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Unlock Food Regulations for Food Sales Health Canada & FDA

food regulations for food sales

Do you want to learn about the food regulations for food sales in North America?  This could include food facility registration, food safety regulation standards, TMAL, food label requirements, FSVP agents, and more. Then your wish is about to be granted.

If you import, export, manufacture, or trade food products in North America you may have had trouble with the complex Food & Beverage Regulatory Requirements.

The food & beverage industry is growing fast, especially with the growing demand for Non-GMO, Vegan/Vegetarian, and other alternatives.

In this blog, we will be discussing the Canadian and US requirements for food importation to Canada & the U.S.  

Canadian Food Regulations & Food Labelling in Canada

Canadian Foods are regulated by Health Canada, the Canadian Food Inspection Agency, and the Canada Border Services Agency. Some applicable regulations for foods and imports in Canada are the Food and Drug Regulations, the Safe Foods for Canadians Regulations, and the Customs Act.

Food labels must be bilingual, and common names, countries of origin, expiry dates, and storage instructions must be included. Any label claims being made must be reviewed against the permitted lists to ensure they are compliant.

All statements must be truthful and not misleading on your label.  At Quality Smart Solutions our team of specialists can help review your labels for compliance.  

TMAL and Supplemented Food Standards

Traditional foods are those that have been consumed for a long time, such as bread, milk, and eggs. Supplemented foods are those that have had new ingredients or manufacturing processes added to them, such as caffeine in an energy drink.

A traditional food must have a compliant label, and a supplemented food must also be approved through a review process called a TMAL or Temporary Market Authorization Letter.

New regulations are set to be published in the spring of 2022 to allow and set out several categories of foods for which certain ingredients can be supplemented.

Looking for help complying with food regulations?

Food Safety Requirements for Importing food into Canada

When shipping food from another country into Canada you must have or use a Safe Foods for Canadians Food Import License (SFCR).  

A Preventative Control Plan (PCP) and a HACCP (Hazard Analysis Critical Control Points) must be set up for your food manufacturing site. Quality Import Solutions can help with this and with bringing your products into Canada.

U.S Labels must be bilingual and there must be enough product testing (for example, for allergens, microorganisms, and heavy metals). Please note that there are also customs and duties required for importing that must be arranged with a broker or freight partner.

Why food regulations are important in the USA?

USA foods are regulated by the US Food and Drugs Administration, the US Department of Agriculture, and Customs and Border Protection. Some applicable regulations are the Food Safety and Modernization Act, and the Bioterrorism Act. These set out requirements for food in the USA.

US Regulations for Food Label Requirements 

It is important to make sure your label meets US standards. This includes the common name, net quantity, ingredients, and nutritional information. The US Department of Health and Human Services has published a labeling guide to help with this.

One tip is to avoid intervening material, which is any text that is not required by regulation. An example of this could be a gluten-free claim between the nutrition facts table and the ingredients list. This can divert the consumers’ attention.

Food Facility Registration in the USA 

FSMA (Food Safety Modernization Act) and the Bioterrorism Act require that all food production facilities must be registered with the FDA and renewed every other year, which allows the agency to track and regulate them. Registration can be revoked if there is a risk to human health. Facilities can submit their registration package online, by mail, or by fax. A US agent is required to communicate with the FDA on behalf of the facility and must be a resident of or located in the USA. 

What is and why do I need an FSVP Agent?

An FSVP Agent is a representative located in the USA who is responsible for reviewing and holding food safety-related documentation that proves a company/food facility meets or exceeds US food requirements.

The goal is to ensure products are not adulterated or misbranded by exceeding the US food requirements for all important documentation. The FSVP agent will assist with compliance reviews and audits, or questions issued by the regulator. 

Importer of Record!

Finally, our sister company Quality Import Solutions can help with the importation and market entry for Canadian and US foods by acting as your Importer of Record.

Additional Information:

For more information on the FDA & Health Canada Food Regulations and how to ensure your Food Products are compliant visit the government websites.

How Quality Smart Solutions can help you TODAY!

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

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

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

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

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Foreign Site Reference Number | FSRN Fruitful Interim Measures

Foreign Site Reference NumberWho needs a Foreign Site Reference Number (FSRN)?

For Natural Health Products (NHPs) manufactured, packaged, and/or labeled by sites located outside of Canada, Canadian importers are required to provide evidence that these sites will be at par with Canadian Good Manufacturing Practices (GMP) under Part 3 of the Natural Health Products Regulations (NHPR).

