• Decrease
  • Normal
  • Increase
U.S. Department of Health and Human Services

About FDA

Implement Section 4205 of the Patient Protection and Affordable Care Act

Description: Implement Section 4205 of the Patient Protection and Affordable Care Act – Nutrition Labeling of standard menu items for chain restaurants, similar retail food establishments and vending machines. Providing understandable and accurate food labeling will aid consumers in selecting more healthful diets.

A. Publish FR notice for comments and voluntary registration conditions for Section 4205 implementation

Accomplishment:The Center for Food Safety and Applied Nutrition (CFSAN) and the Office of Foods (OF) opened a docket to solicit comments from stakeholders about FDA’s implementation of standard nutrition labeling for menu items at chain restaurants. CFSAN and OF received many comments and are currently in the process of evaluating them and incorporating some of them as guidances are being drafted. CFSAN and OF also specified the terms for establishments not covered under Section 4205 of the ACA to register voluntarily with FDA and become subject to the regulations FDA establishes under Section 4205. Both of these efforts will help FDA establish thorough, helpful guidelines for nutrition labeling that will aid consumers in selecting more healthful foods.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Publish Federal Register Notice Opening a docket to solicit comments on implementation of Section 4205

7/10/2010

Completed 7/10/2010

2. Publish Federal Register Notice to specify terms and conditions for implementation of voluntary registration pending final regulations

7/21/2010

Completed 7/23/2010

B. Develop guidance for industry on implementation of Section 4205 of the Affordable Care Act.

The final guidance will not be published. The draft guidance has been withdrawn.

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Publish final guidance on Section 4205 and its impact on State and Local laws

8/25/2010

Completed 8/25/2010

2. Guidance on implementation of self-executing requirements of Section 4205 on standard menu items sold in covered restaurants and similar retail food establishments

12/23/2010

Final Guidance Will Not Be Published N/A

a. Publish draft guidance

8/25/2010

Completed 8/25/2010

b. Review and summarize comments on draft guidance

10/15/2010

Completed 10/15/2010

c. Publish final guidance

12/23/2010

Final Guidance Will Not Be Published N/A

d. Draft guidance withdrawn

1/25/2011

Completed 1/25/2011

C. Develop final regulations mandated by Section 4205 on nutrition labeling in restaurants and similar retail food establishments.

Briefing Status: DELAYED

Prior Briefing Status: DELAYED

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Publish proposed rule

3/23/2011

Completed 4/6/2011

2. Review all comments on proposed rule

9/30/2011

Completed 7/31/2011

3. Prepare summary of comments

12/2/2011

Completed 8/19/2011

4. Prepare final rule

3/30/2012

Delayed

5. Publish final rule

6/30/2012

Delayed

D. Develop final regulations mandated by Section 4205 on nutrition labeling of vending machine items.

Briefing Status: DELAYED

Prior Briefing Status: DELAYED

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

1. Publish proposed rule

3/23/2011

Completed 4/6/2011

2. Review all comments on proposed rule

9/30/2011

Completed 7/31/2011

3. Prepare summary of comments

12/2/2011

Completed 8/19/2011

4. Prepare final rule

3/30/2012

Delayed

5. Publish final rule

6/30/2012

Delayed

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.