Business and Operations
Health Claims + Slow Approvals = No Value Added
November 5, 2007 By Mireille Theriault
Does the U.S. have it right, or do we have it wrong?
If you are of the opinion that nothing worthwhile comes without time and effort, then you should take considerable comfort in the lengthy and exacting process required to establish a health food claim in Canada.
“I think it’s an important process to go through,“ says Dr. Nancy Ames, Research Scientist at the Cereal Research Centre of Agriculture and Agri-Food Canada in Winnipeg. “The fact that a health claim requires so much effort, evidence, and validation makes it all the more significant. I think it holds a lot of weight.”
Dr. Ames knows of which she speaks. She is part of a group of scientists and interested parties, under the umbrella of the Alberta Barley Association, preparing a petition to Health Canada for the approval of a health claim. Such a petition requires at least two or three human clinical studies as part of the overall submission that covers an exhaustive range of information, that can include everything from the relevant history of consumption of the food in question – in this case, barley – to supply and safety.
“I think we’ll be able to submit this within the next nine months – certainly, before next year,” said Dr. Ames “I’m working with other scientists in a number of areas. There are people in clinical nutrition, others who understand the chemistry and biochemistry of barley, and people working on the food side of things. All will be involved at one point in taking a look at some of the literature I put together.”
The most vital portion of the application is the clinical validation of the claim – in this case, that eating barley in the context of a normal, healthy diet will reduce cholesterol in the bloodstream, and by extension, reduce the risk of heart disease. To date, they have gathered the necessary clinical studies that explore that relationship, and will soon begin the process of narrowing down which of those studies show most conclusively, and consistently, the all-important cause and effect between barley and its impact on human health.
In the United States, the Food and Drug Administration (FDA) has already approved this specific health claim for oats, and although Canada can’t be far behind, Health Canada can’t comment on the progress of any petition that may, or may not, already be under review. To put the time frame into perspective, it can take upwards of two years – based on a conservative estimate – to complete a petition. That process, somewhat simplified, will eventually come to the drafting of regulatory amendments that must go through approval by government agencies, the Minister of Health, publishing in the Canada Gazette, Part I, for comment, a 60- to 90-day waiting period, further amendments, and approval — until, finally (!), publication in the Canada Gazette, Part II.
At the Canadian Nutrition Congress, in Winnipeg this past June, Dr. Mary L’Abbé, Director of the Bureau of Nutritional Sciences, Food Directorate, Health Canada, provided encouraging insights to the progress we are making that will help close the gap between claims already approved in the U.S. and yet to happen in Canada.
As far as the five U.S. health claims currently considered for use in Canada, two have been recommended for acceptance – that fruits and vegetables and whole grains reduce the risk of heart disease, and that folate plays a role in reducing the risk of neural tube defects. Two claims not supported include a link between fat and cancer, and fibre-containing grain products and cancer. One more claim to be revisited in discussion with petitioners is the relationship between soluble fibre from certain foods and heart disease. In addition, Health Canada has reviewed 15 of the 16 SSAs (significant scientific agreement) and FDAMA (Modernization Act of 1997) disease risk reduction claims that have gone through to U.S. approval.
Health Canada’s position is that the agency is intent on modernizing its framework for managing health claims, starting with releasing a discussion document over the summer of 2007. Quoting the presentation by Dr. L’Abbé, its purpose will be to “clarify the current management framework, provide international context for claims, and identify issues for discussion focusing on four key themes for consistent and credible claims: 1) an efficient and transparent process; 2) sound evidence; 3) clear policies that address needs for today and tomorrow; and, 4) credible and sustainable outcomes that support consumer choice.”
Ironically, erring so far on the side of caution has caused equally strong opinions that Health Canada is falling far short of meeting the needs of the food processing industry at the most basic level, and adversely affecting consumer choice by limiting the information needed to make sound nutrition-based decisions. Opinion even sways to the point of suggesting that the health care and health quality of Canadian consumers is compromised, because they are not allowed to have vital information communicated to them, based on sound solid evidence about nutrients such as Omega-3 fats and specific fibres.
