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FDA Releases Draft Guidance on Enforcement Discretion for Certain NAC Products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On April 22, 2022, the U.S. Food and Drug Administration (FDA) announced the release of a draft guidance on the policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC).

The draft guidance, when finalized, will outline how the FDA will exercise enforcement discretion with respect to the sale and distribution of certain NAC-containing dietary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 In the interim, the FDA issued this draft guidance to explain the policy regarding products labeled as dietary supplements that contain NAC.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on the use of NAC in dietary supplements, the FDA would intend to exercise enforcement discretion (as described in the draft guidance) until either of the following occurs: completion of notice-and-comment rulemaking to allow the use of NAC in or as a dietary supplement or denying the citizen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.

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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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Prescription Drugs: Interim Implementation of Electronic Labelling

 

Interim Implementation Electronic Labelling of Prescription DrugsBackground

On April 22, 2022, Health Canada issued a notice to the industry on the interim implementation of electronic labelling for human prescription drugs. Consultation on the draft guidance “Electronic media in prescription drug labelling” was open between March 12, 2021, and May 7, 2021. The guidance document released by Health Canada outlines the expectations for distributing information about a prescription drug product using an electronic platform that is linked to that drug product’s label.

An electronic platform refers to any type of electronic technology used to distribute information, for example, a website. A link refers to any type of reference on a label that points to or provides access to an electronic platform such as a barcode or web address.

A drug label is any legend, word, or mark attached to, included in, belonging to, or accompanying a drug. Traditionally, this would include a drugs:

  • package inserts
  • inner and outer labels
  • product monograph (PM)
  • any other physical materials that are included in the drug package or supplied at the time of dispensing

Health care providers and medical patients have become more reliant on digital technologies as a source of health information. To facilitate access to this information, some sponsors have submitted applications to Health Canada seeking authorization to add useful information to prescription drug labels, such as 2D bar codes and web addresses/URLs. These links guide users to a product-specific electronic platform with the help of an electronic device such as a phone or tablet.

Interim Implementation Approach

Health Canada has confirmed that in general, replacement of physical labels (package inserts and other physical materials noted above) with ‘electronic labels’ is not being considered at this time for human prescription drugs. If Sponsors would like to include ‘links’ on their physical product labels directing end-users to electronic platforms, the information contained on such electronic platforms should be limited only to the most up-to-date approved Product Monographs and/or Risk Management Plans or other Health Canada approved documents such as risk communications (i.e., verbatim copies). Health Canada has stated that this interim implementation approach may be revisited in the future, after further consultation with stakeholders.

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Conclusion

The interim implementation approach proposed by Health Canada will streamline the regulatory process for both Sponsors and Health Canada, while also facilitating access to up-to-date approved labelling information to end-users.

Sponsors must continue to ensure that their broader electronic platforms remain in compliance with regulatory advertising requirements. At this time, there are no restrictions on what kind of ‘links’ may be used but consideration should be given to ensure adequate accessibility and legibility of the physical labels.

There will be no impact on any previously approved physical labels containing ‘links’ to information included on electronic platforms. The interim implementation approach will be applied on a go-forward basis. Sponsors are encouraged to reach out to relevant operational areas and through regular engagement channels (e.g., pre-submission meetings) to discuss their labelling submission requirements and/or proposals.

How Quality Smart Solutions can help

The experts at Quality Smart Solutions can support your compliance needs for drugs, natural health products, foods, cosmetics, and medical devices in North America. Contact Quality Smart Solutions today! We can help.

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References

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/notice-interim-implementation-electronic-labelling-human-prescription-drugs.html

 

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7 Principles of HACCP: Everything you need to know before building a HACCP plan

What is HACCP?

A common question that comes up in regulated industries, such as food manufacturing and processing, is “What is HACCP?”. HACCP stands for Hazard Analysis Critical Control Point. HACCP is a widely recognized food processing concept that was developed to enhance the production of safe food.

When is HACCP Used?

HACCP is designed for use in all segments of the food industry from growing, harvesting, processing, manufacturing, distributing, and merchandising to preparing food for consumption. Food safety systems based on the HACCP principles have been successfully applied in food processing plants, retail food stores, and foodservice operations.

How does HACCP work?

The HACCP system involves reviewing each step of the food manufacturing process, from start to finish, to identify every possible hazard or source of contamination. Hazards can be biological (e.g., pathogenic microorganisms), chemical (e.g., pesticides, allergens), or physical (e.g., extraneous material). For every identified hazard or source of contamination, a reliable control or procedure is put in place to ensure that contamination does not occur or is controlled to an acceptable level. Prerequisite programs such as current Good Manufacturing Practices (cGMPs), which address areas such as pest control, traceability & recall, hygiene, and sanitation, are an essential foundation for the development and implementation of successful HACCP plans.

What are the 7 key principles of HACCP?

HACCP outlines seven principles that are key to ensuring the safety of food:

1. Conduct a Hazard Analysis – The initial process of identifying potential hazards that could occur in a food business.

2. Identify Critical Control Points – A Critical Control Point (CCP) is a point in the food preparation process where hazards can be reduced, eliminated, or prevented.

3. Establish Critical Limits – A critical limit is a maximum or minimum value to which a food safety hazard (biological, chemical, or physical) must be controlled. Often critical limit guidelines are set by government regulators.

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4. Monitor Critical Control Points – Monitoring each CCP is essential to make sure that hazards don’t go beyond the critical limits set. Generally, monitoring can be broken down into four different categories: observation, sensory, chemical, and physical.

5. Establish Corrective Actions – If a hazard exceeds its critical limit, corrective action must be taken. Corrective actions are either immediate or preventative.

6. Establish Record-Keeping – Comprehensive and up-to-date records must be kept of any hazard along with details of any corrective actions. These records are kept together in a living document called a Food Safety Plan which is part of a Food Safety Program.

7. Establish Verification Procedures – Verification procedures can help determine if your Food Safety Plan works to prevent the hazards identified. It is important to perform an audit of your Food Safety Plan at least once a year to ensure that everything is working.

Why is HACCP important?

HACCP principles are essential for any business involved in the food industry, including yours. A Food Safety Plan can protect your business from being the cause of a foodborne illness outbreak or severe allergic reaction from food allergens. These incidents can cause your customers to become ill or injured, and your brand and bottom line to suffer.

