Amazon Seller Compliance

Month: August 2022

Categories
Blog

Health Canada NPN & the NHPID Top 6 Things to Know in 2023

Natural Health Products NPN, NHPID, NHP

Natural Health Products NPN, NHPID, NHPWhat is Natural Health Products Ingredients Database (NHPID)?

The Natural Health Products Ingredients Database (NHPID) is an electronic tool that contains a collection of pre-cleared information on natural health products. Presently, in Canada, there is a lack of a comprehensive exhaustive primary reference for substances and terms about Natural Health Products, and hence NHPID is a critical tool for the Natural Health Products Online System.

What is the Natural Health Product Database?

The Natural Health Product Database is an online database maintained by Health Canada. It contains information on the safety, effectiveness, and quality of thousands of natural health products. It also features product labels, listing information including sources, ingredients, and directions. By using the Database, you can get fast facts on specific products or search more broadly to compare different natural health products to find the best option for meeting your needs.

How to Use the NHPD Database for Your Research?

The Natural Health Product Database can be a great resource for anyone looking to find out more about natural health products. It includes detailed information on thousands of natural health products. To use the Database, start by searching for the product you’re interested in either by its brand name or active ingredients. You’ll then be presented with all the relevant product labels for that product, each containing information on sources, active and non-active ingredients, and directions for use. You can also use advanced search features such as filtering by efficacy or safety ratings.

What are the Regulations and Safety measures for Using Natural Health Products?

Health Canada requires that all natural health products meet strict safety, efficacy, and quality standards. To ensure these products can be used safely and effectively, they are closely regulated by the Natural Health Products Regulations. These regulations cover many aspects of natural health products, including studies for safety and effectiveness, product labels, and manufacturing and advertising practices. When purchasing and using a natural health product, it’s important to always check for valid evidence of its safety and quality.

What are the NHPID regulations?

The NHPID is a comprehensive database containing information on all natural health products authorized for sale in Canada. The database is maintained by Health Canada and is used to regulate the marketing and distribution of NHPs. The NHPID contains information on the ingredients, dosage forms, recommended uses, and safety information for each authorized NHP.

To sell a natural health product in Canada, it must be authorized for sale by Health Canada. This involves submitting a product license application to Health Canada, which includes detailed information on the product’s ingredients, dosage form, recommended use, and safety information. Once the product is authorized for sale, it is assigned a Natural Product Number (NPN), which must be displayed on the product label.

What are the requirements for NHPID product licensing?

Obtaining a product license for an NHP involves submitting a comprehensive application to Health Canada. The application must include detailed information on the product’s ingredients, dosage form, recommended use, and safety information. In addition, the application must consist of evidence to support the safety and efficacy of the product.

The product license application process can be time-consuming and expensive. Still, ensuring your NHP is safe, effective, and compliant with NHPID regulations is essential. Working with a regulatory compliance consultant can help streamline the process and ensure your application is complete and accurate.

What are the labeling requirements for NHPID products?

In addition to obtaining a product license, all NHPs must comply with strict labeling requirements. The product label must include the product name, the NPN, the name and address of the manufacturer, the recommended use, the dosage form, and the list of ingredients. The label must also include any relevant warnings or precautions and instructions for use.

Complying with labeling requirements can be challenging, especially for small businesses that need more resources to hire a graphic designer or label printing company. However, ensuring that your product label is clear, accurate, and compliant with all NHPID regulations is crucial.

What are the advertising and marketing regulations for NHPID products?

Advertising and marketing natural health products in Canada is heavily regulated, and all advertising must comply with the Food and Drugs Act and the Natural Health Products Regulations. This includes ensuring that all claims about the product are supported by scientific evidence and are not misleading or false.

In addition, all advertising must include the product name, the NPN, and a statement that the product is a natural health product. Advertising must also comply with the guidelines set forth by Advertising Standards Canada, which regulates advertising across all industries in Canada.

What are the challenges of NHPID regulation compliance?

Complying with NHPID regulations can be challenging, especially for small businesses that need more resources to hire a regulatory compliance consultant. However, there are several steps that companies can take to ensure that they comply with NHPID regulations.

One of the most important steps is to stay up-to-date with the latest regulations and guidelines. Health Canada regularly updates its policies and regulations, so it’s essential to stay informed and make any necessary changes to your products or labeling.

Another critical step is to work with a regulatory compliance consultant. A consultant can help ensure that your products and labeling comply with NHPID regulations and help with product license applications and other regulatory requirements.

What are the common pitfalls to avoid when dealing with the NHPID regulations?

Businesses should avoid several common pitfalls when dealing with NHPID regulations. One of the most common is making false or misleading claims about the product. All claims about an NHP must be supported by scientific evidence and not be deceptive or dishonest.

Another common pitfall is failing to comply with labeling requirements. All NHPs must have a clear and accurate product label that complies with all NHPID regulations.

Finally, businesses should avoid claiming that their products can cure or treat a specific disease or condition. Health Canada prohibits this, which can result in fines or other penalties.

Top 6 things about NHPID:

  1. Presently, the Natural Health Product Ingredient Database can be accessed only through electronic Product License Application (ePLA) forms and Natural Health Products Ingredients Database Web application.
  2. NHPID user interface allows the following 2 types of searches:
  • Ingredient search: This search function allows search for acceptable medicinal and non-medicinal ingredients used in Natural Health Products (NHP). Searches can be made using ingredient names (NHPID names; Proper names; Common names; Taxonomical synonyms (Taxa) or Chemical Abstract Service (CAS) numbers.
  • Controlled Vocabulary Search: This search function allows searches based on standard terminology used by the Natural Health Products Online System e.g., quality test methods, dosage forms, non-medicinal ingredient purposes,
  1. NHPID is also a great repository of pre-cleared information (such as single ingredient monographs and product monographs) for customers. Pre-cleared information (PCI) is any form of information supporting the safety, efficacy, or quality of a medicinal ingredient or natural health product that has been reviewed and approved by the Natural and Non-Prescription Health Product Directorate (NNHPD).
  2. Changes such as additions and modifications can be proposed to NHPID. To propose a change to NHPID, Natural Health Products Ingredients Database Issue Form needs to be filled out and submitted to ingredient_support@hc-sc.gc.ca.
  3. Currently NHPID excludes information related to product names; proprietary flavors; health claims; risk information and evidence information.
  4. Clicking the “What’s New” button at the top of the NHPID web application directs the user to a web page identifying recent additions to the database.

