Since the implementation of the Natural Health Product Regulations (NHPR) on January 1, 2004 a number of products in food formats supplemented with vitamins, minerals, amino acids, herbal and bioactive ingredients which were not compliant with the Food and Drug Regulations (FDR) have been introduced into the marketplace as natural health products (NHPs) in accordance with the Natural Health Products Regulations (NHPR) as part of ongoing reclassification.

As Health Canada continues to work toward their long-term plan of regulating supplemented food products as foods rather than NHPs, the Natural and Non-Prescription Health Products Directorate (NNHPD) and Food Directorate (FD) continue to identify a number of licensed products at the food-NHP interface which best fit the definition of a food, in accordance with pre-existing classification criteria. As such, Health Canada recently announced that the agency will be contacting these Natural Product Number (NPN) holders directly in the near future to inform them about transitioning their products to foods. Read on to learn key information that product license holders need to know about products at the food-NHP interface.

Pre-existing Classification Criteria

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

1. Product format: These products are packaged in a format typical of foods. Such formats are consistent with the ad libitum (quantity and frequency with no restriction) consumption of foods.
2. 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 freely.
3. 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.
4. 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 being classified as a food.

Transition Process – General Steps

The transition of eligible food products marketed as NHPs to the food regulatory framework is 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. Manufacturers also need to commit to comply with the additional requirements as stipulated in the TMAL. These include:

1. Conducting research according to a protocol mutually agreed upon by the manufacturer and Health Canada;
2. collecting and reporting data on consumption incidents when deemed necessary by Health Canada; and
3.  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.

Effective immediately when the TMAL is issued, 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. Other than the aspects that are the subject to the TMA, the product at that point is considered a food and manufacturers would be required to comply with food advertising requirements and the Consumer Packaging and Labelling Act and Regulations (CPLAR). Additional specific conditions under the FDA, CPLAR or other relevant food legislation may also apply depending on the type of product. 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.

For assistance in determining whether your NHP should be marketed as a food and for assistance in transitioning to the food regulatory framework, please contact dicentra. We can be reached at 1-866-647-3279 or info@dicentra.com.

dicentra is a professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the life sciences, food and cannabis industries.

References:
[1] Guidance Document. Classification of products at the food-natural health product interface: product in food formats, January 03, 2017
[2] General Guidance Document for Temporary Marketing Authorization for Foods, May 2013.