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Proposal to Amend the Cosmetic Regulations

What is a Cosmetic?

Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance or mixture of substances manufactured, sold or represented for use in cleaning, improving or altering the complexion, skin, hair or teeth, and includes deodorants and perfumes.”. This is different from a drug or natural health product, even though they are all regulated under the Food and Drug Act

The classification of a product depends on its function, purpose, and representation for use (such as claims that are made for the product on the product label). Ingredients in the formula may also help determine the classification. For example, in Canada, ingredients like corticosteroids can only be licensed as drugs whereas green tea leaf extract may be licensed as a cosmetic product or natural health product.

What is the proposal on?

Currently, stakeholders can use the word “perfume” in the Cosmetic Notification Form and on cosmetic labels to represent the overall fragrance ingredients that are used to produce or mask a particular odour. Alternatively, they can list each fragrance ingredient individually under the ingredient list. On July 16, 2021, Health Canada opened a consultation and proposed to amend the Cosmetic Regulations to eliminate the use of “perfume” so that the industry must list individual fragrance ingredients.

This purpose of this change is to disclose allergens and give consumers more detailed information, allowing them to make better decisions when purchasing cosmetic products. Other amendments to the regulations include administrative updates and improving cosmetics oversight including terminology clarification for risk management purposes and enhancing cosmetic compliance (e.g. one’s responsibility on Health Canada’s safety evidence request).

The Importance of Cosmetic Safety

Even though most cosmetic products are generally safe for use, some of them may still cause health problems such as allergic reactions and skin irritation. To use cosmetics safely, you should always read safety information on the label, especially hazard symbols. If there are directions of use present on the label, you should follow carefully to avoid misuse, which may result in rashes, burns, or eye damage. 

Cosmetics should be kept out of reach of children, as they may be poisonous if swallowed. If swallowed, you should contact a Poison Control Centre or call 411. If it is a spray product, do not spray near a flame or source of heat, which may cause fires and explosions. Although some cosmetics have preservatives, you should still keep them clean to avoid bacteria growing. You can do so by washing your hands before using makeup, not sharing makeup, not adding water to dilute makeup, and keeping your cosmetics stored in a dry, dark area.

If there are changes in colour, smell, or texture of the product, do not use it. Hypoallergenic cosmetics are less likely to cause allergic reactions, but still could do so. If any allergic reaction occurs, stop use, and consult a healthcare practitioner. For certain products such as hair dyes, you may be asked to do a patch test prior to use to ensure cosmetic safety. You could also report cosmetic incidents by submitting a Consumer Product Incident Report on Health Canada’s website.

How We Can Help

Quality Smart Solutions offers regulatory services from registering your cosmetic products to reviewing your cosmetic labels. Our experts are here to help and offer any cosmetic-related regulatory advice!

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Summary of Guidelines for Advertising Health Products

Advertising is something almost all people experience and view daily. Yet, it can be challenging to navigate this space as it can be unclear to identify the truthful claims from the misleading claims. Fortunately, in Canada, Health Canada is the regulatory authority for consumer advertising, more specifically, health products.

How does Health Canada regulate marketing?

Health Canada is committed to ensuring that information in a health product advertisement is not false, misleading, or deceptive. Advertising for Non-prescription drugs and Natural Health Products stems from the terms of market authorization (TMA).  In the case of non-prescription drugs, it is the labelling standard, product monograph, authorized labelling and category IV monograph. While for Natural Health Products, it is the product license.  We will discuss each of the components of a label and ad and the standards around them. 

What statements can be made when advertising a health product?

The recommended use, the direction of use, duration of use, side effects and product performance must be consistent with the TMA. At least one claim should be listed on a label. Additionally, the ad and claims should be a consistent representation of the TMA.  As there are many types of products, health products must be accurately represented as per it’s TMA, such as a non-prescription drug or a natural health product. For products making claims on organic or natural, the following must be satisfied:

Organic:

  • Advertisers should possess evidence of certification, i.e. a copy of the Organic Certificate, issued by a recognized certification body.
  • Products that are certified organic, i.e. where the organic content is greater than or equal to 95%, may be advertised as “organic.” The trademark of the recognized certification body may be included in advertising.

Natural:

  • A synthetically derived ingredient should not be represented as “natural” or “natural source(d).”
  • Claims that a product is “natural” or “natural source(d)” are permissible only if the claim is true for all ingredients (both medicinal and non-medicinal).
  • Claims that one or several ingredients in a multi-ingredient product are “natural” or “natural source(d)” are permissible, as long as it is clear to which ingredient(s) the claim applies.

On the topic of product guarantees, it is inherently clear that this is not permitted as it suggests that a product is suitable for all individuals. While much of this information is a helpful tool in making the right decisions for claims and advertising, the question remains: 

Who preclears ads and ad campaigns? 

Well, advertising material for non-prescription drugs and natural health products directed to consumers is reviewed and precleared by independent agencies that have publicly self-attested to meeting Health Canada’s recommended attestation criteria.

