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COMPLIANCE POLICY GUIDE (CPG)

CPG Sec 555.875 Water in Food Products (Ingredient or Adulterant) February 1989

Final
Issued by:
Guidance Issuing Office
Human Foods Program
Office of Inspections and Investigations

BACKGROUND:

Water is a food as defined in section 20l(f) of the Federal Food, Drug, and Cosmetic Act (2l USC 32l(f)). It is a normal constituent of many foods and is essential in the preparation and processing of most commercially prepared foods. However, it is also one of the most ancient and cheapest of food adulterants and should not be used as such.

Water may be used solely to wash or otherwise prepare foods under conditions which do not lead to its being incorporated as an ingredient in the foods. In other instances, as in bread making, water is added but is later removed by heating or other processing.

Prior to the enactment of the Fair Packaging and Labeling Act and revision of 2l CFR *101.4*, some manufacturers merely declared "sufficient water to prepare". Such a declaration does not comply with the present regulation and may be considered misleading and in violation of section 403(a) of the Federal Food, Drug, and Cosmetic Act.

In addition to the above, under section 402(b)(4) of the Federal Food, Drug, and Cosmetic Act, a food is considered adulterated "if any substance has been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength, or make it appear better or of greater value than it is."

Standards also exist which limit the amount of water being added to a product. Examples are standardized products which give an upper limit of moisture content (e.g., wheat flour, 2l CFR *137.105*), those which specify a minimum solids content (e.g., macaroni and noodle products, 2l CFR *139*) and products for which soaking, etc. is limited by time and the finished product is given a maximum amount of liquid which can be removed by draining (e.g. canned oysters, 2l CFR *161.130(b)*).

POLICY:

Water, when used as an ingredient of a fabricated food, including water used to reconstitute concentrated or dried ingredients, should be declared on the label as an ingredient. This should be in the order of decreasing predominance (2l CFR *101.4(a)*), based on the amount of added water in the finished food.

If all water added during processing is subsequently removed by baking or some other means during processing, water need not be declared as an ingredient (2l CFR *101.100(a)(3)*).

A food to which water has been added unnecessarily or in excessive amounts is considered adulterated in accordance with section 402(b)(4) of the Federal Food, Drug, and Cosmetic Act. *Water added to a food for which a standard of identity has been established, unless the standard provides for added water, violates that standard. Such food also is considered adulterated in accordance with section 402(b)(4) of the act and misbranded in accordance with section 403(g)(l).

  1. Canned tomatoes are considered adulterated, in accordance with section 402(b)(4) of the Federal Food, Drug, and Cosmetic Act, if they bear any added water.
  2. Scallops are considered adulterated under the act if any water has been added, either directly or in the form of melted ice.
  3. Canned sweet potatoes in mashed form (2l CFR 155.200(c)) may not have any added water.
  4. Shell Oysters (2l CFR 161.130(c)(1)) are considered adulterated under the act if held under conditions which result in the addition of water.*

*Material between asterisks is new or revised.*

Issued: 10/1/80
Revised: 12/2/76, 2/1/89


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

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