What is a Natural Product Number (NPN)?

In Canada, all Natural Health Products (NHPs) are regulated by the Natural and Non-prescription Health Products Directorate (NNHPD) and must have a product license before they can be sold in Canada. To get a product license detailed information regarded the product e.g. medicinal ingredients, source, dose, potency, non-medicinal ingredients, and recommended use(s), etc. needs to be submitted by the applicant to NNHPD. Upon reviewal and approval of a product license application, NNHPD issues a product license along with an eight-digit Natural Product Number (NPN).

Do you need help obtaining your NPN?

Contact Quality Smart Solutions today! We can help.

Top 6 things to know about NPN:

  1. As per the guidance document for labeling Natural Health Products, the product Number or NPN must be clearly identified on the Principal Display Panel of an NHP label by the prefix NPN.
  2. The Licensed Natural Health Products Database contains information about natural health products that have been issued a product license by Health Canada. These licensed products have been evaluated by Health Canada and are deemed to be safe and effective. Natural Product Number (NPN) can be used to identify licensed natural health products by looking for the eight-digit.
  3. As per the Natural Health Product Regulations (NHPR), certain post-licensing changes are considered as fundamental changes and cannot be made to the existing NPNs, these changes require a new application and upon approval by NNHPD receive a new NPN. These changes primarily include a change to the quantity of a medicinal ingredient per dosage unit, a change in dosage form, or the route of administration.
  4. Post licensing changes that can be made to an existing NPN include Amendments and Notifications. Amendments and notifications can be made using the Amendment and Notification Form (ANF).
  5. Amendments are post-licensing changes to an NHP that may have an impact on the safety, efficacy, and/or quality of the product. Amendments can only be applied to a product once the change has been approved by Health Canada and the Product License is updated to reflect the changes. Examples of such changes include a change to its recommended dose; a change in the recommended duration of use etc.
  6. Changes that do not have a significant impact on the safety, efficacy, and or quality of the NHP for which NPN was previously issued are regarded as notifications. It is the license holder’s responsibility to notify NNHPD of the change within 60 calendar days after the day change was made. This can be done using ANF. Examples of such changes include the addition or substitution of a non-medicinal ingredient, change in the brand name of a product, etc.

References:

https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/online-solution/ingredients-database.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/natural-health-products/natural-health-products-ingredients-database-web-application-guide-november-2008-health-canada-2008.html

https://www.canada.ca/en/health-canada/corporate/about-health-canada/branches-agencies/health-products-food-branch/natural-non-prescription-health-products-directorate.html

Categories
Blog

Natural Health Products (NHP/NPN) Panel Top 19 FAQs

Natural Health Products NHP NPN

Natural Health Products NHP NPN1. What is the NHP Licensing Process/what is needed for it?

This process involves the submission of a product license application to Health Canada.

Ø Documents normally contained within a submission are Cover Letter and a Product license Application form. Other documents may be required based on the classification of the product and who is applying, depending if this is the applicant or a third party.

Ø Other documents that are submitted are the Designated party authorization form or DPA. Senior Official Letter, Finished Product Specification form. Monograph attestation form. Efficacy safety summary report and research articles, if applicable.

Ø After project quoting and onboarding we proceed to Formula Review

Ø  At Quality Smart Solutions we review your labels, formulas, and raw material certificates of analysis before ensuring an agreeable and accurate submission.

Ø  We also use the process to ensure you are well informed as a future license holder.

Ø  Formula review is where we provide a document with any questions or requests regarding outstanding information that is crucial to the application. Or items that Health Canada may question.

Ø  We discuss attestation to monographs and any research requirements to support safety and efficacy.

Ø  We also discuss health claims here.

Ø  After completion and agreement for the formula review, we proceed to draft the application for you. With all associated forms.

Ø  Then it undergoes an internal quality audit before being provided to the applicant for their review and approval.

Ø  Please know that more recently Health Canada has made site information a requirement on application forms. We will request this during the process as well.

Ø  This means adding manufacturer, packager, labeler, warehouse, and importer information to the application or marking the form as hypothetical.

Ø  Then once all is approved we apply to Health Canada via epost.

Ø  Health Canada will review the application and reach out if any details or confirmations are required via an information request notice or IRN.

Ø  After everything is addressed then you will be assigned a licensing decision. Your NPN!

Ø  Should you need to make any changes you can submit notifications (minor change) amendments (major change) or a new application (fundamental change).

Ø  Quality Smart Solutions is happy to look into your projects and help with applications of all classifications. 

2. Why should someone get an NHP License?

Ø An NHP License is a Legal requirement for the sale of Health Products in Canada. Along with site licensing, a compliant bilingual label is another requirement.

Ø Essentially If your product is best classified as a Natural Health Product you will need an NPN to market it in Canada.

Ø Classification is the first step to deciding how to proceed with your product.

3. How long will it take to receive my Natural Product Number (NPN)?

Ø  This depends on the classification.

Ø  There are three classes for NHPs, classes 1, 2, and 3.

Ø  One being the most simple and 3 being the most complex.

