Food and Drug Regulations

B.25.048 (1) No person shall sell or advertise for sale a human milk substitute that has undergone a major change unless the manufacturer of the human milk substitute, at least 90 days before the sale or advertisement, notifies the Director in writing of the intention to sell or advertise for sale the human milk substitute.

(2) The notification referred to in subsection (1) shall be signed and shall include, in respect of the human milk substitute, the following information:

• (a) the name under which it will be sold or advertised for sale;

• (b) the name and the address of the principal place of business of the manufacturer;

• (c) a description of the major change;

• (d) the evidence relied on to establish 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;

• (e) the evidence relied on to establish that the major change has had no adverse effect on the human milk substitute;

• (f) the written text of all labels, including package inserts, to be used in connection with the human milk substitute; and

• (g) the name and title of the person who signed the notification and the date of signature.

(3) Notwithstanding subsection (1), a person may sell or advertise for sale a human milk substitute that has undergone a major change if the manufacturer has notified the Director pursuant to subsection (1) and is informed in writing by the Director that the notification is satisfactory.