Why it is possible to gain approval to add ingredients to some foods, but not other foods? The answer is that some foods are regulated under food standards—Section 401 of the Federal Food Drug and Cosmetic Act prohibits the addition of anything other than specified ingredients.

Food standards have been adopted to protect consumers from deceptive practices such as adulteration, misbranding, or mislabeling; inferior quality; or replacement with cheaper substitutes. The most recent revision of the law (1978) was intended to prevent economic substitution; e.g., to distinguish between vanilla produced from vanilla beans, the subject of a food standard and thus legally labeled as “vanilla extract,” and vanilla manufactured from wood pulp, which must be labeled as “artificial vanilla.”

Individual food standards vary in their approach; some specify minimum use of ingredients, while others specify compositional or physical characteristics, certain production requirements, or labeling. A food product that does not meet the requirements may still be sold, but it cannot be identified as the standardized product.

Some flexibility is allowed, as many standards provide for “optional” ingredients; however, either the purpose of each of the ingredients is obvious (e.g., a flavor) or the specific functionality is designated (e.g., calcium chloride as a fruit jelling agent).

There are certain circumstances, as with nutrient content claims, when a deviation from the standard is permitted, such as with reduced-calorie or reduced-fat versions of a traditional standardized food. Before these claims were permitted, “reduced-fat ice cream,” for example, required labeling as “ice milk” because the product did not meet the minimum standard for milkfat required by the “ice cream” standard. These modified versions must still meet the provisions of Part 130.10 of Title 21 of the Code of Federal Regulations; i.e., they must (1) meet the provisions of the traditional-food standard except for the deviation described by the nutrient content claim; (2) not be nutritionally inferior to the standardized food (except as indicated by the label as reduced); (3) possess performance characteristics, such as physical properties or shelf life, that are similar to those of the standardized food, unless the label bears a statement informing the consumer of a significant difference in performance characteristics that materially limits the use of the modified food (e.g., “not recommended for baking”); (4) contain a significant amount of any mandatory ingredient required to be present in the standardized food; and (5) contain the same ingredients as permitted in the standardized food, except that ingredients may be used to improve texture, prevent syneresis, add flavor, extend shelf life, improve appearance, or add sweetness so that the modified food is not inferior in performance characteristics to the standardized food.

The inflexible nature of food standards has the potential to stifle innovation. For example, last September, the Food and Drug Administration requested comments on a citizen’s petition submitted by Kraft Foods in August 2000. The petition sought to reduce the minimum curing time for the standardized cheeses Parmesan and Reggiano from 10 months to 6 months because of technological advances and the ability to decrease the cost of manufacturing these cheeses and thus provide less-expensive but “equivalent” product to consumers. As this demonstrates, the citizen petition process to amend food standards is a multi-year (five and counting) and bureaucratically challenging process.

A similar example is the 1999 citizen’s petition submitted by the National Frozen Pizza Institute to modify the standards of identity for “pizza with meat.” Because that standard requires four traditional components—bread-based crust, tomato sauce, cheese, and meat (specifically mandating 15% raw meat)—innovation in the use of alternative and/or exotic toppings (including the use of less meat) has been stifled, even though restaurant chains are free to prepare countless variations, combinations, and concentrations of toppings.

The inclusion of new functional food ingredients, such as fibers or plant sterols or bioactive antioxidants would be precluded from some categories because of food standards, and thus traditional staple “food-standardized” categories would not get the benefit of these new ingredients.

FDA and the U.S. Dept. of Agriculture are attempting to modernize food standards. A proposal in the Federal Register of May 20, 2005, outlined criteria for considering “whether a petition to establish, revise, or eliminate a food standard” becomes the basis for a proposed rule. Until these criteria are in place, addition of non-specified ingredients to standardized foods will be prohibited or continue to be the subject of time-intensive citizen’s petitions.

by Amy C. Mozingo
([email protected])
is Senior Research Associate
by James C. Griffiths
([email protected]),
a Professional Member of IFT, is Director of Toxicology,
Burdock Group, 2001 9th Ave., Suite 301, Vero Beach, FL 32960.