Thursday, March 15, 2012

Listing Ingredients According to the FDA

  1. Answer: The ingredient list on a food label is the listing of each ingredient in descending order of predominance.
    “Ingredients: Pinto Beans, Water, and Salt” 21 CFR 101.4(a)
  2. Answer: Listing ingredients in descending order of predominance by weight means that the ingredient that weighs the most is listed first, and the ingredient that weighs the least is listed last (see illustration for question 3 below).
    21 CFR 101.4(a)
  3. Answer: The ingredient list is placed on the same label panel as the name and address of the manufacturer, packer or distributor. This may be either the information panel or the PDP. It may be before or after the nutrition label and the name and address of the manufacturer, packer or distributor. 21 CFR 101.4
    See also section 3, question 7 of this guidance for information on intervening material on the information panel.
  4. Answer: Use a type size that is at least 1/16 inch in height (based on the lower case “o”) and that is prominent, conspicuous, and easy to read. See the type size, prominence, and clarity requirements for information panel labeling discussed in section 3, question 3 of this guidance. 21 CFR 101.2(c)
  5. Answer: Water added in making a food is considered to be an ingredient. The added water must be identified in the list of ingredients and listed in its descending order of predominance by weight. 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.
    “INGREDIENTS: Water, Navy Beans, and Salt”
    21 CFR 101.4(a); 21 CFR 101.4(c); Compliance Policy Guide 555.875
  6. Answer: Always list the common or usual name for ingredients unless there is a regulation that provides for a different term. For instance, use the term “sugar” instead of the scientific name “sucrose.”
    “INGREDIENTS: Apples, Sugar, Water, and Spices”
    See also section 4 question 3. 21 CFR 101.4(a)
  7. Answer: It depends on whether the trace ingredient is present in a significant amount and has a function in the finished food. If a substance is an incidental additive and has no function or technical effect in the finished product, then it need not be declared on the label. An incidental additive is usually present because it is an ingredient of another ingredient. Sulfites are considered to be incidental only if present at less than 10 ppm. 21 CFR 101.100(a)(3)
  8. Answer: Listing alternative fat and oil ingredients (“and/or” labeling) in parentheses following the declaration of fat and oil blends is permitted only in the case of foods that contain relatively small quantities of added fat or oil ingredients (foods in which added fats or oils are not the predominant ingredient) and only if the manufacturer is unable to predict which fat or oil ingredient will be used.
    “INGREDIENTS: . . . Vegetable Oil (contains one or more of the following: Corn Oil, Soybean Oil, or Safflower Oil) . . . .”
    21 CFR 101.4(b)(14)
  9. Answer: When an approved chemical preservative is added to a food, the ingredient list must include both the common or usual name of the preservative and the function of the preservative by including terms, such as “preservative,” “to
    retard spoilage,” “a mold inhibitor,” “to help protect flavor,” or “to promote color retention.”
    “INGREDIENTS: Dried Bananas, Sugar, Salt, and Ascorbic Acid to Promote Color Retention”
    21 CFR 101.22(j)
  10. Answer: These may be declared in ingredient lists by using either specific common or usual names or by using the declarations “spices,” “flavor” or “natural flavor,” or “artificial flavor.”
    “INGREDIENTS: Apple Slices, Water, Cane Syrup, Corn Syrup, Modified Corn Starch, Spices, Salt, Natural Flavor and Artificial Flavor”
    However, products that are spices or spice blends, flavors or colors must list each ingredient by name. FD&C Act 403(i)(2). 21 CFR 101.22(h)(1)

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