Food and Drug Regulations

B.01.054 (1) In order to generate information in support of an amendment to the Regulations, the Director may issue to the manufacturer or distributor of a food, where the food or the packaging, labelling or advertising of the food does not comply with the requirements of these Regulations, a Temporary Marketing Authorization Letter that authorizes the sale of the food described therein or the packaging, labelling or advertising of the food described therein for a specified period of time, within a designated area and in a specified quantity, in the manner specified in the Letter if

• (a) the manufacturer or distributor of the food has supplied to the Director the following information:

  • (i) the purpose for which the temporary marketing authorization of the food is required,

  • (ii) a description of the food including a sample and proposed label,

  • (iii) a description of any proposed variation from the requirements of these Regulations,

  • (iv) adequate data to show that the use of the food will not be detrimental to the health of the purchaser or user,

  • (v) the proposed quantity of the food to be sold,

  • (vi) the proposed period of time required for such sale,

  • (vii) the proposed area designated for such sale, and

  • (viii) such other data as the Director may require; and

• (b) the manufacturer or distributor of the food has agreed to

  • (i) describe the food on a label or in an advertisement in a manner that is not false, misleading or deceptive,

  • (ii) use such marks or statements on the label or in any advertisement as the Director may require,

  • (iii) on request, submit to the Director results of the temporary marketing, and

  • (iv) on request, withdraw the product from sale where the Director is of the opinion that it is in the public interest to do so.

(2) The Director shall, in any Temporary Marketing Authorization Letter issued pursuant to subsection (1), set out

• (a) the common name and description of the food to be sold;

• (b) the name and address of the manufacturer or distributor of the food;

• (c) the purpose for which the temporary marketing of the food is authorized;

• (d) the quantity of the food that is authorized for sale;

• (d.1) the type of packaging, labelling or advertising authorized in respect of the food where the Letter is intended to authorize a variation from a requirement of any provision of the Regulations respecting packaging, labelling or advertising;

• (e) the period of time during which the food may be sold; and

• (f) the designated area within which the food may be sold.