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NPN & the NHPID Top 6 Things to Know

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 pertaining to Natural Health Products and hence NHPID is a critical tool for the Natural Health Products Online System.

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 for 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 and submitted to ingredient_support@hc-sc.gc.ca.
  3. Currently NHPID excludes information related to product names; proprietary flavours; 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?

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

How can Quality Smart Solutions serve you?

At Quality Smart Solutions, we have a team of experts who are skilled in NHP compliance. We offer several solutions to meet your needs like NHPID, Health Claims Substantiation, Clinical Trial Application (CTA), etc. Please contact us today or call us at 1-888-933-9551 to learn about how we can help you.

 

 

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

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)?

 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.

How Quality Smart Solutions can help

At Quality Smart Solutions, we have a team of experts who are skilled in NHP compliance. We offer several solutions to meet your needs like NHPID, Health Claims Substantiation, Clinical Trial Application (CTA), etc. Please contact us today or call us at 1-800-396-5144 to learn about how we can help you.

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SFCR License and Preventive Control Plans (PCP) Unlocked

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?

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. 

How can Quality Smart Solutions serve you?

Firstly, QSS can help with formula review, product labeling, and nutrition facts creation (for Canada and the USA).

Secondly, we can also help with registering supplemented foods with TMALs (Temporary Market Authorization License) or reviewing when the new Supplemented Food Regulations are published. 

Thirdly, we help with Safe Foods for Canadians Regulations (HACCP, PCP, Import Licensing, and GRAS Notifications). 

Help with facility registration, FSVP agent, and US Agent.  

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5 Reasons Why Drug Identification Numbers (DINs) Are Important

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?

      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.

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

How Quality Smart Solutions can help

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 applications. Please contact us today or call us at 1-800-396-5144 to learn about how we can help you.

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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, 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?

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.

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News

FDA Releases Draft Guidance on Enforcement Discretion for Certain NAC Products

NAC Products Dietary Supplements

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 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.

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!

How Quality Smart Solutions can help

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.

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