Proper implementation of a HACCP program helps reduce the likelihood of customer complaints or a recall by identifying and controlling potential hazards which may come from raw materials, facility processes, and human error.

How Quality Smart Solutions can help

Quality Smart Solutions offers regulatory solutions for food label compliance, HACCP, and Preventive Control Plans (PCP). Our experts are here to help and offer any food safety regulatory advice!

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Top 6 Questions to ask about OTC Drugs

1. What are over-the-counter drug products (OTC drugs)?

Non-prescription drugs also called over-the-counter (OTC drugs), are health products that can be bought without a doctor’s prescription. OTC drugs can include things like hand sanitizer, sunscreens, cold & flu medication, and medicated topical products such as skin treatments, lip ointment, and anti-fungal creams.

2. What licensing is required for OTC drugs?

Non-prescription drugs require a valid Drug Identification Number (DIN) to be sold in Canada. On a product label, this number indicates the drug has met our requirements for safety, quality, and effectiveness.

Furthermore, Canadian companies that manufacture, package, label, and import OTC drugs must:

A DEL is provided after a satisfactory inspection.

3. What is a DIN and how does it apply to OTC drugs?

A Drug Identification Number (DIN) is an eight-digit number that is assigned by Health Canada to OTC drugs prior to them being marketed in Canada. The DIN is a unique number that identifies all drug products sold in a dosage form in Canada. The DIN is located on the label of prescription and OTC drugs that have been evaluated and authorized for sale in Canada.

4. Can a product classified as an OTC drug be sold without a DIN?

If a product defined as a drug under the Food and Drugs Act is sold without a DIN, it is not in compliance with Canadian law, and regulatory action will be taken.

Looking for assistance with securing DIN numbers for your OTC drugs?

5. How do I obtain a DIN for my OTC drugs?

To obtain a DIN for your OTC drugs, a DIN submission must be filed with Health Canada. Prior to issuing DINs, Health Canada’s Drugs Directorate requires the submission of sufficient data to evaluate the safety and efficacy of a drug for its intended use. A submission for a DIN should contain the following information for review:

  • a completed Drug Submission Application, including proposed Canadian labels and prescribing information or a package insert where applicable
  • a completed DIN Submission Certification or Category IV Drug Submission Certification as appropriate
  • specific product type information as requested by Health Canada

6. How long does it take to get a DIN for my OTC drugs?

Health Canada offers the following service standards for DIN submissions:

  • DIN-A – Drug Identification Number Application (Labelling Only) – 180 days
  • DIN-A – Drug Identification Number Application (Labelling Standard) – 45 days
  • DIN-D – Disinfectant Drug Identification Number Application (Non-Clinical/Clinical Only) – 210 days
  • DIN-D – Disinfectant Drug Identification Number Application (Labelling Only) – 180 days
  • DIN-D – Disinfectant Drug Identification Number Application (Labelling Standard) – 45 days
  • DIN-F – Category IV Monograph Drug Identification Number Application (Labelling Standard) – 45 days

How Quality Smart Solutions can help

Our Experts at Quality Smart Solutions are here to help and offer any drug-related regulatory advice and support on successfully securing your DIN, responding to potential information requests, keeping your license updated, and reviewing your drug labels. Contact us today to learn more about how we can support your compliance needs during and after licensing! Please find our contact information here: 

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Health Canada Marketing Authorization Update – Increased Vitamin D

On January 19, 2022, Health Canada announced a marketing authorization (MA) to permit manufacturers to voluntarily increase the amount of Vitamin D in cow’s milk, goat’s milk and margarine.  This was decided in order to facilitate alignment and compliance with the Regulations Amending the Food and Drug Regulations (Nutrition Labelling, other Labelling Provisions and Food Colours).

Background

Vitamin D is a key nutrient that helps the body use calcium and phosphorus to maintain strong bones and teeth. Vitamin D can be obtained from food and supplements and can be made by the body after exposure to sunlight. Vitamin D deficiency can lead to rickets in children and Osteomalacia (softening of the bones) in adults.

The Food and Drug Regulations (FDR) set out the daily value (DV) for vitamin D (i.e. a value that would meet the vitamin D requirements of almost all Canadians) as well as the amount of vitamin D required in cow’s milk and margarine, and permitted in goat’s milk. Manufacturers cannot increase the amount of vitamin D in foods beyond what is currently set out in the FDR.

However, Health Canada has made plans to increase Vitamin D intake with the public health objective of promoting adequate bone health among Canadians without excessive Vitamin D intake. As a first step, Health Canada proposed increases to the amount of Vitamin D required in cow’s milk and margarine and permitted in goat’s milk, as these are the biggest contributors of Vitamin D in the Canadian diet.

Benefits of this change

This marketing authorization will have the following benefits:

  • Helping to promote adequate bone health among Canadians by permitting an increased amount of vitamin D in cow’s milk, goat’s milk and margarine;
  • Allowing for the possibility of financial savings for manufacturers who have not already updated their product labels to comply with the 2016 nutrition labelling regulations. For these manufacturers, the MA enables a single label change (rather than multiple changes) to account for an increase to vitamin D amounts and meeting the requirements set out in the 2016 nutrition labelling regulations
  • Allowing manufacturers to continue to market cow’s milks and goat’s milks as an “excellent source” of vitamin D, thus providing a marketing benefit to manufacturers and
  • Helping to reduce the risk of illness related to certain bone diseases and therefore potentially reduce health care spending on the treatment of these diet-related diseases

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Implementation

Public education efforts to help Canadians understand how best to use nutrition labelling to make informed food choices is ongoing. In addition, Health Canada will post information about the marketing authorization on its website and will notify stakeholders. Industry is not required to submit a premarket notification or a Temporary Marketing Authorization application in order to apply the increased vitamin D levels for cow’s milk, goat’s milk or margarine. Therefore, action can be taken immediately, but must follow the applicable rules and regulations.

Compliance and Enforcement

Compliance and enforcement of the marketing authorization will be incorporated into existing activities carried out by the Canadian Food Inspection Agency (CFIA). The CFIA is responsible for the enforcement of the Food and Drugs Act as it relates to food. While it is the responsibility of the industry to comply with regulatory requirements, compliance will be monitored as part of ongoing domestic and import inspection programs. Appropriate enforcement action will be taken based on risk.

