Last week the United States Food and Drug Administration (FDA) issued draft guidance for the disclosure of calories and other nutrition information by restaurants and vending machine operators. The requirements were mandated by Section 4205 of the Patient Protection and Affordable Care Act, the sweeping healthcare reform legislation enacted in March 2010. Under the law, restaurants and a wide range of other food sellers—including bakeries, coffee shops, delicatessens, food take out and/or delivery establishments), convenience stores, movie theatres, cafeterias—with 20 or more locations will be required to post nutrition information. Vending machine operators that own or operate 20 or more machines will also be required to disclose calories for food items.

Section 4205 requires that the following information be on menus or menu boards at establishments covered by:

• The number of calories in each standard menu item “as usually prepared and offered for sale”
• A statement placing calorie information in the context of total daily caloric intake
• A statement regarding the availability of additional written nutrition information

Additionally, the FDA's draft guidance describes the manner in which the information should be presented and the information to be included in the additional written nutrition information that establishments must provide upon request.

The FDA anticipates issuing final guidance in December 2010 to assist food establishments and vending machine operators with complying with the new regulations. The FDA stated that it "expects to refrain from initiating enforcement action until after a time period established in the final guidance." The FDA is currently seeking comments on the draft guidance with respect to

• The appropriate time period for enforcement after the issuance of final guidance
• What facilities in grocery stores, beyond cafes, food courts, and in-store restaurants, should also be covered by section 4205
• Issues that may pertain to other establishments such as convenience stores

Waller Lansden is collecting comments to submit to the FDA on behalf of clients and other food establishments. Please send your comments to Michael S. Mizell at Waller Lansden via email at mike.mizell@wallerlaw.com. For more information, please contact Michael S. Mizell or any member of Waller Lansden's Regulatory practice at 800-487-6380.
 
The opinions expressed in this bulletin are intended for general guidance only.  They are not intended as recommendations for specific situations.  As always, readers should consult a qualified attorney for specific legal guidance.