FDA: Menu Labeling IFR and Extension of Compliance Date (August 2, 2017)

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Re: Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date; Request for Comments; Docket No. FDA-2011-F-0172.

Dear Sir or Madam,

On May 4, 2017, the Food and Drug Administration (FDA or the Agency) published in the Federal Register an interim final rule (IFR) extending the compliance date for the final rule requiring  disclosure  of  certain  nutrition  information  for  standard  menu  items  in  certain restaurants and retail food establishments (the Menu Labeling rule). The IFR also extends the compliance date for the Menu Labeling rule until May 7, 2018. The IFR goes beyond extending the compliance date by signaling that the agency is reconsidering “fundamental questions and concerns” raised by the final rule. FDA explains in the preamble of the IFR that the Agency is taking this action consistent with Executive Orders (EOs) 13777, 13771, and 13563, as well as in response to the issues raised by affected stakeholders. The interim final rule also announces the establishment of a docket to receive comments on how the Agency might further reduce the regulatory burden or increase flexibility for these rules.

The Food Marketing Institute (FMI) proudly advocates on behalf of the food retail industry. FMI’s U.S. members operate nearly 40,000 retail food stores and 25,000 pharmacies, employing more than 3.5 million workers in the United States and representing a combined annual sales volume of almost $770 billion. Through programs in public affairs, food safety, research, education and industry relations, FMI offers resources and provides valuable benefits to more than 1,225 food retail and wholesale member companies in the United States and around the world. FMI membership covers the spectrum of diverse venues where food is sold, including single owner grocery stores, large multi-store supermarket chains and mixed retail stores. For more information, visit www.fmi.org and for information regarding the FMI foundation, visit www.fmifoundation.org.

In the IFR, FDA seeks comments on the issues that have been identified as posing significant implementation challenges by affected stakeholders. Specifically, FDA is seeking comments on ways to reduce the regulatory burden or increase flexibility of the Menu Labeling rule with respect to:

• Calorie disclosure signage for self-service foods, including buffet and grab-and-go foods;
• Methods for providing calorie disclosure information other than on the menu or menu board, including how different kinds of retailers might use different methods; and
• Criteria  for  distinguishing  between  menus  and  other  information  presented  to  the consumer.

FMI appreciates the opportunity to submit comments to FDA regarding the Menu Labeling rule, and  ways  in  which  the  Agency  can  reduce  the  regulatory  burden  and  provide  additional flexibility. FMI also supports FDA’s decision to extend the compliance date to May 7, 2018. Additional  time  provides  both  FDA  and  covered  establishments  with  the  essential  time  to identify opportunities to address these persistent, fundamental implementation problems through reducing costs and enhancing flexibility beyond what is contemplated in the final rule and current guidance.

FMI members agree that it would not make sense to require establishments covered under the final rule to come into compliance, as well as to maintain significant ongoing compliance costs, when these requirements might change as a result of the IFR. Food retailers are committed to providing their customers with the information they demand, but need the flexibility to do so in a way that is consistent with their business model and operations. We believe if the changes highlighted below are incorporated in a revised rule, retailers will be able to meet the objectives of the statute in a less burdensome manner than the final rule and in a way that promotes continued innovation in the supermarket industry. As noted above and discussed in more detail below, there are still a large number of outstanding questions and concerns with the final Menu Labeling rule. While all of these are important, there are a number of areas that FMI members have identified as the most critical to provide much needed flexibility and to greatly reduce unnecessary regulatory costs.

Key Points

• First, in keeping with the statute, which states that menu labeling applies to “standard menu items,” the rule should only apply to those items that are truly standardized across a chain with 20 or more locations. FMI strongly urges FDA to revise the definition of a standard menu item to mean a restaurant-type food that is routinely included on a menu or menu board or routinely offered as a
self-service food or food on display at 20 or more locations.
• Second, platters, catering menus, and foods to be consumed over a period of time should be exempt from the rule.
• Third, for self-service and foods on display, FDA should allow establishments to identify one primary writing for the calorie disclosure rather than requiring multiple disclosures.
• Finally, FDA should provide flexibility for providing additional nutrition that must be made available upon request to allow companies to use new technology in a way that meets their customer preferences.
 
Finally, FMI believes that FDA has the current authority to make these critical changes under the Agency’s current authority. As noted in the final rule and discussed in more detail below, Section 403(q)(5)(H)(x) of the FD&C Act requires that the Secretary of Health and Human Services (Secretary) issue regulations to carry out requirements in section 403(q)(5)(H). Section
701(a) of the FD&C Act (21 U.S.C. 371(a)) vests the Secretary with the authority to issue regulations for the efficient enforcement of the FD&C Act. FMI strongly believes that  based on the above and the full text of the FD&C Act, FDA has the authority to make the revisions discussed below without additional authority granted by Congress.

Congressional Intent and Support for the Types of Changes FMI Seeks

Since FDA first began the implementation process for the menu labeling statute, Congress has urged the Agency not to exceed the scope or impose unnecessary regulatory burdens.  Since Fiscal Year 2012, Congress has in various forms within FDA-Agriculture Appropriations included Report Language, a Joint Managers Statement, and text urging flexibility and relief under FDA’s menu labeling rule, particularly when applied to food retail establishments.

In the 114th Congress, the House of Representatives passed the Common Sense Nutrition Disclosure Act (H.R. 2017) through regular order and with a strong bipartisan 266-144 vote. The bill, among other things, includes sensible modifications that the supermarket industry has continually requested, such as preserving the ability to sell locally-made and locally-sourced
foods at less than the statute’s 20-location threshold, allowing for the use of a central menu board for salad bars and other food displays, and maintaining oversight through FDA and FDA- authorized officials.  This indicates strong Congressional support for these modifications and others that might similarly increase flexibility.

Prior to publication of FDA’s IFR, an April 7, 2017 letter signed by 49 bipartisan U.S. Representatives to Health and Human Services Secretary Tom Price sought for FDA to delay, withdraw, and revise the final rule and to “suggest that less costly methods are readily available with proven Congressional support within the framework of the Common Sense Nutrition Disclosure Act.” Since the FDA published the IFR, Congress has further expressed its support for the flexibility FMI is seeking through letters, report language and Committee approval of the Common Sense Nutrition Disclosure Act (CSNDA).