This can be demonstrated using pre-cleared pieces of evidence or other acceptable evidence by the Site Licensing Guidance document. Foreign sites can be added to the site license application of Canadian importers by providing GMP evidence from the foreign site. This evidence is intended to demonstrate that manufacturing, packaging, and/or labeling operations carried out at foreign sites are in accordance with Part 3 of the NHPR.

FSRN thus helps in eliminating the need for a foreign site to provide the same GMP evidence multiple times for each importer’s Site License. It is important to note that a Foreign Site Reference Number is not a site license and hence cannot be regarded as authorization for the direct export of NHPs to Canada.

In a recently issued 4-page bulletin, the Natural and Non-prescription Health Products Directorate (NNHPD) has advised stakeholders regarding the interim measures on new Foreign Site Reference Number applications and renewal/modification of existing FSRNs. This bulletin also sheds light on interim measures for the validity of the Foreign Site Reference Number. If your FSRN meets certain criteria, you may be eligible for a longer validity period (extension).

  1. New Foreign Site Reference Number Applications – These applications will be reviewed upon annexation submission. Application for FSRN will be refused if not linked to a Canadian Importer. This measure is effective until further notice. Approval in the form of a Notice of Acceptance (NOA) will be issued if these conditions are met and the site is compliant. Previously FSRN submissions were reviewed and approved as their own application. Now the Foreign site must be linked to a Canadian importer upfront. Previously lower priority was placed on Foreign Site Reference Number applications that did not link to an importer’s site license. Now there is no mention of priority.

Need a licensed importer for your natural health products?

            2. Foreign Site Reference Number Renewal Application – FSRN will be extended until further notice if the site has been inspected by a qualified authority in the last 5 years (e.g., FDA) and there have been no risk issues flagged by a recognized authority (e.g., FDA). FSRNs that were issued based on QAR or SNC from 2020-to 2023 will also be extended.

FSRN holders are required to notify the NNHPD if there are any changes to the site’s GMP that may cause a risk to health, such as a regulatory action.

Each FSRN will be re-reviewed when it is included/linked to a new importer’s submission to ensure there is no risk associated with the site. Previously FSRN sites having expiry dates were required to be renewed prior to that date.

3. Modifications to an existing Foreign Site Reference Number – When submitting changes to FSRN, the information will only be evaluated (in parallel) when the change is also submitted/ initiated by an importer or site license holder. Previously FSRNs were updated and reviewed without being triggered by a site license amendment.

As per these interim measures, the Foreign Site Reference Number holder is responsible for the following:

  • Providing FSRNA (authorization) form to each Canadian importer
  • Providing required records to site license holders in a timely manner
  • Providing required records at the time of site license submission, annexation, and renewal

These requirements are the same as earlier and there are no changes to previous requirements.

According to the interim measures, the Site License holder’s (Canadian Importer) responsibilities include:

  • Finished product testing and stability studies are conducted in accordance with Part 3 of NHPR and the relevant records are held by the importer
  • Ensuring that records are available from Foreign Sites in one of the official languages (i.e., English and/or French)
  • Ensuring that relevant records for production and quality such as Master production documents, recalls, complaints, etc. are retained and readily available

Planning is a critical component of any site licensing activities; hence it is crucial to keep abreast with the impacts of these changes to the plans for your products, sites, and their operational activities. Our experts at Quality Smart Solutions can offer support to your needs for foods, cosmetics, Natural Health Products, NHP Site LicensingOTC drugs, and medical devices for North America. 

References:

https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/good-manufacturing-practices.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/site-licensing-guidance-document.html

https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/applications-submissions/site-licensing/forms/foreign-site-reference-number-authorization-form-site-licensing.html

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5 Common NHP Pitfalls | How to Improve Importing Natural Health Products

Health Canada import requirements

As a license holder for Natural Health Products (NHPs), it is your responsibility to be aware of and educated on all requirements for Canada.

This blog will aim to highlight and summarize the common pitfalls of a company that manufactures NHPs outside of and imports them into Canada. Working with an importer such as Quality Import Solutions (QIS) and a consultant such as Quality Smart Solutions (QSS) will help guide you and bring your products to Canada in a safe and compliant manner.

