the labels of alcoholic beverages (those that contain 7 percent or more alcohol by volume and malt beverages) are regulated in accordance with the Federal Alcohol Administration Act (27 U.S.C. 205) administered by the Bureau of Alcohol, Tobacco and Firearms [now TTB] and are controlled differently from wine coolers. The labeling of wine coolers, like other beverages that contain less than 7 percent alcohol by volume, is regulated under the [Food, Drug, and Cosmetic] act. To the extent that these statutes differ, the products are regulated differently in other labeling aspects as well as in declaration of percentage juice content. It is not up to FDA, but to Congress, to decide that the same requirements must apply to wine coolers, other alcoholic beverages, and malt based beverages.91
NOTES
1 3.34 For more information on alcoholic beverage labeling, visit www.ttb.gov/labeling.
2 3.35 Fruit‐flavored malt beverages versus wine coolers. Wine coolers were popular in the United States in the 1980s. Today, fruit‐flavored malt beverages have largely replaced wine coolers. Economics largely drove this change. Barley malt is cheaper than grapes and taxation on malt beverage is more favorable than wine.
3 3.36 Non‐malt beer. All “malt beverages” with one‐half of 1 percent or more of alcohol by volume fall under the jurisdiction of the FAA Act. However, similar fermented beverages that are not a “malt beverage” fall outside the scope of the FAA Act and, therefore, are not subject to the labeling, advertising, and other provisions of the TTB regulations; for example, sorghum beer with less than 7 percent alcohol. These non‐malt beers are subject to FDA’s ingredient and other labeling requirements. Sake and similar beverages, when they contain at least 7 percent alcohol by volume, fall within the definition of “wine” under the FAA Act, and thus, are subject to TTB regulations and the requirements of the FAA Act.
3.10 USDA FSIS
The FDA labeling requirements apply to all foods except meat, poultry, and egg products. The USDA Food Safety Inspection Service (FSIS) regulates the labeling of most meat, poultry, and egg products. USDA regulation of the labeling of meat, poultry, and egg products generally parallels those for FDA‐regulated foods. One most important distinction is that most USDA‐regulated products require FSIS label approval prior to marketing.
3.10.1 Labeling Approval
FSIS’s labeling approval regulation, 9 C.F.R. § 412.1, states in part: “No final label may be used on any product unless the label has been submitted for approval to the FSIS Labeling and Program Delivery Staff, accompanied by FSIS Form 7234‐1, Application for Approval of Labels, Marking, and Devices, and approved by such staff, except for generically approved labels authorized for use in § 412.2.”
3.10.2 “Generic” Approvals (Labels Without Prior Approval)
Since 1996, the USDA FSIS regulations have allowed food establishments more flexibility for changing meat and poultry labels without prior FSIS approval. The regulations permit certain labels (categories that are not likely to present significant policy issues that have health or economic significance) to be “generically approved.” Once a generic label is approved by FSIS, the regulations provide for changes in the label in certain circumstances without further authorization from FSIS.92
In 2013, FSIS expanded generic approval so that the only four types of labels need to be submitted to FSIS for evaluation and approval as follows:
1 Labels for religious exempt products. Labels for poultry slaughtered under Buddhist, Confucian, Halal, or Kosher religious exemptions that do not bear the mark of inspection must be approved by FSIS.93
2 Labels for export with deviations from domestic labeling requirements.94
3 Labels with special statements and claims. Special statements and claims are claims, logos, trademarks, and other symbols on labels that are generally not defined in FSIS regulations or the Food Standards and Labeling Policy Book, such as geographical landmarks, heart logos, negative claims (e.g., gluten free), health claims, and processing method and ingredient claims.95
4 Labels for temporary approval. These temporary approvals are for minor deviations from the labeling regulations that do not pose any health, safety, or dietary problems to consumers. For example, if a supplier changed ingredients and failed to inform the establishment, the establishment might apply for a temporary approval to use the existing label, even though it does not have the correct ingredients statement.96
FSIS also evaluates labels for egg products and for exotic species under voluntary USDA inspection. Under generic approvals, it is the establishment’s responsibility to prepare final labeling in accordance with applicable regulations and to create and maintain records of final labeling.
3.10.3 Safe Food Handling Instructions Raw Meat and Poultry
The USDA requires safe handling and cooking instructions on raw meat and poultry products. 97 These instructions must state the following:
Safe Handling Instructions
This product was prepared from inspected and passed meat and/or poultry. Some food products may contain bacteria that could cause illness if the product is mishandled or cooked improperly. For your protection, follow these safe handling instructions.
Keep refrigerated or frozen. Thaw in refrigerator or microwave.
Keep raw meat and poultry separate from other foods. Wash working surfaces (including cutting boards), utensils, and hands after touching raw meat or poultry.
Cook thoroughly.
Keep hot foods hot. Refrigerate leftovers.
Mechanically Tenderized Beef Labeling Requirements 98
Tenderizing meat with a needle or blade can transfer pathogenic bacteria from the exterior of the meat to the interior. While intact muscle cuts, such as steaks, can be safe when cooked rare or medium rare because the outside is seared, the mechanically tenderized cuts must be cooked all the way through, like ground beef products, to kill pathogens inside the meat. CDC outbreak data from 2010 to 2014 indicates that consumers and food service facilities sometimes do not cook mechanically tenderized raw beef products to a temperature and for a time sufficient to destroy harmful bacteria that may have been transferred to the tenderized interior of the product.99
However, not all mechanically tenderized products are readily distinguishable from nontenderized products. For this reason, FSIS requires labeling to state that a beef product has been mechanically tenderized along with validated cooking instructions to provide consumers and food service workers the essential information to safely prepare the product.100
The name of raw or partially cooked mechanically tenderized beef must clearly indicate that the product has been mechanically tenderized. The terms “needle tenderized” or “mechanically tenderized” may be used as the descriptive designation for needle tenderized beef and the terms “mechanically tenderized” or “blade tenderized” may be used