Ø  Class 1 which means all ingredients and claims align with 1 Health Canada monograph is posted to take 60 days.

Ø  Class 2 which means all ingredients and claims align with 2 or more Health Canada monographs is posted to take 90 days.

Ø  Class 3 which means any one ingredient steps outside the Health Canada monographs is posted to take 210 days.

Please know that Health Canada currently has a queue for applications and we caution our clients that the review timeline can be somewhat longer than what they have posted. 

4. Is there a government fee associated with licensing Natural Health Products?

Ø  At this time there are no fees associated with submitting a Health Product License application to Health Canada.

Ø  This would be beyond fees that are paid to a consultant to assist, prepare and submit the application.

Ø  That doesn’t mean that Health Canada will not arrange a cost recovery program in the near or distant future, this concept has been discussed previously.

Other similar application pathways have cost recovery in place and we could see how this could be transitioned to this category eventually. 

5. Do NHPs need to be tested?

Ø  Yes Health Canada has posted several guidance documents explaining and detailing testing requirements for Natural Health Products.

Ø  This is an effort to ensure products are safe and effective.

Ø  Testing can be broken down into finished product testing and stability testing, both of which are required.  

Ø  Some testing that is required is physical testing, medicinal ingredient assay, medicinal ingredient identity, microbiology, heavy metals, pesticides, solvents, and ingredient-specific tests.

Ø  Some testing can be confirmed at the raw material stage. But some must be done at the finished product stage.

Quality Import solutions offer testing gap analysis to assist in Canadian compliance with testing requirements. 

6. What recent changes has Health Canada made to the Natural Health Product Regulations (NHPR)?

Ø  July 2022 Health Canada announced changes regarding updating labeling regulations to include Productthe  Facts table, updated font size requirements, and modernizing contact information.

  1. Previously information was in free form and we suggested they be listed as statements or sections. Now they are standardizing content to appear more like a drug in a boxy black and white facts table.
  2. Previously there was no font minimum and text was to appear as legible to the average eye. Now you must show a 5.5-6 point font.
  3. Updates to license holder and importer information can now include a phone number, website, or email rather than postal information.
  1. Please know that license holders for the product approved before July 2022 will have several years to comply with these new label requirements. 3 years for NPNs issued after July 6. and 6 years for NPNs issued before July 6, 2022.
  1. As well as the recent requirement to add site information to the application form is now required.
  2. If no site information is marked, the application is considered hypothetical and may be deprioritized.
  1. Also there are changes to Single mineral products that should now show the total salt amount and elemental amount such as zinc and zinc oxide amounts. This is to ensure the consumer is getting the proper information for the dose amount of elemental mineral.
  1. We are happy to review your labels for regulatory and bilingual compliance.

Natural Health Product Business Development Questions:

7. How long of a lead time does I need when planning for a production run?

  • Give yourself lots of time, there are many variables that need to be managed and aligned (Price quotes, purchase orders placed and confirmed, materials purchased, tested, manufactured, packaged, finish product testing)
  • First-time runs will require 12-14 weeks
  • Next runs will take 10-12 weeks.

Need help with your Natural Health Products (NHP/NPN)?

Contact Quality Smart Solutions today! We can help.

 8. Does my brand need to provide the raw materials or does a manufacturer like Acenzia source them?

This is the customer’s prerogative.  We offer complete turn-key services or a la carte (just product design, manufacturing pills or powders,  just coating, just blending, just bottling)  

9. What are the biggest challenges you face with NHP brands seeking a manufacturer?

Choosing the right manufacturing partner is very important.  Be sure to look out for the following criteria:

    1. They must be a third-party Audited GMP facility – Health Canada has in the past done a few on-site inspections – choose a partner that proves their confidence/commitment to quality – look for  FDA, NSF, other – ask for the report and corrective actions required
      1. Do a walk-through yourself – how does it look?  Would you give your loved one’s products from the facility? 
    2. Responsive, high operating Quality, operations, warehousing, and sales teams that get you answers?
      1. Partner in compliance – formulations, finished product specs and testing, packaging compliance & specs, shelf life, answering consumer questions about formulas, what if a recall happens, are you ready?  Do you have a shelf life program? 
    3. Manufacturing capacities availability – do they have time to fit you in or do they have other overbearing commitments – do they have the brands that they manufacture before you?  
    4. Formulations  – do they have a formulations team?  Do they do trials/benchwork?  Do they charge for this work?  Do you own your formulas/flavors?  Know what every ingredient is called and where to get them.  

In summary, don’t go for the cheapest quotes!  Seek to understand the value you’ll be getting for your money. Everything you need costs money.

10. How is Acenzia dealing with / assisting customers with the continued supply line challenges?

  • Acenzia has a deep network of suppliers and has found alternative suppliers
  • Become forecasting experts together – book purchase orders asap – give yourself lots of time to avoid disappointment / extra costs
  • Recommending alternative options 
  • Airfreighting materials in if they are needed in a rushed timeline

You need to build deep relationships with qualified suppliers that can give you exactly what you need for your business’s operations.  Acenzia has a diligent process for both forecasting supply chain issues and choosing the suppliers they work with.  The sooner you tell them about your requirements the better chance they’ll have of getting you what we need.  their supply, formulation, and quality team are also experts at suggesting alternative solutions. If things are being held up they have emergency freight solutions.  Ultimately it comes down to ownership of your product, cost considerations, forecasting, and planning.  Finally, this is a lot easier when you have a great relationship with your suppliers.

Natural Health Product Retail Questions:

11. What retail opportunities are there in Canada for NHPs?

All Food, Drug & Mass Retailers (over 8,000) in Canada have a “wellness section” where they sell vitamins & supplements (NHP products). There are also over 2000 Independent Health Retailers (IHR) across the country.  

