Health Canada has recently proposed amendments to the Food and Drug Regulations (FDR)1 and the Natural Health Products Regulations (NHPR)2, to introduce a new regulatory framework for supplemented foods and new labelling requirements for natural health products (NHPs), respectively.
What you need to know
- Under the new regulatory framework for supplemented foods, manufacturers will be able to obtain authorizations to sell supplemented foods under the FDR rather than through obtaining Temporary Marketing Authorizations (TMAs) under the current process.
- New labelling requirements for NHPs are intended to improve the labelling of NHPs so that information is clear, consistent and legible for consumers and in alignment with existing rules established for comparable non-prescription drugs.
- Comments on the proposed amendments to the FDR and NHPR can be made to Health Canada until August 25, 2021 and September 4, 2021, respectively.
Framework for regulation of supplemented foods
Supplemented foods are defined as prepackaged foods containing one or more added supplemental ingredients—for example, vitamins, mineral nutrients, amino acids, or other ingredients such as caffeine or herbal extracts. These products have historically been marketed in Canada for the purpose of providing specific physiological or health effects. Examples of supplemented foods include beverages with added minerals marketed for hydration, caffeinated energy drinks for restoring mental alertness, and snack bars with added vitamins. Under the current rules, marketing of supplemented foods is prohibited unless the manufacturer has been granted a TMA from Health Canada.
The proposed amendments to the FDR would create a new regulatory framework for supplemented foods so that TMAs are no longer required for many products. Under the proposed amendments to the FDR, a “List of Permitted Supplemental Ingredients” and a “List of Permitted Supplemented Food Categories” will be defined and incorporated by reference in the FDR. If a food product and supplemental ingredient is found on these lists, the manufacturer will be able to sell the product in Canada without seeking further approval from Health Canada. Health Canada would create a submission process to add, remove or revise the conditions of use of a supplemental ingredient or supplemented food category from their respective lists to streamline the authorization of new products.
Supplemental foods would be subject to the labelling requirements for pre-packaged foods under the FDR and would also have additional requirements specific to this product class. A standard Supplemented Foods Facts Table (SFFT), akin to a nutrition facts panel, must be included on the product label. Cautionary statements in both English and French will be required under a “Caution” heading for certain supplemental ingredients or certain levels of supplemental ingredients as prescribed in the List of Permitted Supplemental Ingredients3.
Transition and implementation
Supplemented foods currently being sold under a TMA would have a transition period of three years once the proposed amendments to the FDR come into force to comply with the new framework.
Health Canada would continue to accept TMA applications until the coming into force date of the proposed amendments to the FDR. If the TMA is approved after the coming into force date, the Minister would send a written notification that the product is authorized to be sold under conditions set out in the transitional provisions under the existing TMA framework. These products would have the remainder of the three-year transition period to comply with the FDR amendments.
New supplemented foods coming to market following the coming into force of the amended FDR would be required to comply with the new FDR immediately.
New labelling requirements for natural health products
NHPs are a category of “drug” under the Food and Drugs Act. In order to improve the labelling of NHPs so that information is clear, consistent and legible for consumers, and in alignment with existing rules established for comparable non-prescription drugs, the proposed amendments to the NHPR introduce a number of new requirements. A standardized product facts table (PFT) setting out the medicinal ingredients, non-medicinal ingredients, recommended use, warnings, directions and storage conditions would be required, with both French and English text. If the NHP contains a food allergen, gluten or aspartame, a warning statement and the source of food allergen or gluten would also be required in the PFT4. The label must also include a postal address, telephone number, email address or web address of the NHP product licence holder that may be used for consumers to report problems or pose questions.
Transition and implementation
The proposed amendments to the NHPR are expected to come into force three years following publication in the Canada Gazette, Part II, with the exception of amendments to the NHPR to clarify existing rules, which would come into force on the date of publication in the Canada Gazette, Part II.
All NHPs marketed in Canada prior to the coming-into-force date of the proposed amendments to the NHPR would be given an additional transition period of three years to comply with the new labelling requirements, amounting to a total transition period of six years following publication in the Canada Gazette, Part II.
New NHPs coming to market following the coming into force of the amended NHPR would be required to comply with the new NHPR immediately.
Representations on the proposed amendments to the FDR and NHPR may be made until August 25, 2021 and September 4, 2021, respectively5. Currently, there is no published timeline on when the proposed amendments to the FDR and NHPR will come into force.
In parallel with the publication of the proposed amendments to the NHPR, Health Canada has also published a draft Guidance Document: Labelling Requirements for Natural Health Products, which is open for consultation until September 4, 20216.
3 Other requirements for cautionary statements include font and type size requirements and clear separation from other information on the label.
4 This statement would also be required in the inner label where applicable.
5 All representations must cite the Canada Gazette, Part I, and the date of publication of the notice, and be addressed to Bruno Rodrigue, Executive Director, Office of Legislative and Regulatory Modernization, Policy, Planning and International Affairs Directorate, Health Products and Food Branch, Department of Health, postal locator 3000A, 11 Holland Avenue, Suite 14, Ottawa, Ontario K1A 0K9 (email: email@example.com).
6 Feedback may be emailed to firstname.lastname@example.org.
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