Questions and Answers: Foods marketed as Natural Health Products

1. Why are food-like Natural Health Products (NHPs) being transferred from the NHP regulatory framework to the food regulatory framework?
2. What are the principles underlying this transition? 
3. Who should I contact to have a product reviewed and approved for sale?
4. What are the steps to have a food NHP product transitioned to the food regulatory framework? 
5. Will all products at the food-NHP interface be transitioned via Temporary Marketing Authorizations (TMAs)?
6. On what requirements will Temporary Marketing Authorization Letter (TMAL) issuance be based? 
7. How will Health Canada determine the classification of a new product?
8. What are the timelines for new products that have not previously been in the NHP queue?
9. What are the key transition dates and deadlines?  
10. What are the rules around allergen labelling and these products?
11. Are there any specific guidelines on the requirements for food NHPs under the food regulatory regime? 
12. What will be required of industry concerning the research protocol, which is a condition of TMAs?
13. What will be required of industry concerning consumption incident reporting? 
14. What happens if I need to reformulate my product?
15. Where can I find more information on food statutory or regulatory requirements? 
16. Can I add vitamins, minerals, or caffeine to my product - which contains an unapproved food additive or novel food - so that it may become eligible for a TMA?
17. How long will TMAs be issued for? 
18. Will companies need to resubmit information in 2 years to extend their products' market authorization?
19. What is required to import a food NHP? 
20. Can the products transitioned to the food regulatory framework continue to have the same claims as they had as NHPs?
21. To obtain a TMA, is it necessary to resubmit information that was already submitted to the Natural Health Products Directorate as part of the Product Licence Application (PLA)?
22. How does a company signal its intent to reformulate?

1. Why are food-like Natural Health Products (NHPs) being transferred from the NHP regulatory framework to the food regulatory framework?

As of April 17 2012, Health Canada intends to transition products at the food-NHP interface that fit the definition of a food from the natural health product regulatory framework to the food regulatory framework. This follows the first phase of the transition of caffeinated energy drinks

Health Canada has decided to classify certain products at the food-NHP interface as foods, in accordance with the principles outlined in the Department's guidance document on the Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats.

The Department has determined in general, that products at the food-NHP interface embodying the following criteria fit the definition of a food:

• Product format: These products are packaged in a format typical of foods. Such formats are consistent with the ad libitum consumption of foods.
• Public perception and history of use: It is Health Canada's position that Canadians tend to perceive and consume these products as foods rather than as therapeutic products because they provide nourishment, nutrition, hydration, satisfaction of hunger/thirst, or desire for taste, texture or flavour irrespective of any associated health claim. This history of consumption, in spite of any specific directions of use, promotes consumer perception that they can be consumed ad libitum.
• Product representation to consumers: These products have been represented and advertised in a manner that makes them appear as a food: they are found in grocery and convenience stores. Regardless of any specific health claims, they are normally regarded as foods, as part of the regular diet, with the intent to provide nourishment, nutrition, hydration, satisfaction of hunger/thirst, or desire for taste, texture or flavour.
• Product composition: In general, products containing ingredients which are expected to provide nourishment, nutrition, hydration, satisfaction of hunger/thirst, or desire for taste, texture or flavour support classification as a food.

2. What are the principles underlying this transition?

For those products that are transitioning from the NHP to the food framework, there are three main principles that underlie this transition:

• A risk-based approach to protect the health and safety of Canadians;
• Procedural fairness and transparency; and
• Minimal disruption to the stream of commerce.

These three principles will be respected and applied throughout this transition.

3. Who should I contact to have a product reviewed and approved for sale?

We encourage manufacturers and/or distributors to contact the Submission Management and Information Unit within Health Canada's Food Directorate at: SMIU-UGDI@hc-sc.gc.cato discuss the requirements for the eligibility of products for a Temporary Marketing Authorization Letter (TMAL) and the process related to the transition to the food regulatory framework.

