Amazon Seller Compliance

Month: July 2021

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What are the components of an NHP Label in 2023?

The product label is something we all look at in our daily lives, but not everyone is well equipped with the tools to read them efficiently. It can be challenging to try and navigate this space, especially for Natural Health Products (NHP), which can have multiple ingredients. First, you may be wondering what exactly is a Natural Health Product. Well, a natural health product is defined as:

A substance set out in Schedule 1 of the Regulations or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine that is manufactured, sold or represented for use in: 

(a) the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans; 

(b) restoring or correcting organic functions in humans; or 

(c) modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

Health Canada regulates Natural Health Products, and there is a subset of applicable requirements at each lifecycle stage of a product. For example, during the licensing stage, the Management of Applications Policy (MAP) guidance is used, while during the labelling phase, the Label Guidance Document is used. 

Each NHP, which has been reviewed and approved for sale by Health Canada, is issued an 8-digit Natural Product Number (NPN) (800XXXXX). This NPN is required to be listed on the front panel of a product label. Therefore, any product which does not have this listed has not been approved for sale. 

Additionally, Health Canada has created a Licensed Natural Health Products Database (LNHPD) for further convenience, which allows you to search and view product information based on the 8-digit NPN number.

The LNHPD provides the following information at your fingertips and is updated nightly to ensure you get the most up to date information:

  • product name
  • product licence holder
  • Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM)
  • product’s medicinal ingredients
  • product’s non-medicinal ingredients
  • product’s dosage form
  • product’s recommended use or purpose (i.e. its health claim or indication)
  • risk information associated with the product’s use (i.e. cautions, warnings, contra-indications and known adverse reactions)

You may be wondering, is there a reliable source of information to do further research on some of the information provided by the LNHPD, such as medicinal ingredients, non-medicinal ingredients, and dosage form? Thankfully, there is a source known as the Natural Health Product Ingredients Database (NHPID).

The NHPID is an electronic tool that provides information on the following:

  • acceptable medicinal and non-medicinal ingredients used in Natural Health Products (NHP)
  • standard terminology used by the Natural Health Products Online System (NHP Online System), known as “Controlled Vocabulary”, referring to acceptable quality test methods, dosage forms, non-medicinal ingredient purposes, and so on.
  • pre-cleared information such as single ingredient monographs, product monographs and abbreviated labelling standards (AbLS)

The NHPID is a living database and is constantly updated with new ingredients or monograph iterations, all of which have been reviewed by Health Canada.

As one can see, many nuances exist in what some may consider a simple product label.  Our experts at Quality Smart Solutions are here to help you navigate through this process.

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America. Contact us today to learn more about how we can support your compliance needs during and after licensing!

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Supplemented Foods Proposed Regulatory Framework

Health Canada has been working on creating/revising the regulations with regards to Supplemented Foods for some time now. A recent Health Canada webinar indicated new proposals/consultation could be on the horizon. Health Canada anticipates publishing a new draft regarding the Supplemented Foods Regulations shortly (June 2021) in Canada Gazette Part I. Until now, supplemented foods have been regulated under a Temporary Market Authorization Licence (TMAL) in Canada.

What They Heard

Industry indicated that new regulations and guidelines must/should be able to capture the following: allow for innovation, limit pre-market burden, consider existing TMAL formulas and their ingredients, and allow health claims. 

Limiting Innovation: 12 categories of supplemented foods would be available to start. Additional categories could/would be added/considered upon safe review. 

Pre-Market Burden: Majority of existing TMALs could go straight to market under this new framework. Required information to proceed would be published in regulations or guidance. 

Permitted ingredients: Majority of TMALs would be able to remain the same/unchanged under the new framework. Some changes would be required based on upper limits to specific ingredients. Approximately 6.5% would require reformulation.  

Health Claims: Limiting claims that contradict required risk statements is a priority. Such as liver benefits when a liver caution is required. Some claims would not require notification. Some higher risk claims would require review prior to marketing.

Canada Gazette Part I, Prepublication:

Upon publication, the documentation will include Regulatory Impact Analysis Statement, List of Permitted Supplemented Food Categories, List of permitted supplemental ingredients, Directory of Supplemented Food Facts Table Formats, Directory of Supplemented food caution identifier specifications, Supplemented food guidance document. 

