have also received reports of adverse reactions to foods in which likely allergenic substances were used as flavors, and not declared by name. Therefore, in addition to the exemption in 101.100(a)(3), the agency is also considering whether an allergenic ingredient in a spice, flavor, or color should be required to be declared, 403(i) notwithstanding. On a substance‐by‐substance basis, the agency has required ingredients covered by the exemption in section 403(i) to be declared when necessary to protect individuals who experience adverse reactions to the substance, e.g., FD&C Yellow No. 5. The agency is open to suggestions on how to best address this problem….
While the agency does so, FDA asks manufacturers to examine their product formulations for ingredients and processing aids that contain known allergens that they may have considered to be exempt from declaration as incidental additives under 101.100(a)(3), and to declare the presence of such ingredients in the ingredient statement. Where appropriate, the name of the ingredient may be accompanied by a parenthetical statement such as “(processing aid)” for clarity.
The voluntary declaration of an allergenic ingredient of a color, flavor, or spice could be accomplished by simply naming the allergenic ingredient in the ingredient list. Because such ingredients are normally present at very low levels, the name of the ingredient could generally be placed at the end of the ingredient list and be consistent with its descending order of predominance by weight. Other, nonallergenic ingredients that are exempt from declaration would remain unlisted.
Another area of concern is the potential, inadvertent introduction of an allergenic ingredient to a food (e.g., in a bakery that is manufacturing two food products on one production line, one product with peanuts and one without, where traces of peanuts, or peanut products, may end up in the product that does not normally contain peanuts). FDA is considering options for providing consumers with information about the possible presence of allergens in these foods.
The agency is aware that some manufacturers are voluntarily labeling their products with statements such as “may contain (insert name of allergenic ingredient).” FDA advises that, because adhering to good manufacturing practice (GMP) is essential for effective reduction of adverse reactions, such precautionary labeling should not be used in lieu of adherence to GMP. The agency urges manufacturers to take all steps necessary to eliminate cross contamination and to ensure the absence of the identified food. The agency is open to suggestions on how best to address this issue.
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3.8.3 Gluten
Gluten is a food of public health significance, but it is not an allergen. Because gluten intolerance shares some similarity with allergic reactions, some other nation’s laws by definition group gluten as an allergen. This is a good example of a term of art, where the term “allergen” is defined in the law for convenience to mean “allergens plus some additional substances.”
Gluten is not an allergen, and it is not in the U.S. list of major allergens. The United States has approached the management of gluten content with regulation of “gluten free” labeling rather than specifically requiring gluten labeling. The FALCPA directed FDA to define “gluten free” labeling rather than requiring gluten labeling.
“Gluten” is defined as “the proteins that naturally occur in a gluten‐containing grain and that may cause adverse health effects in persons with celiac disease (e.g., prolamins and glutelins).” The grains with naturally occurring gluten are three specific grains—wheat, rye, and barley—and their crossbred hybrids (e.g., triticale).76
Gluten Free
FDA defined “gluten‐free” as meaning the food either is inherently gluten free or does not contain an ingredient that is: (1) a gluten‐containing grain (e.g., wheat); (2) derived from a gluten‐containing grain that has not been processed to remove gluten (e.g., wheat flour); or (3) derived from a gluten‐containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food. Also, any unavoidable presence of gluten in the food must be less than 20 ppm.77
Therefore, “gluten free” does not mean zero gluten, and the “may contain gluten” statement could be compatible with the gluten free claim if the unavoidable presence of gluten in the food is less than 20 ppm.
Normally when making a “free” claim for a food that is inherently free of that substance, it is considered misleading unless the claim is qualified. For example, one cannot claim, “cholesterol free,” on soybean oil but rather must make a qualified statement, such as “a cholesterol free food.” A different approach, however, is taken with gluten because of the public health significance. Among other reasons, it might be misleading to suggest that a particular food category is always gluten‐free because cross‐contact with gluten‐containing ingredients can and does occur in facilities where gluten‐containing ingredients are present. In short, foods that are inherently free of gluten can make “gluten free” claims without being considered misleading.78
NOTE
1 3.33 Oats and gluten. Oats contain avenin, a protein complex that some include generically as a gluten; however, avenin is different than the gluten in wheat, rye, and barley. About 1 percent of those with celiac disease have a reaction to the avenin (gluten) of oats. Most of the gluten problem with oats comes from cross contamination with wheat, rye, or barley. Klara Garsed & Brian B. Scott, Can oats be taken in a gluten‐free diet? A systematic review, 42(2) SCAND. J. GASTROENTEROL. 171–78 (2007).
3.9 ALCOHOLIC BEVERAGES
The Alcohol and Tobacco Tax and Trade Bureau (TTB) of the U.S. Department of Treasury (formally the Bureau of Alcohol, Tobacco, and Firearms, BATF) has jurisdiction over the labeling of alcoholic beverages under the Federal Alcohol Administration Act (FAA Act), 27 U.S.C. § 201 et seq. The FAA Act applies to distilled spirits, malt beverages, and wines with 7 percent or more alcohol by volume. TTB’s dual mission is to collect alcohol tax and to protect consumers.
TTB regulates the labels of alcoholic beverages. Thus, for example, the nutrition facts labeling required for food is not required on TTB‐regulated beverage. The FAA Act requires importers and bottlers of beverage alcohol to obtain certificates of label approval or certificates of exemption from label approval (COLAs) for most alcohol beverages prior to their introduction into interstate commerce.
The TTB also examines formulas for alcoholic beverages for proper tax classification and to ensure that the products are manufactured in accordance with federal laws and regulations. TTB ultimately regulates what ingredients are permitted to be added to alcoholic beverages, but FDA still regulates the safety of ingredients that may be added to food and drink, including alcohol beverages.
Allergen Labeling
Although the FALCPA does not apply to alcoholic beverages regulated by the TTB, the agency proposed making labeling of the major allergens mandatory.79 In addition, TTB issued voluntary, interim rules that require specific information and wording to be included if a producer, bottler, or importer of any alcoholic beverage discloses information. For example, any allergen declaration must
