Which products can be used for low-lactose or lactose-free finished products?

To make a claim about lactose in a food product, one is making a nutrient content claim. A nutrient content claim on a food label characterizes how much of that particular nutrient is present in the food. It does not link the nutrient with a specific disease or health condition. Nutrient content claims can only be made if a food product meets the criteria for a content claim as set by the FDA. Absolute nutrient content claims, i.e., referring to a specific nutrient content in a single food, do not make comparisons of nutrient content to other food products. Absolute nutrient claims use phrases such as ”high,” “low,” or “free.” Absolute claims are well defined in the FDA’s nutrient content claim regulations contained in 21CFR 101.13 (see also FDA Guidance Document, Guidance for Industry: A Food Labeling Guide (8. Claims) dated January, 2013, to better understand the regulations for making a nutrient content claim).

From the Guidance document:

“N24. May a food that is normally low in or free of a nutrient bear a ”low” or “free” claim if it has an appropriate disclaimer (e.g.,fat-free broccoli)?

Answer: No. Only foods that have been specially processed, altered, formulated, or reformulated so as to lower the amount of nutrient in the food, remove the nutrient from the food, or not include the nutrient in the food may bear such a claim (e.g., “low sodium potato chips”). Other foods may only make a statement that refers to all foods of that type (e.g., “corn oil, a sodium-free food” or “broccoli, a fat-free food”). 21 CFR 101.13(e)(1)-(2)

N25. When is a formulated food considered to be specially processed and permitted to bear a “low” or “free” claim?

Answer: If a similar food would normally be expected to contain a nutrient, such as sodium in canned peas, and the labeled food is made in such a manner that it has little or none of the nutrient, then the food is considered specially processed and may bear a “free” or a “low” claim. 21 CFR 101.13(e)(1)”

It does need to be mentioned that there is no specific FDA definition for the terms “lactose free,” “low lactose,” or “lactose reduced.” A “lactose-free” or “low-lactose” product may still contain low levels of lactose.

When choosing an MPC or MPI to use in a lactose-free, low-lactose, or lactose-reduced food application, one is required to calculate that amount of lactose present per serving in the food application and then calculate how much lactose would be added to the food via addition of an MPC or MPI to the food product. We would suggest that a low-lactose MPC or low-lactose MPI would be best to use in such applications.

Note: The information provided here is thought to be accurate but because of the sensitive nature of label claims, we recommend that you seek legal counsel before making any claims on food product labels. FDA regulations are very specific for food labeling claims and, as such, need to be interpreted by an expert in the regulations for each food application.