Established 12 Categories Proposed Upfront:

  1. Carbonated and non-carbonated water-based beverages including concentrates and mixes 
  2. Caffeinated energy drinks including mixes
  3. Fruit and vegetable drinks from fruit and vegetable concentrates
  4. Fruit and vegetable based smoothies
  5. Juices
  6. Protein beverages including mixes other than workout supplements
  7. Single serving prepackaged tea, coffee, and herbal infusions
  8. Bars
  9. Hard, soft and semi-soft candies
  10. Chocolate confectionery
  11. Chewing gums
  12. Ice pops

Supplemental Ingredients:

Charts are being proposed for each ingredient allowable in Supplemented foods, based on the category of product to be used. 

For example: Vitamin A: limit of 745 mcg per serving size.

For example: Magnesium as a List 1 category up to 175 mg, and up to 23 mg for a List 2 category product allowed per serving size.

Amounts/limits for amino acids will be published for supplementation in specific categories as well. 

For example: up to 1537 mg Leucine per serving size. 

Cautionary statements may be required per category, should an ingredient surpass a certain threshold. 

Caffeine:

150 ppm would be regulated under the food additive framework, not as a supplemented food.

Over 150 ppm would be considered a caffeinated energy drink. Where any new uses would require a pre-market review. 

Other ingredients would have set limits when formulated with caffeine as well. 

Not recommended for those under 14 years old, would be a required risk statement. 

List Modification:

Modifications will be able to be made to the List of Permitted Food Categories and List of Permitted Supplemental Ingredients by request. (Additions, removals, changes, etc.)

Changes would require sound rationale and support, The process to make updates will be explained in the regulations and guidance documents. 

Supplemented Food Facts Table:

The table Would include various formats such as: standard, narrow, horizontal, simplified, linear, aggregate, dual, etc. Like the Nutrition Facts Tables. 

They are also proposing a front of package text box to signify this is a supplemented food.

The size of the SFCI would be dependent on the label and principal display surface size. There also would be an additional smaller/boxier version available. 

Post Market Monitoring:

Based on TMAL data reviewed by Health Canada, Supplemented Foods were generally found to be safe. However, Incident reporting and post market requirements still showed some gaps to be addressed.  Health Canada is recommending the CFIA be a single window for post market monitoring for follow ups and recalls. Collaboration between HC, CFIA and Poison Control are important to ensure these products are properly overseen. 

Proposed Transition:

There is a 3-year proposed transition once the regulations are published. Current TMAL products would still be exempt from the Food and Drug Regulations during this period until the coming into force date. These products can remain on market with an existing and compliant Nutrition Facts Table and ingredient listing. Anything submitted prior to the coming into force would also qualify for the transition up until the deadline.  After the label coordinator policy is finalized a compliance date would be set that likely aligns with the transition period.  

Proposed Timelines:

April – May 2021: Stakeholder engagement sessions

June 2021: Canada Gazette Part 1 Publication. (Target)

Summer 2021: 60-day consultation period, technical briefings for stakeholders

*All current TMALS will be extended until the regulations come into force. *

How Quality Smart Solutions can help:

If you would like to be involved in the consultation period (Summer 2021) or have any questions once the draft regulations are released, reach out to our team!

Please also contact our team for more information on food safety, food classification, formula review, labelling projects or for your importing needs. Our specialists are here to help!

Resources: Health Canada Webinar 2021

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News

Public Consultation on Medical Devices Clinical Trials Modernization Initiative

Health Canada has published a consultation paper on proposed changes to the regulation and oversight of clinical trials for drug, medical devices and natural health products (NHPs). The purpose of these changes is to improve the speed at which these trials are approved, to avoid stifling medical advances that could help improve the health of Canadians, and to improve transparency and regulatory oversight.

The proposed changes would integrate all health products into the same framework and feature:

  1. Proportional risk-based oversight 
  2. New regulatory agilities over the lifecycle of the trial 
  3. Greater transparency through registration and public disclosure of results
  4. A modernized compliance and enforcement regime (see figure 1)

Health Canada is accepting feedback on the proposed changes until 4 July 2021.

