Are You Ready for the FDA Food Labeling Rule? (The FDA Has Released a Compliance Guide)

On December 1, 2014, the U.S. Food and Drug Administration (“FDA”) published a food labeling rule requiring “chain” restaurants and similar retail food establishments to list calorie information on menus and menu boards, including food on display and self-service food (the “Rule”). The Rule implements the nutrition labeling provisions of the Patient Protection and Affordable Care Act of 2010, which is intended to give consumers direct, point-of-purchase access to nutritional information, including the calorie content of foods. When the Rule was published, we blogged about the Rule’s applicability to and impact on restaurants and vending machines.

Food establishments must comply with the rule by December 1, 2015, if they are subject to the requirements of the rule on or before that date.

The FDA has now released a Small Entity Compliance Guide, which is intended to restate the Rule’s requirements in plain language. The Guide is organized in a question/answer format, and each answer cites the related regulation. While the Rule is binding, the Guide only makes recommendations, providing the FDA’s “current thinking” on the Rule.

The Guide provides detailed guidance on many topics:

• What establishments the Rule does and does not cover;
• What types of food the Rule does and does not cover;
• Compliance dates;
• How to label menus and other displays with nutritional information (see detailed discussion below);
• How to determine nutritional content of foods, including how to substantiate menu labels to the FDA;
• How to voluntarily register to be subject to the Rule; and
• Consequences of misbranding.

The Guide also discusses the Rule’s food labeling requirements in detail:

• Labeling requirements for standard menu items sold in a covered food establishment;
• Formatting requirements for declaring calories;
• Formatting requirements for variable menu items,* combination meals, and toppings (and applicable exceptions);
• Requirements for certain beverages (including alcoholic beverages);
• Required statements regarding daily calorie intake and additional nutritional information;
• Nutritional information for standard menu items that must be provided in written form; and
• Requirements for food that is self-service or on display.

* For example, chicken that can be grilled or fried or different flavors of ice cream.

The Guide also provides helpful visual examples, such as this declaration of calories on different types of pizza:

Plain pizza pie: Small (12”) 500 cal * Medium (14”) 750 cal * Large (16”) 1000 cal

The Rule’s requirements for determining caloric content and labeling menus are highly detailed. Both the Guide and experienced counsel can be valuable in helping covered food establishments achieve compliance by the FDA’s deadline.