After initial delays that we covered in our previous post, FDA Delaying Enforcement (Again) for Menu Labeling Final Rule,1 we now report that on April 29, FDA issued its Final Guidance on Menu Labeling (Final Guidance).2,3 Importantly, the FDA intends to begin enforcing the Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments Final Rule (Menu Labeling Final Rule)4 one year from the date that the Final Guidance’s Notice of Availability (NOA) is published in the Federal Register. The NOA for the Final Guidance is expected to be published in early May 2016. Thus, enforcement of the Menu Labeling Final Rule will likely begin in May 2017.
The 58-page Final Guidance is largely a reprint of the previous draft guidance of the same name. The Final Guidance contains many nonsubstantive changes from the draft guidance and provides additional examples (as well as several new, revised, and/or reformatted questions and answers on topics such as covered establishments, alcoholic beverages, catered events, mobile vendors, grab-and-go items, and record-keeping requirements).
To view the more notable changes in the Final Guidance, read our LawFlash: FDA Issues Menu Labeling Final Guidance.
As previously stated, the Menu Labeling Final Rule and Final Guidance provide that the categories of covered establishments include not only restaurants and similar retail food establishments, but also movie theaters, amusement parks, bowling alleys, sports arenas, other entertainment venues, food service vendors, food takeout and delivery establishments, quick service restaurants, table service restaurants, convenience stores, coffee shops, bakeries, delis, grocery stores, supercenters, and fitness clubs.
However, the Common Sense Nutrition Disclosure Act of 2015, which passed in the US House of Representatives and is pending in the US Senate, would
- direct the secretary of the US Department of Health and Human Services to issue new rules that allow a food establishment to post nutritional information exclusively on its website if the majority of its orders are placed online,
- clarify that advertisements are not necessarily considered menus, and
- aim to protect establishments from being sued for human error.5
We will continue to monitor congressional and FDA menu labeling activities.
1See FDA Delaying Enforcement (Again) for Menu Labeling Final Rule (Mar. 21, 2016), http://blogs.morganlewis.com/welldone/2016/03/fda-delaying-enforcement-again-for-menu-labeling-final-rule/.
2FDA CFSAN Constituent Update, FDA Issues Final Guidance on Menu Labeling (Apr. 29, 2016), http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm498356.htm.
3A Labeling Guide for Restaurants and Retail Establishments Selling Away From-Home Foods – Part II (Menu Labeling Requirements in Accordance with 21 C.F.R. 101.11): Guidance for Industry (Apr. 2016), http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM461963.pdf.
4Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Calorie Labeling of Articles of Food in Vending Machines; Final Rule. 79 Fed. Reg. 71156 (Dec. 1, 2014), https://www.gpo.gov/fdsys/pkg/FR-2014-12-01/pdf/2014-27833.pdf.
5See Text of the Common Sense Nutrition Disclosure Act of 2015, H.R. 2017 (Referred to Senate Committee Feb. 22, 2016), https://www.govtrack.us/congress/bills/114/hr2017/text.