12. What are some of the retail requirements to sell NHPs? (eg. Costco requires special corrugated boxes, unit sizes may need to be customized, listing fees, etc).

  • In the Food & Drug channel, the most significant requirement is listing/slotting fees.
  • Costco requires Club Pack

13. How do I bring products into my country by shipping directly to a retailer?  Do my products need to land at a site-licensed facility first? 

According to Health Canada, all sites involved have to be an annexed licensed site or a foreign site until it’s released.  Our sister company Quality Import Solutions can help you with this.  

Even if you can ship from your facility outside of Canada directly to the retailer, distance and lead time would make that strategy prohibitive. Retailers expect to be able to replenish easily and quickly, especially if their strategy is on-demand inventory. 

14. How should I best enter the Canadian market if I’m a start-up?

  • Proof of Concept – if you are launching an entirely new brand/product and need proof of concept, we would recommend launching in the IHR channel because they will provide wonderful feedback. 
  • Consider your path to success so far; we recommend that you duplicate your path to success as you enter the Canadian Market. For example, if you started in IHR and built your brand that way, we recommend you start in IHR as well.
  • Consider who your end consumer is and where they shop.

These steps will guide you on how to best enter the Canadian Market. 

15. Can I get a commitment from retailers before I invest in the NPN process?

No. Canadian Retailers expect that you have done all of the leg work before presenting for their consideration. 

Natural Health Product Manufacturing Questions:

16. How do you guarantee quality Natural Health Products? 

  1. Vendor Qualification process
  2. Raw materials testing/micros/assays, heavy metals, etc
  3. In process controls and testing
  4. FPS/testing

17. How does shelf life work?  How is it determined?  Who is responsible for shelf stability data?

  1. the product owner is responsible for the shelf life study and assigning the shelf life of the final product 
  2. Acenzia can assist with your shelf life study and monitor the shelf life of the final product quality before the expiration date.

18. How do NPN amendments/notifications work?

  • Most of the time the customer wants to know the amendment or notification procedure of their NPN if there is a change of formulation and other information
  • Acenzia will advise for the procedure

19 What are some common Amazon de-listing issues for NHPs?

A few common de-listing issues with Amazon Quality Smart Solutions has seen is miscategorizing protein powders as NHPs when they can be considered a food product. Another one would be cosmetics being mispositioned as NHPs (often driven by claims on the packaging).

How can QSS ensure your NHPs are compliant and transported without the worry of rejection?

Working with regulatory consultants such as Quality Smart Solutions and Quality Import Solutions will help bring your products into Canada in a safe and compliant manner. We hold an NHP Site License which allows us to import products and annex foreign sites for our clients. Please reach out to our team of specialists for all your NHP regulatory needs! 

Special thanks to Brewin and Associates and the Acenzia Team for their expertise in this panel.

Categories
Blog

SFCR License and Preventive Control Plans (PCP) Unlocked

SFCR License and Preventive Control Plans

SFCR License and Preventive Control Plans

In this blog, we’ll focus on answering your questions about the SFCR License and Preventive Control Plans, including why they are important and how they go together.

What is a Safe Food for Canadians Regulations License (SFCR)?

The Safe Food for Canadians Regulations (SFCR) and the Safe Food for Canadians Act (SFCA) came into effect on January 15, 2019. The SFCR consolidates 14 sets of existing food regulations into one single set of regulations to maintain consistency of regulations for your food business, reduce administrative burden and allow food business to focus on outcome-based provisions. Under the SFCR, certain food businesses will require a license to conduct one or more activities.

This is to establish a framework and improve food safety in Canada. The SFCR applies to food and food ingredients for human consumption, whether they are imported, exported, or traded within the provinces. There are new elements covered in the SFCR regarding licensing, preventive controls, and traceability. The SFCR lists out requirements to issue, renew and amend a license and rules relating to meat products. It also lists out what kind of food businesses will require a license and when they need to have one. Having the license allows the Canadian Food Inspection Agency (CFIA) to know who the manufacturers are and what activities they conduct.

Why do I need an SFCR License?

As per Part 3, Division 1 of the Safe Food for Canadian Licence Regulations. The Canadian Food Inspection Agency (CFIA) issues an SFRC license to businesses conducting food-related activities, such as manufacturing, trading, importing, or preparing food products for export or to be sent across territorial or provincial boundaries.  This CFIA SFCR license helps the agency in aligning Canada’s regulations with global food standards, identifying food businesses, and taking responsive action when their activities fail to be compliant with the regulations. Certain requirements of the SFCR License may apply in 2021 based on food type of activity, commodity, and business size.

Need a Preventive Control Plan or SFCR License?

Contact Quality Smart Solutions today! We can help.

What is a Preventive Control Plan (PCP)?

The SFCR has a section focusing on preventive controls. These measures are to maintain food safety, reduce contamination, and ensure food that enters the Canadian market is safe. These controls cover areas including sanitation and pest control, treatments and processes, equipment, maintenance, and operation of establishments, unloading, loading, and storing food, employee competence, employee hygiene, employee health, and complaints and recalls. A preventive control plan (PCP) is written to explain how to identify and control the risks to food and food animals.

They are based on Hazard Analysis Critical Control Point (HACCP) principles and include areas related to packaging, labeling, grades, and standards of identity. Foreign suppliers and Canadian importers must explain how they meet the preventive food safety control requirements. According to SFCR section 86-89, food businesses must have and maintain a written PCP. However, some small businesses may be exceptions. This is to ensure businesses are manufacturing, exporting, and importing safe food. These measures help to identify, prevent, and correct issues during the production stage, which then protects Canadians, avoids product recalls, and continues market access with other countries that have similar requirements.

We can provide PCP plans, employee training, certification audit preparation, food safety documentation, and food safety plan development. 