On July 12, 2017, the House Appropriations Committee approved a Committee Report accompanying the Fiscal year 2018 Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Bill.  The report expresses the Committee’s views on FDA’s current final rule and recent IFR related to menu labeling at restaurants and similar retail food establishments.  Specifically, page 72 of House Report 115-232 states:
 
Menu Labeling.—The FDA extended the compliance date for menu labeling requirements until May 7, 2018, stating that, ‘‘This extension allows for further consideration of what opportunities there may be to reduce costs and enhance the flexibility of these requirements beyond those reflected in the final rule.’’ In providing flexibility, the Committee urges FDA to consider provisions of H.R.
772 as well as other proposals that reduce burden and add flexibility for businesses to implement the rule and provide consumers with certain nutrition information. FDA should ensure that businesses are protected from regulatory enforcement from federal, state, municipal or other oversight agencies until after a potential revised rule is promulgated and effective.

On July 27, 2017, the House Committee on Energy and Commerce, by a 39-14 bipartisan vote, approved the Common Sense Nutrition Disclosure Act, H.R. 772, to amend the FD&C Act to improve and clarify certain disclosure requirements for restaurants and similar retail food establishments.3  The Committee’s bipartisan approval of the legislation demonstrates strong support for FDA using its existing authority to incorporate as many provisions of the legislation as possible into revisions to the current final rule.  Additionally, a letter signed by more than 40 bipartisan Members of Congress from the U.S. House of Representatives was submitted to FDA on July 31, 2017.  Among other things, the letter states:

We greatly appreciate the Food and Drug Administration’s issuance of the Interim Final Rule (IFR - 82 FR 20825) that extended the compliance date for menu labeling in restaurants and retail food establishments (79 FR 71156) until May 7,
2018, while maintaining the federal statute’s preemption. We believe this action is consistent with previous Congressional and stakeholder requests to incorporate flexibility into the rule before enforcement by FDA or any other entity begins. As you consider comments, we urge you to include the provisions laid out in the Common Sense Nutrition Disclosure Act (H.R. 772) as part of the final implementing regulations.

Similarly, a letter from bipartisan Members of Congress from the United States Senate was submitted to FDA on July 31, 2017, encouraging the use of existing authority to modify the current final rule in accord with the provisions of the Common Sense Nutrition Disclosure Act. Among other things, this letter by the Senators states:

We encourage you to use the CSNDA as a factor in your decisions pertaining to menu labeling.

We similarly encourage FDA to recognize Congressional support for these changes through the current rulemaking, and ask that the Agency consider the Common Sense Nutrition Disclosure Act when making any modifications to the final rule.

Background

FMI members are committed to providing nutrition information to their customers and are dedicated to implementing calorie labeling for foods within a grocery store that are similar to foods offered in a restaurant. A large number of FMI members are currently providing information required under the menu labeling statute and will continue to do so in the future.  In fact, long before the menu labeling statute, more than 90 percent of the foods sold at a typical supermarket were already labeled with Nutrition Facts under the Nutrition Labeling and Education Act.  Many challenges with implementation of the Menu Labeling rule stem from the fact  that  the  rule  was  written  for  chain  restaurant  settings  rather  than  accounting  for  the significant differences in the way a grocery store and restaurant operate.

Unlike chain restaurants where the menu items are standardized across national chains, grocery stores offer a large variety of unique, local and seasonal offerings. Additionally, while chain restaurants generally utilize standardized menus across all locations, many items offered for sale in a grocery store are not offered for sale on a menu or menu board at all. The fundamental differences that exist between national chain restaurants and grocery store offerings make the Menu Labeling rule more challenging within this framework. FMI members have gone to great lengths to provide nutrition information and programs for their customers and fully support FDA’s goal of communicating essential nutrition information to their customers, however, supermarkets need adequate flexibility to do so.

FDA Dramatically Underestimated the Costs of Compliance for Supermarket Chains

Earlier this year, President Trump issued Executive Order 13771, Reducing Regulation and Controlling Regulator Costs,4 instructing federal agencies to identify two regulations for repeal for every new rule proposed or finalized.  The Order recognizes that “it is essential to manage the costs associated with the governmental imposition of private expenditures required to comply with Federal regulations.” Then, on February 24, 2017, the President issued an Executive Order on enforcing his regulatory reform agenda. The Order calls for Regulatory Reform Officers and Task Forces in each agency to identify regulations that impose costs that exceed benefits or inhibit job creation, among other things. Such regulations are to be considered for repeal, replacement or modification because, as the Order states “[i]t is the policy of the United States to alleviate unnecessary regulatory burdens placed on the American people.” FMI believes the FDA’s action to consider potential modifications to the final Menu Labeling rule are consistent with the recently issued executive orders.

In its Final Regulatory Impact Analysis (“RIA”),5 FDA estimated that there would be approximately 298,600 covered establishments, organized under 2,130 chains.   The Agency further estimated a mean initial cost of complying with the final requirements of $388.43 million, and a mean recurring cost of $55.13 million. These estimates, however, are significantly lower than the actual costs incurred by food retailers to prepare for compliance under the final rule.

The total burden on the industry is estimated to be more than $1 billion for the first year alone with ongoing compliance costs in the hundreds of millions of dollars.  This underestimation by the Agency is based upon a number of factors that are discussed in more detail below.

