U.S. FDA withdraws draft guidance on menu labeling

January 26, 2011

The U.S. Food and Drug Administration (FDA) has announced that it is withdrawing the draft guidance on menu labeling it published in August 2010. The withdrawal of the draft guidance is effective immediately.

This action appears to mean that the FDA plans to implement the menu labeling law by regulation, not by guidance. The FDA intends to publish a proposed rule by March 23, and will consider the comments it received on the draft guidance in developing the proposed rule. The FDA will not initiate enforcement activities prior to issuance of a final rule. Since the FDA did not withdraw its guidance document on federal preemption, it appears that the agency continues to view inconsistent State and local menu labeling laws as preempted by federal law.

Section 4205 of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act) amended the Federal Food, Drug, and Cosmetic Act to require mandatory nutrition labeling of standard menu items sold in chain restaurants. Specifically, the new law requires that any restaurant or similar retail food establishment that is part of a chain with 20 or more locations doing business under the same name, regardless of type of ownership, and offering substantially the same menu items (“chain retail food establishments”) must provide the following disclosures: 1) calories on the menu or menu board (including drive-through menu boards); 2) a succinct statement about suggested daily caloric intake on the menu or menu board; 3) a clear and conspicuous statement on the menu or menu board notifying consumers of the availability of additional nutrition information; and 4) additional nutrition information (i.e., calories, calories from fat, total fat, saturated fat, cholesterol, sodium, total carbohydrate, sugars, dietary fiber, and protein) available in writing on the premises.

Withdrawal of the draft guidance does not necessarily mean that the FDA has abandoned the policy positions expressed in the draft guidance (e.g., requiring nutrition labeling for alcoholic beverages). Therefore, stakeholders would be well advised to anticipate that the proposed rule may reflect the same policy preferences as the draft guidance.

Press release