Choosing the right regulatory pathways is critical to the development and success of CLA products, says Jyoti Sahasrabudhe.
The road to CLA success is strewn not only with scientific challenges but with the formidable task of navigating a complex regulatory environment.
To provide insight into the best regulatory pathways for CLA success, Jyoti Sahasrabudhe, of Calgary-based Sahasrabudhe & Associates, delivered a presentation titled "Canadian Regulatory and Novel Food Aspects" at the CLA Summit 2007.
As a consultant to the CLA Network, Sahasrabudhe has worked with network leaders to not only examine the current marketplace and evaluate opportunities for CLA products, but to develop specific strategic approaches to potential food content declarations, health claims and novel food hurdles.
The current regulatory environment in Canada, concerning CLA, is shaped by three major forces, says Sahasrabudhe. These are: The Food and Drugs Act (FDA) and Regulations, which has been around since 1953; the Canadian Food Inspection Agency's (CFIA) 2003 Guide to Food Labelling and Advertising; and, most recently, Health Canada's Interim Guidance Document on preparing a submission for foods with health claims.
Current labelling regulations, which govern the content of the mandatory "Nutrition Facts" table on most prepackaged food products marketed in Canada, include mandatory listing of 13 key nutrients such as calories, fat – including breakdown of saturated fat and trans fat – cholesterol, carbohydrate and protein. In addition, the regulations allow option for inclusion of information on an additional 30 nutrients, including omega-3 and omega-6 fatty acid content.
"Under the current regulations, a quantitative declaration of content of CLA would be allowed outside this table, to complement the table information," says Sahasrabudhe.
Nutrition claims, which go beyond declarations of content, must be approved by Health Canada, she says. They take the form of regulated statements made when or if a food meets certain criteria. "Nutrition claims should assist the consumer in making choices and they are based on current science and health criteria," says Sahasrabudhe. There are a number of approved claim statements that food companies can use, each with specific additional requirements.
The framework for health claims distinguishes between two types of claims. The first is a generic claim for nutrients and other food components or food groups which contribute to a dietary pattern of eating associated with a reduction in risk for a disease. The second is a product specific claim for a specific food which demonstrates a measurable health benefit beyond body function, growth, development or maintenance of good health. The five currently allowable claims are generic claims.
Of more immediate relevance for CLA is an additional element – the new Novel Food regulations, introduced in 1999 as an amendment to the Food and Drug Act. Under these regulations, "novel food" applies to products that do not have a history of safe use as a food, as well as to those that have been manufactured, prepared, preserved or packaged by a process that has not been previously applied to that food and / or causes the food to undergo a major change.
"Novel Food regulations do not apply to food products that already contain what are considered normal levels of CLA," says Sahasrabudhe. "But they would apply if levels are enhanced to a level that would meet the 'major change' criteria of the regulations."
The CLA Network's approach has centred on investigating two phases of regulatory initiatives, she says. The first is to get a product on the shelf that declares levels of enhanced CLA that are considered within a normal range of variation. The second is to further enhance the CLA content to levels considered outside the normal range of variation and obtain novel food approval for that type of product."
Reprintable with credit. Individual articles in the Report on CLA Summit 2007 are available for reprint, with acknowledgement of the source: The CLA Network. For broader reprint requests or reprint assistance contact the CLA Network at CLAnetwork@gov.ab.ca.