The  Agency’s  RIA  states  that  “[b]ecause  of  the  more  limited  offerings  for  restaurant  or restaurant-type foods at grocery and convenience stores, FDA estimates that these establishments have on average approximately one half the number of menu items of an average restaurant, or
40 menu items.”   By contrast, FMI estimates that an average of 1,500 items per chain are covered by the rule.  The number of items per chain could be significantly higher with FDA’s current determination that the rule applies to local offerings sold at only a few locations within a chain.  Additionally, FDA’s RIA further estimates that “there are approximately 120 grocery chains with approximately 20 or more establishments.”  The RIA indicates that, out of these 120 chains,  “we estimate that  approximately 36  percent.  .  .  would  be covered  under the rule,” meaning only 43 chains.  This number differs largely from our experience, as FMI estimates that
150 grocery store chains are affected by the rule.6

FMI further estimates that the cost of determining nutrition information for each item could be at least $1,000.  Accordingly, the cost of getting the nutrition information initially could be at least
$225,000,000 for the grocery industry.   Additional costs include updating menu boards and signs, estimated to be $1,000,000 for each retailer leading to a cost of $150,000,000.  New scale/software investments are estimated at $1,500,000 per retailer or $225,000,000.  Training store level associates and developing training materials could add an additional $150,000,000 in costs across the industry.  Cumulative recordkeeping costs are estimated to cost $2,000,000 per chain annually for a total of $300,000,000 for the grocery industry.   The total burden on our industry is estimated to be more than $1 billion for the first year alone with ongoing compliance costs in the hundreds of millions of dollars. While these numbers are staggering in and of themselves, they are even more significant in the supermarket industry where retailers operate on extremely thin profit margins, generally between 1.0 and 2.0%.7  At such low profit margins, grocery retailers have virtually no ability to absorb unnecessary regulatory costs and are ultimately forced to pass the cost on to consumers in the form of higher prices.  While FMI members support the FDA’s goal of providing nutrition information to their customers, it is important to FMI members that the Menu Labeling rule is defined and implemented in a way that will limit the financial burden as much as possible.

Additionally, although compliance with the rule is important to FMI members, significant questions and challenges remain that have made implementation efforts difficult. FMI and our members have been closely involved in efforts to comply with and better understand the rule. FMI and its members attended public meetings hosted by FDA, hosted numerous store tours to assist the Agency in understanding our industry, and worked closely with the Agency in developing an implementation guide to help ensure proper compliance in member stores; however, despite significant involvement throughout the implementation process, there is still considerable confusion regarding even basic questions such as which foods are covered by the rule and what constitutes a menu or menu board.  Further, differences in grocery retail operations as compared to chain restaurants have made it extremely challenging in developing appropriate implementation plans and maintaining workable menus and menu boards.  Finally, based on the current lack of flexibility in the rule, grocery stores with differing formats, food offerings, and corporate structures are unable to comply with the rigid framework of the final rule.

Based  on  these  challenges,  FMI  appreciates  the  opportunity  to  comment  on  areas  where flexibility and clarification are needed and on ways in which the Agency can help reduce the regulatory burden on industry and consumers alike while meeting the shared goal of providing useful nutrition information for consumers.  We also appreciate all of the work FDA has done thus far to assist FMI members with many of the questions and concerns that have created confusion since the final rule was published.

I.         The Final Rule Should Only Apply to “Standard Menu Items” Offered at 20 or
More Locations

Background

In the IFR, FDA explains that the questions raised about the final rule suggest that “critical implementation issues, including some related to scope, may not have been fully understood, and the agency does not want to proceed if we do not have all of the relevant facts on these matters.” The agency also states, “[w]e do not want to proceed with a rule that might turn out to be too inflexible  to  support  innovation  in  delivering  information  to  consumers.”  FMI  shares  this concern as retailers have created a marketplace for nutrition information in response to consumer demand and supermarkets continue to strive for innovative new ways to provide nutritional information. In fact, prepared foods are a large part of retailers’ offerings; retail executives are expecting further investments in these key areas of success, especially prepared foods with fresh ingredients. The intense and varied competition, along with the ever-growing number of options in foodservice, is spurring the need for constant in-store innovation for grocery operators. These fresh, healthy items offered in a grocery store increasingly appeal to consumers as a less expensive, healthier alternative to standardized fast-food items. Offering these items also makes good business sense by sustainably utilizing fresh, wholesome produce, and other items that would otherwise become food waste.

With a plethora of competitive forces targeting the same dinner dollar, continuous innovation is needed for deli/fresh prepared foods to meet and exceed shopper expectations. Improvements to drive increased fresh prepared purchases can be approached in many different ways, including meal solution type, operational improvements, and aligning specific food items and featured cuisines most closely to the intended store audience and the community it serves. Additionally, the local foods movement has encouraged retailers to explore new and innovative ways to offer specialized, unique items depending on their specific customer demands. According to the Power of Fresh Prepared Deli 2016, more than one in five shoppers would like to see locally- sourced/grown food and organic items. Variety is key as well, both through item count and cuisine variety, and a regular rotation of offerings. Deli, including fresh prepared, is the fastest growing area in the fresh perimeter, driving both innovation and differentiation among retailers. Stores can drive consumer satisfaction by incorporating new trends and flavors, which will also help set them apart from the competition. With these growing areas of the supermarket, it is critical that the Menu Labeling rule is applied in a way that promotes rather than hinders this innovation and differentiation.

Definition of Standard Menu Item

One critical concern FMI members have faced in working toward compliance is the impact of the Menu Labeling rule’s application of and definition of “standard menu item.”  Specifically, one of the most significant concerns is its application to items sold in fewer than 20 stores.  The impact of this application significantly raises the compliance costs and the burden at store-level. As explained above, our members pride themselves in offering a variety of specialty items that cater to the specific geographical region and tastes of its customers.  Examples include regional preferences (e.g., certain salads like a cherry salad in Michigan and a southwest salad in California), locally sourced items (e.g., bagels from a popular local bakery), variable items based on popularity (e.g., one store chooses to sell turkey chili because it outperforms beef chili, whereas all other locations of that chain sell only beef chili), specialty items (e.g., one store hires a chef specializing in vegan dishes and offers many of these items regularly), etc.

Customers vary significantly from store-to-store even within the same chain based on ethnicity, gender, and income and supermarkets are working hard to develop offerings based on these different demographics. Further, many supermarkets have flagship stores that may be very different from others within the same chain to test out new products and offerings, many of which are offered for more than the 60 or 90-day threshold. Application of the rule to these unique concepts and items is more than problematic; it runs afoul of the intent of the rule, which only applies to “standard” menu items offered in establishments with 20 or more locations. The intent of the “standard menu item” requirement was for the menu labeling requirements to apply to the most standardized items, typically offered regionally or nationally, for which it will be most practicable to obtain and declare calorie information.  In contrast, the cost of compliance for items offered at fewer than 20 or more locations of a chain grocery store will often be too high to justify the small margins earned by offering the product locally.  For example, a retailer operating in a predominantly urban area may offer a chef station for customers to visit during a busy lunchtime.   Requiring such a retailer to comply with the already burdensome regulation with respect to these unique, non-standardized items is stifling these local and unique offerings and innovation in a profound way and is essentially requiring standardization across grocery store chains. FDA should not implement a policy that deters new innovative ways for retailers to serve their customers.