Step-by-Step Guide for Preparing a Preventive Control Plan?

Here’s a step-by-step guide to help you prepare a comprehensive Preventive Control Plan:

  1. Understand Applicable Regulations:

    • Research and understand the relevant food safety regulations and standards that apply to your specific industry and region. In the United States, for instance, the Food Safety Modernization Act (FSMA) establishes preventive controls requirements for food facilities.

  2. Identify Hazards:

    • Conduct a thorough hazard analysis to identify potential biological, chemical, and physical hazards that could pose risks to food safety at each stage of your operation.

  3. Determine Preventive Controls:

    • For each identified hazard, establish preventive controls that can effectively minimize or eliminate the identified risks. Preventive controls can include process controls, sanitation practices, allergen controls, supplier verification, and more.

  4. Set Critical Control Points (CCPs):

    • Determine critical control points in your process where preventive controls are essential to prevent or eliminate hazards. These are specific points where control measures are applied to prevent, reduce, or eliminate hazards to an acceptable level.

  5. Establish Monitoring Procedures:

    • Develop procedures to monitor the effectiveness of your preventive controls at each CCP. Monitoring activities could include visual inspections, measurements, testing, and more.

  6. Implement Corrective Actions:

    • Outline steps to be taken if monitoring indicates that a preventive control is not being met or a hazard is not being adequately controlled. Corrective actions should address the root cause of the issue and prevent the product from entering commerce if necessary.

  7. Create Verification Procedures:

    • Develop procedures to verify that your preventive controls are consistently implemented and effective. Verification activities may include reviewing records, calibrating equipment, conducting internal audits, and testing samples.

  8. Establish Recordkeeping Protocols:

    • Detail the records that need to be maintained to demonstrate compliance with your preventive controls. These records should include monitoring results, corrective actions taken, verification activities, and more.

  9. Develop Supplier Approval and Verification Procedures (if applicable):

    • If you source ingredients or materials from suppliers, establish procedures for approving and verifying their safety practices and products.

  10. Train Employees:

    • Provide training to employees involved in implementing the preventive controls. They should understand their roles and responsibilities in ensuring food safety.

  11. Document the Plan:

    • Compile all the information into a comprehensive written Preventive Control Plan. This plan should be well-organized and easily accessible to relevant personnel.

  12. Implementation and Review:

    • Put your Preventive Control Plan into action and regularly review its effectiveness. Make updates as needed based on changes in processes, hazards, regulations, or industry best practices.

  13. FDA Registration and Compliance (U.S. Only):

    • In the United States, food facilities are required to register with the U.S. Food and Drug Administration (FDA) and comply with the regulations outlined in the Food Safety Modernization Act (FSMA).

Remember that the specific steps and requirements for creating a Preventive Control Plan can vary based on your industry, geographical location, and applicable regulations. It’s important to tailor your plan to your specific operations and seek guidance from food safety experts or regulatory authorities to ensure full compliance.

What are the benefits of a comprehensive Preventive Control Plan?

Creating a comprehensive PCP can provide numerous benefits for your food manufacturing business, including:
– Ensuring the safety of your products and protecting consumers from illness or injury.
– Meeting regulatory requirements and avoiding fines and penalties.
– Improving the efficiency and effectiveness of your manufacturing processes.
– Enhancing your reputation as a responsible and trustworthy food manufacturer.
– Providing a framework for continuous improvement and ongoing success.

What are the common mistakes to avoid when creating a Preventive Control Plan?

When creating a PCP, it’s essential to avoid common mistakes that can undermine the effectiveness of your plan. Some common mistakes to avoid include:
– Failing to conduct a thorough hazard analysis and risk assessment.
– Establishing ineffective or inappropriate preventive controls.
– Need to develop appropriate monitoring procedures for your specific manufacturing processes.
– Neglecting to establish procedures for taking corrective action in case of a problem.
– Failing to maintain accurate and up-to-date records and documentation.
– Neglecting to verify and validate the effectiveness of your PCP.
– Failing to provide adequate employee training and education.
– Failing to review and update your PCP regularly.

Resources for Creating a Preventive Control Plan

Numerous resources are available to help you create a comprehensive PCP that meets regulatory standards. Some resources to consider include:
– FDA Food Safety Modernization Act (FSMA) website
– FDA Preventive Controls for Human Food guidance document
– FDA Hazard Analysis and Risk-Based Preventive Controls for Human Food course
– FDA Food Safety Plan Builder tool
– Food Safety Preventive Controls Alliance (FSPCA) training courses

Categories
Blog

5 reasons why Drug Identification Numbers are Important

Drug Identification Number DIN

Overview

Manufacturers of prescription and non-prescription drugs are required to obtain a Drug Identification Number (DIN) before the drug product is marketed in Canada. A DIN is a unique, computer-generated, eight-digit number issued to the manufacturer and printed on the front of package labels. A DIN identifies the following product characteristics: manufacturer; product name; active ingredient(s); strength(s) of active ingredient(s); pharmaceutical form and route of administration. 

Drug Identification Number DIN

A DIN indicates that the product has undergone an evaluation by Health Canada and has been determined to successfully meet relevant requirements of the Food and Drugs Act and its Regulations. A drug product sold in Canada without a DIN is not in compliance with Canadian law. While the authorization of a drug includes the issuance of a DIN to the manufacturer, the DIN is the property of Health Canada.

Why is a Drug Identification Number Important?

