Document ID: chunk:federal_register_of_legislation:F2024C00897:body:0:p20
Version: federal_register_of_legislation:F2024C00897
Segment Type: other
Provision Reference: 
Character Range: 54668–58063

required for a special medical purpose product for infants must state the following information in accordance with the provision indicated:

               (a) a name or description sufficient to indicate the true nature of the food (see section 1.2.2—2);
               (b) lot identification (see section 1.2.2—3);
               (c) if the sale of the product for sale is one to which Division 2 or Division 3 of Standard 1.2.1 applies:
                   (i)  information relating to *foods produced using gene technology (see section 1.5.2—4); and
                   (ii) information relating to irradiated food (see section 1.5.3—9);
               (d) any mandatory statements and declarations (see section 2.9.1—50);
               (e) information relating to ingredients (see section 2.9.1—51);
               (f) date marking information (see section 2.9.1—52);
               (g) directions for the preparation, use or storage of the product, if the product is of such a nature to require such directions for health or safety reasons;
               (h) nutrition information (see section 2.9.1—53).

            (2) The label that is required for a special medical purpose product for infants must comply with section 1.2.1—24 of Standard 1.2.1.

           2.9.1—50 Mandatory statements and declarations— special medical purpose product for infants

             For paragraph 2.9.1—49(1)(d), the following statements are required:

               (a) a statement to the effect that the product must be used under medical supervision;
               (b) a statement indicating, if applicable, any precautions and contraindications associated with consumption of the product;
               (c) a statement indicating the medical purpose of the product, which may include a disease, disorder or medical condition for which the product has been formulated;
               (d) a statement describing the properties or characteristics which make the product appropriate for the medical purpose indicated in paragraph (c);
               (e) if the product has been formulated for a specific age group—a statement to the effect that the product is intended for persons within the specified age group;
               (f) a statement indicating whether or not the product is suitable for use as a sole source of nutrition;
               (g) if the product is represented as being suitable for use as a sole source of nutrition:
                   (i) a statement to the effect that the product is not for parenteral use; and
                   (ii) if the product has been modified to vary from the compositional requirement of this Division such that the content of one or more nutrients falls short of the prescribed minimum, or exceeds the prescribed maximum (if applicable):
                      (A) unless provided in other documentation about the product—a statement indicating the nutrient or nutrients which have been modified; and
                      (B) unless provided in other documentation about the product—a statement indicating whether each modified nutrient has been increased, decreased, or eliminated from the product, as appropriate; and
               (h) the declarations required by section 1.2.3—4.

           2.9.1—51 Information relating to ingredients—special medical purpose product for infants

             For paragraph 2.9.1—49(1)(e), the information