Transition process for foods marketed as Natural Health Products
Health Canada has previously indicated its intent to resolve the confusion around foods that are marketed as Natural Health Products (NHP). Since May 2010, the department has been working with manufacturers to safely transition food products currently marketed as NHPs to the food regulatory framework while attempting to minimize disruption to the stream of commerce. As a first step Health Canada announced in October 2011 its intent to transition caffeinated energy drinks to the food regulatory framework. Additional categories of foods currently being marketed as NHPs will begin to transition in April 2012. It is expected that the transition process will be completed by December 2012. For answers to frequently asked questions regarding the transition of food products currently marketed as NHPs, please visit Questions and Answers: Foods marketed as Natural Health Products.
The end goal of this transition process is to ensure that products that look like foods and are consumed as foods are regulated as foods. In doing so, Canadians will be able to make more informed choices due to consistent nutrition information and labelling requirements. For the food industry, this transition will level the playing field, reduce red tape and continue to help support innovation. Please visit foods that have transitioned from the Natural Health Products Regulations (NHPR) to the Food and Drug Regulations (FDR) to view the current list of authorized food products.
As of March 2012, there were several hundred foods marketed as NHPs that could transition to the food regulatory framework.
Three general categories of products were identified to be sitting at the Food-NHP interface:
Category 1: Products ready to transition immediately "as is" under the current food regulatory framework and requiring no regulatory changes to accommodate the products.
- All transitioned products will need to make label changes in order to comply with mandatory food labelling requirements including Nutrition Facts table and allergen labelling.
Category 2: Products that would require regulatory changes (e.g. claims, fortification, additives) to accommodate the products for the long term.
- Transition will be enabled through the issuance of Temporary Marketing Authorization Letters (TMAL) and / or Interim Marketing Authorizations (IMA) where applicable to maintain market access.
- Data collection is a requirement under the TMAL and will address the information gaps required to develop the final regulatory decision and amendments.
Category 3: Products likely unsuitable to be sold as food without major reformulation or the need to change representation so as to not be confused for a food.
Transitioning caffeinated energy drinks (within Category 2) was considered as a first step.
Overview of the transition process
Eligible food products that will be captured under the transition are those where a Product Licence Application (PLA) has been received by the Natural Health Products Directorate and have been issued either a Natural Product Number (NPN), an Exemption Number (EN) or are considered an "application in progress".
The transition of eligible food products marketed as NHPs to the food regulatory framework will be facilitated through the issuance of a Temporary Marketing Authorization Letter (TMAL). Manufacturers will be required to collect and provide data to Health Canada to fill the knowledge gaps needed to finalize the regulatory requirements for these products ( section B.01.054 of the Food and Drug Regulations). Manufacturers must also commit to comply with the additional requirements as stipulated in the TMAL, including:
- conducting research according to a protocol mutually agreed upon by the manufacturer and Health Canada;
- collecting and reporting data on consumption incidents when deemed necessary by Health Canada;
- withdrawing the product if requested.
Products deemed to be safe (i.e., pose no health and safety concerns) will be issued TMALs. Products that pose an unacceptable risk to health and safety, for example that contain an unsafe level of an ingredient or that do not meet the conditions for the issuance of a TMAL, will be required to reformulate or re-label (in the case of an undeclared priority food allergen) to be eligible for a TMAL.
Upon issuance of a TMAL, the product's status within the NHP queue will be revoked and a classification decision that the product is considered a food will be issued. The product is at that point considered a food and manufacturers would be required to comply with food advertising requirements.
In general, all requirements for labelling and advertising for food in the Food and Drugs Act (FDA), Part B of the Food and Drug Regulations (FDR) and in the Consumer Packaging and Labelling Act and Regulations (CPLAR) will apply, other than the aspects that are the subject of the TMA. Additional specific conditions under the FDA, CPLAR or other relevant food legislation may also apply depending on the type of product. This is effective immediately when the TMAL is issued. New products and products that need to be reformulated will have to meet all food labelling requirements prior to the issuance of a TMAL. Eligible products that can transition without undergoing any changes will be given a specified period of time to meet the food labelling requirements.
The transitioning of food products marketed as NHPs to the food regulatory framework will proceed in a phased manner. Next steps include the classification of products currently within the NHP queue and the development of formulation requirements for products where "in-market" research is needed to address data gaps supporting regulatory decisions.
The end goal of this transition process is to ensure that products that look like foods and are consumed as foods are regulated as foods. In doing so, Canadians will be able to make more informed choices due to consistent nutrition information and labelling requirements. For the food industry, this transition will level the playing field, reduce red tape and continue to help support innovation.
- Classification of products at the Food-Natural Health Product interface: Products in food formats
- General Guidance Document for Temporary Marketing Authorization for Foods
- Caffeinated energy drinks
- Category Specific Guidance for Temporary Marketing Authorization: Caffeinated Energy Drinks
- Natural Health Products
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