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Draft Guidance for Industry and FDA Staff: Whole Grain Label Statements

DraftHuman Foods Program02/17/2006

Description

For questions regarding this draft document contact, Food Labeling and Standards Staff (HFS-820), Office of Nutrition, Labeling and Dietary Supplements, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, College Park, Maryland 20740, 240-402-2371.

Scope & Applicability

Product Classes

2
Whole wheat macaroni products

Standardized food made from whole wheat flour

whole grain products

foods containing intact, ground, cracked or flaked caryopsis

Stakeholders

1
Manufacturers

Responsible for declaring acceptable market names on labels.

Related CFR Sections (8)

  • 21CFR139.138§ 139.138 Whole wheat macaroni products.

    (a) Whole wheat macaroni products are the class of food each of which conforms to the definition and standard of identity and is subject to the requirements for label statement of ingredients, prescribed for macaroni products by § 139.110(a) , (f)(2) , (f)(3) , and (g) , except that:Read full regulation →

  • 21CFR136.180§ 136.180 Whole wheat bread, rolls, and buns.

    (a) Each of the foods whole wheat bread, graham bread, entire wheat bread, whole wheat rolls, graham rolls, entire wheat rolls, whole wheat buns, graham buns, and entire wheat buns conforms to the definition and standard of identity and is subject to the label statement of ingredients prescribed forRead full regulation →

  • 21CFR137.220§ 137.220 Durum flour.

    (a) Durum flour is the food prepared by grinding and bolting cleaned durum wheat. When tested for granulation as prescribed in § 137.105(c)(4) , not less than 98 percent of such flour passes through the No. 70 sieve. It is freed from bran coat, or bran coat and germ, to such extent that the percent Read full regulation →

  • 21CFR137.105§ 137.105 Flour.

    (a) Flour, white flour, wheat flour, plain flour, is the food prepared by grinding and bolting cleaned wheat, other than durum wheat and red durum wheat. To compensate for any natural deficiency of enzymes, malted wheat, malted wheat flour, malted barley flour, or any combination of two or more of tRead full regulation →

  • 21CFR137.225§ 137.225 Whole durum flour.

    Whole durum wheat flour conforms to the definition and standard of identity, and is subject to the requirements for label statement of ingredients, prescribed for whole wheat flour by § 137.200 , except that cleaned durum wheat, instead of cleaned wheat other than durum wheat and red durum wheat, isRead full regulation →

  • 21CFR137.200§ 137.200 Whole wheat flour.

    (a) Whole wheat flour, graham flour, entire wheat flour is the food prepared by so grinding cleaned wheat, other than durum wheat and red durum wheat, that when tested by the method prescribed in paragraph (c)(2) of this section, not less than 90 percent passes through a 2.36 mm (No. 8) sieve and noRead full regulation →

  • 21CFR101.13§ 101.13 Nutrient content claims—general principles.

    (a) This section and the regulations in subpart D of this part apply to foods that are intended for human consumption and that are offered for sale, including conventional foods and dietary supplements.Read full regulation →

  • 21CFR102.5§ 102.5 General principles.

    (a) The common or usual name of a food, which may be a coined term, shall accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients. The name shall be uniform among all identical or similar products and maRead full regulation →

See Also (5)