Regulation of foods with health claims: a proposal.

Health claims linking foods and food components to disease are prohibited in Canada because of limitations of the Food and Drugs Act. Changes to the Act to permit such claims would require a Bill to Parliament, a lengthy and impractical solution. In this paper, an alternative approach is proposed, that is, to regulate "Foods with Health Claims" under a subsection of the Drug Regulations. Generic claims would be regulated in a similar manner to Class IV or minimum risk drugs, whereby monographs would be created for constituents for which claims are proposed. Product-specific claims would be individually evaluated. Each food bearing a claim would carry a Food Identification Number (FIN), provided by Health Canada through application. Details of procedures and conditions for the FIN process are suggested. The FIN plan would provide an expedient, balanced and accountable approach to allow health claims on food products in Canada.