This article originally appeared in Food in Canada and is republished with the permission of the publisher.
For many years the Canadian Food Inspection Agency (CFIA) and the Food Directorate of Health Canada took the position that if the Food and Drug Regulations (FDR) did not specifically permit a health claim, then such a claim had to be approved by the Food Directorate through a pre-market assessment process. This interpretation is somewhat at odds with the actual provisions of the FDR, which do not explicitly mandate such an approval for these “other” health claims.
In recent years, the Food Directorate has taken a fresh approach to the traditional view requiring pre-market approval. Through stakeholder meetings and presentations, Health Canada made it abundantly clear that it would no longer require pre-market approval for health claims not specifically contemplated under the FDR. Under this modern approach, Health Canada assured industry that structure-function, disease reduction, and therapeutic claims may be made, provided they are truthful and not misleading. Only “Schedule A Claims” (for example, claims related to a food being a treatment, preventative or cure for any of the diseases, disorders or abnormal physical states listed in Schedule A of the Food and Drugs Act, such as cancer, depression, and diabetes) require a pre-market assessment and/or regulatory amendment.
Unfortunately, as a result of this shifting view, it is becoming increasingly unclear to industry to what extent it can rely on this modern approach to the regulation of “other” health claims. The policy change was informal in that there was no direct announcement of the policy shift or an official enumeration of the exact claims that would now be allowed, nor is there any clear guidance on the standards of evidence required to support a claim under the new approach. In plain terms, this means the type and degree of scientific support required for a claim to avoid being considered false or misleading is unclear. While the shift in Health Canada’s perspective seems like a positive step forward, its very informality leads to confusion in the industry and has left many industry members either too timid to make innovative claims or facing uncertain enforcement by CFIA.
Furthermore, the CFIA has not provided any definitive statement that its position is aligned with that of the Food Directorate, and in many ways has shown that its position may in fact not be consistent. On at least one recent enforcement we acted on, the CFIA indicated that our client could not make a specified claim because it was not approved under a TMA (Temporary Marketing Authorization). This stance is inconsistent with the Food Directorate’s position that TMAs only apply to formulas and cannot be used for pre-market approval of claims. If the CFIA’s interpretation were correct, in order to make a claim that is not specifically authorized under the FDR, a company would either have to pursue a lengthy pre-market assessment, or re-formulate to make the product non-compliant and apply for a TMA. This would put a compliant formula at a strange strategic disadvantage from its TMA-approved counterpart, and does not make for good policy.
Another inconsistency is that the CFIA website has not been updated to align with the Food Directorate’s position on the matter. To further confuse the matter, the CFIA added the following statement to its website in February 2015: “When a health claim brings a food under the definition of a ‘drug’ (definition) through the use of a disease risk reduction claim (definition) or a therapeutic claim (definition), a pre-market assessment of the claim, by the Food Directorate of Health Canada, is mandatory.”
While we recognize that both organizations fulfill different roles – the Food Directorate is policy-focused, while the CFIA’s role is enforcement – both organizations are part of the Canadian government and therefore industry members should reasonably expect, and be able to make investment decisions, on the understanding that the two entities will maintain consistent positions. Otherwise, it is a case of the left hand not knowing what the right hand is doing. The Canadian food industry and consumers deserve better.