Agile Life Cycle

With the adoption of a more agile life cycle approach, Health Canada is looking to be able to give themselves the tools to oversee clinical trials in their entirety while better enabling sponsors to conduct innovative types of trials. As part of these changes, Health Canada will be able to authorize a trial rather than just the sale or importation of an investigational product, authorize a trial with multiple product types through a single authorization, and streamline the application requirements across all product lines for greater efficiency, while maintaining the protection of the health and safety of participants.

Under this scheme Health Canada will allow for the authorization of Master protocols that include multiple sub-studies for different therapies or indications for use. Types of proposed Master protocols include:

  • Basket trials, which investigate the safety/efficacy/effect of an investigational product across a variety of indications
  • Umbrella trials, which investigate the safety/efficacy/effects of several investigational products in a single indication
  • Platform trials, which investigate several investigational products in one or multiple indications in a highly dynamic design

By integrating all health products into a common framework, products from multiple categories can be approved under the same protocol. For medical devices this would result in an expansion of who can sponsor a clinical trial. It will now include independent investigators (such as a researcher, clinician or health care facility) in addition to the manufacturers and importers of medical devices. These changes will also result in any medical device trial being required to adhere to Good Clinical Practices (GCP).

Health Canada is also seeking to improve safety monitoring of clinical trials through improved clarity and increased authority to request information relating to adverse events including the ability to request an analysis of safety data while the trial is ongoing. This may include an assessment of safety signals to determine if the benefit/risk balance has changed during the conduct of the trial.

In this approach, Health Canada will have the ability to suspend or cancel either the whole trial or only a part of the trial if there’s a lack of efficacy or a safety concern.

Risk-Based Approach

All health products will follow a common risk-based approach to authorization. To do this they will create risk-based categories with differing levels of oversight and regulatory requirements for drugs and NHPs. The pre-existing risk-based device classification scheme for medical devices will be maintained and integrated into the new scheme. See figure below:

Source: www.canada.ca

Health Canada will be granted the authority to impose terms and conditions on a clinical trial authorization before and during the trial to address significant uncertainties or mitigate risks related to the product(s) being tested, or to the conduct of the trial. These terms and conditions may include:

  • More frequent safety reporting
  • Monitoring of specific populations because of potential increased risk (e.g. children, pregnancy)
  • Additional information to characterize and mitigate newly identified risks

To allow for greater trial participation from volunteers outside of major urban areas, changes will be made to allow for studies to take place remotely, without a physical visit to a trial site. Monitoring will be allowed using videoconferences with investigators, visits at home by study personnel, internet-based tools for data collection and reporting, and mobile technology such as biosensor devices.

Transparency

Health Canada is looking to expand on its current  Clinical Trials Database and is exploring new ways to publish clinical trial information. This may include mandatory registration of any trial conducted in Canada on an existing international registry of Health Canada’s choosing. Sponsors may be required to make the results of their trials available to all members of the public by publishing the information in this database. Health Canada is also proposing making this information available on its website to ensure it’s easy to find and available in both official languages.

Modernization of Compliance and Enforcement

Although Health Canada already has the authority to conduct inspections on clinical trial activities under Section 23 of the Food and Drugs Act, its activities have been limited to drugs. As part of the modernization, Health Canada will extend its compliance and enforcement to NHPs and medical devices. Inspections will be conducted using a risk-based and pro-active approach based on trial design, the medical condition under study, target population, and the risk classification of the investigational product. Health Canada will also implement a cyclical risk-based inspection approach that considers the compliance history and the volume of activities. Highly compliant entities would be inspected less frequently while less compliant ones would be inspected more frequently.

At present Health Canada only has direct oversight over the sponsors of the trials. Health Canada is proposing regulatory changes that would ensure that all third parties conducting trials on behalf of a sponsor are legally responsible for any activities they conduct. This would result in an increased regulatory burden for these third parties but will increase the safety of clinical trial participants by allowing Health Canada to require them to take corrective action instead of directing the sponsor to take the action against the third party.

Anticipated Outcomes for Stakeholders

Health Canada believes these changes will help encourage clinical trials in Canada by providing greater agility in oversight of the development of healthcare products, ensuring that regulatory requirements are proportional to risks, improving access to clinical trial information, creating a more streamlined approach that is better aligned internationally and leverage partnerships and provide leadership in Canada’s health ecosystem to further facilitate clinical trials in Canada.

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How to sell a Dietary Supplement NHP on Amazon.ca (or online in Canada)

How to Sell Dietary Supplements or NHPs on Amazon or Other Online Platforms in Canada?

