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October 2015

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From:
Arlene Spark <[log in to unmask]>
Date:
Tue, 27 Oct 2015 19:04:49 +0000
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The FDA is asking for public comment on their draft guidance on menu labeling. Comments are due Nov 2nd.  CSPI has prepared an example comment, and several NANA members have provided edits and feedback on it.  If you would like to use it as a model, please email Sara ([log in to unmask]<mailto:[log in to unmask]>) and she can share it with you.

The comment urges the FDA to finalize the guidance as soon as possible to allow restaurants and other food service establishments to move forward with posting calories on menus and menu boards and for foods on display.  We also ask the Agency to clarify the guidance around the list of covered venues, Internet menus, labeling of combo meals, ways to reduce the use of calorie ranges, and multi-serve items.

Let us know if you need more information.  Also, please let me or Sara know if you plan to comment.  It would be helpful to have a sense of how many organizations comment.

Margo

Margo G. Wootan, D.Sc.
Director, Nutrition Policy
Center for Science in the Public Interest
1220 L Street, NW, Suite 300
Washington, D.C. 20005
202-777-8354
www.cspinet.org/nutritionpolicy<http://www.cspinet.org/nutritionpolicy>

On Friday, the U.S. Food and Drug Administration (FDA) issued a draft guidance document<http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm461934.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery> to help companies comply with the menu labeling final rule by December 1, 2016.  The guidance was issued as a "draft" and the FDA has invited public comment. The comment period is 45 days (by 11/2/15<x-apple-data-detectors://0> to be incorporated in to the final guidance).

FDA guidance documents do not establish legally enforceable responsibilities, but rather describe the agency's current thinking on a topic and are recommendations unless specific regulatory or statutory requirements are cited.  Comments should focus on how the FDA interpreted the final rule, as the guidance cannot be used to change the regulations.

I'm wondering if groups are thinking about commenting, and if so if you would be interested in working together on a model NANA comment.  From my read of the guidance, it generally looks good.  However, I did see a few issues that might be worth considering commenting on.

Let me know (email Sara or [log in to unmask]<mailto:[log in to unmask]>) if you are interested in commenting or working on a model comment together, and we can set up a conference call to walk through the guidance together and to discuss possible area that might be worth commenting on.

Best,
Margo

Margo G. Wootan, D.Sc.
Director, Nutrition Policy
Center for Science in the Public Interest
1220 L Street, NW, Suite 300
Washington, D.C. 20005
202-777-8354
www.cspinet.org/nutritionpolicy<http://www.cspinet.org/nutritionpolicy>


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Center for Food Safety and Applied Nutrition - Constituent Update
http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/default.htm<http://links.govdelivery.com:80/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTUwOTExLjQ4OTk3MjExJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE1MDkxMS40ODk5NzIxMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MTg2Njg3JmVtYWlsaWQ9c2hhcm1pLmRhc0BmZGEuaGhzLmdvdiZ1c2VyaWQ9c2hhcm1pLmRhc0BmZGEuaGhzLmdvdiZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&100&&&http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery>

________________________________

FDA Statement on Release of Menu Labeling Guidance

By Dr. Susan Mayne, Director, Center for Food Safety and Applied Nutrition

September 11, 2015

Today, the U.S. Food and Drug Administration (FDA) is issuing a draft guidance document<http://links.govdelivery.com:80/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTUwOTExLjQ4OTk3MjExJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE1MDkxMS40ODk5NzIxMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MTg2Njg3JmVtYWlsaWQ9c2hhcm1pLmRhc0BmZGEuaGhzLmdvdiZ1c2VyaWQ9c2hhcm1pLmRhc0BmZGEuaGhzLmdvdiZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&101&&&http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm461934.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery> that will help companies to comply with the menu labeling final rule, which requires that calorie information be listed on menus and menu boards in chain restaurants and similar retail food establishments with 20 or more locations. In July, FDA extended the compliance date an additional year, beyond the original December 2015 compliance date, to help facilitate efficient compliance across all covered establishments. The guidance document issued today is an important resource in our efforts to assist those in covered establishments to comply with the rule by December 1, 2016. Ultimately, consumers will be able to make more informed choices for themselves and their families.

We appreciate the extensive input we have received from stakeholders throughout the process of establishing requirements for menu labeling in certain restaurants and other retail food establishments. The guidance document responds to many of the most frequently asked questions that the agency has received to date in emails and during meetings with and presentations to representatives of the range of establishments covered by the new menu labeling rule. These interactions have been invaluable.

This guidance is intended to help establishments implement the rule and better understand the flexibility in the rule. The guidance also answers questions and helps explain how the final requirements work for different types of establishments. The guidance does not and cannot change the final requirements of the menu labeling rule.

The guidance is being issued as a "draft" and we welcome your comments. We will consider all comments before finalizing the guidance and will consider updates to the guidance as needed. We are committed to working collaboratively with establishments covered by the menu labeling final rule, including chain restaurants, covered grocery stores serving restaurant-type food, and others, now and in the future, to answer additional questions. In addition, we will be providing educational and technical assistance for covered establishments and for our state, local, and tribal regulatory partners to support consistent compliance nationwide.

We encourage covered establishments to consider the information in this draft guidance as they prepare to comply with the final rule by December 2016. We will work flexibly and cooperatively with individual companies making a good faith effort to comply. We believe that this cooperative approach helps to improve the dialogue surrounding the requirements and facilitates successful implementation in a practical way.

As a result of these efforts, consumers will have ready access to calorie information they currently may not have to help them make healthy decisions. That's a worthy outcome of which we can all be proud.

For more information:

  *   Draft Guidance for Industry: A Labeling Guide for Restaurants and Retail Establishments Selling Away-From-Home Foods - Part II (Menu Labeling Requirements in Accordance with 21 CFR 101.11)  <http://links.govdelivery.com:80/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTUwOTExLjQ4OTk3MjExJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE1MDkxMS40ODk5NzIxMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MTg2Njg3JmVtYWlsaWQ9c2hhcm1pLmRhc0BmZGEuaGhzLmdvdiZ1c2VyaWQ9c2hhcm1pLmRhc0BmZGEuaGhzLmdvdiZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&102&&&http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm461934.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery>
  *   Menu and Vending Machines Labeling Requirements<http://links.govdelivery.com:80/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTUwOTExLjQ4OTk3MjExJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE1MDkxMS40ODk5NzIxMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MTg2Njg3JmVtYWlsaWQ9c2hhcm1pLmRhc0BmZGEuaGhzLmdvdiZ1c2VyaWQ9c2hhcm1pLmRhc0BmZGEuaGhzLmdvdiZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&103&&&http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm217762.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery>
  *   FDA Statement on Extension of Menu Labeling Compliance Date<http://links.govdelivery.com:80/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTUwOTExLjQ4OTk3MjExJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE1MDkxMS40ODk5NzIxMSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3MTg2Njg3JmVtYWlsaWQ9c2hhcm1pLmRhc0BmZGEuaGhzLmdvdiZ1c2VyaWQ9c2hhcm1pLmRhc0BmZGEuaGhzLmdvdiZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&104&&&http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm453529.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery>



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