If a product has a DIN on the medication label, this indicates to consumers that Health Canada has approved the formulation, labeling, and instructions for use. Drug Identification Number’s are also important to the consumer for the following reasons:

  1. Safety and Efficacy
  • Health Canada requires manufacturers to provide data ensuring product safety, effectiveness in satisfying label claims, potency, and purity. Once the manufacturer meets these criteria, Health Canada issues a registration number for the drug. These measures provide confidence that medicines have been adequately tested and are safe for the use intended when administered according to label directions. 
  1. Manufacturing Standards
  • Consumers can also be ensured that the DIN is manufactured at a site that has been authorized to conduct drug-related activities in compliance with Good Manufacturing Practices (GMP).
  • As part of Health Canada’s ongoing commitment to openness and transparency, the Department is publishing information regarding emerging issues identified via their drug inspection program. The information is posted in the form of a tracker and provides an insight into the potential health and safety issues Health Canada is tracking with companies that produce drugs for sale in Canada.

Need help obtaining a DIN Number in Canada?

Contact Quality Smart Solutions today! We can help.

      3. Quality Monitoring

  • Continuous monitoring for adverse effects is required by DIN license holders while the product is on the market. Post-market monitoring is an important aspect that Health Canada has been increasingly focusing on over the last few years to improve health risks to the public. OTC Drugs
  1. Verification for Consumers and Healthcare Professionals
  • Health Canada assigned DINs uniquely identifies each drug on the market in Canada, allowing both consumers and medical professionals the ability to verify drug products. Many products on the internet do not have DIN and consumers can be easily misled about the safety of the product. Drug Identification Numbers allow consumers to trust the product has been approved by Health Canada.
  • Additionally, DINs are used by drug insurance companies to identify whether or not a drug is covered.
  1. Recall
  • If a DIN is recalled, the responsible party must complete a series of actions outlined by Health Canada. Health Canada’s recall procedure ensures that the responsible parties act in a timely and effective manner to mitigate potential risks to consumers.

How can DIN numbers help with product management?

DIN numbers can be a useful tool for product management, allowing manufacturers to track and classify their products more easily. A DIN number helps to identify a specific product and its various attributes, making it easier to locate the right product when needed. They also enable manufacturers to keep track of production batches and other information related to each product they make. This makes sharing Product Data Sheets (PDS) more efficient because manufacturers don’t have to manually sort through large amounts of data!

How do DIN numbers aid certification processes?

DIN numbers play an important role in product certification processes, as they allow manufacturers to register products and obtain the right certificates. For example, many electrical products have to be tested and certified according to specific regulations. To ensure that the necessary certificates are obtained quickly and accurately, manufacturers bundle different tests under the same DIN number. This way, all relevant tests related to a product can be carried out at the same time instead of separately.

What other applications do DIN numbers have?

While the primary use of DIN numbers is in product certification, they are also extremely useful as identifiers for individual components, parts and materials during internal product management processes. Using a unique ID number to mark every part simplifies product tracking and inventory oversight, and drastically streamlines sales orders. By doing so, businesses can quickly locate required components in their inventory and dispatch them on time.

Where can I find a list of all valid DINs?

One of the best places to find a full list of valid DINs is on the German Institute for Standardization’s (DIN) website. There, you can browse through specific DIN categories and view appropriate individual DIN numbers. Alternatively, there are multiple independent websites that curate lists of valid DINs, thus making it easier for companies to quickly identify correct codes and proceed with product certification processes.

Further information

The Drug Product Database (DPD) contains product-specific information on drugs approved for use in Canada. The database is managed by Health Canada and includes human pharmaceutical and biological drugs, veterinary drugs, and, disinfectant products.

It contains approximately 23,000 products that companies have notified Health Canada as being marketed. The DPD, allows consumers to search for information on products that have a DIN.

Bibliography

Canada, H. (2022, January 14). Government of Canada. Canada.ca. Retrieved August 9, 2022, from https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/fact-sheets/drug-identification-number.html

Din’s and NPN’s: What are they? Stafford Pharmacy. (n.d.). Retrieved August 9, 2022, from https://www.staffordpharmacy.com/pharmacy/rx-pad/rx-center/dins-and-npns-what-are-they/

Ministry of Agriculture, Food and Rural Affairs. The Need to Read – Drug Label Directions Enhance Health of Livestock and Bottom Line. (n.d.). Retrieved August 9, 2022, from http://omafra.gov.on.ca/english/livestock/dairy/facts/need.htm

Are you looking to have your drug product registered with Health Canada? Quality Smart Solutions has a team of experts who are skilled with DIN numbers and DIN applications. Please contact us today or call us at 1-800-396-5144 to learn about how we can help you.

Categories
Blog News

Regulatory & Market Landscapes of CBD as a NHP

Natural Health Products that contain CBD

Market Analysis and Overview of CPG Market:  Will CBD Products be considered an NHP?

The consumer packaged goods (CPG) market, including cannabis and natural health products (NHPs), is always on the lookout for changes in the regulations that allow for new products, be it new packaging, formulation, or types. 

One of such recent developments is Health Canada’s consideration for developing a potential framework for non-prescription health products containing cannabidiol (CBD) as a medicinal ingredient following a 2019 consultation that sought external scientific advice on the short-term self-care use of the compound.

Canadian Cannabis Market:

Since its legalization in 2018, the Canadian cannabis market has experienced consistent annual growth, especially in the recreational sector. Although cannabis products are now available in many different types, the market’s interests are concentrated on high THC (>20%) or high CBD with lower demand for other combinations in between as published by the Ontario Cannabis Store (OCS). The high demand for CBD has made it an attractive partner for NHPs.

CBD has been of interest as a therapeutic compound for many years now. Unlike delta-9-tetrahydrocannabinol (THC), CBD is not intoxicating (has no psychoactive effects) and there is a body of research that provides evidence for its safety and potential therapeutic uses, although as we will see, more research is needed for longer-term treatments.

CBD OIl

This piece discusses the public’s interest in CBD, safety considerations, and how the regulatory and market landscapes might look when CBD is used as a medicinal ingredient in NHPs.