4. What are the steps to have a food NHP product transitioned to the food regulatory framework?

The transition of products at the food-NHP interface to the food regulatory framework will be facilitated mainly through the issuance of TMALs to eligible products. TMALs will allow eligible products to be marketed subject to specific conditions, while industry collects and provides to the Department data that are required to finalize regulatory amendments for these products (Section B.01.054 of the Food and Drug Regulations (FDR)). For more information on how to submit a Temporary Marketing Authorization (TMA) information package, please consult the General Guidance Document for Temporary Marketing Authorizations for Foods.

In order to demonstrate eligibility for a TMA, companies will need to submit information in accordance with section B.01.054 of the FDR to Health Canada's Food Directorate by June 15, 2012. The Department will conduct a risk-based review of the TMAL submission package to determine if there are any potential significant health and safety concerns presented by the product composition. Products that do not pose such a risk will be eligible for TMAs, provided they also have an ingredient that is prohibited under the FDR that requires research to address information/data gaps (e.g. added vitamins, minerals). Products that are deemed unsuitable to be sold as foods "as is" will not be eligible for a TMA unless they are reformulated (or alternatively, reformatted to not be confused for a food). Products that are deemed to be compliant foods will not require a TMA to transition to the food regulatory framework.
 
Should a product be eligible for a TMA without reformulation, the company can expect to receive simultaneously from the Department by December 31, 2012:

1. depending on the status of the product's submission at the Natural Health Products Directorate (NHPD), either a notice of cancellation of the product's Natural Product Number (NPN), a notice of the revocation of the product's Exemption Number (EN), or a notice of refusal of the Product Licence Application (PLA);
2. confirmation of the classification of the product as a food subject to all legislation and regulations applicable to food products; and
3. a TMAL permitting market access for the product under specific conditions.

As part of this process, a transition period is planned for labelling of products that were marketed with an NPN or an EN (see 8. What are the key transition dates and deadlines?). However, companies are encouraged to bring the labelling into compliance as quickly as possible so that Canadians will have the information they need to make informed and appropriate decisions on their use of the product. Data collection related to the product consumption and market share will also be required, according to an agreed protocol. Consumption incident reporting by manufacturers or distributors may be required for some products.

5. Will all products at the food-NHP interface be transitioned via Temporary Marketing Authorizations (TMAs)?

It is anticipated that most products at the food-NHP interface will need to be transitioned via TMAs, but some products may not require TMAs if they are already compliant foods. Furthermore, some products may not be eligible for TMAs without reformulation (or the need to change representation so as to not be confused for a food), if they have been identified as unsuitable to be sold as foods following a risk-based review. The Department will work closely with companies that wish to reformulate and bring their products into compliance with the FDR.

6. On what requirements will Temporary Marketing Authorization Letter (TMAL) issuance be based?

Products that are not deemed to pose an unacceptable health and safety risk by Health Canada following a risk-based assessment of the most current information available on the ingredients of the products will be eligible for TMAs, provided those products have an ingredient that is prohibited under the FDR and requires research to address information/data gaps (e.g. added vitamins, minerals). Products that are deemed unsuitable to be sold as foods would not be eligible for a TMA unless they are reformulated (or alternatively, reformatted to not be confused as a food).

7. How will Health Canada determine the classification of a new product?

Specific classification criteria have been developed for pre-packaged, ready-to-consume drinks; conventional foods; and granulated and powdered products. These criteria were used by Health Canada to notify manufacturers and distributors of the intent to classify specific products as food and will be used to similarly classify new products.

If you are still unsure about whether your product is a food or an NHP, please contact the Submission Management and Information Unit within Health Canada's Food Directorate at: SMIU-UGDI@hc-sc.gc.ca.

8. What are the timelines for new products that have not previously been in the NHP queue?

During the transition process, Health Canada's Food Directorate will be focused as a short term priority on those products at the food-NHP interface requiring transition to the food regulatory framework. TMA submissions may still be submitted to the Food Directorate for new products. In July 2012, once we have more information about the products at the interface, we will be announcing a service standard for new submissions, explaining our commitment and timelines to processing them.

9. What are the key transition dates and deadlines?

For products at the food-NHP interface that had submitted applications to the Natural Health Products Directorate before April 17 2012, the Department is asking manufacturers or distributors to submit information in accordance with the requirements for a TMA stated under section B.01.054 of the FDR by June 15, 2012. The Department plans to have TMALs issued for eligible products by December 31, 2012. However, this will be partly dependent on manufacturers and distributors providing the required information in a timely manner.