What is an NHP?

In Canada, a Natural Health Product (NHP) is regulated by Health Canada under the Natural Health Products Regulations. Under the regulations, it is defined as products containing naturally occurring substances including probiotics, herbal remedies, vitamins and minerals, homeopathic medicines, traditional medicines (e.g. Traditional Chinese and Ayurvedic medicines), and other substances (e.g. amino acids and essential fatty acids). These products are used to treat or prevent an illness, reduce health risk, and maintain general good health. In the U.S., the Food and Drug Administration (FDA) refers this type of product as a Dietary Supplement.

Natural Health Products Ingredients Database

Natural Health Products Ingredients Database (NHPID) is a database that Health Canada built to store pre-cleared information approved by the Natural and Non-prescription Health Products Directorate (NNHPD). The NHPID provides details to the approved medicinal ingredients, non-medicinal ingredients, non-NHP ingredients, and NNHPD single ingredient and product monographs which contain dose information, recommended purpose and risk information. The NHPID also includes a search engine and allows you to navigate the database with ingredient terminology such as NHPID name, common/proper name, and chemical abstracts service (CAS) numbers. The NHPID can be updated by submitting Issue Form requests and this is a service offered by QSS.

Natural Product Number

All NHPs must have a product license and the Canadian site must have a site license to conduct activities including manufacturing, packaging, labeling, and/or importing in Canada. Prior to selling the product, the company must submit NHP applications for Health Canada to review and assess its safety, efficacy, and quality. Once it has been approved, Health Canada will authorize the product license and give permission for the company to sell the NHPs in Canada. This product license comes with an eight-digit Natural Product Number (NPN) or Homeopathic Medicine Number (DIN-HM), and this number is required to be present on the front panel of the NHP product label.

NHP Label

All NHPs must have a bilingual NHP label that is compliant with the NHP Regulations. This is to ensure the NHP is labelled and packaged according to regulations to help consumers make more informed choices about the NHP they take. There is a list of specific requirements and information that must appear on the NHP labels, both inner and outer, and the information is based on the product license you received from Health Canada, including dosage form, recommended purpose, risk information, medicinal ingredients, non-medicinal ingredients, and product license holder information.

Amazon Requirements

To sell on Amazon Canada, the product must have a bilingual NHP label and packaging and an NPN number, which means it must be licensed and have received market authorization from Health Canada. The listing and description of the product must also be truthful and accurate and not have misleading claims and marketing information. QSS offers regulatory services on submitting Issue Form, submitting applications for your NHPs, preparing French translations and reviewing your NHP labels. Our experts are here to help and offer any NHP-related regulatory advice!
Source: www.canada.ca
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COVID-19 and Hard Surface Disinfectants

COVID-19 and Hard Surface Disinfectants – What You Need to Know

In Canada, chemical products that are used to clean, sanitize or disinfect environmental surfaces and inanimate objects are regulated under different regulatory frameworks. As of recently, these products have been in high demand to help stop the spread of COVID-19. To provide some background, coronaviruses are enveloped viruses which are the easiest types of viruses to kill with the appropriate disinfectant. It’s important to always follow label directions and acknowledge safety warnings. 

The way these virus-killing products are regulated is not always based on chemical composition. Rather, regulation is based on the use or purpose of the product. Therefore, the presence or concentration of a certain antimicrobial active ingredient in a product does not solely indicate how it is regulated. 

In general, there are two key factors which determine the regulatory framework that applies to a product:

  1. the intended use of the product (represented by the expressed or implied claims on the product label) including the level of antimicrobial activity 
  2. the type of surface or object to which the product is intended to be applied

Before these products can be sold in Canada, they require a pre-market assessment and a Drug Identification Number (DIN). To receive a DIN number and market authorization, applicants must provide safety, efficacy and quality evidence that the product performs as indicated by the label. This information is submitted to the regulator, Health Canada, in the form of a DIN application. There are a few different types of DIN applications, based on if the product is subject to a category IV monograph or labelling standard (LS).  