For items such as those discussed above that are unique to certain stores, the financial burdens of conducting  a  nutrition  analysis,  keeping  and  maintaining  records,  and  developing labeling/signage and additional written nutrition information are typically incurred at the individual stores rather than being developed in and distributed by a food retailer’s headquarters. This exponentially expands the scope and economic impact upon the supermarket industry. Additionally, the rule as currently written is affecting small businesses and suppliers of foods sold at fewer than 20 locations, which undermines the statute’s small business-focused, 20- location provision. Even though they are not sold across several locations, under FDA’s final rule, these local foods would all be considered “standard menu items” and trigger a nutrition analysis, labeling/signage, and recordkeeping (including potentially the recipe), which has ultimately led retailers to limit local arrangements.  Similarly, small local vendors who are not covered under the rule because they do not have 20 or more locations do not have the nutrition information  available  to  provide  to  stores  and  are  hesitant  to  communicate  proprietary information of their recipes for obvious reasons. This exacerbates the problem. As a result, retailers who are striving to innovate with local offerings and innovative concepts have been forced to forgo these offerings for fear of noncompliance and the unbelievable costs associated with managing signage and nutrition analyses at the store-level. For supermarkets that already operate on incredibly thin margins, it is simply not feasible to hire full-time employees to oversee menu labeling compliance at the individual store level. FDA should not penalize food retailers for empowering employees to innovate or for seeking smaller or local suppliers and vendors.

While innovation for local and unique food items is proliferating in supermarkets, retailers also strive to provide consistency for a large number of items throughout a chain. Chains have a large number of offerings that are standard menu items in every location throughout the country. Customers expect to find their favorite items offered within every store throughout the country and expect the item to be prepared and offered in the same way regardless of where it is purchased. In turn, retailers have robust programs and policies in place to ensure this consistency by providing recipe guidance and training on preparation of these items. In these cases, corporate programs can be developed to perform the nutrition analyses and provide signage to assist store- level employees with menu labeling compliance. Having these programs in place at the corporate level ensures that the information provided is accurate and mitigates the risk of error by a store associate.  For example, a supermarket chain may require 90% of all standard menu items offerings to be consistent across all stores while 10% of offerings are left to the individual store manager or chef depending on local offerings or specific customer preferences.  In this case, the cost of compliance with the standard menu items can be managed at the corporate headquarters, minimizing the cost of compliance and likelihood for inadvertent human error.  FMI sees no reason why FDA should apply a rigid framework for the other 10% of items that are unique to one store.   As stated above, doing so has forced companies to forgo  these innovative and growing programs due to compliance costs and resources at store-level.

FMI strongly urges FDA to apply the menu labeling regulations to “standard menu items” in a manner that is consistent with the statute.    That is, the term “standard menu item” should be defined  as  “a  restaurant  or  restaurant-type  food  item  with  the  same  recipe  prepared  in substantially the same way with substantially the same food components that—is routinely included on a menu or menu board or routinely offered as a self-service food or food on display at 20 or more locations doing business under the same name; and is not an item referenced in the statute’s or implementing rule’s section related to “NONAPPLICABILITY TO CERTAIN FOOD.”

II. FDA Should Exempt Items Offered from Grocery Store Catering Menus from the
Final Rule

Many FMI member stores offer catering items to customers, ranging from a small number of offerings to a large variety of food types.  The variability within these items is large and often
 
includes many factors such as size, flavors (e.g., in a bagel platter customers could pick any variety of bagels, all of which will differ in calorie content), and ingredients (e.g., items that are build-your-own,  such  as  build-your-own  sandwich  platters),  among  others.    Based  on  this variety, determining the calorie and nutrition information and relaying that information to customers if required by the rule would be time consuming and financially burdensome.   As such, FMI strongly believes that catering menus should be exempt under the rule. The costs associated  with  labeling  potentially  hundreds  of  different  items  on  a  catering  menu  are significant and provides no corresponding benefit to consumers.  The nutrition information is provided at the point of purchase, while the food is consumed at a later date and often by individuals  who  do  not  make  the  order  selection  and  therefore  never  see  the  nutrition information.

Section 5.5 of FDA’s guidance document indicates that covered establishments that offer off-site catering must provide calorie declarations for “standard menu items listed on its catering menu to the extent such menu meets the definition of a ‘menu’ in the Menu Labeling rule;” however, this guidance fails to take into account whether or not the item is a restaurant-type food.  As noted above, Section 101.11 defines restaurant-type food as “food that is: (i) Usually eaten on the premises, while walking away, or soon after arriving at another location. . .”  By their nature, catering items offered by grocery stores are generally reserved for a later event and, thus, do not meet the definition of restaurant-type food.  Further, section I3 of FDA’s Questions and Answers on the Menu and Vending Machines Nutrition Labeling Requirements discusses how restaurant- type food is defined and says:

Foods that would generally not be covered under the definition of “restaurant- type” food include certain items purchased in a grocery store or other similar retail food establishment that are eaten over several occasions or stored for later use (e.g., a whole cake, a loaf of bread, bags/boxes of rolls), foods that are typically  intended  for  more  than  one  person  to  eat  or  require  additional preparation before consuming (e.g., pounds of deli meats and cheeses, large-size deli salads), and certain foods bought from bulk bin cases in grocery stores (e.g., nuts, dried fruits, olives from bulk bins).

Items offered on catering menus, like sandwich platters or vegetable trays, are foods that are typically “eaten over several occasions or stored for later use.”  We fail to see a meaningful difference between the items offered on a catering menu and a whole cake, which FDA has appropriately determined is not a restaurant-type food.  Both types of food are ready to eat but may not be eaten until days later, are often eaten by multiple people, and may also be eaten over several occasions.  Additionally, the person placing the order is often not the person consuming the item.

