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 state “Contains” followed by the common name for the major food allergen.80
General Labeling Requirements
The TTB labeling requirements are codified at Title 27 C.F.R. part 4 for wine, part 5 for distilled spirits, and part 7 for malt beverages. Use of words of geographic significance on wine labels is additionally covered in part 12. The alcohol beverage warning statement is covered in part 16.
The general labeling requirements bear similarities with those of food. For example, a wine label must include the brand name,81 the class of wine,82 name and address of where the wine was bottled or packed preceded by words “bottled by” or “packed by” for American wine or “imported by” or similar term for imported wine,83 the net contents,84 and a declaration of sulfites if a sulfur dioxide or a sulfiting agent is detected at a level of ten or more parts per million.85
However, there are a number of distinctions from food labeling. For example, a wine label must include the alcohol content and there are a number of considerations about the appellation of origin and related terms. The alcohol content is declared as “Alcohol ____% by Vol.” or wineries can use “Table Wine” or “Light Wine” if the alcohol content is 7 percent to 14 percent.86 The class of wine includes terms such as “grape,” “table,” “light,” “white,” “red,” “pink,” “amber,” “rose,” or “dessert” followed by the word “wine.”87 An appellation of origin, such as “Napa Valley” or “Chilean,” is mandatory in certain circumstance where the type, vintage date, or the term “estate” is used.88 On blends consisting of American and foreign wines, if any reference is made to the presence of foreign wine, the exact percentage by volume must be declared.
Label Approval
The TTB reviews and approves alcoholic beverage labels and issues certificates of label approval (COLA) under the authority of 27 U.S.C. § 205(e) and 26 U.S.C. § 5301. The COLA procedures are codified at 27 C.F.R. part 13.
Warning Statement
All alcoholic beverages with 0.5% or more alcohol by volume must bear a warning statement separate and apart from all other information.89 The wording of the warning is the following statement:
GOVERNMENT WARNING: (1) According to the Surgeon General, women should not drink alcoholic beverages during pregnancy because of the risk of birth defects.
(2) Consumption of alcoholic beverages impairs your ability to drive a car or operate machinery, and may cause health problems.
Wine Coolers versus Flavored Wine
The TTB only regulates those wine products that contain 7 percent or more alcohol. The FDA regulates wine coolers and other non‐malt beverages containing less than 7 percent alcohol by volume. Therefore, wine coolers that purport to contain unfermented fruit or vegetable juice are covered by 21 C.F.R. § 101.30 and are required to bear a percentage juice declaration.
Wine coolers that do not contain unfermented juice are not covered by this requirement unless they purport to contain juice by means of advertising, labeling statements, vignettes, or physical characteristics. Thus, if a wine cooler does not contain any juice, has labeling that makes clear that it contains flavors rather than juice, and does not bear a vignette that implies fruit juice content, it is not subject to 21 C.F.R. § 101.30. Noncarbonated beverages that purport to contain juice—but do not, in fact—contain any juice are required by 21 C.F.R. § 102.30 to state that they contain no juice.90
A Double Standard
The requirement for a percentage juice declaration on wine coolers has been called unfair because the same requirement does not apply to most other alcoholic beverages including spirits‐based and malt‐based coolers, which compete directly against wine coolers. FDA has commented: