Food and Drug Regulations — 33
33 (1) Subject to section 35, if a manufacturer of a food has submitted a request for a Temporary Marketing Authorization Letter for the food before the day on which these Regulations come into force and a Temporary Marketing Authorization Letter has not been issued under subsection B.01.054(1) of the Food and Drug Regulations before that day, the manufacturer is exempt from the application of sections B.29.031, D.01.009, D.01.011, D.02.009 and D.03.002 of those Regulations in respect of the food if the following conditions are met: (a) the Minister notifies the manufacturer, in accordance with subsection (2), that the sale of the food is authorized; (b) [Repealed, SOR/2024-244, s. 160] (c) no substance set out in column 1 of the List of Permitted Supplemental Ingredients has been added to the food, with the exception of a substance (i) contained in the food in the amount specified in the request in response to which the Minister has issued a notice referred to in paragraph (a), or (ii) that is a permitted food additive; (d) with respect to a food, other than a food referred to in paragraph (f) or (g), if a substance set out in column 1 of the table to Part I of the Threshold Levels for Cautionary Statements and Other Conditions of Use has been added to the food — other than as a permitted food additive — and the total amount of that substance contained in the food is above one or more of the thresholds set out in columns 2 to 6 for that substance, the label of the food carries the applicable cautionary statements set out in the headings to columns 2 to 6 or statements with equivalent meaning; (e) if the cautionary statement “Not intended for children”, “For adults only” or “If you are pregnant or breastfeeding consult a Health Care Practitioner prior to use”, or a statement with equivalent meaning, appears on the label of the food, there are no marks, statements, labels or advertisements, including product sampling, that promote the food for consumption by children or by pregnant or breastfeeding women, as the case may be; (f) with respect to a food that is a beverage that contains added caffeine and has a total amount of caffeine of more than 200 parts per million, the label of the food carries the following cautionary statements or statements with equivalent meaning: (i) if a substance set out in column 1 of the table to Part I of the Threshold Levels for Cautionary Statements and Other Conditions of Use has been added to the food — other than as a permitted food additive — and the total amount of that substance contained in the food is above the threshold level set out in column 8 for that substance, the applicable cautionary statement set out in the heading to column 8 or a statement with equivalent meaning, and (ii) the cautionary statements set out in the headings to columns 2 to 4 of the table to Part II of the Threshold Levels for Cautionary Statements and Other Conditions of Use or statements with equivalent meaning; (g) with respect to a food that contains added caffeine, other than a food referred to in paragraph (f), the label of that food carries the following cautionary statements or statements with equivalent meaning: (i) if a substance set out in column 1 of the table to Part I of the Threshold Levels for Cautionary Statements and Other Conditions of Use has been added to the food — other than as a permitted food additive — and the total amount of that substance contained in the food is above one or more of the thresholds set out in columns 2 to 6 for that substance, the applicable cautionary statements set out in the headings to columns 2 to 6 or statements with equivalent meaning, and (ii) if the total amount of caffeine contained in the food is above one or more of the thresholds set out in columns 2 to 4 of the table to Part II of the Threshold Levels for Cautionary Statements and Other Conditions of Use for the food category set out in column 1 to which the food belongs, the applicable cautionary statemen