Special edition: Probiotic regulations and claims
How Canada regulates probiotics
claims in different markets around the world examines the situation
in the Canadian market.
The overview was given in a presentation by Dr Claire Kruger from the scientific research firm Spherix, as part of the International Probiotics Association (IPA) World Congress earlier this month. The congress, which took place in Los Angeles, California, was the first global probiotics event to bring together industry, academia and health care representatives under one roof for an in-depth examination of probiotic organisms. Canada In Canada, probiotics are defined by the Natural Health Products Regulations as a monoculture or mixed culture of live microorganisms that benefit the microbiota indigenous to humans. A probiotic is limited to non-pathogenic microorganisms and are regulated by the Natural Health Products Directorate (NHPD). Probiotics are also sold in foods (almost exclusively dairy products) regulated by Food Product Directorate. Dr Kruger told congress attendees that when considering probiotic efficacy, a number of criteria need to be met, to be demonstrated through both animal studies and human clinical trials. These include: minimum daily dose; acid and bile stability; intestinal mucosal adhesion properties; impact of diet on probiotic bacteria; and viability throughout product shelf life. Health Claims Products on the Canadian market can carry three types of health claims: structure/function, non-specific; risk reduction; or treatment. These are assessed by the NHPD based on the credibility, strength and quality of evidence provided. According to Dr Kruger, a claim made on a probiotic or prebiotic product will depend on the 'Standard of Evidence' that is submitted "Depending on the strength of the claim, supporting evidence may not have to include clinical trials (for example, a non-specific claim of health maintenance)," she said. Structure/function claims Structure/function claims describe the role of a nutrient or ingredient intended to affect normal structure or functions of the human body. This category includes claims of maintaining or promoting health. These vary widely from health maintenance to treatment of disease or conditions, said Dr Kruger. Non-specific claims may also be accepted, with supporting evidence from traditional or scientific literature. Nonspecific claims could include 'a factor in the maintenance of good health' or 'immuno-modulator', she said. Disease reduction claims Disease reduction claims describe the relationship between using a medicinal ingredient and reducing the risk of developing a specific disease or abnormal physiological condition. These are usually based on observational studies that demonstrate a significant change in the major risk factors in the development of a chronic disease, explained Dr Kruger. An example of this type of claim for use with probiotics is: "probiotics reduce the risk of colon cancer". Treatment claims These refer to the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or symptoms. An example of a treatment claim used with probiotics is: "clinical trials have shown that probiotics can be used in the treatment and prevention of pouchitis". Traditional/Non-traditional In the NHPD, products can be considered as either 'traditional' or 'non-traditional', Dr Kruger said. Traditional use claims encompass the sum total of knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures, used in the maintenance of health. They require a product to have a history of at least 50 consecutive years of use. Non-traditional claims occur when the evidence based on scientific data and all three types of claims (i.e. structure/function, risk reduction or treatment) are considered. Evidence is assessed on the basis of its strength, credibility and quality. These claims are based on references from scientific evidence, expert opinion reports, reputable regulatory authority reports, and previous marketing experience. To access the NutraIngredients-USA.com article on probiotic regulations and claims in the United States, click here.