Unlike take-out or delivery menus, items on a grocery store catering menu are not consumed shortly after an order is placed and are intended for more than one person to eat. In contrast to restaurant delivery, when a customer places an order from a supermarket catering menu it is often not picked up for a number of days or is purchased to pick up along with other grocery type items for either delivery or with other grocery items in the store.
 
The inconsistency of requiring menu labeling for catering menu items is illustrated by the example of a large vegetable tray in the grab-and-go section of a grocery store.   This item is clearly not covered under the Menu Labeling rule, as it is to be eaten over multiple eating occasions.  Assume, however, that a grocery store decides to list this same vegetable tray on the catering menu as an additional way to sell the product.  Based on the language in Section 5.5 of the  guidance  document,  the  vegetable  tray  would  require  labeling  when  also  listed  on  the catering menu, although the nature of the food has not changed. It was clearly not the intent of the rule to require complex calorie posting on catering menus.

Finally, in addition to being outside the scope of the rule and extremely burdensome to food retailers, requiring catering items to comply with the Menu Labeling rule does not support its overall purpose and does not provide a benefit to the ultimate consumer.  Specifically, the preamble to the rule makes clear that the purpose of the rule is to help provide consumers with information regarding the calorie and nutritional content of the foods they select.  With catering items, however, the calorie and nutritional content would be reviewed solely by the person making the catering selections, but not by those ultimately consuming those food selections. FMI sees no reason why items like an entire vegetable platter should be subject to a chain-restaurant menu labeling law.

For the reasons discussed above, the purpose and consistent application of the Menu Labeling rule is lost when applied to catering items, and creates significant costs and burdens to the food retailer. FMI strongly urges FDA to clarify that items offered on catering menus are not covered under the final rule.

III.      FDA Should Clarify that Items Consumed Over Several Eating Occasions and
Platters are Not Covered Under the Rule

The Agency has made it clear that if an item is intended to be eaten over several eating occasions (e.g., a whole cake, a loaf of bread, bags/boxes of rolls that are self-service foods or foods on display), then it is generally not a restaurant-type food and would not be covered by the rule.8
However, the Agency has provided only limited guidance regarding which items are considered to be consumed over several eating occasions and are therefore more like grocery foods than restaurant-type foods.  FMI member companies have found interpreting this language to be challenging, as stores offer many sizes of the same foods.  For example, many stores offer a pre- packed pasta salad in the grab-and-go section in multiple sizes, such as a 4 oz, 16 oz, and 32 oz container, and it is unclear in the final rule which of these would be considered typically consumed over multiple occasions.

The lack of guidance in this regard has proven burdensome to say the least.  Most notably, many stores are worried that it will be necessary to over-label in gray areas to avoid both FDA and state/local enforcement.  That is, without guidance addressing the determination of what is multi- serving, inspectors may enforce this exemption inconsistently.   Over-labeling of products that might not be covered is extremely costly to our members. The exemption for whole cakes, loaves of bread, and other items consumed over several eating occasions was provided for a reason – to limit the scope of the rule to restaurant-type foods.

In order to alleviate the concern of inconsistent enforcement for items that may or may not be considered items consumed over several eating occasions, FMI asks that the Agency clarify that food retailers may determine what is a reasonable single serving for immediate consumption, based on their own marketing practices, the RACC standards for packaged foods, or any other reasonable means of determination.  For example, the RACC for pasta salad is 140 grams or 4.94 oz.  A store selling the pre-packed pasta salad in the example above and choosing to base the multi-serve analysis on RACC standards would determine that the 4 oz salad is for immediate consumption by one individual, but the 16 oz and 32 oz containers are multi-serve and intended to be eaten over several eating occasions.

Additionally, we recommend the agency reconsider its position on platters and other items offered in grocery stores that are intended to eaten over a period of time.  The FDA already provides an exemption for foods such as loaves of bread and cakes and pies that will serve multiple people, and platters and other foods to be consumed over a period of time should similarly be exempt.  Similar to items offered on catering menus, customers for whom the platter is intended to serve are not the individuals making the actual purchase decisions. For example, a large platter of cold sandwiches or wraps sold in the grocery store is clearly being sold to be consumed over several eating occasions. This also means that the individual making a choice about what to consume will not see the nutrition information.

IV.      FDA Should Provide Flexibility for Posting Calorie Information for Self-Serve
Foods and Foods on Display by Allowing A Single Sign to Be Used

In the IFR, FDA seeks comments on approaches to increase flexibility with respect to calorie disclosure signage for self-service foods and foods on display, including buffets and grab-and-go foods. FDA also seeks comments on methods for providing calorie disclosure information other than on the menu itself, including how different kinds of retailers might use different methods. As noted above, unlike chain restaurants, supermarkets generally do not have menus or menu boards for self-service items and foods on display. Additionally, in the final rule, FDA greatly expanded the scope of foods that are covered, exacerbating this problem and increasing compliance costs.

There  are  certain  areas  where  additional  flexibility  in  the  rule  would  greatly  reduce  the regulatory burden on food retailers.  One example involves the prescriptive way in which the rule and guidance are being applied with regard to aligning food labels and calories with individual self-serve items and foods on display.   While FMI believes that FDA intended to provide flexibility for calorie posting for self-serve and food on display by permitting the disclosure to be on either a sign adjacent to the food, a sign attached to the sneeze guard, or on a single sign or placard, the final rule stipulates that a customer must be able to view the listing when they are selecting an individual food item.  This language is in practice quite prescriptive.  The rule and current Agency guidance indicate that a number of signs may be used “so long as the sign or placard is located where a consumer can view the name, calorie declaration, and serving or unit of a particular item while selecting that item.”
 

In FDA’s Guidance, the agency elaborates that there are three options for the placement of
calorie information for standard menu items that are self-service foods or foods on display.

One option is to place the calorie information on a sign adjacent to and clearly associated with the food for which the calories are provided.

