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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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CPG Sec. 510.800 Beverages-Serving Size Labeling

 
BACKGROUND:

FDA regulations require that the serving size for beverages be determined from the Reference Amounts Customarily Consumed (RACC), which is 240 ml (8 fluid ounces) (21 CFR 101.12(b)); that the declared nutrient values are based on a single serving; and that the Nutrition Facts panel reflects the number of servings in the container (21 CFR 101.9(b)).  

In a May 27, 2010 letter, the American Beverage Association (ABA) requested that FDA exercise its enforcement discretion for industry to describe 12 fluid ounces as a “serving” on the front of beverage containers larger than 20 fluid ounces and to make conforming changes to the Nutrition Facts panel on such containers to reflect a 12 fluid ounce “serving size.”  In a subsequent letter dated June 24, 2010, the ABA clarified that its request was limited to: (1) sports drinks; (2) bottled water and water beverages; (3) soft drinks and diet soft drinks; (4) energy drinks; (5) juice drinks; and (6) ready-to-drink teas.  ABA indicated that its request did not include 100 % juices, alcoholic beverages, or 100% milks.

In FDA’s July 12, 2010 response to ABA, we stated “that the agency intends to exercise enforcement discretion for the beverage industry to describe 12 fluid ounces as a ‘serving’ on products that display calorie information on the [PDP] of certain beverage containers larger than 20 fluid ounces.”  We also stated, “the agency intends to exercise enforcement discretion so that the change [in the serving size] is reflected in the Nutrition Facts panel.”  Finally, we specified that “the beverage products in question are as follows:  (1) sports drinks (this term is used by industry and has not been defined by the agency); (2) bottled water and water beverages; (3) soft drinks and diet soft drinks; (4) energy drinks (this term is used by industry and has not been defined by the agency); and (5) ready-to-drink teas.”

POLICY:

 FDA will typically consider not taking an enforcement action when a beverage container larger than 20 fluid ounces states the calories for 12 fluid ounces on the PDP and correspondingly provides the number of 12 fluid ounce servings in the container and the nutrition information is based on a 12 fluid ounce serving in the Nutrition Facts panel.  This policy applies to the following beverages in containers larger than 20 fluid ounces that display calorie information per 12 fluid ounce serving on the PDP: (1) sports drinks (this term is used by industry and has not been defined by the agency); (2) bottled water and water beverages; (3) soft drinks and diet soft drinks; (4) energy drinks (this term is used by industry and has not been defined by the agency); and (5) ready-to-drink teas.  This policy does not apply to any other beverages, including 100% juices, diluted juice beverages, alcoholic beverages, or 100% milks.  

REGULATORY ACTION GUIDANCE:

FDA staff typically should not submit a recommendation for an enforcement action when “12 fl oz (360 mL)” is stated as the labeled serving size on the following beverages in containers larger than 20 fluid ounces that display calorie information per 12 fluid ounce serving on the PDP: (1) sports drinks; (2) bottled water and water beverages; (3) soft drinks and diet soft drinks; (4) energy drinks; and (5) ready-to-drink teas.

Issued:  December 2010