How Quality Smart Solutions can help

Quality Smart Solutions can help your business with food label compliance (Canada & USA), food importing, GRAS, food quality and much more. Our specialists are here to help!  

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Top 10 Fruitful Medical Device Development Principles

Regulatory agencies across the globe, including the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA), have come together to identify 10 guiding principles that can inform the development of Good Machine Learning Practice (GMLP). The goal of GMLP is to help promote safe, effective, and high-quality medical devices that use artificial intelligence and machine learning (AI/ML).

The 10 guiding principles compiled by the regulatory agencies will hopefully lay the foundation for developing Good Machine Learning Practice that address the unique nature of medical devices using artificial intelligence and machine learning. They will also help cultivate future growth in this rapidly progressing field.

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The 10 guiding principles may also be used to

  • Adopt good practices that have been proven in other sectors
  • Tailor practices from other sectors so they are applicable to medical technology and the health care sector
  • Create new practices specific for medical technology and the health care sector

The 10 guiding principles are summarized below: 

1. Multi-Disciplinary Expertise Is Leveraged Throughout the Total Product Life Cycle: It’s important to have a thorough understanding of a device’s intended integration into clinical workflow (e.g. desired benefits, associated patient risks) to help ensure that the medical device is safe and effective and addresses clinically meaningful needs.

2. Good Software Engineering and Security Practices Are Implemented: Model design is implemented with attention to the “fundamentals”: good software engineering practices, data quality assurance, data management, and robust cybersecurity practices. 

 3. Clinical Study Participants and Data Sets Are Representative of the Intended Patient Population: Data collection protocols should ensure that the relevant characteristics of the intended patient population (e.g. age, gender, sex, race, and ethnicity), use, and measurement inputs are sufficiently represented in a sample of adequate size in the clinical study and training and test datasets, so that results can be reasonably generalized to the population of interest. 

4. Training Data Sets Are Independent of Test Sets: Training and test datasets are selected and maintained to be appropriately independent of one another.

5. Selected Reference Datasets Are Based Upon Best Available Methods: Accepted, best available methods for developing a reference dataset (that is, a reference standard) ensure that clinically relevant and well characterized data are collected and the limitations of the reference are understood. 

6. Model Design Is Tailored to the Available Data and Reflects the Intended Use of the Device: Model design is suited to the available data and supports the active mitigation of known risks, like overfitting, performance degradation, and security risks. The clinical benefits and risks related to the product are well understood, used to derive clinically meaningful performance goals for testing, and support that the product can safely and effectively achieve its intended use. 

7. Focus Is Placed on the Performance of the Human-AI Team: Where the model has a “human in the loop,” human factors considerations and the human interpretability of the model outputs are addressed with emphasis on the performance of the Human-AI team, rather than just the performance of the model in isolation.

8. Testing Demonstrates Device Performance During Clinically Relevant Conditions: Statistically sound test plans are developed and executed to generate clinically relevant device performance information independently of the training data set. 

9. Users Are Provided Clear, Essential Information: Users are provided ready access to clear, contextually relevant information that is appropriate for the intended audience (such as health care providers or patients) including: the product’s intended use and indications for use, performance of the model for appropriate subgroups, characteristics of the data used to train and test the model, acceptable inputs, known limitations, user interface interpretation, and clinical workflow integration of the model. 

10. Deployed Models Are Monitored for Performance and Re-training Risks Are Managed: Deployed models have the capability to be monitored in “real world” use with a focus on maintained or improved safety and performance. Additionally, when models are periodically or continually trained after deployment, there are appropriate controls in place to manage risks of overfitting, unintended bias, or degradation of the model (for example, dataset drift) that may impact the safety and performance of the model as it is used by the Human-AI team.

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FDA Requests Information Relevant to the Use of NAC as a Dietary Supplement

On November 24, 2021, The Food and Drug Administration (FDA) sent correspondence to industry requesting information on the past use of N-acetyl-L-cysteine (NAC) in products marketed as dietary supplements.

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. Recently, the FDA has been issuing warning letters to companies marketing dietary supplements with NAC that are indicated for the treatment of hangovers. The reason for this is that products containing NAC do not meet the definition of a dietary supplement (since NAC was already categorized as a drug in 1963).

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Earlier this year, the FDA received two citizen petitions asking the agency to reconsider its position on the use of NAC as a dietary supplement.

The Council for Responsible Nutrition (CRN) was pulled into the matter and requested the FDA consider reversing the agency’s position on NAC-containing products (ie. that NAC-containing products can be dietary supplements). In addition, the Natural Products Association (NPA) requested the FDA to either determine that NAC is not excluded from the definition of a dietary supplement or enact legislation to make NAC a lawful dietary supplement under the Federal Food, Drug, and Cosmetic Act

On November 24, the FDA issued responses to both petitions in which they requested additional information from the petitioners and any interested parties. The agency noted that more time is needed to carefully and thoroughly review the complex questions posed in these petitions.

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As such, to help the agency respond to these petitions, the FDA is interested in receiving data and evidence as to the earliest date that NAC was marketed as a dietary supplement or as a food, the safe use of NAC in products marketed as a dietary supplement, and any safety concerns with products containing NAC. The FDA will use the information submitted to the public docket and other applicable information to determine if changes to legislation to make NAC lawful as a dietary supplement is appropriate.

The FDA is asking interested parties to submit any information by January 25, 2022, while the agency continues to evaluate both citizen petitions. The agency will use the information submitted for analysis and provide a final response to both petitioners directly once the review is completed.

Individuals may submit electronic comments or written comments regarding these petitions at any time up until the docket is closed; submissions must be received by January 25, 2022, in order to ensure that the FDA is able to review all information in a timely manner. Submit electronic comments to Regulations.gov.

How We Can Help

Our Experts at Quality Smart Solutions can offer support to your needs for dietary supplements, foods, cosmetics, OTC drugs and medical devices for North America.

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Top 9 Cosmetic Compliance Label Components | Health Canada Cosmetics Regulations

What is a Cosmetic?

Cosmetics are a part of just about everyone’s life. Every day, most of us use products like soap, moisturizing creams, or shampoo. In Canada, cosmetic products are defined as “any substance or mixture of substances, manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants and perfumes.” All cosmetic products sold in Canada must comply with the Canadian Food and Drugs Act and its Cosmetic Regulations. Before selling any cosmetic products according to section 30 of the Cosmetic Regulations, all manufacturers and importers are required to submit a fully completed Cosmetic Notification Form (CNF) to Health Canada within the first 10 days of the first sale within Canada. 

