"Self-Care Framework" for Natural Health Products: What has changed, and what is next?

March 6, 2018 by Ariel Smith, Innovate Phytoceuticals

Last year, Health Canada's Natural and Non-Prescription Health Products Directorate (NNHPD) began consulting on a new set of regulations that would set to govern the use and sale of "Self-Care Products" such as cosmetics, natural health products, and non-prescription drugs.

The proposed regulations were immediately met with concern by members of the natural health community, who worried that the proposed changes would not only dissolve the Natural Health Products Regulations but would also clump Natural Health Products together with over-the-counter drugs and cosmetics under a blanket set of regulations. Campaigns such as the ‘Save Our Supplements' campaign from the Canadian Health Food Association (CHFA), encouraged members of the natural health community to speak out, send letters, and visit members of parliament to voice their concerns about the proposed regulations.

The CHFA West regulatory forum on February 22nd set the stage for members of the NNHPD to come and speak to concerned brand-holders, manufacturers, distributors, and members of industry about the fate of their natural products. Fortunately, the director of the NNHPD, Manon Bombardier announced that the NNHPD has heard the concerns of Canadians, and that they will be proceeding with a modified version of the original proposal. Instead of dissolving the regulatory framework for NHP's in favour of a blanket set of regulations, NNHPD will be preserving the current set of regulations for now, starting off with small modifications to the current structure.

The new proposal will include amendments to the Natural Health Products Regulations and will take place in three phases over many years.

Phase 1 (Fall 2018)

Health Canada repeatedly cited the need to improve the labelling of natural health products to simplify information and make labels easier to read from a consumer standpoint. Phase one will include the introduction of a "Product Facts" table for NHP labels to include mandatory information such as medicinal ingredients, recommended uses, warnings, directions and non-medicinal ingredients. The format of this facts table has not yet been finalized, and Health Canada is looking to introduce a standard version in addition to a "flexible version" that could be condensed to fit on smaller product labels. A flexible product facts tables would include a link to a website that would contain the full product facts table for the product.

Phase 2 (Early 2019)

Phase two will focus on introducing amendments to the Food and Drug Regulations to evaluate products based on the level of risk for consumers. Low-risk products could undergo an expedited review pathway due to the low risk nature of the product, whereas higher risk products would require a full review.

Phase 3 (2020)

Phase three contains many of the same elements that were of original concern to members of the natural health industry, and the details remain vague. Starting in 2020, consultations will be introduced to the public to discuss evidence standards for natural health products. This was a main point of concern in the original self-care products proposal, as Health Canada noted that self-care products making similar health claims would require similar types of evidence. This could mean that a herbal medicine product claiming to relieve allergies would need to obtain the same level of scientific efficacy evidence as an over-the-counter antihistamine like Benadryl. As many natural health products rely on traditional evidence to get licensed, the 2020 changes, if they come into fruition, could potentially remove many products from the shelves that could not meet evidence standards.

Overall, there was a tangible feeling of relief from concerned members of the natural health industry. The current changes to the self-care proposal mean that at least for the current time, the Natural Health Products Regulations will be preserved. Health Canada plans to release public consultations as more details of each phase are released, so members of the industry and the public can stay informed.