Another option is to provide the calorie information on a sign attached to the sneeze guard (glass should be positioned above the food at about chest height). If you place the calorie information on the sneeze guard, a sign with the calorie declaration and the serving or unit used to determine the calorie content must be above each specific food so that the consumer can clearly associate the calorie declaration with the food to which it applies. (21 CFR 101.11(b)(2)(iii)(A))

The third option is to place the calorie information on a single sign or placard listing the calorie declaration for several food items along with the names of the food items, so long as the sign or placard is located where a consumer can view the name, calorie declaration, and serving or unit of a particular menu item while the consumer is selecting that item. For self-service foods, if the menu board is not visible to the customers as the customers moves down the line to make their selections, you must provide the calorie declarations through additional signage such as a large posted sign, individual signs by the item or signs over the item on the sneeze guard so that the customers can view the name, calorie declaration, and serving or unit of a particular item while the customers are selecting that item (21
CFR 101.11(b)(2)(iii)(A))

For stores that feature a diverse set of products and where freshness is paramount – i.e., for most of our members – this rigidity is problematic.  If the first or second option is selected, there is a strong likelihood that individual labels will be mismatched with the corresponding food due to frequent changeover depending on store availability and as items get replaced.  For example, a salad bar within a grocery store may offer different items for breakfast, lunch and dinner.  These items are placed in various bins or on a hot surface throughout the salad bar and are switched out as needed and to ensure freshness.   The concern with the current rule is that it is simply impossible for the individual shelf tags to align with the individual item given the variety of items offered and the frequency with which they change.

If the third option is selected, in many circumstances, there is not a single sign that would be large enough to list each individual items with the calorie declaration that would be visible from every area of the salad/hot bar, due to the number of items that are offered within the same salad/hot bar throughout the day. In this case, FDA would require additional and redundant signage even if all of the calorie information was posted in a central location on the salad bar, adding additional costs with no corresponding benefit to the consumer since the information would already be available within the salad bar area. Based on the Agency’s current interpretation, this misalignment could easily trigger corresponding enforcement or liability exposure for technical non-compliance.
 
FMI requests that FDA amend the rule to allow stores to designate a single calorie sign posted prominently in the specific self-service food location (e.g., the salad bar) or food-on-display location (e.g., the display case or grab-and-go refrigerator) as the “primary calorie sign”, similar to the statutory concept of a menu or menu board as the “primary writing.”  As long as the sign could be viewed prior to selecting the item – even if it cannot be viewed “while” the item is being selected as the current rule requires, the consumer would have the information they need before making their choice.  This approach would allow a food retailer to provide customers the same  information  and  succinct  statement  for  menu  items,  self-service  foods,  and  foods  on display on a centrally-located sign, menu, or menu board.

Additionally, providing one writing near or on the salad/hot bar would improve customers’ ability to compare items and is more practical from a compliance standpoint.  For example, a retailer could post a single sign on either end of the salad bar with all of the possible foods offered throughout the day along with the calorie information for each item.   The single sign could then be switched out during the next meal of the day.  This would limit the compliance burden and prevent the unavoidable occurrence that a sign or shelf tag could inadvertently be misaligned or moved by a customer.  It would allow customers to consider all of the various food offerings together so they can compare calories for all of the options and make a decision accordingly.  Again, FMI members are committed to providing nutrition information for these items, but need the flexibility to do so in a way that works with their business practices.

Suggested Regulatory Change

(iii) The following must be provided for a standard menu item that is self service or on display. (A) Calories per displayed food item (e.g., a bagel, a slice of pizza, or a muffin), or if the food is not offered for sale in a discrete unit, calories per serving (e.g., scoop, cup), and the serving or discrete unit used to determine the calorie content (e.g., ‘‘per scoop’’ or ‘‘per muffin’’) on either: A sign adjacent to and clearly associated with the corresponding food; (e.g., ‘‘150 calories per scoop’’); a sign attached to a sneeze guard with the calorie declaration and the serving or unit used to determine the calorie content above each specific food so that the consumer can clearly associate the calorie declaration with the food, except that if it is not clear to which food the calorie declaration and serving or unit refers, then the sign must also include the name of the food, e.g., ‘‘Broccoli and cheese casserole—200 calories per scoop’’; or one primary sign listing the calorie declaration for several food items along with the names of the food items, so long as the designated sign is located where the establishment reasonably determines a consumer can view the menu or menu board prior to selecting the listed item (e.g., a single sign located at one end of the salad bar listing multiple food items and the corresponding calorie declaration).

V.        FDA Should Provide Flexibility for Providing the Additional Nutrition Information
Upon Customer’s Request

In addition to the calorie disclosure required for restaurant-type foods, the statute and final rule provide that additional nutrition information for a standard menu item must be available in written form on the premises of the covered establishment and provided to the customer upon request.  FDA further stipulates in guidance that while a covered establishment can provide additional written nutrition information to consumers at the covered establishment using an app or Internet link, access to this additional information must be available on the premises of the establishment (such as, at a kiosk or other electronic device available at the establishment) and provided to the consumer upon request without the need for customers to supply their own electronic device.

FDA further states that in addition to ensuring that written nutrition information is available on the premises of the establishment, a covered establishment also could provide the written nutrition information on its website or include a link directing the consumer to a website providing the written nutrition information for consumers ordering from an Internet menu on a covered establishment’s website.

While FMI members work diligently to provide full nutritional information to customers in a manner that is most convenient to the customer’s time with the product purchasing decision process, a rigid requirement to provide the additional nutrition information on the store premises in incredibly problematic and adds an additional regulatory burden at the store-level.  We agree that full information should be permitted online, but FMI members are very concerned that the way the current rule is written, they will be forced to either invest in expensive technology such as new computers made accessible to customers; or resort to providing expensive and wasteful paper printings for the thousands of items that might be offered in the store.

Without investing millions in new technology that would allow consumers to access this information without assistance, an associate would need to leave the work area and walk to a back office, look up the item on the company’s website where full nutritional information is already available, and print this information from a computer.  Having to provide the written information in-store could overwhelm the entire Bakery or Deli department by one demanding customer requesting nutrition information on multiple products.  The process can take between
10 and 15 minutes provided the customer only asks for the nutrition information for one product. Not only would the customer be dissatisfied with having to wait for the store associate to provide full nutritional information in writing through this process, but other customers would also be dissatisfied because of the potential lack of service in the Bakery or Deli departments while associates retrieve written nutrition information.

