In late October 2014, Health Canada published its “Proposal to Accept a Health Claim about Soy Products and Cholesterol Lowering.” The draft was prepared for consultation purposes, which of itself is not out of the norm. What is particularly fascinating in this case is the science review within the article drafted by Health Canada, as well as how it is presented.
Traditionally one might expect to see drafts on Health Canada’s own website. This time it was published as an open source document in the International Food Risk Analysis Journal, posted on the InTech website. The Health Canada article was under what is referred to as a Food Risk Analysis Communication. This is a specific section in the journal that caters to shorter food risk analysis documents and is subject to an adapted peer review process to permit a more timely publication. Much of the peer review process is done by the various disciplines within Health Canada’s Food Directorate scientific and regulatory community before papers are published. Two of the current editors-in-chief are Health Canada’s Food Directorate director general Dr. Samuel Godefroy and senior science and medical advisor Dr. Sébastien La Vieille. Once published, articles are open for comment by the larger scientific and regulatory communities, for a period of anywhere between 30 and 90 days. This is paradise for scientific and regulatory nerds. It is also something that everyone involved in food compliance must become familiar with.
The use of this publishing forum for Health Canada is relatively new. There have been articles posted in the past several years, but 2014 saw the largest number of contributions by Health Canada. Statistics on published articles, like the number of downloads, can also be viewed. In the case of the proposed soy protein and cholesterol lowering health claim proposal, there have been 280 downloads, only 86 of those from within Canada. As a forum for providing greater transparency it has a bit of growing to do. It is, however, eloquently positioned to recruit input and interest from peers. A chief complaint is the fact that Health Canada does a poor job linking to it from within its own website. That would seem to be a larger obstacle to transparency. A comment period greater than 30 days might also be welcome, for more complex subjects.
Health Canada’s health claim proposal related to soy protein and cholesterol lowering is well written, concise, to the point and well referenced. It presents opposing views, such as those of the European Food Safety Authority, and offers a rational explanation why conclusions by Health Canada differ. Concerns related to soybean trypsin inhibitors (SBTI), which have an adverse nutritional effect, are recognized by Health Canada as a processing deficiency. Because of this Health Canada will be developing further guidance that would limit active SBTI in soybean products. The undertones of a disciplined internal peer review are evident. The format of how and where it is presented also gives the proposal a greater air of credibility. Overall, it’s a refreshing alternative to the status quo.
The health claim proposal related to soy products (with associated isoflavones) and cholesterol lowering follows the format of past reviews. A primary health claim such as, “250 mL (one cup) of enriched soy beverage supplies 30 per cent of the daily amount of soy protein shown to help lower cholesterol,” is proposed for products meeting the criteria established for the claim. Secondary statements such as, “Soy protein helps reduce/lower cholesterol,” “High cholesterol is a risk factor for heart disease” or a combination of the two may appear in addition to a primary statement. A daily amount of 25 g is proposed. The food will also need at least six grams of soy protein (non-alcohol washed) per serving of stated size, as well as per its applicable reference amount in Schedule M – Food and Drug Regulations (FDR).
Perhaps it’s also time to think about how protein claims are regulated in Canada. With a marketing authorization (MA), a ministerial regulation, Health Canada would be able to provide some remedy. MAs in the future may be used for health claims. Soya have to work with what you’ve got, at least until changes are made!