Celiac Support Association

Definitions in Food Labeling

Lifeline, Summer 1993, Vol XI, No 3, pp 1-2 
Reprinted from the Federal Register

Before passage of the 1990 Nutrition Labeling and Education Act (NLEA), the former Food, Drug, and Cosmetic Act did not require flavorings, colorings or spices to be identified by their common or usual names. Instead, they could be declared collectively as "flavorings," "spices," or "colorings." Under the NLEA, however, color additives that FDA certifies for food use – FD&C colors Yellow No. 5, Red No. 40, Red No. 3, Yellow No. 6, and Blue No. 1, Blue No. 2, and Green No. 3, and their likes (specially formatted nonsoluble colors) – now must be declared on all foods except butter, cheese, and ice cream.

Colors exempt from certification, such as caramel, paprika, and beet juice, do not have to be specifically identified; they can still be listed simply as "artificial colors."

People often look to the ingredient label for health reasons – perhaps to avoid substances they are allergic or sensitive to – or as in the case of the celiac, those substances for which they have a malabsorption – or for those persons with religious or cultural reasons. Some examples meaningful to celiacs follow:

Caseinate. If it says "nondairy," does it mean no milk? Many people are not aware that certain products claiming to be nondairy, such as some coffee whiteners, contain a milk derivative called caseinate, in this case used to whiten effectively.

People expect there to be no milk ingredients in products marketed as dairy substitutes. But this issue has never been clear in the past. It is a particularly important concern for people with lactose intolerance and for persons with milk allergies. The nondairy label may lead consumers to think that caseinates are not milk-derived. Furthermore, it guides people away from even checking the label for milk-derived ingredients.

Under the new rule, caseinates will now have to be identified as milk derivative in the ingredient statement when it's used in food that claim to be nondairy. This requirement will help to flag it for casein-sensitive people and those with a lactose intolerance.

Protein Hydrolysates. Consumers will get more information about protein hydrolysates in their food, too. Hydrolyzed proteins (proteins broken down by acid or enzymes into amino acids) are added to foods to serve various functions. They can be used as leavening agents, stabilizers (to impart body or to improve consistency, for example) thickeners, flavorings, flavor enhancers, and as a nutrient (protein source), to name only a few uses.

Since the law does not require flavors to be identified by their common or usual names, some members of the food industry have made a practice of declaring protein hydrolysates as "flavorings" or "natural flavors" even when they are used as flavor enhancers – a use not exempt from declaration. After reviewing the data, FDA concluded that protein hydrolysates added to food as flavorings always function as flavor enhancers as well, and such, must be declared by their common or usual name.

The source of protein in hydrolysates used for flavor-related purposes also must be identified. Previously the general terms "hydrolyzed vegetable protein," hydrolyzed animal protein," or simply "hydrolyzed protein" were permitted, but the new regulation requires identification of the specific protein source, such "hydrolyzed corn protein" or "hydrolyzed casein." There are two reasons for this part of the regulation:

First, the law requires that the common or usual name of a food should adequately describe its basic nature or characterizing properties or ingredients. FDA reasoned that the more general terms "animal" and "vegetable" don't mean this requirement because protein hydrolysates from different source best serve different functions. Manufactures select protein hydrolysates from specific sources depending on how they will be used in a product. Hydrolyzed casein is generally used in canned tuna, for example, whereas hydrolyzed wheat protein is used in meat flavors.
Second, the source of the additive is particularly important to consumers who have dietary requirements such as celiac and dermatitis herpetiformis patients; and for religious, cultural, or other health reason. If hydrolyzed casein is added to canned tuna, for example, it must be identified as such rather than simply as "hydrolyzed protein" or "hydrolyzed milk protein."

Furthermore, the agency concluded that to minimized confusion, the source of protein in hydrolysates should also be identified. Thus, the source of all protein in hydrolysates – regardless of use – will now have to be identified.

Other final provisions of the new rule will include the following items:
Provide a uniform format for voluntary declaration of percentage ingredient information. Manufacturers who choose to declare ingredients by percent content would present them by weight rather than volume to avoid inconsistent calculations. Firms may use percentage declarations for as many as 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, as required by law.

Require label declaration of sulfiting agents in standardized foods. This is required because some people are sensitive to these preservatives. FDA has required listing of sulfiting agents in nonstandardized foods since 1986.

Nutritional Label Commentary

During the past two years, FDA and the food industry designed and tested eight or more label formats with consumer group input. In the end, they selected the "least disliked" format. USDA was unhappy about the reduction of the Daily Value for fat to "less than 65g" and apparently insisted that would show that if you eat more calories, you can also eat more fat.

It is in many ways reminiscent of the apocryphal story about new product development in industry. After years of research, many flavor panels, focus groups, and test marketing, a sample of the new product is taken home by the Executive Vice President of the company. His wife sends back the message that "it needs a little more salt." So, the product gets a little more salt.

FDA may say that good rulemaking is based on food science, but in the end the decisions on the nutrition labeling format were made without any scientific rationale at all. The present labeling format, which is more crowded more confusion, and more space-consuming than any previously tested, was never published as a proposal.

Specific type sizes and fonts are to be used for each line in the label. One questions whether science or populism dictated the listing of sugars in 8-pt type and calcium and other micronutrients in 6-pt. Is sugar really more important than calcium?

New labeling may appear as soon as the regulations are published and must be on products introduced into interstate commerce no later than May 8, 1994. Rules pertaining to health claims went into effect on May 8, 1993.

Packages with less than 12 square inches available for label do not have to carry nutrition labeling. Some of the foods that will be exempt from nutrition labeling include food produced by small business (foods sales of less than $50,000 per year) restaurant food, and ready-to-eat food prepared on site in bakeries, delis, and candy stores.

The label must be headed "Nutrition Facts" (in at least 13-pt Helvetica flush left and flush right), which signals to consumers that it conforms to the new regulation.

The title must be followed by a listing of mandatory nutrients (bold print) and voluntarily listed nutrients (regular print) in a specific order. Total calories, calories from fat, calories from saturated fat, total fat, saturated fat, polyunsaturated fat, monounsaturated fat, cholesterol, sodium, potassium, total carbohydrates, protein, vitamin A, vitamin C, calcium, iron, other essential vitamins or minerals. The listing of thiamin, riboflavin, and niacin is no longer required unless as an enrichment.

Regardless of the format used, the nutrient content is based on "serving size." The new label reference value, called the Daily Value (DV) comprises two sets of dietary Standards: Daily Reference Values (DVRs) and Reference Daily Intakes (RDIs). The RDIs replace the term US RDA, but the numerical value remains unchanged, as a result of the last-minute passage of the dietary Supplement Act of 1992. FDA expects to publish new numerical values for RDIs after 1993.

The proposed listing of "sweeteners," which would have lumped all the sugars and artificial sweeteners into a collective group, has been eliminated, as has the preamble statement about listing in order of predominance, etc. Ingredient declarations will be required on all foods containing more than one ingredient, and all certified food colors must be identified by FD&C numbers.


CSA Library Series

CSA Library Series is a collection of articles that pertain to celiac disease and dermatitis herpetiformis. Most of these articles have appeared in CSA’s quarterly newsletter, Lifeline, which all CSA members receive. Historic articles included in these resources may or may not include updated notes. Updated information indicated in red type. Articles represent the work of the author.

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