Document ID: chunk:federal_register_of_legislation:F2024C00915:body:0:p5
Version: federal_register_of_legislation:F2024C00915
Segment Type: other
Provision Reference: 
Character Range: 10072–12937

and contraindications associated with consumption of the food;
 (c) a statement indicating the medical purpose of the food, which may include a disease, disorder or medical condition for which the food has been formulated;
 (d) a statement describing the properties or characteristics which make the food appropriate for the medical purpose indicated in paragraph (c);
 (e) if the food has been formulated for a specific age group—a statement to the effect that the food is intended for persons within the specified age group;
 (f) a statement indicating whether or not the food is suitable for use as a sole source of nutrition;
 (g) if the food is represented as being suitable for use as a sole source of nutrition:
 (i) a statement to the effect that the food is not for parenteral use; and
 (ii) if the food has been modified to vary from the compositional requirements of section 2.9.5—7 such that the content of one or more nutrients falls short of the prescribed minimum, or exceeds the prescribed maximum (if applicable), and the food is not a *very low energy food:
 (A) a statement indicating the nutrient or nutrients which have been modified; and
 (B) unless provided in other documentation about the food—a statement indicating whether each modified nutrient has been increased, decreased, or eliminated from the food, as appropriate,
 (h) if the food is a *very low energy food:
                   (i) a statement to the effect that it is important to maintain adequate daily fluid intake while using the food; and
                   (ii) a statement to the effect that the food is not recommended for pregnant, nursing, or lactating women or use by infants, children, adolescents and elderly, other than under medical supervision; and
                   (iii) a statement indicating that the food is suitable for use as a sole source of nutrition when consumed according to the directions for use on the label.

 (2) For paragraph 2.9.5—9(1)(d), the required advisory statements and declarations are any that are required by:
  (a) items 1, 4, 6 or 9 of the table to section S9—2; or
  (b) subsection 1.2.3—2(2); or
   (c)   section 1.2.3—4.
  (3) For paragraph 2.9.5—9(1)(d), the *warning statement referred to in section 1.2.3—3, if applicable, is required.
2.9.5—11 Information relating to ingredients—food for special medical purposes
  For paragraph 2.9.5—9(1)(e), the information relating to ingredients is:
 (a) a statement of ingredients; or
 (b) information that complies with Articles 18, 19, 20 of Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers; or
 (c) information that complies with 21 CFR § 101.4.

2.9.5—12 Date marking information—food for special medical purposes
 (1) For paragraph 2.9.5—9(1)(f), the required date marking information