Are your Cosmetic Ingredients safe by Health Canada Standards?

Most cosmetics are safe, but they can sometimes cause health problems, like allergic reactions and skin irritation. To determine if an ingredient is safe for use in cosmetics, You must ensure that none of the ingredients are restricted as shown on the Cosmetic Ingredient Hotlist. You can also refer to Health Canada Cosmetic Safety for more information related to cosmetic safety and other adverse effects.

What are the Key Components I Need on My Cosmetic Label?

Manufacturer Name

Sometimes the consumer or other interest groups must know the identity of the party that is responsible for a product. This party is often known as the manufacturer or dealer. Therefore, cosmetic labels need to include the name of the manufacturer or dealer if they need to be contacted.

INCI Name

The INCI name refers to the International Nomenclature of Cosmetic Ingredient name. INCI is the acceptable terminology for listing ingredients on the label. The INCI names are based on Latin and considered multi-lingual therefore the French or English ingredient names do not need to be provided on the label, only the INCI names. 

Outer Label 

The outer label is often described as the outer carton label (i.e., the label on a box containing a bottle of a cosmetic product). On the outer label, the declaration of product identity must appear in both English and French on the principal display panel. The declaration must contrast both with the background of the label and all other information. All cosmetic products require the ingredient names to be listed on the outer label. Ingredients must be listed in decreasing order of predominance in their concentration by weight

Inner Label 

On the inner label, the declaration of product identity must appear in both English and French on the principal display panel. The declaration must contrast clearly with the background and all other information that appears on the label.

Obvious Identity: In certain cases, if the identity of a product such as an eyebrow pencil, an automatic mascara applicator, or a compact including powder and puff may be considered obvious, a written declaration of product identity would not be necessary. However, if the product is in an opaque container, the identity of the product must be expressed. 

Single Expressions: Certain expressions are considered officially bilingual in themselves, such as “parfum,” “eau de toilette,” or “cologne.” The requirements are the same as those for the outer labels of products that have both an outer and inner label. 

Additional Panels: The labels of some pre-packaged products are composed of one or more additional panels of the same size and prominence as the principal display panel. The product identifier may be given on the principal display panel in only one of the two official languages if it is also given in the other language on one of the other panels.

Typeface: There is no restriction concerning the typeface that may be used. The information, however, must be legible.

Net Quantity of the Product

The packaging and label should be constructed or presented in such a way that the consumer will not be misled about the quality or quantity of the product contained inside.

As required by sections 22, 23, and 36 of the Consumer Packaging and Labelling Regulations, the declaration of the net quantity of a pre-packaged product must be expressed

  • by volume when the product is a liquid, gas, or viscous substance (mL, L) 
  • by weight when the product is a solid (g, kg) 

Cosmetic Notification

Failure to notify Health Canada may result in a product being refused entry into Canada or removed from sale. A Cosmetic Notification is not a product application, evaluation, or approval procedure.  You are required to make sure that the product is classified as a cosmetic and complies with all regulatory requirements. Our Experts at Quality Smart Solutions can help review your ingredients, file your Cosmetic Notification and ensure you have a compliant label. Contact us today to learn more about how we can support your smooth entrance to market as well as your compliant needs during and aftermarket. 

References

Canada, Health. “Government of Canada.” Canada.ca, / Gouvernement Du Canada, 22 July 2020, https://www.canada.ca/en/health-canada/services/consumer-product-safety/reports-publications/industry-professionals/labelling-cosmetics.html.

Canada, Health. “Government of Canada.” Canada.ca, / Gouvernement Du Canada, 16 Feb. 2021, https://www.canada.ca/en/health-canada/services/consumer-product-safety/cosmetics/regulatory-information.html.

Branch, Legislative Services. “Consolidated Federal Laws of Canada, Consumer Packaging and Labelling Regulations.” Consumer Packaging and Labelling Regulations, 16 Nov. 2021, https://lois-laws.justice.gc.ca/eng/regulations/C.R.C.,_c._417/.

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FDA Issues Sodium Reduction Final Guidance

On October 13, 2021, the U.S. Food and Drug Administration (FDA) issued final guidance for the food industry that provides voluntary, short-term (2.5 years) sodium reduction targets for a broad range of processed, packaged, and prepared foods to help reduce the amount of sodium in the U.S. food supply.

It is widely known that humans require small amounts of sodium as part of the daily diet, however, consuming too much sodium can increase the risk of high blood pressure and heart disease. Most dietary sodium (over 70%) comes from eating packaged and prepared foods—not from table salt added to food when cooking or eating. The food supply contains too much sodium and Americans who want to consume less sodium can have a difficult time doing so. That is why the U.S. Food and Drug Administration is working with the food industry to make reasonable reductions in sodium across a wide variety of foods. 

The sodium reduction targets in the guidance are designed to support decreasing average daily sodium intake by about 12%—from approximately 3,400 milligrams (mg) to 3,000 mg per day. Hopefully, this reduction results in tens of thousands of fewer cases of heart disease and stroke and billions saved in healthcare costs. The FDA believes these targets are feasible to achieve in two and a half years and covers both manufactured foods and foods prepared by commercial establishments, such as restaurants.

sodium_proccess

The FDA has modified the voluntary sodium targets, timeframe, certain food categories, and descriptions in the final guidance. The guidance extends the milestone date for the short-term goals from 2 years in the draft guidance to 2.5 years from the publication of the final guidance.

The FDA is not finalizing the long-term (10-year) sodium reduction targets. The agency plans to continue its dialogue with the industry, monitor and evaluate progress in achieving the short-term targets, and expects to issue revised subsequent targets in a few years to facilitate a gradual, iterative process to reduce sodium intake. 

How we can help

Our Experts at Quality Smart Solutions can offer support to your needs for dietary supplements, foods, cosmetics, OTC drugs, and medical devices for North America.

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FDA Warning Letters Targeting N-Acetyl Cysteine (NAC) Supplements

Background on NAC

N-acetyl-L-cysteine (NAC supplement) 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, according to a summary of the study sponsored by the Memorial Sloan Kettering Cancer Center in New York. NAC is an amino acid that was approved by the FDA as a drug in 1963. 

