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Ingredient declaration is required on all foods that have more than one ingredient. The ingredient statement allows consumers to identify foods that have ingredients to which they are allergic or have ingredients they want to avoid for other reasons. The listing also helps consumers select foods with ingredients they prefer.

The ingredients in a food must be listed by their common or usual names in decreasing order of their predominance by weight. The ingredient listing must include all the ingredients of any multi‐ingredient food used in the food’s recipe.⁴³ However, foods with two or more discrete components, such as cherry pie—which has filling and pie crust—may alternatively have a separate ingredient list for each of the components; e.g., “Ingredients: Pie crust (flour, soybean oil, salt), filling (cherries, sugar, corn starch). The ingredients must be listed in descending order of predominance by weight in each component list, and the components must also be listed in descending order by weight. However, for ingredients that are present at two percent or less by weight, they may be declared alternatively in a grouping at the end of the ingredient statement following an appropriate quantifying statement (e.g., “Contains less than 2% or less of ____________”).⁴⁴

Specialized Ingredient Labeling Requirements

Percent Ingredient Labeling

When a certain ingredient is a characterizing one in a food and the proportion of that ingredient has a material bearing on the price (e.g., the shrimp in shrimp cocktail) the percent of that ingredient is required as part of the common or usual name of the food.⁴⁵ Percent ingredient labeling is also required in the name of the food when it has a bearing on consumer acceptance or when the labeling or the appearance of the food may otherwise create an erroneous impression that such component is present in an amount greater than is actually the case.⁴⁶ For example, “Shrimp Cocktail (contains 45% shrimp)”.

On a related note, beverages purporting to contain juice must list the percentage of juice on the information panel. “Purport to contain juice” includes any representation in the product’s advertising, label, or labeling—directly or indirectly—to any fruit or vegetable juice, or the product contains color and flavor that gives the beverage the appearance and taste of containing a fruit or vegetable juice.⁴⁷

Voluntary declaration of percentage ingredient information is permitted in the ingredient statement, but the percent must be presented by weight rather than volume to avoid inconsistent calculations.⁴⁸ The percentage must be in parentheses following the name of the ingredient and expressed to the nearest 1 percent. Firms may use percentage declarations for as many or as few ingredients as they choose, as long as the information is not misleading. Manufacturers must still list ingredients in descending order, by weight.

Certified Colors

There are two categories of colorings, those requiring FDA certification and those exempt from certification. Each batch of synthetic colorings must be certified by FDA as meeting the color additive’s requirements for composition and purity. These “certified colors” must be named specifically in the ingredient statement; e.g., “FD&C Blue No. 1”.⁴⁹ However, the law exempts butter, cheese, and ice cream from having to show the use of color, with the exception of FD&C Yellow No. 5. Yellow No. 5 must always be declared for all foods because it triggers allergic reactions in some people.⁵⁰

Noncertified Colors

Colors exempt from certification, such as caramel, paprika, and beet juice, do not have to be specifically identified, but can be listed simply as “artificial colors.” Alternatively, noncertified colors may be listed by their common or usual names, such as “caramel coloring” and “colored with beet juice”. Note that the functional purpose of added coloring must always be declared (e.g., “____color” or “colored with____”).⁵¹

Spices and Flavors

Spices, flavors, and noncertified colors may be listed generically, without naming the specific source, except that any artificial colors or artificial flavors must be identified as artificial.⁵²

Flavor versus Flavor Enhancers

Although flavorings or flavors may be listed generically, ingredients that are used as flavor enhancers are not exempt from individual declaration in the ingredient statement. For instance, MSG is a flavor enhancer and must be declared individually in the ingredient statement of a food to which it is added.

Protein Hydrolysates

Hydrolyzed proteins are proteins that have been broken down by acid or enzymes into amino acids. Protein hydrolysates are added to foods to serve many functions, such as leavening agents, stabilizers (to improve consistency), thickeners, flavorings, flavor enhancers, or as a protein source. When protein hydrolysates are added to foods as flavorings, they always function as flavor enhancers and, as such, must be declared individually by their common or usual name. The source of protein in hydrolysates used for flavor‐related purposes also must be identified, such as “hydrolyzed corn protein” or “hydrolyzed casein.”⁵³

Caseinate

A declaration of casein and caseinate as a milk derivative must be included with the ingredient listing for foods that claim to be non‐dairy, such as coffee whiteners. Some states require products marketed as dairy substitutes to be labeled as “nondairy.” However, the nondairy label may lead consumers to think that caseinates are not milk derived. When caseinate is added to a food that is labeled nondairy, the caseinate must be identified as a milk derivative in the ingredient statement. This is in addition to the allergen labeling requirements of the Food Allergen Labeling and Consumer Protection Act (FALCPA).

Incidental Additives and Processing Aids

“Incidental additives” are additives that are present in a food at insignificant levels and have no technical or functional effect in that food. Incidental additives are not required to be listed in the ingredient statement.⁵⁴

“Insignificant amount” is quantitatively defined only for sulfiting agents, which is less than 10 ppm (10 mg/Kg) in the finished food. Sulfites being the single additive with a defined insignificant amount indicates how rarely this category applies. The sulfite 10‐ppm threshold is the only additive where scientific literature has established the quantitative amount for a lack of technical and functional effect. The sulfite threshold is the level where sensitive individuals begin having allergic‐type reactions. Any amount of a substance that would cause an allergic reaction in an individual is no longer insignificant.

To invoke the exemption from listing an incidental additive in the ingredient statement, the manufacturer must document that the incidental additive is nonfunctional in the finished food. If FDA challenged a company on an ingredient being listed in the ingredient statement, the burden falls on the company to prove their ingredient is nonfunctional. A qualified food scientist or food chemist should sign off on the facts and reasoning, and this should be kept in writing in a file in case FDA asks for it. Without such proof, failure to declare these ingredients would result in the food being deemed misbranded.

For the purposes of the incidental‐additive exemption, most are processing aids which:

1 Were added to a food but removed before packaging;

2 Were converted to constituents normally present in the food and do not significantly increase the amount normally found in the food (for example, as salt); or

3 Are substances added for their functional effect in processing but are present in insignificant amounts and have no functional effect in the finished food.⁵⁵

For example, water may be added during food processing but cooked off and no added water is present in the final food. Beyond processing aids, additives that remain present but that have no technical or functional effects in the final food are rare. Almost everything added to a food has a technical or functional effect.

Another category of incidental additives is substances that migrate to food from packaging or equipment as authorized under the food additive requirements. Like other incidental additives, to be exempt from ingredient labeling, the substance must present in a food at insignificant levels and have no technical or functional effect in that food. In addition, of course the substance migration must be authorized as safe.