The rules enact a key provision of the Food Allergen Labeling and Consumer Protection Act, passed in 2004 after Congress deemed voluntary industry guidelines inadequate to protect consumers with food allergies. Each year, 150 Americans die from allergic reactions to foods, and roughly 30,000 Americans seek emergency room treatment.

While roasted coffee itself contains none of the covered allergens, the law’s specific inclusion of flavorings may impact certain coffee products. Coffees flavored with natural essences or ingredients as well as pre-whitenend or sweetened instants could trigger the labeling requirement.

Requirements

Under the new rules, foods containing a “major food allergen” must say so prominently on the label. Defined as the eight substances that cause 90% of allergic reactions in the US -- milk, eggs, peanuts, tree nuts, fish, shellfish, soy and wheat – they also include food ingredients containing proteins derived from any of these food categories.

The label must clearly specify the substances immediately after or next to the ingredient list in a typeface at least as large. Manufacturers have several options, though, such as stating that the product “CONTAINS” the substances, followed by the names of the food sources from which the allergens are derived.

Alternatively, food makers can include the allergens in the list of ingredients, although the list must use the allergen’s common or usual name followed in parentheses by the derivative food source. This parenthetical source information, however, is not required if the ingredient’s common or usual name incorporates the name of the allergen food source. Also, the added information is unnecessary if the food-source name appears elsewhere on the ingredient list.

For example, labeling options for a product containing milk include: 

1. A statement immediately following the ingredient list -

• ALLERGEN INFORMATION: Contains Milk -- immediately following or next to the ingredient list
• CONTAINS MILK -- at the end of ingredient list

    2.  Ingredient listing –

• MILK -- listed with other ingredients 
• CASEIN (MILK) or WHEY (MILK) – adding the food source in parentheses where the technical term is used in ingredient list

In recognition of the special problems of persons with celiac disease, the law also calls on the FDA to develop a proposal to define use of the term ”gluten-free” on food labels. Disease treatment requires avoidance of glutens in foods. The FDA must develop a draft rule by August 2006 and a final rule by August 2008.

Flavorings/Packaging

The law specifically extends to labeling for flavorings, colorings or “incidental additives” that may contain major food allergens. “Incidental additives” include substances migrating into food from packaging.

Under ingredient labeling law, some foods, including spices, flavorings and certain colorings, may be listed simply as a class. Other ingredients, such as incidental additives, are exempt. As a result, allergens present in such flavorings, colorings or additives may be invisible to consumers. Extension to these ingredients furthers legislative intent to enable informed choices by consumers who read labels, something not possible when additives containing allergens do not appear on the ingredient list.

Under the statute, the Secretary of Health and Human Services also has discretion to require labeling for substances outside of its major allergens definition. The Secretary, in fact, gets specific legislative authority to require labeling for any “spice, flavoring, coloring or incidental additive that constitutes, bears or contains any other food allergen.”

Notable, too, is the new law’s omission of any small-business exemptions like those carved out of the Nutrition Labeling and Education Act of 1990. Under 1993 amendments to that law, some businesses with few employees and limited sales could secure an ingredient labeling exemption, as could retailers with limited sales revenues. Also, while foods with no significant nutrition, including coffee and instant coffee as well as most spices, were exempt under the labeling law, that is not the case with the new allergen legislation.

Cross-Contact

The Food Allergen Labeling and Consumer Protection Act also requires the FDA to inspect food facilities to ensure that their operations minimize cross contamination of major food allergen residues into foods in which they are not ingredients, as well as to ensure that food allergens are properly labeled. The FDA has already focused in such inspections in recent years, but law now gives them a legal footing to use against manufacturers and labelers.

The statute also calls for a major FDA report, due in February 2006, on how manufacturing and processing can unintentionally introduce major allergens to foods in which they are not intended ingredients. Among the issues to be examined are the use of the same production lines to produce different products, how allergens not intended as ingredients get into foods made on dedicated production lines, and whether good manufacturing practices can be used to reduce or eliminate cross-contact.

The statute also specifically empowers the HHS Secretary to conduct inspections of facilities in which foods are manufactured, processed, packed or held to ensure that the facilities comply with practices to reduce or eliminate cross-contact and to ensure proper labeling on foods.

Retail Guidelines

The new law also instructs the Secretary to pursue revising the U.S. Food Code to create guidelines for preparing allergen-free foods in food establishments, including restaurants, grocery stores, delicatessens, bakeries, and school cafeterias. It also suggests that the Secretary consider current guidelines and recommendations developed by public and private entities in connection with preparing allergen-free foods in public and private food establishments.

Exemptions

The legislative language clearly excludes raw agricultural commodities from the statute’s purview. Green coffee would likely fall into that category, but not so coffee extracts and flavors used to create consumer coffee products.

The legislation also carves out explicit exemptions for situations in which the public is otherwise appropriately protected. However, such a determination requires a specific FDA finding and must be published in the Federal Register. If a manufacturer can provide scientific evidence demonstrating that a food ingredient contains no allergenic protein, it can also be exempted through a petition process. Another explicit exemption is offered for highly refined oils of substances that might otherwise be major allergens or allergen proteins.

Any person may petition the Secretary of HHS to exempt a food ingredient from the allergen labeling requirements, and the Secretary is required to approve or deny such petition within 180 days of receipt. However, the burden of proof is on the petitioner to demonstrate that a food ingredient, as derived by the method specified in the petition, does not cause an allergic response that poses a risk to human health.

The Statute

The Food Allergen Labeling and Consumer Protection Act amends Section 403 of the Federal Food, Drug and Cosmetic Act and is the result of years of work and cooperative efforts involving the food industry, FDA, the Food Allergy & Anaphyliaxis Network (FAAN), consumer advocacy groups, concerned families nationwide and bi-partisan efforts by federal legislators such as Senators Judd Greg (R-NH) and Edward Kennedy (D-MA).

The new requirements are not unique to the United States. In 2003, the European Union issued a broader directive that requires food manufacturers to list twelve potentially allergenic ingredients and their derivatives, extending to other ingredients such as celery, mustard, sesame seed and sulphites.

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