FDA Announces Withdrawal of Draft Guidance on Implementation of PPACA Menu Labeling Provisions

January 25, 2011

By Susan J. Matthees

FDA is withdrawing its draft guidance titled “Draft Guidance for Industry:  Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010,” which was published in August 2010.  As we blogged in August, the draft guidance consisted of commonly asked questions and answers about implementation of PPACA § 4205, which requires disclosure of calories and additional nutrition information on the menus of chain restaurants. 

The draft guidance was intended to help industry comply with the provisions of the PPACA § 4205 that became effective upon enactment, and in it FDA stated it would delay enforcement of those provisions until it published a final guidance document, which it anticipated would be in December 2010.  FDA did not meet that anticipated date.  In announcing the withdrawal of the draft guidance, FDA states that it received “extensive comments” on the draft guidance, and it now intends to finalize notice and comment rulemaking of the regulations implementing PPACA § 4205 before initiating enforcement actions.  FDA states it intends to publish the proposed regulations by March 23 and will consider the comments to the draft guidance in publishing its proposed regulations.  FDA states it hopes this approach will “minimize uncertainty and confusion” and lead to consistent disclosure of nutrition information.
Note that FDA is not withdrawing its guidance document on the effect of PPACA § 4205 on state and local menu and vending machine labeling laws, which was published at the same time as the withdrawn draft guidance.