Canada seeks opinion on health claims review
health claims review, as it plans to update its assessment
framework to make the system clearer and the claims more credible.
As the health and wellbeing trend continues to grow, so has interest in the health impacts of foods among both industry and consumers, thereby shining a spotlight on the management of health claims.
The current assessment process in Canada has been criticized as being slow, unpredictable, and restrictive as well as unclear concerning what types of health claims need to be submitted for consideration and the process to be used to evaluate them.
Ultimately, this means it is a disincentive for industry to develop a wider variety of healthy food products and confusing to the consumers to which the claims are aimed.
Health Canada, the federal department responsible for protecting the health of Canadians, is therefore updating its policies and evaluation processes, and asks for feedback by March 31, 2008.
Proposals regarding functional foods According to Health Canada's discussion paper, there is confusion surrounding the differences in standards and processes when food-like products are sold and regulated as Natural Health Products (NHP) rather than as foods.
The Food Directorate is cooperating with the Natural Health Products Directorate, so that consistent decisions are made for products with similar regardless of the regulatory regime under which the products are managed.
Many functional foods contain added bioactive ingredients, which may be supplemented to a higher level or may not traditionally be associated with that food.
While some such foods can safely be consumed in any quantity by the general population, others may pose health concerns for certain groups.
There is a growing interest in widening the use of foods containing added bioactive substances, and so the marketing of such foods is expected to expand, posing potential risks for populations for which the product was not intended.
Health Canada is seeking input on expected areas of new development, and on the suitability, rationale and risk management strategies for the addition of bioactive substances that may present a risk for some people.
Function claims The industry is becoming more interested in making function claims rather than disease risk reduction claims, partly because there are fewer regulatory requirements for these.
The distinction between different types of function claims and related requirements is not always obvious and can cause confusion for industry, says the paper.
While some argue there need not be as much oversight of these claims because they have a lesser impact than disease risk reduction claims, research indicates consumers do not make clear distinctions between different types of health-related claims and suggests that function claims may be as persuasive as disease risk reduction claims.
The paper says lack of clear guidelines for function claims could lead to inappropriate use, confusion among consumers, and, ultimately, loss of confidence in the credibility of health claims.
The Directorate intends to provide guidance to clarify which function claims have fewer regulatory requirements and, for these claims, will continue to maintain an up-to-date list of function claims.
The Directorate will encourage industry to voluntarily submit new claims for review.
Front-of-package Implied claims on food labels are considered misleading and the Food and Drug Regulations forbid implied disease risk reduction claims.
However, the paper says this is hard to enforce.
To maintain credibility and clarity of health claims in the marketplace, the Food Directorate is proposing to pursue alternative formats for disease risk reduction claims that provide additional flexibility to food manufacturers.
Symbols, graphics and slogans that suggest general nutritional or health values without referring to specific health claims may make it more difficult for consumers to make informed choices and result in skepticism about the validity of health claims.
Health Canada proposes to undertake consumer research on the interpretation of symbols or other representations.
It will also examine the possible forms of nutritional profiling that could underlie standardized nutritional criteria.
Health Canada also hopes to increase public access to the decision-making process for health claims, improve consumer understanding of health claims and monitor the impact of health claims on food supply and consumer choice.
International situation Canada is not alone in reviewing its health claim system.
The Food and Drug Administration (FDA) has long been carrying out a consultation on the effectiveness of its two types of health claims - 'qualified' and 'unqualified'.
Last month, the FDA made two US firms remove the health claims from their supplements and extracts after promoting unapproved claims on their products.
Similarly, the European Union is reviewing thousands of health claims made by manufacturers throughout all 27 member states - a process it expects will take two years.
Health Canada's discussion paper can be found at http://www.hc-sc.gc.ca/fn-an/consultation/init/man-gest_health_claims-allegations_sante_e.html