1. Not having an Importer of Record

For Natural Health Products that are manufactured outside of Canada. You are required to have and work with an Importer of Record. This party will act as a liaison within Canada for your NHPs. Health Canada inquiries will be sent to the Senior Official of the license holder as well as the listed Importer of Record.

This requirement aims to ensure there is a domestic contact person for all marketed products that can respond and act promptly.  If you do not have an importer of record, in place or marked on your label, your products may be held or refused at the time of import. This can lead to further enforcement action.

2. Not obtaining approval for Sites

Health Canada requires that all sites involved in the licensable activities (manufacturing, packaging, labeling, warehousing, and importing) hold a Site License.

Domestic/Canadian sites will hold a Site License themselves. For all foreign sites, this will mean that they are annexed/attached to the site of a licensed Importer. This licensing process aims to ensure the handling of NHPs before the sale is done so within an environment that is sanitary, well-controlled, and adheres to Good Manufacturing Practices (GMPs).

If your sites are not approved your NPNs may be suspended until GMP evidence for each site is provided to, reviewed, and approved by Health Canada. This can also lead to further enforcement action.

3. Not being aware of Site License timelines

Please know that the posted Health Canada timelines for Site License applications and amendments are not currently being met by the regulator. It is difficult to give a clear timeline for approval since there are many variables such as Health Canada’s backlog/queue, the complexity of submission/sites, gaps in testing or GMP documentation, responding to Health Canada inquires, etc. We recommend building ample buffer time for your launch plan to account for expected delays in site licensing and annexation.

If you do not anticipate and plan for proper timing with Health Canada and begin making deals with retailers prior to approval, it is possible these deadlines may not be met. We suggest wherever possible, waiting for all approvals (labels, licenses, sites) to be in place prior to setting the deadlines to avoid potential conflict.

Need a licensed importer for your natural health products?

            4. Not having testing results or labels that meet Health Canada requirements

All NHPs must undergo testing at the finished product stage and through shelf life (stability). This testing will show that your product meets Health Canada requirements for physical characteristics, purity, and potency. The Quality Guide is a great reference tool that shows all required testing. Product testing results or proof of future testing in the form of a template is required at the time of site annexation.

All NHPs must have a compliant and bilingual label. The Labelling Checklist is another great reference that shows elements for an NHP label. The importer of record and license holder address must be present on your label for imported products. For all products we import, we suggest a label review be conducted before print.

If you are not testing or labeling your products compliantly, you may not receive a release decision for your product at the time of import. You may also face a Health Canada audit or a trade complaint, which can lead to further enforcement action.

 5. Not knowing the above are legal requirements

Again, as a license holder (you can learn about registering here), it is your responsibility to know the requirements for Canada. The main requirements for Natural Health Products are an NPN (Natural Product Number), a compliant bilingual label, and ensuring all sites are either licensed or annexed. Review and knowledge of the regulations and associated guidance are imperative to success in the Canadian market.

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

How Quality Smart Solutions can help

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

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Ultimate OTC Drug NHP Cosmetic Product Classification Guide Unlocked

This blog unpacks the distinctions between NHPs, Health Canada & FDA-approved drugs, and cosmetic product regulations that define these products.  This will include product classification, product and representation composition along with other considerations that need to be considered.  If you have any questions about the classification of these products after reading this blog feel free to book a consultation.  

What is a Drug?

Under Section 2 of the Food and Drugs Act, a drug is defined as “any substance or mixture of substances manufactured, sold or represented for use in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals; restoring, correcting or modifying organic functions in human beings or animals, or; disinfection in premises in which food is manufactured, prepared or kept”.

What is an NHP?

A Natural Health Product (NHP) is regulated by the Natural and Non-prescription Health Products Directorate (NNHPD) under the Natural Health Products Regulations. Under the regulations, it is defined as products containing naturally occurring substances including Probiotics, Herbal remedies, Vitamins and minerals, Homeopathic medicines, Traditional medicines (e.g. Traditional Chinese and Ayurvedic medicines), and other substances (e.g. amino acids and essential fatty acids). These products are used to treat or prevent an illness, reduce health risks, and maintain general good health.

What is a Cosmetic Product?

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 drug and natural health products even though they are all regulated under the Food and Drug Act

Classification of your Product

To classify your product, your product must meet one of the definitions above. Product risk, public health safety, and applicable regulatory framework must also be taken into consideration. Two main factors in determining product classification include representation and composition of the product.

