BACKGROUND:

In response to an inquiry submitted by the State of Florida, Department of Citrus, concerning whether orange or grapefruit juices, which otherwise comply with applicable standards of identity, can be fortified or enriched in any manner provided they are appropriately labeled, the Associate Commissioner for Regulatory Affairs issued an advisory opinion (Docket Number 87A-0237). The relevant policy expressed in the advisory opinion is quoted under the POLICY heading of this guide.

POLICY:

The agency believes that it will be necessary to consider each product, its fortification, use, and labeling, on its own merits. Generally, FDA believes that fortification of a standardized product would violate the standard of identity if the resultant fortified product purports to be or is represented as the standardized product. Specific foods that are subject to a standard may, however, be fortified, and the resultant products marketed as a non-standardized product under certain conditions.

In 1980, FDA adopted a fortification policy (21 CFR 104.20) ... that identifies the basis for food fortification that FDA considers reasonable (45 FR 6316). The agency stated: "Indiscriminate fortification of foods could lead to confusion about the necessity or propriety of food fortification. It could mislead consumers about the overall nutritional value of various kinds of foods and could lead to potentially serious health problems" (45 FR 6322).

It is therefore FDA's position that fortification of a food in a manner that is not consistent with FDA's fortification policy may be misleading. If the act of fortification is misleading, it follows that a common or usual name that reflects that act is also misleading. In addition, the agency is concerned that the declaration of the fortification may be accompanied by deceptive or misleading claims for the fortified food that lead the consumer to believe that there is some special benefit from eating the food, which may not be the case. To the contrary, consumption of a food that has been fortified in a manner not consistent with 21 CFR 104.20 may lead to excessive intake of a nutrient, which can have harmful consequences.

Therefore, while it may be possible to make a fortified orange juice or grapefruit juice product, such a product cannot be made in any manner that a manufacturer may choose. The orange or grapefruit juice to which the nutrients are to be added must meet the definition and standard of identity for the unfortified juice.

In addition, the product must be labeled as required by the Food, Drug, and Cosmetic Act and the regulations promulgated under 21 CFR Part 101. In particular, the labeling of the fortified product must bear, among other things, a common or usual name or descriptive term which includes the name of the added nutrient, e.g., "orange juice product with added _____." The purpose of this requirement is to assure that the fortified juice product is easily distinguishable from the non-fortified standardized juice.

Finally, the fortification *should* be consistent with 21 CFR 104.20. Nutrients may appropriately be added to a food to correct a dietary insufficiency recognized by the scientific community. FDA urges manufacturers who may be contemplating making a fortified juice product to present to the agency, before implementing a fortification plan, information that, among other things, demonstrates that a dietary insufficiency exists; identifies the affected population groups; and shows that the nutrient is stable in the food, is physiologically available from the food, is present in the food at a level that will not result in excess consumption of the nutrient, and is suitable for its intended purpose.

If the guidelines as set forth in 21 CFR 104.20 are not followed in the fortification of food products, such as juices in question, the fortification products and their labeling may be misleading and subject to regulatory action.

*Material between asterisks is new or revised.*

Issued: 5/13/88
Revised: 8/96