Canada safety claims

Abbott Laboratories, which has conducted additional toxicity and carcinogenicity studies with cyclamate, a 10 1 mixture of cyclamate—saccharin, and cyclohexylamine, claimed to be unable to confirm the 1969 findings. Abbott then filed a food additive petition for cyclamate in 1973, which was denied by the FDA in 1980. In 1982, the Calorie Control Council and Abbott Laboratories filed a second food additive petition containing the results of additional safety studies (73). That petition was stiU pending as of 1996. Cyclamate is, however, allowed for use in any or all three categories, ie, food, beverage, and tabletop, in about 50 countries. Sweet n Low, known in the United States as a saccharin-based table-top sweetener, contains exclusively cyclamate in Canada. 

If drugs are not approved for lack of evidence to support safety, efficacy, or quality claims, Health Canada will not grant a marketing authorization for the drug however, the sponsor has the opportunity to offer additional supporting data and resubmit the submission at a later date. 

The National Health Products Directorate and Health Products and Food Branch of Health Canada believe these new policies, when fully enacted, will serve the consumer well. By meeting quality and safety standards based on good manufacturing practices and only allowing health claims supported by appropriate levels of evidence to accompany natural health products, the basis for rational use has been established (Health Canada, 2004). 

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