Regulations Focused on Plant Breeding
CFIA and Health Canada have been working on new Food Safety guidance documents pertaining to Novel foods focused on plant
... Read more
Mitchell Kiernan
June 23, 2021
News
Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19
As of March 1, 2021, Interim Order No. 2 replaces Interim Order No. 1 Respecting the importation and sale of
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Andrew Parshad
June 15, 2021
News
FDA’s Addition of the 9th Allergen (Sesame)
Sesame will become the 9th major food allergen officially recognized by the United States (FDA) on January 1st, 2023. The
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Mitchell Kiernan
June 9, 2021
News
Performance Standards for NHP Applications
The coronavirus-19 (COVID-19) pandemic has had a long-lasting effect on many of the processes done in business and everyday life.
... Read more
Maron Daniel
May 12, 2021
News
Coming into Force: Human Milk Fortifiers Regulations
After consultation with stakeholders and based on a noticeable lack of current regulations and need for availability and innovation for
... Read more
Mitchell Kiernan
May 7, 2021
News
Veterinary Health Products to be allowed in Livestock Feed
Health Canada and the Canadian Food Inspection Agency have joined forces to evaluate the incorporation of Veterinary Health Products (VHPs)
... Read more
Mitchell Kiernan
March 15, 2021
News
Validation of the Safe Food for Canadians Licence to Import
In order for food that is regulated under the Safe Food for Canadians Regulations, to be imported into Canada, the
... Read more
Andrew Parshad
February 15, 2021
News
Additional Packaging and Labelling Requirements for Alcohol Based Hand Sanitizers in Beverage Containers
On October 5, 2020, the Natural and Non-Prescription Health Products Directorate (NNHPD) sent a notice to all Canadian product licence
... Read more
Kalpna Mistry
October 9, 2020
News
FDA Announces FSMA Food Traceability Proposed Rule
On Monday September 21st, the U.S. Food and Drug Administration (FDA) announced a proposed rule to establish additional traceability record
... Read more
Quality Smart Solutions
September 25, 2020
News
Interim Order Respecting Clinical Trials Relating to COVID-19
On May 23, 2020, the Minister of Health of Canada approved an Interim Order (IO) Respecting Clinical Trials for Medical
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Xin Yi Gao
June 6, 2020
News
Health Canada expedites access to COVID-19 diagnostic laboratory test kits and other medical devices
Recently in Canada, the Minister of Health has signed an Interim Order to allow expedited access to COVID-19-related medical devices
... Read more
Xin Yi Gao
April 15, 2020
News
Amazon.ca removing non-compliant Natural Health Products in October
In September Amazon.ca notified every Natural Health Product vendor (whether they had an NPN or not) that, effective in October
... Read more
Andrew Parshad
October 7, 2018
News
Canada Natural Health Product (NHP) Labelling Revision Update for Products Containing Green Tea Extract (GTE)
On November 14, 2017 the Natural and Non-prescription Health Products Directorate (NNHPD) announced that there are several updates to the
... Read more
Andrew Parshad
November 15, 2017
News
FDA proposes extended dates for Nutrition Facts and Supplement Facts labels compliance
This past June 2017 the Food and Drug Administration (FDA) put a hold on the compliance dates for Nutrition Facts
... Read more
Andrew Parshad
September 29, 2017
News
Changes to Regulation of Veterinary Health Products (VHP) in Canada
As discussed in an earlier post (PLL – Plain Language Labeling: What it means and how it affects you), the
... Read more
Andrew Parshad
September 19, 2017
News
Import Solutions for Natural Health Products – Our New Website!
Our sister company, Quality IMPORT Solutions has a new website with all the information you need to make an informed
... Read more
Andrew Parshad
August 6, 2017
News
Keeping An Eye On The Global Health Products Landscape
Significant changes are occurring in the global regulatory landscape as of late, and this is just another example of how
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Andrew Parshad
March 1, 2014
News
Thank you for visiting us at the NATURAL PRODUCTS EXPO WEST in Anaheim, California in March!
We hope you found it as successful as we did. Feel free to email us at info@qualitysmartsolutions.com or give us
... Read more
Andrew Parshad
March 1, 2014