Key transition dates and deadlines are set out in the table below:

Key transition dates and timelines

	Timeline
Products not requiring reformulation
No new food products will be accepted into the NHP queue after this date.	April 17, 2012
Information Update Letters sent to companies	April 26, 2012
Deadline for companies to submit TMAL application	June 15, 2012
Simultaneous issuance of TMALs and NHP status revocation to eligible products	Ongoing - Completed by winter 2012
Deadline for meeting all food labelling requirements	March 2014
Products requiring reformulation
No new food products will be accepted into the NHP queue after this date.	April 17, 2012
Information Update Letters sent to companies	April 26, 2012
Deadline for companies to submit TMAL application	June 15, 2012
Companies informed of need to reformulate	July 15, 2012
Deadline for companies to signal intent to reformulate	August 30, 2012
Deadline for reception of new TMA information for reformulated product by companies	November 15, 2012
Cancellation/Revocation/ Refusal Letters to companies electing not to reformulate	September 30, 2012
Reformulation and re-labelling deadline	December 31, 2012
Deadline for product withdrawal (for products electing not to reformulate)	December 31, 2012

10. What are the rules around allergen labelling and these products?

All transitioning food-NHP products must be compliant with current allergen labelling regulations as per Section B.01.010 of the FDR.

However, published amendments to the FDR that took place in February 2011 will further strengthen the labelling requirements for pre-packaged foods containing substances most frequently associated with food allergies and food intolerances. As of August 4, 2012, these enhanced labelling requirements for priority allergens, gluten sources, and added sulphites will be in force for pre-packaged products regulated as food, with the exception of standardized beers. Some food-NHPs may contain certain ingredients such as whey protein, soy or cream, which could trigger the new allergen, gluten, or sulphite labelling requirements. Accordingly:

• Manufacturers of food-NHPs being transitioned to the food regulatory regime and not requiring reformulation will be provided a transition period for the new allergen labelling requirements rather than being immediately subject to the new regulations on August 4, 2012. This is consistent with the broader labelling transition period (see 8. What are the key transition dates and deadlines?). These products must fully comply with the enhanced food allergen labelling requirements along with all other labelling requirements by March 2014.
• In the case where a transitioning product requires reformulation in order to be transitioned to the food regulatory framework, that product must be fully compliant with the enhanced allergen labelling requirements at the same time as its reformulation (i.e., to receive a TMA by December 2012), since re-labelling will already be required based on the product's new formulation.
• New products which were not at the food-NHP interface must comply with all food labelling requirements before gaining market access, either as compliant foods or via the issuance of a TMA. Manufacturers of new products will not be provided an additional transition period for allergen labelling and will be immediately subject to the new regulation on August 4, 2012.

Food manufacturers are also urged to comply with Health Canada's policy intent with regard to precautionary labelling, where consumers may need to be warned due to the inadvertent presence of allergens, gluten source or sulphites through cross-contamination.

Should Health Canada identify a significant health risk with respect to the undeclared presence of priority food allergens, added sulphites or gluten sources in a pre-packaged products, whether label transition has occurred or not, the Canadian Food Inspection Agency will take appropriate enforcement action, which may include recall of the product.

11. Are there any specific guidelines on the requirements for food NHPs under the food regulatory regime?

Details on the process to apply for a TMA can be found in the General Guidance Document for Temporary Marketing Authorizations for Foods.  

Category-specific guidance documents will be developed after the initial transition period, as the focus is currently on transitioning eligible products to the food regulatory framework with minimal disruption to the stream of commerce. It is anticipated that these specific guidance documents will be finalized by mid-2013. These guidance documents will outline the requirements to obtain longer-term TMAs. In the interim, TMALs will be issued for two years based on a risk-based review.

12. What will be required of industry concerning the research protocol, which is a condition of TMAs?

Health Canada has determined that a number of data and information gaps need to be addressed to support its efforts to regulate the transitioning products, and similar new products, as foods and to appropriately manage potential health risks associated with these products. The collection of data relevant to a regulatory need is a critical element of the TMA instrument.

