Food and Drug Regulations

B.25.060 (1) Where the manufacturer of a human milk substitute or of a food that is represented as containing a human milk substitute is requested in writing by the Director to submit on or before a specified day evidence with respect to the human milk substitute, the manufacturer shall make no further sales of that human milk substitute or food that is represented as containing human milk substitute after that day unless he has submitted the evidence requested.

(2) Where the Director is of the opinion that the evidence submitted by a manufacturer pursuant to subsection (1) is not sufficient, he shall notify the manufacturer in writing that the evidence is not sufficient.

(3) Where, pursuant to subsection (2), a manufacturer is notified that the evidence with respect to the human milk substitute is not sufficient, he shall make no further sales of that human milk substitute or of that food that is represented as containing the human milk substitute unless he submits further evidence and is notified in writing by the Director that the further evidence is sufficient.

(4) In this section, evidence with respect to the human milk substitute means

• (a) evidence that establishes that the human milk substitute is nutritionally adequate to promote acceptable growth and development in infants when consumed in accordance with the directions for use; and

• (b) the results of tests carried out to determine the expiration date of the human milk substitute.