Safety & Efficacy of CBD:

As mentioned earlier, the Canadian cannabis market demands are focused on either high THC or high CBD (with no or little THC). While the THC causes intoxication and poses a risk of developing addiction, CBD is not psychoactive or habit-forming and is now being considered a medicinal ingredient to be used in NHPs. In a recent report published by a science advisory committee, the safety and efficacy of CBD for human and animal use were discussed and recommendations made.

Although more scientific data is needed for the safety and efficacy of long-term use of CBD, there is early evidence that shows using CBD for 30 days or less can help with relieving minor symptoms and stress and nervousness, promoting sleep, and relieving minor pain. 

It is important to keep in mind that the recommended 20-200 mg/day of CBD is for generally healthy adults and applies to oral administration of CBD. This can be made safer if the consumer consults with their physician, especially if they are taking other medication which CBD could interfere with. Additionally, people with pre-existing medical conditions, women who are lactating, pregnant, or planning to become pregnant, and those with cannabinoid allergies should refrain from using CBD-containing products.

Natural Health Products that contain CBD

Global CBD Market:  Important Regulatory Considerations:

Important regulatory considerations in this context include precautionary messages about possible CBD-drug interactions and other risk factors on the packaging.

Both CBD and NHPs enjoy sizable global markets. The CBD global market had an estimated value of USD 551 million in 2021 and projections indicate a CAGR of 28.30% until 2028 with a value of over USD 3 billion. Even bigger is the NHP market with a value of USD 152 billion in 2021 with a CAGR of 8.9% from 2022-2030. The new path to integrate CBD and NHP regulations and products can certainly open doors to new opportunities and products that the market can enjoy.

Challenges with mixing CBD & NHPs:

The main challenge of mixing CBD with NHPs that can be used without a practitioner’s oversight is the lack of scientific evidence/clinical data to show the long-term effects of CBD use in generally healthy adults. This is especially pronounced in the absence of studies on the long-term use of CBD in different populations and age groups, including vulnerable groups. 

Contributing to this challenge is that CBD is a biphasic compound, meaning that it elucidates different or even opposing effects when used at different concentrations. For example, higher CBD doses are correlated with promoting sleep, while lower doses can delay it.

Non-Prescription Use of CBD & Natural Health Products:

Concerning the non-prescription use of CBD in non-human subjects, there is not enough evidence to recommend it for horses or food-producing animals since very little is known about the extent to which this could affect human health in the latter case. It seems like the cats also have to wait until more concrete evidence is put together for the safety and efficacy of CBD.

However, there are indications that dogs who suffer pain due to osteoarthritis could benefit from 0.2-2 mg/kg of CBD when taken orally. Similar to the safety measures concerning human intake of CBD, administering the right dose for dogs must also be accompanied by a veterinarian’s input and oversight as necessary.

The sizable markets of CBD and NHPs are certainly a good incentive for the regulatory merger we are discussing here. However, no good strong idea comes to life without some struggles and obstacles.

CBD & NHP Market Strength/Challenges:

The strength of the market comes from different sources. To name some, both cannabis and NHP industries have well-established procedures in place to meet Health Canada and in some cases other standards, e.g., GMP, ISO, etc. 

Additionally, the main ingredients of NHPs, including CBD, are readily available and both have shown to be reliable markets in product delivery. Additionally, locally sourced and environmentally friendly packaging and printing shops could benefit from the new line of business. Finally, more post-secondary education intuitions are developing new courses and programs that fit the market’s demands.

CBD Products may soon be NHPs! Need compliance help?

Contact Quality Smart Solutions today! We can help.

The challenges are also multifaceted. Reliable clinical data, especially for long-term use of CBD and/or at-risk populations are yet to be obtained. This goes both for human and animal use. Another challenge is the availability and accessibility of information and educational sources on the topic.

Potential Side Effects of CBD Products:

Without a good understanding of the product and its possible side effects, the public would be reluctant to become returning consumers. And of course, with the rather rapid rise of the costs of goods and services across the globe, the investors will be more careful and stringent with their spending, which could negatively affect the smaller and newer businesses.

Those who decide to venture off into this new territory and face the challenges are welcomed by Health Canada to provide their market considerations, including product types, their intended use, formats, dosage, and any other considerations regarding the potential markets for such products.

Regulatory Considerations:

Regulations and the industry work hand in hand to maintain and improve the state of affairs through mutual feedback. For developing new regulatory frameworks for the topic of CBD as NHP, Health Canada is accepting input from interested parties on the regulatory aspects of packaging and labeling, point of sale, access, and post-market surveillance among others.

CBD as a NHP

For CBD to be used as a medicinal ingredient in NHPs, it must have a monograph available, which will subsequently require certain packaging and especially labeling requirements. As more side effects and/or adverse events are reported and documented in clinical environments, the closer we become to having a copy available. The monograph can also prevent application bottlenecks at Health Canada, which affects both CBD and non-CBD NHP applications as the regulatory authorities deal with the post-epidemic backlogs.

GMP Standards and Good Production Practices (GPP):

Cannabis Act products must meet good production practices (GPP) standards, although many license holders are now also GMP-certified. For CBD-containing NHPs, GMP standards are an automatic must to ensure quality products that are suitable for human consumption. In this regard, safety, efficacy, quality, and post-market surveillance are of utmost importance and successful businesses must have approved and effective procedures for recall and for responding to the reports of adverse events.

It is worth mentioning that the CBD we are discussing here must meet the following criteria:

  • CBD is ≥98% of the total cannabinoid content of the preparation,
  • Any cannabinoids other than CBD must be only those naturally found in cannabis and together equal no more than 2% of the total cannabinoid content of the preparation,
  • THC content must not be more than 1% of the total cannabinoid content.