As a result, Health Canada will require data which may cover: Canadians' consumption patterns for these products (in order to better estimate exposure to certain ingredients), consumers' understanding and use of label information, and the effectiveness of product labels as a risk management tool.

As a condition of the TMA, details of the research to be conducted by industry during the TMA period must be submitted to Health Canada for review.

Due to the large number of products that may require a TMA, and the fact that some of the data gaps that need to be addressed are common to all transitioning products, and similar new products, some of the research may be conducted collectively (via a trade organization representative of the sector). However, additional product-specific information may be required and would need to be provided by individual manufacturers or distributors.

13. What will be required of industry concerning consumption incident reporting?

Manufacturers or distributors may be required to undertake consumption incident reporting as a condition of their TMAs, depending on the nature of their product. In such a scenario, consumption incident reports will need to be submitted to Health Canada annually. Health Canada is developing a form that industry can use to report information on consumption incidents. This form will be shared with all TMA holders and applicants, if applicable, once finalized. Health Canada anticipates that most products, with the exception of caffeinated energy drinks, will not require consumption incident reporting.

14. What happens if I need to reformulate my product?

In the case where a product is determined to present an unacceptable health and safety risk, and is therefore unsuitable to be sold as a food "as is", the company will be informed by Health Canada's Food Directorate no later than July 15, 2012, that the product will need to be reformulated to be eligible for a TMA or it will become a non-compliant food.

The company must, in turn, signal its intent to reformulate by August 30, 2012, and would then be required to submit a new TMAL application for the reformulated product by November 15, 2012. Such companies will have until December 31, 2012 to work with the Department to complete the reformulation process. In this scenario, the product would also need to be re-labelled to meet all food labelling requirements by December 31, 2012. By this date, with reformulation complete, the company could expect to receive from the Department:

1. a notice of the NHP status cancellation, revocation or refusal, depending on the status of the submission with the Natural Health Products Directorate;
2. a food classification decision (as outlined above); and
3. a TMAL permitting market access for the reformulated product under specific conditions.

Data collection related to the product's consumption, and market share will also be required as part of the TMAL conditions, according to an agreed protocol.

If, by August 30, 2012, a company indicates that it does not intend to reformulate and wishes instead to withdraw its product from the market, or does not respond with respect to the choice to reformulate, it will have until December 31, 2012 to exhaust or stop the sale of remaining product inventory. Depending on the status of its submission(s) the company could expect to simultaneously receive from the Department by December 31, 2012:

1. a classification decision letter confirming the product is subject to all legislation, including Part B of the FDR that apply to it as a food product; and
2. notice of NHP status cancellation, revocation, or refusal.

In this scenario, the product would no longer be able to be legally marketed as an NHP or food in Canada.

15. Where can I find more information on food statutory or regulatory requirements?

For more information on statutory and regulatory requirements for food, including any questions pertaining to pre-market notification and assessment requirements or the use of health claims for food, please consult:

• The  Food and Drugs Act and its  Regulations;
• Guidelines and policies applicable to foods on the Food Directorate website;
• Guidelines and policies related to health claims for foods; and
• The Canadian Food Inspection Agency's  Guide to Food Labelling and Advertising and other food-related regulations and guidelines.

For any general questions regarding the regulatory requirements for food, please contact Health Canada's Food Directorate at Food-Aliment@hc-sc.gc.ca.

16. Can I add vitamins, minerals, or caffeine to my product - which contains an unapproved food additive or novel food - so that it may become eligible for a TMA?

The addition of vitamins, minerals, or caffeine - where none existed previously - to an existing product (i.e., at the interface) which contains an unapproved food additive or novel food so that it may be eligible for a TMA will result in that product being considered a new product and subject to the timelines for new products.

Health Canada's Food Directorate will work closely with companies that have products containing unapproved food additives or novel foods but no vitamins, minerals, or caffeine - products that do not meet the technical research purpose requirements for a TMA - to find a transition approach, for example through reformulation (effectively to become a compliant food by substituting an approved food additive for an unapproved one) or the processing of a novel food submission.

