This policy allows modified versions of fresh (species) sausages, ground beef, or hamburger to contain non-meat or poultry, "fat-replacing ingredients" (e.g., binders such as carrageenan, modified food starch) and to be identified by certain nutrient content claims in accordance with nutrition labeling regulations effective on August 8, 1994, in conjunction with descriptive labeling, e.g., "Lean Pork Sausage with a X percent Solution of ...," or "Low Fat Ground Beef, Water, and Carrageenan Product."

This policy allows for the use of terms defined in regulations, e.g., "Lean," "Reduced Fat," "Low Fat," etc., to be used to describe fresh (species) sausage, ground beef, or hamburger products with a reduction in fat content resulting from the use of added ingredients (i.e., "fat replacers" such as carrageenan and isolated soy protein). These products must meet the criteria for use of the nutrient content claim associated with the fat reduction. The nutrient content claim may be used in conjunction with the standardized name provided the consumer is informed of the actual components of the product through labeling, i.e., descriptive product name, ingredients statement, and Nutrition Facts.

Meat products, including those that meet the criteria established for claims, such as "Lean," "Low Fat," "Lower Fat," "Reduced Fat," etc., that combine fresh (species) sausage, ground beef, or hamburger, and other safe and suitable ingredients, for the principal purpose of replacing fat, may be descriptively labeled. Examples of such products are "Lean Ground Beef, Water, and Carrageenan Product," "Low Fat Ground Beef with a X percent Solution of ...," "Lean Beef Sausage, Water, and Carrageenan Product," or "Reduced Fat Pork Sausage, Water, and Binders Product," provided conditions prescribed in the regulations, viz., 9 CFR 317, for use of the nutrient content claim are satisfied. In contrast, modified versions of fresh (species) sausage, ground beef or hamburger product containing added ingredients that do not qualify for use of a nutrient content claim prescribed in the nutrition labeling regulations must be labeled as Imitation Pork Sausage, Imitation Beef Sausage, Imitation Ground Beef, Imitation Hamburger, Beef Patty or Beef Patty Mix in accordance with 9 CFR Section 317.2(j)(1) and Sections 9 CFR 319.141 (Fresh pork sausage), 319.142 (Fresh beef sausage), and 319.15 (Miscellaneous beef products), respectively.

Descriptively labeled, modified, substitute versions of fresh (species) sausage, ground beef, or hamburger product with a reduction in fat content must comply with the following guidelines:

1. The descriptive name of a modified, substitute product with a reduction in fat content is the applicable nutrient content claim used in conjunction with the appropriate standardized name and fat-replacing ingredients, e.g., "Low Fat Ground Beef, Water and Carrageenan Product," or "Lean Pork Sausage with a X percent Solution of Water, Modified Food Starch, Spices, and Salt." Words in the descriptive name may be of a different size, style, color, or type but, in all cases, the words must be prominent, conspicuous, and legible. Moreover, no word in the descriptive name should be printed in letters that are less than one-third the size of the largest letter used in any other word in the descriptive name. The solution statement, when used, is considered to be part of the descriptive product name and must comply with descriptive name sizing requirements.

2. Fat-replacing ingredients (e.g., binders and water) and fat in the finished product may not exceed 30 percent of the product as formulated for the modified, substitute ground beef, hamburger, or fresh beef sausage product, and no more than 40 percent of the product formulation for the substitute fresh pork sausage. The fat content must be in accordance with requirements for use of the applicable nutrient content claim.

3. The product includes mandatory nutrition labeling prescribed in the meat inspection regulations, viz., 9 CFR 317.

4. The product is formulated with approved safe and suitable ingredients, e.g., those identified in 9 CFR 424.21(c)(4), and which are determined to be safe and suitable by the Labeling and Consumer Protection Staff, that are used at the lowest level necessary to achieve the intended effect as a fat-replacing ingredient (i.e., binder).

See: Policy Memo 121B dated January 20, 1995