As stated above, the requirement to have additional information available at the store-level seems unduly burdensome considering that the majority of customers and associates have access to smartphones and the Internet.   Many FMI member companies already provide nutrition information on restaurant-type and other products through their websites, which are publicly accessible to all customers.  This online solution is both fast and customer-friendly, reaffirming the supermarkets commitment to providing nutritional information for their customers.  We recommend the agency allow retailers to meet their obligation to provide full nutrition information upon request by providing such information through new technology or on their websites, permitting customers to the use their smartphones and personal computing devices to obtain full nutritional information, as this is currently the most expeditious manner to satisfy the customer’s request.
 

V.        FDA Should Clarify that Advertisements and Promotional Materials Are Not
Menus or Menu Boards

FMI and its members are concerned with FDA’s interpretation that certain advertisements and promotional materials can be considered menus or menu boards.  This interpretation is contrary to the statutory concept of the menu or menu board as the “primary writing” from which consumers place their order.  Put simply, advertisements and promotional materials are not the primary means through which consumers order covered foods.

Section 101.11 of the rule defines a menu or menu board as follows:

Menu or menu board means the primary writing of the covered establishment from which a customer makes an order selection, including, but not limited to, breakfast, lunch, and dinner menus; dessert menus; beverage menus; children’s menus; other specialty menus; electronic menus; and menus on the Internet. Determining whether a writing is or is part of the primary writing of the covered establishment from which a customer makes an order selection depends on a number of factors, including whether the writing lists the name of a standard menu item (or an image depicting the standard menu item) and the price of the standard menu item, and whether the writing can be used by a customer to make an order selection at the time the customer is viewing the writing. The menus may be in different forms, e.g., booklets, pamphlets, or single sheets of paper. Menu boards include those inside a covered establishment as well as drive-through menu boards at covered establishments.

Based on this definition and FDA’s three-factor test, there are a number of signs, advertisements, etc. in our members’ stores that could constitute menus or menu boards under the rule but that are not used by consumers to place an order.  For example, if a coupon or an ad in a weekly grocery store circular included the name and price of a standard menu item, such as a sandwich from the in-store deli, as well as the grocery store’s website or phone number, and the item could be ordered through the website or by calling the store, the coupon or ad would be considered a menu.  In reality, consumers primarily order the deli sandwich from the in-store deli, where there is calorie labeling on the menu or menu board.   If the item can be ordered online, the online menu would bear calorie labeling.  These examples are outside of the statutory intent of which writings would need to bear calorie labeling.

In order to alleviate concerns in this area, we ask that the Agency clarify that advertisements and promotions such as the examples above would not constitute menus or menu boards because they are not the primary writing from which consumer place their order.
 
VI. FDA Should Amend the Definition of a Menu or Menu Board  to Reduce Redundant Calorie Disclosures by Allowing Establishments to Designate One “Primary Writing”

In the IFR, FDA seeks comments on approaches to increase flexibility with respect to additional criteria for distinguishing between menus and other information presented to the consumer. FMI and its members are very concerned with the lack of clarity, limited flexibility, and significant burdens associated with the definition of menus and menu boards under the current regulations. This is important because FDA’s current definition is so broad that its arbitrary application conflates the purpose of the rule itself and provides very little guidance to industry, making inconsistent enforcement virtually certain.  These concerns are discussed in greater detail below.

There are many different ways in which food retailers display and sell food products.  For example, our members utilize a range of signs, posters, boards, paper menus, brochures, individual tags, etc. in displaying foods that might be covered under the rule.   Based on the current definition of menu or menu board, however, for each of these items grocery stores would potentially need to include calorie content on multiple mediums.  Labeling of multiple signs, posters, etc. is redundant, of minimal additional benefit to the customer, and significantly raises costs and reduces flexibility for an establishment to offer or display food items to customers in a way that works best for their business.

In order to reduce this financial burden, FMI requests that the Agency allow the establishment to determine one method and location to be designated as the “primary menu or menu board” that the establishment can reasonably determine is available to the most customers in the vicinity where restaurant-type foods, self-service foods and foods on display are being offered for sale. Writings, signs, posters, circulars, and other materials that are not designated as the primary menu or menu board should not be subject to the rule’s calorie labeling or requirements to post the  succinct  statement  and  the  statement  on  availability  of  additional  written  nutrition information.

VII.     Additional Areas Where Flexibility is Needed

Below are some additional areas where flexibility in the Menu Labeling rule would help reduce the regulatory burden for grocery retailers.

a.   FDA Should Provide Flexibility in Type Size by Requiring Calorie
Disclosures to be “Clear and Conspicuous”

In the final rule, FDA’s prescriptive font size requirements state that the number of calories must be listed adjacent to the name or the price of the associated standard menu item, in a type size no smaller than the type size of the name or the price of the associated standard menu item, whichever is smaller, in the same color, or a color at least as conspicuous as that used for the name of the associated standard menu item, and with the same contrasting background or a background at least as contrasting as that used for the name of the associated standard menu item.
 
As one can imagine, maintaining a type size no smaller than that of the name or the price of the associated standard menu item, whichever is smaller, has posed significant challenges in terms of space on menu boards and signage; as well as in legibility of the item name, price, and calorie information.  Due to the required type size of the calorie information, existing signs and menu boards within a grocery store need to be completely redesigned in many cases.  The type size requirements have also resulted in the removal of marketing and advertising information in order to provide sufficient room for the calorie information.   Finally, and potentially of most significance, having the same font-size for calorie counts as the price of a food item is causing customers to confuse the calorie count and price of an item.  This has ultimately resulted in a cluttered, more difficult to read disclosure that does not benefit the consumer.