Dr. Peter Jones, director of the Richardson Centre for Functional Foods and Nutraceuticals, based at the University of Manitoba, has been involved at the ground level of leading edge functional food research globally for many years. “The confirmation is that compared to other jurisdictions – where there are multiple health claims allowed, not only for generic products but also for product specific health claims – we are abysmally slow. Although fibre is one of the specific five that has a very generic claim, you can’t really do much with what Canada permits right now.
“Is it that the U.S. has got it wrong or is it that we haven’t got it right?” Dr. Jones asked. In his opinion, the inability to make the same claims approved by our largest trading partner is probably the biggest hindrance that Canadian value-added foods face.
“Until we get through that impasse, we’re going to be slamming the box door shut on the rail cars, exporting gross commodities out of this country, and cheating ourselves with paper-thin margins of profit. Instead of being able to identify value added, instead of being able to communicate the health benefits of these foods to the consumer, and instead of seeing the producers get a better profit margin, we are stuck where we are right now.
“On the one side, we’re doing all these new and wonderful things here at the Richardson Centre, but a lot of it is going to leapfrog right outside of Canada. We’re working with Danone and Unilever. We’re working with WhiteWave. All of that research is going right over the heads of Canadians into the international spectrum, where the action is. They won’t even go near Canada, because they know there is no value in trying to penetrate that market,” Dr. Jones said.
While it could easily be argued that the whole purpose of regulatory bodies is to safeguard the interests of Canadians, there has to be a more balanced approach that will provide nutritional information, based on sound clinical studies, while not solely advancing the marketing agenda of business.
Still, for all the angst and frustration at the limitations of the present regulatory process, there is a healthy sense of optimism when it comes to the future of the food industry in general, the potential for growth in novel foods, and, ultimately, the benefits to the Canadian consumer as the biggest payoff.
Dr. Jones said, “Let’s say that on the positive side one of the most exciting areas of the future is going to be this whole probiotic and prebiotic area. We know that these bacteria operate very differently from bug to bug, but even more interestingly, what feeds those bugs has an awful lot to do with how they react – such as if you eat beans and raisins, versus white bread. I think we’re going to see a huge amount of interest from the consumer, and research, in getting the fibres right.”
There is a massive impact on the baking industry on the rise. In fact, five clinical studies, sponsored by Pulse Canada, to determine the health benefits of yellow peas, for example, are already underway to the tune of $1.3 million. Dr. Jones enthusiastically adds that the Richardson Centre has been part of those trials through its own on-site bakery.
“We’re adding yellow pea flour to bread, for example, as well as making muffins and breads with pea-hull fibre. In some cases, you could almost take the name away from fibre and call it a prebiotic, because it’s encouraging the growth of specific bacteria in the gut, which have health promoting benefits,” said Dr. Jones.
Enthusiasm aside, during the same nutritional congress, Dr. Ted Farnworth of Agri-food and Agriculture Canada, clarified some of the hurdles associated with the development of active bacteria, in the context of a viable health claim.
To quote Dr. Farnworth’s presentation: “Probiotics are a subset of functional foods, but they present some unique problems when it comes to obtaining health claims. At the present time, there is no universally accepted definition of a probiotic. In addition, the absolute identification and classification of the responsible micro-organism is often difficult. If a probiotic micro-organism is added to food, and brings about a fermentation, there is some question about what exactly is the active ingredient… . However, many effects are species specific, and to date, a scientific consensus has not been reached as to which diseases/conditions can be improved by consuming probiotics.”
In what is sure to be an equally engaging (and enraging) few years – as far as the progress of taking the research to market goes – it certainly should be safe to say that the food processing industry, in general, and the baking industry, in particular, had best not wait around for the proverbial seal of approval. It may be that if we hope to close the competitive gap between Canada and the U.S., we’d best look for alternatives to product labelling, such as public relations which has been so successful for dark chocolate, or be left behind at the cash register. If we aren’t proactive promoting the health benefits of products based on credible research, such as that Dr. Jones has published, even if we can’t make health claims, we’ll be spending our time reading the case studies our government has commissioned – and mourning the loss of consumers’ and corporate dollars as Canadian bakers are left so far behind.
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