NAC has also been widely marketed in another category of products overseen by the FDA—dietary supplements. However, there have been several instances where the FDA has challenged the legality of NAC use in dietary supplements.

FDA Warning Letters

In 2010, the FDA issued a warning letter indicating that it believed that NAC was a drug and as such is not allowed to be used as an ingredient in dietary supplements. However, the FDA has still received several dietary supplement claims notifications including NAC as an ingredient tied to a structure/function claim. Up until recently, NAC had been successfully marketed as a dietary supplement product with no enforcement action.

As of recently, the FDA has issued warning letters to companies marketing dietary supplements indicated for the treatment of hangovers, as the ingredient NAC is excluded from the definition of a dietary supplement (since it was already categorized as a drug in 1963). Dietary Supplement products containing NAC are considered an unapproved drug product, and therefore illegal.

Response from Retailers

Amazon has recently been quietly removing dietary supplement products containing NAC from their site, shortly after the news of FDA’s warning letters. There has also been a push by Amazon and other retailers such as Walgreens to ensure products that are being sold through their channels are compliant.

How can we help

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US Establishment Registration Renewals

It’s that time of year again! Any domestic and foreign establishments registered with US FDA must renew their registration annually between October 1st and December 31st. Even facilities that registered as late as September 30th, 2021 are still required to renew their registration. 

Facilities located outside of the U.S. must also designate a U.S. Agent to communicate with the FDA on their behalf. The FDA will not finalize a facility’s renewal until the U.S. Agent accepts the designation. Failure to renew a facility registration during the renewal period could result in the cancellation of the registration.

Drug Facilities

When an establishment registration renewal is filed with the FDA, the facility identifier will remain the same after the renewal. Drug manufacturers must have at least one drug listing with the FDA to keep their establishment registration and NDC label code active. 

Medical Device Facilities

Foreign manufacturers of medical devices whose products are available in the US Market must identify all US Importers at the time of registration renewal. US Importers are required to identify all foreign manufacturers at the time of registration renewal. 

Food Facilities

Section 415 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) requires food facilities that are registered with FDA to renew such registrations during the period beginning on October 1 and ending on December 31 of each even-numbered year (2020, 2022, 2024, etc.). Therefore, food facility registrations will need to be renewed next year.

How We Can Help

Our Experts at Quality Smart Solutions can offer US regulatory compliance services for dietary supplements, foods, cosmetics, OTC drugs and medical devices.

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

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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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Consultation on Proposed Feeds Regulations

On June 12, 2021, the Canadian Food Inspection Agency (CFIA) opened a consultation as part of the process to modernize the Feeds Regulations, 1983. The consultation to obtain feedback from the public will close on September 10, 2021. The pre-published proposed regulations are currently posted in the Canada Gazette, Part I for individuals to read through prior to participating in the consultation.

What are the Feeds Regulations?

The Feeds Regulations, 1983, set out requirements for the importation, manufacture, and sale of feed (including feed ingredients) in Canada. Feed is defined as “animal food” which is also regulated by the Health of Animals Regulations. These regulations also regulate the use of rendered animal protein products (e.g. animal meat and bone meal, feather meal, tallow, poultry fat) for use in ruminant and other animal feed.

The CFIA verifies that livestock feed manufactured, sold or imported in Canada are:

  • safe for animal health and the environment
  • effective for animal production
  • comply with standards
  • are labelled appropriately 
  • are safe for livestock that would be used for human consumption (meat, milk, eggs)

What is the objective of this modernization process?

The amendments that are being proposed to the Feeds Regulations, 1983 are required to ensure that a more robust regulatory framework is placed. This would include things such as hazard identification, preventive controls, traceability, increased record-keeping requirements and licensing requirements. 

These measures would allow the CFIA to better understand and manage risks that livestock feeds pose to human, animal and plant health and the environment. In addition, they would allow the proposed Regulations to align with international frameworks and best practices.

What are some of the key changes being proposed?

The proposed Regulations would apply to feed ingredient and mixed feed manufacturers, feed retailers and distributors, feed importers and exporters, as well as on-farm feed manufacturers that sell off the farm or incorporate any drug or other substance that presents a risk of harm to human or animal health or the environment into their feeds. The scope of the framework would apply to the domestic supply chain as well as to feeds being imported and exported.

Scope of species — Definition of livestock

The additional species to which the Feeds Act and the proposed Regulations would apply are game birds, ratites, bison, water buffalo, cervids, llamas, alpacas, molluscs, crustaceans and bees. Mink and fox would be removed, as they are not considered food producing animals.

Incorporation by reference

The amendments would incorporate by reference nine documents, written, maintained and published by the CFIA:

  • Canadian Feed Ingredients Table;
  • Compendium of Medicating Ingredient Brochures;
  • Compendium of Non-Feed Product Brochures;
  • Tables of Nutrient Guarantees and Conditions for Feed Labels;
  • Tables of Permissible Claims for Feed Labels;
  • List of Weed Seeds and Maximum Levels for Feeds;
  • Tables of Maximum Nutrient Values for Feeds;
  • Tables of Maximum Contaminant Levels for Feeds; 
  • List of Prescribed Deleterious Substances.

Permissions (approvals, registrations and licences)

An updated, clearer and broader permissions approach for feed products (approvals and registrations) and individuals (licensing) would be established in the proposed Regulations. This includes:

  1. Feed ingredient approval
  2. Feed registration
  3. Licensing of individuals

General and safety standards for feeds

General and safety standards for feed would be updated to better reflect current science, risks, production practices and technology. 

Labelling

Labelling requirements would be updated to reduce prescriptiveness and rigidity, provide better information to purchasers, with health and safety labelling requirements to appear in both official languages. Improved flexibility would be provided by allowing additional information, such as claims and guarantees, to be added to the label without requiring the feed to be registered. To increase the traceability of feeds through the supply chain (in the event recalls are necessary), feeds would need to be labelled with a lot number/identification code. 

Mandatory bilingual labelling requirements would be required for any label information that could impact the health and safety of the purchaser or livestock to be fed with the feed product. This would include medication information, and caution and warning statements.

