New Labeling Requirements for Food Allergens and Trans Fat
Snack food manufacturers and other food processors that make products containing food allergens or trans fat face two major types of labeling changes, effective January 1, 2006. The Food Allergy Labeling and Consumer Protection Act of 2004 (FALCPA), enacted just this past August, mandates plain language labeling for the “Big 8” allergens—peanut, eggs, milk and milk by-products, wheat, tree nuts, soy, fish and shellfish—known to cause 90% of severe life-threatening reactions. The trans fat final rule, promulgated by the U.S. Food and Drug Administration (FDA) in July 2003, establishes trans fat as a mandatory nutrient that must be declared on a separate line in the standard Nutrition Facts Panel. With less than a year to the effective date, gaining a good understanding of these new requirements is key to the success of the food industry in achieving compliance.
Legislative History of FALCPA
In 1998, the FDA formed a partnership with the Minnesota Department of Agriculture and the Wisconsin Department of Agriculture, Trade and Consumer Protection in response to an increase of allergen-related recalls and concerns about controls of cross-contamination of undeclared allergen residue. The goals were to eliminate duplicate inspection and sample collections, ensure uniform enforcement, obtain current information on allergen awareness and provide feedback on useful allergy control information and training to the food industry.
One of the activities undertaken by these two states was an inspectional study of more than 80 food manufacturing establishments in Minnesota and Wisconsin to obtain an overview of industry practices as they pertained to allergen control. The states looked for the presence of peanut and egg allergens on food processing lines in the ice cream, bakery and candy industries—specifically, three ice cream, 31 bakery and six candy manufacturers in Minnesota and 10 ice cream, 23 bakery and 12 candy manufacturers in Wisconsin. Label verification, rework procedures, cross-contact prevention, and in general, allergen-control procedures used were reviewed in inspected firms. Firms were selected which made similar products with and without these two food allergens. During the inspections, samples of finished products that were not labeled as containing peanuts or eggs were collected for analysis at the state laboratories.
In March 2001, the states released a report on this inspectional study, and the results were striking. A major finding of the study demonstrated that 18 out of 73, or 25%, of final food product samples tested positive for peanut allergens even though peanuts were not declared on the product label. Positive products included one ice cream, one donut, eight cookies, two cookie dough and six candy samples. Ten percent of samples analyzed were positive for egg protein. Egg protein-positive products included three ice cream, one donut and one cookie sample.
The findings were highly publicized at the time, bringing a great deal of attention to the fact that food allergens—in this case, allergenic residues found in foods not labeled as containing peanut or egg—were a much more common problem than many previously thought. This was especially important as approximately 11 million Americans suffer from food allergies. The report brought visibility to the issue of food allergens and was a catalyst for increased efforts by FDA to develop an action plan. In addition, the Grocery Manufacturers of America (GMA), the National Food Processors Association (NFPA) and the Food Allergy and Anaphylaxis Network (FAAN) formed a food allergen alliance that developed voluntary labeling guidelines to support the use of plain English language on food labels. These activities eventually led to the Food Allergy Labeling and Consumer Protection Act signed into law by President Bush in August 2004. FALCPA establishes specific labeling requirements for the “Big 8” major allergens.
Allergen Labeling Requirements
Prior to this law, FDA required a complete list of ingredients on food labeling; however, there were exceptions. These exceptions—ingredients considered incidental additives, and spices, flavors and colors—were problematic because they were listed generically, which meant that, if any of these excepted ingredients contained a food allergen, the allergen was not explicitly listed. Thus, if a flavor or incidental additive used in a product contained a food allergen, it was essentially “hidden” under the generic label listing of “flavors” or simply not listed at all.
If an ingredient was not incidental or otherwise exempted, FDA required that allergenic foods had to be identified by their “common or usual name” on the list of ingredients. However, the “common or usual name” of an ingredient is not always commonly understood. For example, the term “milk” is more commonly understood by consumers than “casein” or “whey,” which are both milk derivatives. In other words, the common or usual name is not necessarily in plain English, which poses a problem for consumers as they read the label.
The new allergen labeling law is designed to correct these two issues. FALCPA essentially stands for two principles: (1) plain English language labeling; and (2) no hidden allergens on food labels. The law takes a common-sense approach to labeling requirements by addressing the major food allergens that cause the vast majority, approximately 90%, of all allergic reactions. “Major food allergen” is defined as any of the following:
1) The “Big 8” food allergens: milk, egg, fish (e.g., bass, flounder), crustacean shellfish (e.g., crab, lobster or shrimp), tree nuts (e.g., almonds, pecans or walnuts), wheat, peanuts and soybeans; or
2) A food ingredient that contains protein derived from a food specified in paragraph (1), except any highly refined oil derived from a food specified in paragraph (1) and any ingredient derived from such highly refined oil; or a food ingredient that is exempt under procedures outlined elsewhere in the law.
As such, the plain English and no hidden allergens requirements under FALCPA relate specifically to the labeling of the eight major food allergens, with one specific exception stated in the statute. The allergen labeling law does not apply to highly refined oils because it is recognized that refined, bleached and deodorized oils do not present food allergen problems. Basically, the labeling requirement under the new law dictates that these “Big 8” allergens must be labeled by their common English names specific to the allergen source (i.e., milk is milk, not casein or whey) and that labeling applies to ingredients derived from the “Big 8” allergens that contain protein. FALCPA also requires explicit labeling for flavors, colors and incidental additives if they contain a “Big 8” allergen.
Allergen Labeling Format Requirements
The labeling format requirements for food allergens are straightforward and involve two formatting options from which food manufacturers can choose. The first option is to use a “contains” statement, which means that the word “contains” is followed by a list of all the major food allergens contained in the product. This phrase must be immediately adjacent to the ingredient statement. The second option is “parenthetical” listing, which means that—intertwined within the list of ingredients—the plain English name of all food allergens is included in parentheses behind their common or usual names; i.e., “casein (milk).”
Under this second option, a parenthetical listing is not required if the ingredient name already identifies the major allergen (i.e., “tuna gelatin (tuna)” is redundant) or if the name of the major food allergen appears elsewhere such as in the name of the product (i.e., “Sam’s Old-Fashioned Peanut Butter”). When considering which allergen labeling format to use, food manufacturers should be cognizant that the choice is one or the other for any given label; in other words, the manufacturer cannot use the “contains” statement for some ingredients and the “parenthetical” statement for other ingredients on the same label. This is to ensure ease of reading for the consumer: persons with food allergies will learn to look for the “contains” statement and, if not there, will know to read the entire ingredient listing carefully.
The FALCPA labeling format also requires the use of common English names for the major food allergens. Simply put, if the product includes milk, the label must say “milk.” If tree nuts are used in the product, they must be identified by the specific nut such as “almond,” “pecan” or “walnut.” Similarly, fish/shellfish must be identified by species, such as “tuna,” “bass,” “flounder,” “shrimp” and “lobster.” Consumers with food allergies are allergic to specific kinds of nuts, specific species of fish, and so on, and this labeling format requirement addresses that need for specificity. Figures 1 and 2 show the use of common English names in both the “contains” and “parenthetical” labeling format options.