Representation and Composition of your Product

The classification of your product depends on two main factors: Representation and Composition. Representation can be its function, purpose, and representation for use (such as proposed claims). These claims can be in words, sentences, pictures, symbols, and any implications on the product label, inserts, and associated advertisements. 

These claims inform consumers of what this product does and is intended for. The composition of your product is the ingredients and their concentrations contained in the formula. 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. However, composition alone may not be sufficient in determining its product classification.

Other Considerations

Another consideration is the level of action. The level of action is how the product exhibits its efficacy through absorption from its dosage form. Some routes of administration such as ingestion, inhalation, and injection cannot be considered cosmetics. Other considerations include new policy/knowledge, classifications by other global authorities, and risk-benefit balance related to product efficacy.

How can we help

QSS offers regulatory services on product classifications, notification submissions for your cosmetics, application submissions for your NHPs/drugs, and label review of your NHP/drug/cosmetic label artwork. Our experts are here to help and offer any cosmetic/drug/NHP-related regulatory advice!

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

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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.

Looking for assistance with drug label review? Contact

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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5 Reasons Why Food Labelling is Important for your Food Products

5 Reasons why Food Labelling is Important

Food Labelling 101

Food labelling is an important aspect for consumers across the globe. Food labels are used as reliable sources of information to help consumers make knowledgeable decisions. It is important for consumers to understand how to properly read and interpret food and nutrition labels.

What is on a Food Label?

Food labels will contain the following core labelling requirements in Canada:

  • Ingredient List

The ingredient list must list all the ingredients in food by weight, i.e. starts with the ingredient that weighs the most and ends with the ingredient that weighs the least.

  • Nutrition or health claims

Nutrition claims are considered optional on food labelling and must follow specific rules set by Health Canada to ensure the claims are consistent and not misleading.

There are two types of claims:

Nutrition Facts Table

  1. Nutrient claims: describe how much of a particular nutrient is in a food, i.e. high source of fiber
  2. Health claims: describe the effect of food on health and must be based on scientific evidence, i.e. Vitamin A aids in the development and maintenance of night vision
  • Food allergen

Allergen information is mandatory to be included on food labels as part of the ingredient list or on a ‘Contains’ or ‘May Contain’ list.

  • Date labelling

Prepackaged products with a durable shelf life of 90 days or less are to be labelled with date markings and even storage instructions.

Nutrition facts table (please see figure 1 below for reference)

The Nutrition Facts Table will give you information on the following:

  • Serving size
  • Calories
  • Percent daily values
  • Information on 13 major nutrients; fat, fib
  • re, saturated and trans fats, protein, cholesterol, vitamin A, vitamin C, sodium, carbohydrates, calcium, sugars, and iron.

Why is Food Labelling Important?

A few reasons for how food labelling can help the average consumer make the right purchasing decision:

  1. Nutrition/Dietary Intake

Food labels can help you understand the composition of your food via the information provided on the Nutrition Facts Table. The Nutrition Facts Table allows the purchaser to understand the type of vitamins, minerals, facts etc. that they will be consuming. By monitoring your intake of micronutrients and macronutrients, you will be able to eat a balanced diet for your body.

Looking for assistance with food label reviews?

  1. Allergens

Food allergies are considered a rising, global epidemic. The proper comprehension of food labelling with regard to allergens is critical to avoid serious consequences. In Canada, common allergens and gluten sources must always be clearly declared on food labels when present as ingredients or components of ingredients. They will appear in the ingredient list or in a “Contains” statement located immediately after the ingredient list.

  1. Origin

Origin information on food labels can be very important to consumers. For example, some consumers choose to purchase products from only local producers due to political or environmental motivations. Also, consumers are increasingly linking quality to geographical origins and traditions.

  1. Production

Many consumers are invested in how their food is prepared due to religious, ethical, and cultural reasons. Production details on food labelling may include information for the following types of products: Halal, Kosher, Organic and free-range.

  1. Compare and contrast products

Information is power and by understanding how to read and analyze food labels, the consumer has the power to take control of their own health. Food labels may be easy to ignore, but by taking a few extra minutes at the grocery store, will allow you to become more conscious of the products you are eating and may alter your purchases moving forward.

How Quality Smart Solutions can help

At Quality Smart Solutions, we have a team of experts who are skilled in both Canadian and USA food labelling compliance. We offer several solutions to meet your needs and understand the importance of food labelling. Please contact us today or call us at 1-800-396-5144 to learn about how we can help you.

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