Food Regulation. Neal D. Fortin

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       200 Percent or More of the RACC16

      If a unit weighs at least 200 percent and up to 300 percent of the reference amount, the serving size is the amount that approximates the reference amount. In addition, there must be dual columns with the Nutrition Facts label per serving size and a column that lists the amounts based on the individual unit.

       Additional Rules on Determining Serving Size

There are a number of special rules for various types of products. For instance, there are rules for the division of large units, such as pie or cake¹⁷; non‐discrete bulk products, such as breakfast cereal or flour¹⁸; and meal and main dishes.¹⁹

       Individual Units in a Multiserving Package20

      For products that have reference amounts of 100 grams (g) (or milliliter (mL)) or larger and are individual units within a multiserving package, if a unit contains more than 150 percent but less than 200 percent of the reference amount, the manufacturer may decide whether to declare the individual unit as one or two servings.

       Products Sold in Individual Containers Containing Less Than 200 Percent of the RACC21

      Special rules apply to food products that are packaged and sold individually. If such an individual package is less than 200 percent of the applicable reference amount, the entire contents must be labeled as one serving. For example, a 591‐mL (20‐fluid‐ounce) can of soda is one serving because the reference amount for beverages is 360 mL (12 ounces).

      However, if the product package contains more than 150 percent but less than 200 percent of the reference amount, manufacturers may voluntarily provide an additional column that provides nutrition information per household measure that most closely approximates the reference amount. For example, the reference amount for soup is 245 grams. Thus, a 15‐ounce (420 grams) can of soup must be declared as one serving, but an additional column may provide nutrition information for 1 ½ cups (240 grams) soup.

      4.3.5 Declaration of Serving Size

       Common Household Measures

Serving sizes must be expressed in both common household and metric measures.²² FDA allows the following as common household measures: the cup, tablespoon, teaspoon, piece, slice, fraction (e.g., “1/4 pizza”), and common household containers used to package food products (e.g., jar or tray). Ounces may be used, but only if a common household unit is not applicable and an appropriate visual unit is given—for example, 1 oz (28 g/about 1/2 pickle).

The number of servings per container is rounded to the nearest whole number when greater than 5 and to the nearest 0.5 for 2 to 5 servings.²³ Rounding should be indicated by using the term “about” in declaring the number of servings.

      4.3.6 Specific Exemptions to Nutrition Facts Labeling

      Specific exemptions to mandatory Nutrition Facts labeling are found in 21 C.F.R. 101.9(j). Note that all exemptions to Nutrition Facts labeling are lost if a nutrient content claim or a health claim is made for that food or if any other nutrition information is provided.

       Small Businesses

Two small business exemptions are available. The first applies to retail businesses selling directly to consumers that have total annual sales of less than $500,000 or food sales less than $50,000.²⁴ The second small business exemption applies to low‐volume businesses. This exemption is based on the number of employees and number of units of product sold.²⁵

       No Nutritional Significance26

      Foods that may declare zero or less than 1 gram for each nutrient on the Nutrition Facts panel are exempt. Bottled water and coffee beans fall in this exemption.

       Dietary Supplements27

      Dietary supplements are exempt from the Nutrition Facts labeling but must comply with their own Supplement Facts labeling.

       Medical Foods28

      Similar to dietary supplements, medical foods are exempt from Nutrition Facts labeling but must comply with their own distinctive requirements.

       Bulk Shipments29

      Food shipped in bulk and intended for further processing is exempt from Nutrition Facts labeling.

       Raw Fruits and Vegetables and Fish30

      Raw fruits and vegetables and fish fall under voluntary nutrition labeling.

       Small Packages31

      Food packages with less than 12 square inches of available space for labeling are exempt from mandatory nutrition facts labeling. However, the label must provide a means for the consumers to obtain nutrition information, such as a toll‐free number to call.

       Bulk Containers32

      Food sold from bulk containers is exempt from having the nutrition information on the container, provided this information is available somewhere at the point of purchase, such as a reference notebook.

      DISCUSSION QUESTION

      1 4.3. Infant food. Why did FDA decide to prohibit nutrient content claims on infant and toddler foods?

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       Good Reading for Good Eating

Paula Kurtzweil, FDA CONSUMER, SPECIAL ISSUE, FOCUS ON FOOD LABELING ³³

      It may not have the power of a Pulitzer prize‐winning novel or the luridness of a checkout counter tabloid, but the new food label still promises to make for good reading….

      [T]erms used to describe a food’s nutrient content—“light,” “fat‐free,” and “low‐calorie,” for example—will meet government definitions so that they mean the same for any product СКАЧАТЬ