With anything, there are always some outliers who chose to heed some of the regulatory guidelines around advertising. Should individuals find instances of suspected misleading practices, there is an online tool to submit complaints for Health Canada to review. The complaints are prioritized and acted on based on the risk that they pose.

As you take steps to understand this complex marketing space, there may be many things that remain unclear. Advertising practices are plenty and frequently changing, and having the quality level expertise can help ensure you are up to date on the most current regulatory information.

Our Experts at Quality Smart Solutions can offer support to 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!

Sources:

www.canada.ca

www.adstandards.ca

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News

Public Consultation on Medical Devices Unique Device Identifier Initiative

On June 28, 2021, Health Canada opened a public consultation on a Unique Device Identification (UDI) system for medical devices in Canada. This is Health Canada’s first consultation on the UDI system for medical devices.

What is a Unique Device Identifier (UDI)?

A Unique Device Identifier (UDI) is a series of numeric or alphanumeric characters assigned to a specific medical device on the market and is created through globally accepted standards. A UDI code on a medical device allows tracing and tracking of the medical device through the healthcare system, from its entrance into the market through to its use in a patient.

 

What is the purpose of the consultation?

The purpose of the public consultation is to explore the feasibility of introducing a UDI system in Canada, including options for the development of a UDI database by leveraging internal existing infrastructure. Health Canada proposes building on the work and experience of the International Medical Device Regulators Forum (IMDRF), as well as the United States Food and Drug Administration’s implementation to inform the principles and design of a UDI System for Canada. The focus of the public consultation is to seek feedback on:

  • Introducing a Unique Device Identification (UDI) system for medical devices in Canada
  • Who should be responsible for establishing and maintaining the Canadian UDI database
  • The potential scope of regulatory and legislative amendments required to establish a UDI System in Canada

What is IMDRF and what do they do?

IMDRF stands for International Medical Device Regulators Forum. The International Medical Device Regulators Forum is a voluntary group of medical device regulators from around the world who work to support convergence in the area of medical device regulations. The International Medical Device Regulators Forum published the original guidance on a global Unique Device Identification System for Medical Devices in December of 2013. The guidance provides a high-level framework for how a globally harmonized device identification system should work.

According to the guidance document on UDI developed by the International Medical Device Regulators Forum, a UDI system must have three interrelated components:

  1. UDIs must be based on global standards
  2. UDIs must be applied to the label of a medical device and its associated packaging
  3. Information about the medical device must be submitted to a UDI database for the purpose of data sharing amongst regulators and other healthcare stakeholders

What will the feedback from this consultation be used for?

The feedback gathered through this public consultation will be used to inform the assessment of options for the potential implementation of UDI in Canada and the next steps. Should Health Canada choose to pursue a UDI system, there will be further consultation with stakeholders. Health Canada will share the results of this consultation in a timely manner on the Health Canada website.

What are the benefits of implementing a UDI system?

Implementing a UDI system in Canada will bring several benefits to industry, government, consumers, healthcare providers, and the healthcare system, such as:

  • More accurate reporting
  • Reduced medical errors
  • Collection of “real-world data”
  • Patients can track their own devices
  • Effective management of medical device recalls
  • Addressing counterfeiting and diversion of medical devices

Who should participate in the consultation?

Health Canada is seeking feedback from industry professionals, provinces and territories, health care organizations, and the general public.

Interested parties can participate in the public consultation. The consultation will close on September 30, 2021.

How We Can Help

Quality Smart Solutions offers many avenues of support including full support for obtaining any Medical Device License. Our team is equipped with professionals who have extensive experience in the Canna, Pharmaceutical, Natural Health Product, Food and Medical Device industries.

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CFIA & Health Canada Policy on Food Labelling

Health Canada and the CFIA (Canadian Food Inspection Agency) are teaming up to plan advancements and improvements for the timing of food labelling changes in Canada. This is in accordance with the most recent 2019 Agri-food and aquaculture sector regulatory review roadmap. Changes of this nature may be required based on aligning with Canadian and International standards, for scientific improvements or to keep Canadians safe and healthy. 

The goal is to enhance coordination between the departments and make the food labelling change process more predictable. Implementing these changes would reduce the cost needed to make multiple changes required by each governing body at separate intervals. The alignment of requirements will make things more efficient and cost-effective for the industry to implement. 

The essential components of this project are:

  1. Establishing a process for interdepartmental food labelling changes
  2. Establishing predictable (2-year) compliance dates

Consultation

Based on consultation from February to April 2021, comments were received from 32 parties. The summary is available for the public at the official website of Health Canada.

USA

The USA currently uses a 2-year (1-3 year) transition period for these types of changes. The US FDA and USDA align and publish new rules that culminate in a two-year compliance window. This timeline allows the industry to make changes and use up current inventory. Currently, the USA is the only country with a published labelling cycle for foods. 

Scope

Regulatory amendments that do not initiate a label change would be considered out of scope for this program. Business decisions to update labels vs. government-required updates would be the deciding factor here. 