Feed hazard identification and preventive controls

Under the proposed Regulations, regulated parties would be required to conduct a hazard identification (e.g. biological, chemical and physical hazards) for the feeds they manufacture. In addition, they would be required to develop, implement, and maintain a written preventive control plan to demonstrate how the preventive controls (e.g. cleaning and sanitation, pest control, conveyances, equipment, contaminated material, interior of the facility, movement of persons, and water, steam and ice) and other requirements (e.g. packaging and labelling) are met. 

Traceability

New traceability requirements would require more detailed record-keeping requirements to better support risk management along the feed supply chain, especially where timely responses to incidents of risks to public, animal or plant health or the environment are involved.

How do I participate in the consultation?

The first step would be to read the proposed regulations in Canada Gazette Part I. Once you have an understanding of the changes being proposed, submit your comments using the online regulatory consultation system.  You can also read the fact sheets and guidance documents to better understand the proposed regulations and join a webinar to learn more!

How We Can Help

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 for NHPs registration and importation.

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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!

How We Can Help

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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Ensuring Predictability for Interim Orders Relating to COVID-19

Health Canada recently published an additional notice regarding all interim orders relating to COVID-19 and Medical Devices. This notice is showing the understanding from Health Canada that stakeholders require predictability for applicable regulatory aspects in respect to the interim orders.

The notice will be updated with links to notices regarding any consultations, and any related measures, as they are occurring/released.

The following outlines key information and updates that were delivered through this notice.

  • The flexibilities and regulatory oversight that has been provided through the use of these IOs will be maintained until at least the fall of 2021.
  • After the fall of 2021, regulatory amendments will be introduced that will allow for many of these temporary flexibilities to continue.
  • In the coming months, interested industry stakeholders, health system partners and other government departments will be consulted by Health Canada on the proposed regulations.

Interim Orders (IOs)

An IO is one of the fastest options for change available to the federal government to help make health products available to address larger-scale public health emergencies.

The objective of the Interim Orders is to expedite any necessary authorization for the importation, sale, and advertising of drugs used in relation to COVID-19 while taking into consideration urgent public health needs.

It allows for Medical Device Establishment Licences to be issued in relation to COVID-19 drugs in a manner that ensures pandemic related medical supplies remain accessible to all Canadians.

These Interim Orders further provide the Chief Public Health Officer of PHAC the ability to notify the Minister of a need to pre-position a promising COVID-19 drug in Canada. In order for a drug to be pre-positioned, the Government of Canada must have entered into a contract for its procurement and the manufacturer must have filed an application for the drug’s authorization in Canada, or abroad with a foreign reference regulator. Together, these measures help ensure Canadians have timely access to COVID-19 drugs.

A total of 5 interim orders have been issued in response to the COVID-19 pandemic since March 2020. These IOs have focused on making changes necessary to ensure that necessary Medical Device Licenses can be issued quicker in response to the current pandemic while also ensuring that the products and licenses continue to have sufficient oversight.

The following will summarize some important information from the currently issued IOs.

Importation and Sale of Medical Devices

Part 1 of the Regulations, with the exception of sections 52 to 56 and 63 to 65.1, no longer apply to the importation or sale of a COVID-19 medical device if the following conditions are met:

  1. the Minister determines that there is an urgent public health need for the importation or sale of the device;
  2. the manufacturer of the device has filed with the Minister an application for the authorization of importation or sale of the device in a form established by the Minister;
  3. the Minister has issued the authorization; and
  4. the authorization has not been cancelled.

All shipments of COVID-19 medical devices that are imported in Canada must be accompanied by a copy of the proper authorization for importation.

Permitting Exceptional Importation of Key Products

If a shortage of a specified medical device — or of its components, accessories, parts or consumable materials — has been reported or is likely to occur, the manufacturer and the importer of the device must each submit the following information to the Minister in both English and French in the form and manner determined by the Minister:

(a) the name and contact information of the manufacturer and of the importer;

(b) in the case of a Class II, III or IV device, the medical device licence number;

(c) the identifier of the device, including the identifier of any medical device that is part of a system, test kit, medical device group, medical device family or medical device group family;

(d) the name of the device and of any component or accessory of the device, including, if applicable, the model name;

(e) a description of the device;

(f) the date when the shortage began or is anticipated to begin; and

(g) the anticipated date when the manufacturer will be able to meet the demand for the device if that date can be anticipated.

This information must be submitted within 5 days after the manufacturer or importer becomes aware of a shortage. This also applies to any anticipated shortages

If any information previously submitted by the manufacturer or importer changes, the new information must be submitted to the Minister within 2 days after the change is made or 2 days after becoming aware of the change.

Once the shortage has been resolved and the manufacturer is once again able to meet the full demand for the medical device – or for its components, accessories, consumable material or parts – the manufacturer or importer will have 2 days to notify the Minister in writing to that effect.

Specified medical devices involved in the COVID-19 interim measures can be located on the Health Canada website within the COVID-19 Health Product Industry page. (https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry.html)

Prevention and Alleviation of Drug Shortages

As previously noted, the COVID-19 pandemic has caused an unprecedented demand for certain drugs and medical devices. As such, an interim order was issued in order to properly manage the subsequent drug shortages.

Under certain conditions;

  • Anyone who sells a drug may now be required to provide information that is relevant to a (potential) shortage of that drug relating to COVID-19.
  • The Minister of Health may also impose or amend terms and conditions placed on authorizations for selling drugs.

This Interim Order will assist with trending the usage of certain drugs in order to ensure all Canadians have uninterrupted access to the necessary COVID-19 related drugs.

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

References

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/ensuring-predictability-interim-orders-notice.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/interim-order-importation-sale-medical-devices-covid-19.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/covid19-interim-order-drugs-medical-devices-special-foods.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/interim-order-drug-shortages/notice.html

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Additional Packaging and Labelling Requirements for Alcohol Based Hand Sanitizers in Beverage Containers

On October 5, 2020, the Natural and Non-Prescription Health Products Directorate (NNHPD) sent a notice to all Canadian product licence holders to announce a new policy being introduced to help reduce unintentional ingestion of alcohol-based sanitizers packaged in beverage containers.

Due to the COVID-19 pandemic and global supply shortages, the high demand for alcohol-based hand sanitizer has led to significant shortages in raw materials, products and standard packaging material. The Government of Canada issued guidance to industry on acceptable packaging materials and sizes for hand sanitizer products to ensure their availability during the COVID-19 pandemic. Manufacturers were encouraged to consider the appearance of their containers to avoid potential confusion by consumers. However, such packaging shortages have resulted in the use of unconventional types of containers such as beverage or food containers. These containers include water bottles, sports drink bottles, soda bottles, wine and liquor bottles, and children’s food pouches.

