Description
In theFederal Registerof 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 theCode 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).
Scope & Applicability
Product Classes
3Articles of food sold from a vending machine subject to calorie labeling.
Articles of food sold from a vending machine
The category of products covered by the labeling requirements
Stakeholders
4Person permitted to submit registration on behalf of the operator
A vending machine operator subject to the rule
Target audience for enforcement discretion
Person or entity that controls or directs the function of the vending machine; entity responsible for providing calorie declarations; The person or entity responsible for complying with the calorie labeling rule.
Regulatory Context
Attributes
2Requirement for the physical appearance of calorie declarations; must be at least 50 percent of the size of the largest printed matter; The font size of calorie declarations, which must meet specific minimums.
Required disclosure of energy content
Related CFR Sections (2)
- 21CFR101.8§ 101.8 Vending machines.
(a) Definitions. The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this section. In addition, for the purposes of this section:Read full regulation →
- 21CFR10.115§ 10.115 Good guidance practices.
(a) What are good guidance practices? Good guidance practices (GGP's) are FDA's policies and procedures for developing, issuing, and using guidance documents.Read full regulation →
See Also (8)
- Small Entity Compliance Guide: Calorie Labeling of Articles of Food in Vending Machines (Status: Final)
- Small Entity Compliance Guide: Alpha-Linolenic Acid, Eicosapentaenoic Acid, and Docosahexaenoic Acid Omega-3 Fatty Acids Nutrient Content Claims (Status: Final)
- Small Entity Compliance Guide: Revision of the Nutrition and Supplement Facts Labels (Status: Final)
- Draft Guidance for Industry: New Dietary Ingredient Notification Master Files for Dietary Supplements (Status: Draft)
- Questions and Answers Regarding Mandatory Cosmetics Recalls: Guidance for Industry : Draft Guidance for Industry (Status: Draft)
- CPG Sec. 460.300 Return of Unused Prescription Drugs to Pharmacy Stock (Status: Final)
- CPG Sec. 444.100 Recovery of Investigational New Drugs from Clinical Investigators (Status: Final)
- CPG Sec. 400.900 Class I Recalls of Prescription Drugs (Status: Final)