Hard Surface Disinfectants

Disinfectants referred to in this blog are for use on:

  • non-critical medical devices
  • hard non-porous environmental surfaces
  • inanimate objects in domestic, industrial/institutional, hospital, food processing and/or barn premises

They are also referred to as “hard surface disinfectants”. Sometimes, the labels for hard surface disinfectants may also have hard non-porous food and non-food contact surface sanitizer claims, classifying them as “disinfectant-sanitizers”. A disinfectant-sanitizer is a chemical product represented for primary surface disinfectant uses and secondary uses as a sanitizer on environmental surfaces and inanimate objects.

Health Canada has published a list of hard-surface disinfectants that are likely to be effective for use against (COVID-19). to see them, visit the official website of Health Canada. 

Surface Sanitizers

A surface sanitizer is a substance, or mixture of substances, that reduces the population of microorganisms on environmental inanimate surfaces and objects. Unlike hard surface disinfectants, surface sanitizers do not destroy or eliminate all microorganisms.

In Canada, surface sanitizers are considered pest control products. These products must be registered before they can be manufactured, imported, distributed, sold or used in Canada to ensure they meet Canadian health and environmental standards. 

As surface sanitizers are not as effective as hard-surface disinfectants, Health Canada is prioritizing the availability of disinfectants at this time.

If your hard surface disinfectant product requires a DIN number, reach out to Quality Smart Solutions today and our team will be happy to help!

How Quality Smart Solutions can help:

As demand for medical devices, disinfectants and hand sanitizers continues to increase to keep the public safe, our team continues to work tirelessly to deliver the compliance and import solutions that are needed.  

Our Experts at Quality Smart Solutions continue to support your needs for natural health products, foods, cosmetics, OTC drugs and medical devices for North America. Contact us today to learn more about how we can support your compliance needs during and after licensing!

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Cancellation of MDELs for Non-Compliance with Annual Licence Review Requirements

Cancellation of Medical Device Establishment Licence for A Non-compliance With Annual Licence Review Requirements

On May 27, 2021 Health Canada issued a bulletin about cancellation of Medical Device Establishment Licence (MDELs) for the sites that are not compliant with the annual licence review requirements. About 700 MDEL holders have not submitted an annual licence review application for the 2020/2021 fiscal year, and as a result Health Canada cancelled their MDELs. This means that these sites are not able to conduct their activities and must re-apply for a new establishment licence and pay the applicable fees. 

Annual Licence Review

An annual licence review (ALR) ensures that medical device establishment licence (MDEL) holders are complying with regulatory requirements associated with the Medical Devices Regulations. An ALR also ensures that their licence information is up-to-date.

As a courtesy, Health Canada sends an ALR application package to all active MDEL holders at the end of each calendar year. Health Canada also sends out 2 reminder notices to the licence contact person on file.

MDEL Holder Responsibilities

To continue doing business, active MDEL holders must submit an ALR application before April 1 of each year as per section 46.1 of the Medical Devices Regulations. Licence holders with a suspended MDEL do not need to apply.

Health Canada will cancel the MDEL for those licence holders who do not submit their ALR application within the required timeline. This authority is set out in section 51.1(b).

Under section 48, active MDEL holders must also notify Health Canada within 15 calendar days if they change their contact information. This includes changing the name or address of their establishment or the information of the establishment representative associated with their MDEL.

Cancellation of MDELs

Since the ALR deadline of April 1, 2021, about 700 MDEL holders have not submitted an ALR application for the 2020/2021 fiscal year. As this violates section 46.1, Health Canada have cancelled their MDELs and removed them from the active MDEL live listing.

MDEL holders whose establishment licence is cancelled are no longer authorized to conduct licensable activities (such as manufacturing, distributing or importing medical devices). They must cease their activities immediately once they receive their cancellation notice.

Resuming Licensable Activities

To resume licensable activities, companies whose MDEL has been cancelled must re-apply for a new establishment licence and pay the applicable fees. In line with the compliance and enforcement policy for health products (POL-0001), Health Canada carries out compliance monitoring activities. Cancelled MDEL holders may be subject to compliance and enforcement actions if Health Canada finds they are conducting non-compliant activities.

For more information on how to re-apply for a MDEL or if you need assistance filling your ALR please visit our website. Our Experts at Quality Smart Solutions continue to support your needs for medical devices, natural health products, foods, cosmetics and OTC drugs for North America. Contact us today to learn more about how we can support your compliance for Medical Device Establishment licence.

References:

Cancellation of MDELs for non-compliance with annual licence review requirements – Health Canada.

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