lunes, 22 de agosto de 2016

FDA Law Blog: FDA Issues Calorie Labeling Guidance Documents for Vending Machine Operators

FDA Law Blog: FDA Issues Calorie Labeling Guidance Documents for Vending Machine Operators

Posted: 18 Aug 2016 03:23 AM PDT
By Riëtte van Laack –

On August 15, 2016 FDA simultaneously issued two guidance documents, the Draft Guidance, Calorie Labeling of Articles of Food in Vending Machines and the Final Guidance, Small Entity Compliance Guide (SECG), Calorie Labeling of Articles of Food in Vending Machines, to help Vending Machine Operators comply with the December 1, 2014 final rule, Food Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines (“the rule”) codified at 21 C.F.R. 101.8 (see our prior posting here).  Except for certain guns, mints and roll candy products in glass-front machines, the effective date is December 1, 2016.

The SECG is intended to help small businesses comply with the rule and restates the requirements of the final rule in plain language. The draft guidance provides additional information and clarification regarding certain aspects of the rule, and responds to frequently asked questions.

Although the SECG is intended to help small businesses, it provides useful information for any business, e.g., pictures of various formats used to declare calorie content of the product with details about font size requirements.

Vending Machine Operators are Subject to the Rule

The draft guidance clarifies what constitutes a vending machine operator subject to the rule.  The labeling requirements apply to vending machine operators who own or operate 20 or more vending machines that dispense food items (the term food includes dietary supplements); the number of vending machines that dispense only non-food items is not relevant. Vending machine operators who own or operate less than 20 vending machines that dispense food items may voluntarily register with FDA.  According to FDA, voluntary registration exempts a vending machine operator from “State or local nutrition labeling requirements for foods sold in vending machines that are not identical to the [federal] requirements.”  However, this voluntary registration does not mean that the operator is exempt from state and local licensing requirements.  Vending machine operators that own or operate 20 or more vending machine do not need to register because they are automatically covered by the rule.

FDA explains that in situations where vending machines are owned or leased, and another entity is contracted to control or direct the function of the vending machine (including selecting the foods to be vended), and the owner or lessee is not compensated for the control or direction of the vending machine, then that owner or lessee would not fit the definition of a vending machine operator and therefore would not be responsible for posting the calorie declarations.

Total Calorie Declarations Must be Declared and Visible Prior to Purchase

Calories must be declared prominently in a clear and conspicuous manner for the total calories in the vended food not per serving if the vended food constitutes more than one serving. If the vended food includes condiments the total calories must include the condiment.  If, however, the condiment is provided next to the vending machine, the labeled calorie content does not include the condiment.  If the food comes in variations, such as coffee with options for cream, sugar, or sugar substitute, then the calories must declared per option, or as the total calories of each variation in the final vended product.

Calorie declarations may be based on various sources, including the Nutrition Facts Label provided by the manufacturer or supplier, nutrient databases (i.e., USDA database, or FDA Nutrition Facts found in Appendix C of 21 C.F.R. 101 for fruits and vegetables), cookbooks, or laboratory analysis. If a food varies in calorie content, such as an apple, then the approximate standard size for calorie declarations may be used or different size calorie declarations may be used.

Calorie declarations may be on or near the food, or on or near the vending machine (e.g. using a sign). Because the side of the vending machine usually is not visible to the consumer, the information may not be placed on the side.  The calorie declarations that are displayed must be for foods that are currently or typically sold from that machine.  Calorie declarations may be presented in any format as long as they are clear and conspicuous.  Although not required, if a sign adjacent to the vending machine is used for calorie declaration of a number of foods, FDA encourages including the calorie information for all foods sold in the vending machine, even for foods which have calorie labeling on the food (i.e., front of package),

The compliance date is December 1, 2016. Any vending machine operator that becomes subject to the rule after that date, e.g., by adding vending machines to their operation, must comply immediately.  FDA recently extended the compliance date for type size requirements and calorie disclosure requirements for certain gums, mints, and roll candy products in glass-front machines until July 26, 2018.

Comments to the draft guidance are due September 30, 2016. Comments to the SECG may be submitted any time. 

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