FSIS Statement: Interim Labeling Guidance the Labeling of Factual Statements on Nutrients in Meat and Poultry Products
This policy provides guidance on how factual statements can be declared for nutrients in a serving of meat or poultry product when the nutrients come from a food that is produced or fortified under the jurisdiction of the Food and Drug Administration (FDA) for the purpose of improving the overall nutritional profile of the finished food. Unapproved nutrient content claims (or implied claims) about specific nutrients, as well as the direct fortification of meat or poultry products, are not permitted.
FSIS has received an increasing number of requests to approve labels that make factual statements about the amount of various vitamins, minerals and other nutrients present in meat or poultry products. In accordance with FDA's fortification policy in Title 21 of the Code of Federal Regulations (CFR), Section 104.20, FSIS does not permit the addition of nutrient additives (e.g., vitamins and minerals) to meat and poultry. FSIS continues to believe that the indiscriminate addition of nutrients to meat and poultry is not in the best interest of consumers since, to-date, there is no demonstrated need or consensus in the scientific community that the fortification of meat and poultry is necessary.
FSIS does not object to the addition of foods that are fortified under FDAs jurisdiction to meat and poultry products in a Federal establishment (e.g., an enriched spaghetti noodle that is added to a sauce with meatballs in order to make spaghetti with meatballs which is under FSIS jurisdiction). If a company intends to make a nutrient content claim or factual statement on the level of the particular nutrient contributed by the FDA fortified food, FSIS expects that the statement will identify the food that is the source of the nutrient (e.g., enriched pasta is a good source of Calcium, Vitamin D, and Magnesium). Similarly, FSIS does not object to a food produced under FDA's jurisdiction that contains a substance not specified in FDA's fortification policy (e.g., Lycopene, Omega-3 Fatty Acids, and Lutein) being added to a meat or poultry product as long as the safety of the use of the substance in meat and poultry products has been established. If a company intends to make a factual statement on the presence or level of such a substance on the meat or poultry product label, the statement will also need to identify the food that is source of the nutrient (e.g., 250 mg Omega-3 Fatty Acids per serving from the Flax seed in crust or 250 mg of Omega-3 Fatty Acids per serving from fish oil in breading). This information on labeling is to inform consumers about what food component has been added to the meat or poultry product that is the source of the nutrient. Statements of this type would be misleading if the source of the nutrient is not disclosed because it would create the impression that the meat or poultry is the source of the substance, which would not be correct. In some situations, however, the feeding practices employed by the producer would be the reason the substance is present (e.g., feeding flax seed to cattle and swine can introduce Omega-3 fatty acids to the meat tissue). In this situation, because there is nothing added to the meat after the animal is slaughtered, the source of the source of the substance would not need to be declared, although presence of the substance should be (e.g. X mg of Omega-3 fatty acids per serving).
The addition of an FDA regulated food (e.g., vegetable and fish oils such as menhaden oil, tuna oil, canola oil, or olive oil) to meat or poultry products cannot be done in a way that conflicts with a FSIS standard of identity or any other Federal regulation. For example, if a processor wished to add an FDA regulated seasoning that contains caffeine to meat or poultry, it would not be permitted to do so because under 21 CFR 182.1180, caffeine is only GRAS for addition to cola-type beverages. In regard to FSIS food standards of identity, standardized foods such as Italian Sausage (9 CFR 319.145) and Ham, With Natural Juices (9 CFR 319.104) do not provide for the addition of ingredients such as fish and vegetable oils. If a Federal establishment wishes to formulate a meat or poultry product with a food that is not provided for in the standard of identity, the common or usual name of the meat or poultry product will need to be modified to describe the new food so that consumers can distinguish it from the traditional product (e.g., Ham with Natural Juices with Olive Oil or Italian Sausage with Menhaden Oil).
[This is an interim policy statement and may be withdrawn or modified if information is received by FSIS that shows that significant consumer confusion exists in this subject area.]