The additional flexibilities that were provided to industry on acceptable packaging materials and sizes are outlined below:

  • Any food or pharmaceutical grade packaging can be used to package hand sanitizers (for instance, bottles, bags, pouches), provided that it is chemically resistant to the hand sanitizer.
  • Although hand sanitizers are generally packed in clear (see-through) containers, appropriately graded packaging that is opaque (for example, white, coloured) can also be used.
  • Health Canada does not regulate the size of hand sanitizer packaging:
    – As long as the formulation is identical to what has been authorized by us, any size of packaging that ensures appropriate shelf-life will suffice.
    – The same Natural Product Number (NPN) can be used for different container sizes.
  • Keep the size of the opening on the container small to prevent evaporation (for instance, no wide-mouth containers
    – large openings increase the surface area where alcohol and other ingredients can evaporate, lessening the effectiveness of the product.
  • Label large-format containers used for bulk packaging as refill containers
  • Use only lids designed for use with the container to prevent contamination and evaporation
  • Use packaging that is not re-sealable only once, as this may be prone to contamination and evaporation once opened
  • Make refill formats compatible with existing pump or lid components

Furthermore, suppliers were encouraged to facilitate or advise users to continue to recycle used containers in accordance with the recommended practices and waste management systems available locally.

Unfortunately, the use of beverage containers for alcohol-based hand sanitizers may increase the risk of unintentional ingestion, as consumers are led to believe that these products are consumable products at first glance. These product packaging materials/labels and branding may be similar to the labels and branding of known alcoholic beverages or bottled water resulting in confusion of hand sanitizer for water or other beverages. Accidental ingestion of alcohol-based hand sanitizers could cause serious harm or even be fatal, particularly in children, because of the high alcohol content. Data from the Canadian Poison Control Centres (PCCs) show that the number of reported incidents related to hand sanitizer has increased in 2020 compared to 2019, up to 4.5 fold higher on a month-to-month basis.

Currently, alcohol-based hand sanitizers must comply with:

  • the packaging and labelling requirements of the Natural Health Products Regulations (NHPR)
  • Health Canada’s safety and efficacy standards as outlined in the Antiseptic Skin Cleansers monograph

All hand sanitizer products authorized for sale by Health Canada have an eight-digit Drug Identification Number (DIN) or Natural Product Number (NPN) on the label, and are listed on the List of Hand Sanitizers Authorized by Health Canada.

Currently, under the Antiseptic Skin Cleansers monograph, hand sanitizer labelling must include the following caution/warning statements:

  • For external use only
  • When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Stop use and ask/ consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops.
  • Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.
  • Flammability warning Keep away from open flame and sources of heat. (if the product contains ethanol or isopropanol)

In addition to these requirements, products cannot be marketed in a manner that misleads the consumer about its composition or safety. Otherwise, they may be viewed as contravening section 9 of the Food and Drugs Act and enforcement action may be taken by Health Canada. Under the Antiseptic Skin Cleansers monograph, hand sanitizers are permitted to make the following claims on product labelling:

  • Antiseptic (skin) cleanser
  • Medicated (skin) cleanser
  • Antibacterial (skin) cleanser
  • Kills harmful bacteria/germs
  • Effective in destroying (harmful) bacteria to provide antiseptic cleansing
  • For personal hand hygiene to help prevent the spread of bacteria

To reduce the likelihood of any further incidents of hand sanitizer ingestion, the Natural and Non-Prescription Health Products Directorate (NNHPD) is implementing a new policy requiring an alternative closure as well as an additional warning statement and symbol, to alcohol-based hand sanitizers packaged in a beverage containers.

To develop this policy document, Health Canada reviewed existing labelling requirements for other health products and consulted with experts in labelling of food and health products, industry stakeholders, consumer and patient groups, provincial and territorial governments as well as other government departments.

These measures must be put in place no later than 8 weeks after this policy comes into effect, allowing existing stock to be used up. Therefore, hand sanitizers packaged in beverage containers and distributed after November 27, 2020, must have an appropriate closure along with the warning statement and graphic. Distribution in Canada of alcohol-based hand sanitizers packaged in beverage containers without these measures must stop after this date.

Beverage or food containers that are unable to accommodate the required closures and, as such, should not be used for hand sanitizers include beer and soda cans, food and beverage pouches, tetra packs and vaping cartridges.

The intent of this new policy is to ensure hand sanitizer products packaged in beverage containers:

  • are presented to the public in a manner consistent with their market authorization
  • use a simple and symbol-based warning and
  • include the use of a closure to help prevent unintentional ingestion and injury to health

These measures are especially important for hand sanitizers that are produced by companies that:

  • are associated with beverages or other ingestible products
  • use the same containers and visual branding elements as beverages or other ingestible products

Specific details on the packaging and labelling requirements under this new policy (use of both an alternative closure and an additional warning statement and symbol) for alcohol-based hand sanitizers packaged in a beverage container are outlined below:

