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GUIDANCE DOCUMENT

Draft Guidance for Industry: Calorie Labeling of Articles of Food in Vending Machines August 2016

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Docket Number:
FDA-2011-F-0171
Issued by:
Guidance Issuing Office
Office of Nutrition and Food Labeling

In the Federal Register of December 1, 2014 (79 FR 71259), the Food and Drug Administration (FDA or we) issued a final rule entitled “Food Labeling:  Calorie Labeling of Articles of Food in Vending Machines” (“the rule”).  The rule is codified at 21 CFR 101.8.  The rule implements section 403(q)(5)(H)(viii) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and amends FDA’s food labeling regulations in title 21 of the Code of Federal Regulations (21 CFR) by adding § 101.8.  The rule requires vending machine operators who own or operate 20 or more vending machines, or who voluntarily register with FDA to be covered, to declare calories for those vending machine foods for which the Nutrition Facts label cannot be examined before purchase or for which visible nutrition information is not otherwise provided at the point of purchase (see section 403(q)(5)(H)(viii) of the FD&C Act). 

We have prepared this guidance to help vending machine operators and industry to better understand and comply with the rule.  In the remainder of this guidance, “you” refers to persons or entities that are subject to the rule.  In addition, we cite the applicable regulations in many places throughout this document.

FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities.  Instead, guidances describe our current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word should in our guidances means that something is suggested or recommended, but not required.

Download the Draft Guidance

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You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2011-F-0171.