The regulations dictate the product lifecycle design and budgeting. This is why regulated businesses invest in hiring compatible and competent regulatory affairs specialists and/or consulting companies like Cannabis License Experts CLE, and Quality Smart Solutions (QSS) who can help you navigate the multifaceted regulations and requirements to satisfy your compliance needs.

Conclusion

It is great news for the industry to see CBD on its way to being considered an NHP. The path won’t be easy but seems worth the trouble. Both CBD and NHP enjoy growing markets that have the potential to benefit from this merger. As more data from clinical and lab-based analyses become available, we also get closer to having a monograph to make licensing as well as importation and exportation processes easier.

Other questions to contemplate are how the rescheduling of CBD from cannabis to NHP will impact the cannabis market and whether CBD products will still require a cannabis processing license. Considering CBD-only and CBD-dominant are one of the high demands in the current cannabis market, there might be resistance in the path of complete separation of CBD from the Cannabis Act. In the case of separation, facilities can likely operate under a site license as opposed to the more supervised cannabis facility license.

Importing NHPs with CBD Ingredients:

The import of NHPs with CBD will most likely follow the current framework, although generally speaking, Canada resists the importation of cannabis products to safeguard the domestic market.

Filling more of the clinical and laboratory data gap in addition to proper educational resources for the willing and potential consumers will provide a suitable environment for the new regulatory framework to be established.

Categories
News

FDA Releases Draft Guidance on Enforcement Discretion for Certain NAC Products

NAC Products Dietary Supplements

NAC Products Dietary Supplements

Navigating the FDA and NAC regulations can be intimidating, but with the right information and guidance, you’ll be able to understand and comply with all applicable rules. In this article, we’ll provide a comprehensive overview of the FDA and NAC regulations so you can ensure your product meets all necessary requirements.

What is the NAC?

The NAC, or the Dietary Supplement Health and Education Act of 1994, is legislation that establishes guidelines for dietary supplements within the United States. This legislation sets standards to ensure a product’s safety and requires labels to accurately reflect the desired uses of an herbal supplement. It also requires manufacturers to provide appropriate information regarding the manufacturing process and ingredients used in a supplement.

What’s New?

On April 22, 2022, the U.S. Food and Drug Administration (FDA) announced the release of a draft guidance on the policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC).

The draft guidance, when finalized, will outline how the FDA will exercise enforcement discretion with respect to the sale and distribution of certain NAC-containing dietary supplements. The enforcement policy would apply to products that would be lawfully marketed as dietary supplements if NAC were not excluded from the definition of “dietary supplement” and are not otherwise in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Background

Historically, the FDA has determined that NAC is excluded from the dietary supplement definition under the FD&C Act because NAC was approved as a new drug before it was marketed as a dietary supplement or as a food. With regards to the drug classification, N-acetyl-L-cysteine (NAC) has been approved by the FDA to treat liver side effects from an overdose of Tylenol (acetaminophen), and to loosen the thick mucus in the lungs of people with cystic fibrosis or chronic obstructive pulmonary disease.

The FDA received two citizen petitions asking the agency to reconsider its position on the use of NAC as a dietary supplement and has since been conducting a review of the ingredient and any potential safety concerns. If the FDA does not identify safety-related concerns following a review of the available data and information on NAC, a rule may be proposed providing that NAC is not excluded from the definition of dietary supplement.

NAC-containing products represented as dietary supplements have been sold in the United States for over 30 years and consumers continue to seek access to such products. In the interim, the FDA issued this draft guidance to explain the policy regarding products labeled as dietary supplements that contain NAC.

Tips for Compliance with NAC and FDA Regulations:

Following a strict set of NAC and FDA regulations is crucial for ensuring the safety of dietary supplements on the market. Manufacturers should have familiarization with each regulation, maintain accurate records and verify the product’s claims. Additionally, ensure proper packaging and labeling to meet regulatory standards while also adding clarity and transparency to product information.

It’s also important to be aware of special requirements for products marketed across state lines, as well as regulations applicable to combinations of products or marketing techniques.

Preparing Documents to Satisfy NAC and FDA Requirements:

Manufacturers should keep detailed documents to meet NAC and FDA requirements. This includes a record of each step in the manufacturing process, which must be maintained to demonstrate the company’s safety standards and production processes comply with the regulations.

Copies of invoices, labels, certificates of analysis, and other relevant documents should be kept for audit purposes. Furthermore, proper inspection and testing records should be created and kept on file to prove that products conform to established standards before being released into markets.

Conclusion

Unless the FDA identifies safety-related concerns on the use of NAC in dietary supplements, the FDA would intend to exercise enforcement discretion (as described in the draft guidance) until either of the following occurs: completion of notice-and-comment rulemaking to allow the use of NAC in or as a dietary supplement or denying the citizen petition’s request for rulemaking. If the FDA determines that this enforcement discretion policy is no longer appropriate, stakeholders will be notified by withdrawing or revising the guidance.

How we can help

The experts at Quality Smart Solutions offer regulatory compliance support for dietary supplements label compliance, foods, cosmetics, OTC drugs, and medical devices in North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

Need compliance help regulating your dietary supplements including the New Dietary Ingredient Notification (NDIN)? Contact Quality Smart Solutions today! We can help.  Email us at info@qualitysmartsolutions.com, or call us at 1-800-396-5144.  We would be happy to serve your compliance needs.

Get Updates And Stay Connected -Subscribe To Our Newsletter
Subscribe Now
About us

Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

Know More
Twitter Facebook-f Youtube Linkedin Instagram
Compliance Solutions
Quick Links
Contact Us

Subscribe to global regulatory updates

We use cookies to display personalized content, analyze site traffic, provide recommendations, and ensure you have a great browsing experience. By continuing to use our site, you consent to our use of cookies. Privacy Policy.