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SMALL ENTITY COMPLIANCE GUIDE

Small Entity Compliance Guide: Calorie Labeling of Articles of Food in Vending Machines August 2016

Download the Final Small Entity Compliance Guide Read the Federal Register Notice
Final
Docket Number:
FDA-2011-F-0171
Issued by:
Guidance Issuing Office
Human Foods Program

On December 1, 2014, FDA (we) published a final rule entitled “Food Labeling; Calorie Labeling of Articles of Food in Vending Machines” (“the final rule”) in the Federal Register (79 FR 71259, December 1, 2014). The final rule, which is now codified at Title 21 of the Code of Federal Regulations at § 101.8 (21 CFR § 101.8), requires that vending machine operators who own or operate 20 or more vending machines, or who voluntarily elect to be covered, provide calorie declarations 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. Covered vending machine operators must comply with the final rule by December 1, 2016. 

However, in the Federal Register of August 1, 2016 (81 FR 50303), we issued a final rule entitled “Food Labeling: Calorie Labeling of Articles of Food in Vending Machines: Extension of Compliance Date.” This rule provides that the compliance date for type size front-of-pack labeling requirements (§ 101.8(b)(2) (21 CFR 101.8(b)(2))) and calorie disclosure requirements (§ 101.8(c)(2)) for certain gums, mints, and roll candy products in glass-front machines in the final rule published December 1, 2014 (79 FR 71259) is extended to July 26, 2018.  The compliance date for all other requirements in the final rule (79 FR 71259) remains December 1, 2016. We have prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28). This guidance document restates in plain language the legal requirements set forth in the rule and is intended to assist small entities in complying with the final rule (21 CFR 101.8). The final rule is binding and has the full force and effect of law.

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.

In the remainder of this guidance, “you” and “I” refer to vending machine operators that are subject to the rule. Many of the answers in this guidance are followed by parenthetic citations that indicate where the information in the answer is codified.

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

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