  • Closures such as a pump or dispensing cap are conspicuous and are not generally used on beverage containers. Such closures will help to differentiate hand sanitizer packages from beverages or other ingestible products. By having to open or use the container in this way, the consumer will understand the product is not to be consumed. These types of closures will be required for alcohol-based hand sanitizers packaged in beverage, drinking or food containers.
  • Section 95 of the Natural Health Product Regulations requires safety seals or security packaging for all natural health products, including alcohol-based hand sanitizers. These measures will continue to be required. They assure consumers that the product has not been opened or tampered with before purchase. However, they are not sufficient to reduce unintentional ingestion and do not meet the requirements outlined in this policy.
  • Acceptable closures include:
    – Pumps
    – Dispensing caps (maximum width/diameter of opening should be no more than 20% of the width of the cap):
           – flip top lids
    – disc top caps (like those on cream-type cosmetic products)
    – any cap or dispensing lid that forces interaction with the product and
    is not listed below as an unacceptable closure
    – other closures that clearly differentiate the hand sanitizer container from a beverage container and force consumer interaction
  • Unacceptable caps or closures include:
    – drinking spouts
    – beer bottle caps
    – conventional twist-off caps or lids
    – corks
  • A warning statement on the front label is considered an effective way to inform consumers that the product is not a beverage. Symbols or pictures used along with a warning statement also help to communicate potential health risks.
  • Additional labelling requirements include a front-of-pack warning featuring a red octagon with the text “Do not drink / Ne pas boire” and “Health Canada / Santé Canada.” Attributing the warning to Health Canada will lend credibility, as the public recognizes Health Canada’s role to protect the health and safety of Canadians.
  • This warning must include the text “Do not drink / Ne pas boire”
    – bolded black text on a white background
    – English and French text on separate lines in either official language order
    – font size is proportional to the size of the container, label and branding of the hand sanitizer:
    – equal to or greater than the product’s brand name or a minimum of 22-point font
    – acceptable font types include non-decorative sans serif fonts, such as Arial and Helvetica
    – letters cannot touch
  • the text “Health Canada / Santé Canada”
    – black text on a white background
    – font size can be 50% smaller than warning text (minimum font size is 11 point, Helvetica font, letters cannot touch)
  • a symmetrical octagon graphic symbol that:
    – precedes the warning statement
    – is red in colour and framed or enclosed with a black border of a minimum of 1 point weight on the white background
    – is in the same height as the stacked warning statement
  • The graphic symbol, warning statement and Health Canada attribution must appear together within a black border, of at least 1 point, with a white background to ensure visibility. The warning should appear on the top 50% of the main display panel label.
  • An example of the warning:

As mentioned above, these measures must be put in place no later than 8 weeks after this policy comes into effect, allowing existing stock to be used up. Distribution in Canada of alcohol-based hand sanitizers packaged in beverage containers without these measures must stop after this date.

Over-stickers with the graphic symbol and warning statement will be permitted for 6 months from implementation and up to April 2, 2021, or by the next labelling run, whichever comes sooner. By this date, the warning statements must be incorporated into the packaging and permanent label design. The over-sticker cannot cover other labelling text or information.

The addition of the warning over-sticker should be placed on products before distribution and as soon as possible within the 8-week implementation period. Additionally, product sponsors are expected to make every effort to shift to using traditional hand sanitizer containers.

Health Canada strongly recommends against marketing hand sanitizers to children given the additional heightened risk to this vulnerable subpopulation. For additional information, please see Health Canada’s public advisory on hand sanitizers and children’s safety and the consumer advertising guidelines for marketed health products.

Compliance and Enforcement

Enforcement efforts will focus on compliance monitoring and promotion. Health Canada will consider escalated enforcement if risks to health and safety are identified.

When Health Canada identifies or is notified of potential non-compliance with the Food and Drugs Act and/or its Regulations, the information is assessed. A case may be opened to verify if non-compliance has occurred. Each case is assessed and prioritized, and the appropriate compliance action is taken in proportion to the risk posed to the public. The main goal of Health Canada’s compliance and enforcement approach is to manage the risks to Canadians by using the most appropriate level of intervention.

For more information on Health Canada’s national compliance and enforcement approach for health products regulated under the Act and its regulations, please refer to the compliance and enforcement policy (POL-0001).

As demand for hand sanitizers, disinfectants and medical devices 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!

How We Can Help

At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.

Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.

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Regulatory Considerations for Non-Medical Masks or Face Coverings

Earlier this summer, Health Canada provided a notice to industry on the regulatory considerations for non-medical masks or face coverings, and the circumstances under which such masks or face coverings would be subject to the regulatory requirements for medical devices during the COVID-19 pandemic.

Generally, non-medical masks or face coverings are made of fabric and come in various shapes, sizes and styles. They are typically sewn and secured with ties or straps around the head or behind the ears. They may be made in a factory, by a home-based small business or hand-made by people for self-use or donation to others. Such masks and face coverings may help reduce the spread of respiratory droplets from the user to others or to the surroundings.

In the context of the COVID-19 pandemic:

  • Masks or face coverings that make medical claims or representations to reduce the risk of or prevent the user from contracting COVID-19 are deemed medical masks. They are regulated as Class I medical devices and require medical device licensing.
  • Masks or face coverings that DO NOT make any medical claims, representations or indicate they will reduce or prevent the user from contracting a disease, do not require any type of licensing.

Examples of medical claims or representations include:

  • to protect the user from contracting COVID-19
  • for anti-viral or anti-bacterial protection (for example, contains a drug or biologic)
  • for use as a medical mask
  • to provide liquid barrier protection
  • designed as a respiratory protective device (for example, used for particulate filtration)
  • for use in high-risk aerosol generating medical procedures

Whereas examples of non-medical claims are:

  • Face coverings can play an important role in situations where physical distancing is not possible or is unpredictable.
  • When worn properly, a person wearing a non-medical mask or face covering may reduce the spread of their respiratory droplets.
  • These non-medical masks or face coverings have not been tested to meet any standards. Although encouraged, wearing a non-medical mask or face covering is not a substitute for physical distancing and hand washing.

All medical masks and face coverings (that make medical claims, as noted above) must meet specific international standards for Class I medical devices, such as ASTM F2100. These standards include requirements for bacterial filtration effectiveness, and may include specifications for particle filtration efficiency, flammability and fluid resistance. Furthermore, the labelling for medical masks must contain clear statements on their intended use and specific performance specifications for their proper use (for example, filtration efficiency and fluid resistance). Medical masks must come with bilingual labelling, either on the packaging or with the device itself.

Medical masks may be authorized for sale or import into Canada through the following routes:

  • interim order authorization to import and sell medical devices related to COVID-19
  • expedited review and issuance of Medical Device Establishment Licences related to COVID-19
  • exceptional importation and sale of certain non-compliant medical devices related to COVID-19

The regulatory pathways outlined above provide Canadians with information about the degree of protection they may expect from a medical vs. non-medical mask or face covering. This will allow them to select a product based on their individual risk profile. For example, people who are at risk of more severe disease if infected with COVID-19 may wish to use a mask with an established higher level of protection.

Companies importing masks/face coverings, medical or non-medical, may be requested by the Canada Border Services Agency (CBSA) to provide proof of a Medical Device Establishment Licence (MDEL). To ensure there are no hold ups at the border and that product is imported smoothly and in a timely fashion, our specialists recommend securing a MDEL for your business to be on the safe side.

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!

How We Can Help

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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