Food and Drug Regulations
B.24.306 (1) No person shall sell or advertise for sale a food represented for use in a very low energy diet that has undergone a major change, unless the manufacturer, at least 90 days before the sale or advertisement, notifies the Director in writing of the intention to sell or advertise for sale the food that has undergone the major change.
(2) The notification referred to in subsection (1) shall be signed by the manufacturer and shall include, in respect of the food represented for use in a very low energy diet that has undergone a major change, the following information:
(a) the name under which the food is to be sold or advertised for sale;
(b) the name and 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 food meets the nutritional requirements, other than energy requirements, of a person for whom it is intended, when the food is consumed in accordance with the directions for use;
(e) the evidence relied on to establish that the major change has no adverse effect on the food or its use;
(f) the written text of all labels, including package inserts, to be used in connection with the food; 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 food represented for use in a very low energy diet that has undergone a major change, if the Director, after having been notified by the manufacturer pursuant to that subsection, has informed the manufacturer in writing that the notification meets the requirements of subsection (2).
- SOR/94-35, s. 4.
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