Compliance Dates

The compliance date would be the date of registration. Two-year intervals for label changes will start in January 2026. This will align with US rules.  Product owners are responsible for ensuring their food products meet regulatory requirements including labelling. Health Canada and the CFIA will continue using their risk-based approach to product oversight. 

Transition Period

Transition periods will range from 1-3 years and will be individually tailored based on the extent of the change required with any new regulatory requirement. This piece will be built into the consultation period of any new/proposed regulation that requires food labelling changes. 

For predictability purposes, the minimum transition time will be 2 years, unless there is a safety concern. Any complicated or multi-level changes brought on by regulatory requirements/updates may have multiple deadlines, these will be communicated within the proposal/consultation for each regulatory revision.  

Exceptions

Areas or items that are detrimental to human risk will be assigned a different timeline. As these label updates are of greater concern shorter update timelines would likely be assigned to allow shift revisions and prevent injury/harm. 

Regulatory Development

Updates to new policies and guidance documents will follow this new clear approach. This establishes an open path for aligned label changes at predictable intervals. Scope, complexity, and cost are all factored into new consultations. Long intervals limit flexibility for factors like scope and complexity. 

Further Assistance

For any questions regarding this policy, any food labelling needs or help with product registration/classification that you may have, please reach out to our team of specialists!

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Important Notice Regarding the Transition of COVID-19 Site Licenses

In March 2020, Health Canada introduced interim measures to expedite the issuance of site licences for alcohol-based hand sanitizers, to address the shortage of these products due to the COVID-19 pandemic. Alcohol-based hand sanitizers are considered natural health products (NHP) and all Canadian companies engaged in manufacturing, packaging, labelling, or importing a natural health product for sale, require a natural health product site licence.

However, as the demand for alcohol-based hand sanitizers stabilizes, the interim order is approaching an end. The Natural and Non-Prescription Health Products Directorate (NNHPD) of Health Canada has set forth that temporary COVID-19 site licences (COVID-19 SL) for manufacturing, packaging, labelling and/or importing alcohol-based hand sanitizers will expire on September 30, 2021. Health Canada issued a bulletin to all temporary COVID-19 SL holders that gave a 60-day notice period in advance for the end of interim measures.

Therefore, COVID-19 SL holders are presented with two options prior to licence expiry:

  1. Stop manufacturing, importing, packaging, labelling, or distributing alcohol-based hand sanitizers.
  2. Apply for a valid SL to continue producing hand sanitizer until you receive a decision on your application.

If the SL holder would like to continue activities beyond September 30, 2021, then a complete site licence application (SLA) must be submitted, as per Section 28 of the NHPR, by September 30, 2021, at 11:59 pm PST. The applicant will be required to complete the web SLA form and must select the “COVID-19 SL Transition” option. The applicant will also be required to demonstrate compliance with the Good Manufacturing Practices (GMPs) (i.e. Quality Assurance Report (QAR), and applicable testing, release, and batch records).

Once the SLA form is completed and GMP evidence documents are collected, the applicant then must retrieve the ePost Connect conversation thread. If the applicant does not have a COVID Applications conversation, Health Canada has recommended to contact the following e-mail address: hc.nnhpd-dpsnso.sc@canada.ca with the subject line “COVID transition – No applications conversation”. It is worth noting that any applications submitted through other means will not be accepted.

If Health Canada deems that the application requires more information to be sent, then an Information Request Notice (IRN) may be sent. The IRN will state a timeline and define the additional information required. Failure to respond adequately or on time will result in an application refusal.

The service standards normally in place for new applications will not apply to COVID-19 SL transition applications. Therefore, temporary COVID-19 SL holders will be allowed to continue activities under the temporary licence, until a decision is issued. The NNHPD is striving to issue an acknowledgement within 30 days of receiving the application. Please be advised, if you receive a site licence, you will be required to renew it within one year.

Alternatively, if you wish to discontinue activities under the COVID-19 SL licence, Health Canada has requested that you send an email to the following e-mail address; hc.nnhpd-dpsnso.sc@canada.ca ahead of the September 30, 2021, end date. The email will need to include a cover letter, reference your COVID-19 SL number and the discontinuation date.  

It is important to understand that if you choose to discontinue activities, you may liquidate the remaining stock that was imported or manufactured while the interim COVID-19 SL was valid. You will be asked to confirm that you have ceased licensable activities. Also, you must retain samples of your products and records to enable a recall should the need arise.

In the event you have already stopped or never carried out activities under your interim COVID-19 site licence, you can notify the NNHPD that you wish to discontinue your license ahead of the September 30 deadline, following the same directions as above.

If you take no action, the activities listed on your interim COVID-19 SL will no longer be allowed after September 30, 2021.

 

How Quality Smart Solutions can help:

We offer site license application services that consist of preparing and submitting applications, as well as handling communication with Health Canada. Also, our sister company, Quality IMPORT Solutions, can be your importer of record. Our team of experts can handle all site licencing matters and are happy to help you with future projects or questions! Please find our contact information here: Contact our Compliance Experts to get a Permanent Site License.

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