Natural Health Products to see improved labelling requirements
One of the interesting aspects of working in the Natural Health Product (NHP)/Cosmetic/Over-the-Counter (OTC or, non-prescription) space often comes down to classifying the product you hope to market. Similar products, such as varieties of toothpaste, can be subject to significantly different rules depending on what classification they fall under. If one toothpaste fights cavities with cetylpyridinium chloride, another uses sodium fluoride, and yet another claims only to clean your teeth, are these products honestly so different they warrant being subject to entirely different oversight, fees, and regulatory process?
In an effort to modernize its approach to regulating self-care products, Health Canada has proposed a new Self-Care Framework that attempts to take on these discrepancies and offer oversight proportional to the risk of the product. There will be 3 levels of risk, with Category 1 products being lowest risk, and Category 3 the highest.
Health Canada tells us implementation of the Self-Care Framework is not an amalgamation of regulatory frameworks; NHPs, cosmetics, and OTCs continue to exist as separate regulated products. Rather the Framework will see phases of targeted amendments to our existing regulations, so they are more aligned with each other. Ultimately, the aim is that products of similar risk to the consumer should require similar levels of evidence before being marketed, and subject to similar post-market oversight. Even more, as a consumer, you should be able to pick up two similar products – say, sunscreen with oxybenzone or sunscreen with zinc oxide – and make an informed choice comparing the two with the information provided, despite one being an OTC and the other an NHP.
Health Canada has announced three phases to updating self-care product regulations.
Phase I – Improved labelling of NHPs
Health Canada will introduce, for consultation, targeted amendments to the Natural Health Products Regulations to improve labelling of NHPs.
This proposal builds on the precedent set by the Plain Language Labelling Regulations, passed in 2013 and applicable to OTCs. The proposed amendments intend to standardize the format of NHP labels, including the requirement for a facts table for all but the lowest risk NHPs. While there will be changes to account for the differences in labelling for NHPs, overall the new labelling requirements should offer a comparative experience to other self-care products.
Phase II – Amendments to the Food and Drug Regulations
Health Canada will introduce, for consultation, targeted amendments to the Food and Drug Regulations to introduce a risk-based approach to regulatory oversight for non-prescription drugs.
These suggested amendments seek to reduce the regulatory burden currently on OTCs, bringing them to the same risk level (as appropriate) to NHPs and cosmetics of a similar risk profile.
Phase III – Other regulatory amendments
Health Canada will introduce, for consultation, regulatory amendments to address evidence standards for similar health claims, extending risk-based regulatory oversight, and seeking additional powers for Health Canada, such as the ability to require a recall or label change for all self-care products.
This third phase appears an opportunity to bolster the powers of Health Canada over self-care products currently lacking oversight. In our current framework, for instance, Health Canada does not have the authority to initiate a recall over cosmetics and natural health products – which, upon consideration, is a sizeable gap. This will also be an opening for Health Canada to level the playing field so that products with similar risk profiles require a similar level of evidence before being placed on the market, and post-market undergo appropriate levels of scrutiny.
While Phase II overall seemed to be aimed at loosening some of the requirements expected of OTCs, Phase III will likely be the introduction of some obligations that cosmetic manufacturers will have to get used to.
What does this mean for you?
If you currently sell or soon will be selling an NHP, now is a great time to look closely at your labelling. Health Canada has issued the guidance Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products, which offers instruction on the design of safe and clear health product labels.
The guide offers an interesting stepping stone between the various moving parts of the different regulatory frameworks. Through the Plain Language Labelling Initiative, the Food and Drug Regulations have already been amended and OTCs are in the midst of their transition period to update labelling. While we are still waiting for both the proposed amendments to the Natural Health Products Regulations and an updated labelling guidance for NHPs specifically, we can look ahead to what they will likely be prescribed, all before these obligations are concrete. This gives manufacturers of NHP products a jump-start in updating their labelling.
CCI is well equipped to help you navigate the new requirements. From the formatting and content of a “Product Facts” table to what is permitted in the design of your label, our consultants can help you maintain compliance.