17. How long will TMAs be issued for?

With the exception of caffeinated energy drinks, TMAs will be issued to eligible products for an initial time period of two years. As more information is gathered about these products and specific guidance documents are developed, market authorization for these products will be extended should products meet the compositional requirements, and in some instances labelling requirements, as outlined in the guidance documents.

18. Will companies need to resubmit information in 2 years to extend their products' market authorization?

If there is a requirement to submit or resubmit information to extend a product's temporary market authorization beyond two years, Health Canada will contact the affected company. The publication of specific guidance documents by mid-2013 may lead to some needs for additional/new product information; desired changes in product formulation by the company would also be a factor.

19. What is required to import a food NHP?

There is currently no requirement to obtain an import licence for foods; however, most products at the food-NHP interface will need to receive a TMA in order to be legally marketed in Canada due to their composition, not origin. For additional information on the TMA process, please see 3. Who should I contact to have a product reviewed and approved for sale?.

20. Can the products transitioned to the food regulatory framework continue to have the same claims as they had as NHPs?

Certain statements, such as nutrient content claims and health claims may be made on the label or in advertisements for food products on a voluntary basis. However, when they are made, they must comply with the Food and Drugs Act and the food provisions of the FDR along with applicable guidance.

Companies with products on the market (or in queue) that are going to be transitioned from the NHP regulatory framework to the food regulatory framework should be aware that differences exist in determining the acceptability of claims between the two frameworks.

Health claims on foods are generally not subject to pre-market review. The exception is for health claims pertaining to diseases, disorders, or abnormal physical states listed in Schedule A of the Food and Drugs Act and for nutrient content claims not stipulated in the Food & Drug Regulations.

Health claims on foods must be truthful and not misleading -- per Section 5.(1) of the Food and Drugs Act -- and substantiated with appropriate scientific evidence for which documentation may be required for compliance and enforcement purposes. Health claims should be measurable and quantifiable to the extent possible, and therefore allow scientific verification. This will reduce the possibility of claims being vague, uninformative or misleading. For example, a claim about "temporarily restoring alertness" is more specific than a claim about "enhancing cognitive performance".

In addition, another difference that exists between the two frameworks for health claims is that claims on food products must be linked to a specific substance or substances in the product and not to the consumption of the product itself.

With respect to the transition of food products at the food-NHP interface to the food regulatory framework, health claims that have been used in the NHP context and that may not meet Food and Drug Regulations requirements "as is" will generally not be an impediment to the issuance of Temporary Market Authorization Letters (TMALs). In most cases, a transition period is being permitted to bring labelling and claims into compliance with the food regulatory framework. One exception is the use of explicit or implied claims about diseases, disorders, or abnormal physical states listed in Schedule A of the Food and Drugs Act. Such claims will not be permitted on foods under the TMA process.

The Food Directorate will be pleased to work with any companies interested in reviewing or assessing their claims in this context.

For more information, please consult Health Canada's current policy and guidance on health claims on foods.

As a part of the food regulatory modernization work being conducted by Health Canada, the Department will review the health claims framework to develop a risk-based oversight associated with the use of health claims on food labels. In conducting this work, the Food Directorate will undertake broad consultations with stakeholders from academia, food industry, health professional organizations and international regulatory bodies.

21. To obtain a TMA, is it necessary to resubmit information that was already submitted to the Natural Health Products Directorate as part of the Product Licence Application (PLA)?

Manufacturers or distributors are advised to follow the application process outlined in the document General Guidance Document for Temporary Marketing Authorization for Foods.

Submissions may be sent electronically by email as outlined in that document to the following address: SMIU-UGDI@hc-sc.gc.ca. Please make reference to the PLA submission number or NPN in the subject line.

22. How does a company signal its intent to reformulate?

Companies that have been informed that they need to reformulate a product are required to signal their intent to reformulate to Health Canada's Food Directorate by August 30, 2012. This intent to reformulate needs to be communicated to Health Canada's Food Directorate in writing via SMIU-UGDI@hc-sc.gc.ca.

Contact us: SMIU-UGDI@hc-sc.gc.ca