FDA should revise the overly prescriptive requirements and provide flexibility with respect the type size of the calories and allow the type size to be smaller than the price or name of the associated standard menu item, as long as the calorie disclosure is clearly visible to the customer. The statute requires the calorie disclosure to be “clear and conspicuous” and we recommend FDA adopt similar language in the Menu Labeling rule.  Under such a standard, establishments would still need to ensure that the declaration is clearly visible to the customer, but would maintain the flexibility to accommodate different types of menus and menu boards based on their existing and future business models.  FDA has afforded such flexibility under nutrition labeling rules for foods sold through vending machines, and the Agency should provide no less flexibility for foods sold by restaurants and similar retail food establishments.

b.  Serving Size

The Menu Labeling rule prescribes the specific serving size upon which calorie declarations for self-service items and foods on display should be based.  The rule is that calories must either be presented “per displayed food item”, or if the item is not offered as a discrete unit, “per serving.” The rule defines “per serving” in a particularly burdensome way that has proved difficult to implement.  Specifically, Section 101.11(b)(2)(iii)(A)(2)) of the rule indicates that:

(2) For purposes of paragraph (b)(2)(iii)(A) of this section, ‘‘per serving’’ means, for each food: (i) Per serving instrument used to dispense the food offered for sale, provided that the serving instrument dispenses a uniform amount of the food (e.g., a scoop or ladle); (ii) If a serving instrument that dispenses a uniform amount of food is not used to dispense the food, per each common household measure (e.g., cup or tablespoon) offered for sale or per unit of weight offered for sale, e.g., per quarter pound or per 4 ounces;. . . (emphasis added).

The language implies that common household measures, like cups, tablespoons, etc., can only be used for the calorie declaration where the item is not served with a serving instrument that dispenses a uniform amount of food.   As explained in more detail below, given the problems with the uniform serving utensil as the basis for calorie declarations, we believe it would be more appropriate for a common unit of household measure to be used, regardless of the type of serving utensil used.
 
The uniform serving utensil concept is problematic for grocery retailers for a number of reasons. First, there are many factors that will affect the calories per serving even when a utensil that could be considered to “dispense a uniform amount of food,” such as a soup ladle, is used. Consumers may not always consistently fill the utensil.  As another example of the variation “per serving utensil”, consider a beef and vegetable soup.  Customers have particular preferences, and may intentionally fill their soup with more of certain ingredients, such as the beef meatballs. This would likely result in higher calorie content for these customers, and lower calorie content for customers who get more vegetable content or broth in their soup or serve their portion towards the end of the day when many meatballs have been picked out by other customers.

Second, serving utensils may be unintentionally switched and are expensive to standardize. Utensils are generally cleaned using high heat and water, which typically removes any type of label that designates the utensil as e.g., a 6 oz chili ladle vs. a 10 oz soup label.   Thus, it is difficult  for  stores  to  differentiate  between  similar  utensils  using  labeling.    As  such,  after cleaning, similar utensils may be unintentionally switched making the calorie counts for the items incorrect when they are based on the amount in a particular utensil.  More permanent labeling, such as engraving “soup ladle”, into the utensil is generally cost prohibitive. Additionally, standardizing utensils across the entire ready-to-eat area is nearly impossible, as the food items being sold differ extensively.  (This leaves aside the cost of standardizing utensils within a single grocery-store chain, which itself imposes a significant expense.)

Based on the issues discussed above, FMI requests that the rule provide additional flexibility in this  area.     Namely,  we  request that  the  Agency allow  Section  101.11(b)(2)(iii)(A)(2)(ii)  –  permitting  calories  to  be  based  on  a  common  household  unit  –   to  apply  even  where  a standardized serving utensil is or can generally be used.  Moreover, FDA should delete the language “offered for sale” in (b)(2)(iii)(A)(2)(ii) because there should not be a requirement that the item be priced by “cup” or by “tablespoon” in order to declare calories on that basis.

c.   Unit Versus Entire Item

FMI members are seeking additional flexibility regarding labeling for multiple-serving food items sold in discrete units, such as a bucket of chicken wings.  Section 101.11(b)(2)(i)(A) of the Menu Labeling rule specifies that menu and menu boards must display “[t]he number of calories contained in each standard menu item listed on the menu or menu board, as usually prepared and offered for sale.” The rule further specifies that in the case of multiple-serving standard menu items, “the calories declared must be for the whole menu item listed on the menu or menu board as usually prepared and offered for sale (e.g., ‘‘pizza pie: 1600 cal’’); or per discrete serving unit as long as the discrete serving unit (e.g., pizza slice) and total number of discrete serving units contained in the menu item are declared on the menu or menu board, and the menu item is usually prepared and offered for sale divided in discrete serving units (e.g., ‘‘pizza pie: 200 cal/slice, 8 slices’’).”

Under this provision, in order to avoid declaring the calories in the entire multiple-serving item, the item must be offered for sale in discrete units, and the discrete unit must be specified, along with the number of discrete units.  For a multiple-serving item that is not pre-divided into discrete units, like a pan of lasagna or a whole chicken, calories must be declared for the entire
 
item under the current rule.  Instead, FDA should permit calories to be declared “per serving” as reasonably determined by the establishment, as long as the “serving size” is disclosed as part of the calorie declaration.  This flexibility would allow calories to be provided more in line with the amount consumers actually consume, rather than providing unhelpful information that an entire chicken or pan of lasagna contains a particular number of calories.

Our members have also encountered uncertainty with respect to multi-serving items that come in discrete units but are also offered with a component not in a discrete unit, such as a platter of bagels with a tub of cream cheese.  The rule does not address how the calories for the cream cheese should be declared, and suggests that because the cream cheese is not pre-divided,
calories must be declared for the entire tub.  FDA should provide flexibility to provide calories on a per serving basis for the cream cheese, e.g., “xxx cal per 2 tbsp” (based on the FDA reference amount customarily consumed or RACC for cream cheese of 30 g) or “xxx cal for 1/8 tub” for a platter of 8 bagels.

In order to address these two situations, we ask FDA to recognize that for multiple-serving foods, including those that are in discrete units and those that are not, calories can be provided “per serving size” as reasonably determined by the establishment and disclosed on the menu, menu board, or sign.

VIII. Scope of Foods that Are Covered

One of the greatest challenges in implementing the Menu Labeling rule has been determining which foods fall within the scope of the regulation.  While the Agency has provided some guidance in this regard, determining which foods are covered in a grocery store setting is often much more difficult than in your traditional chain restaurant.  Additionally, as noted above, the estimated cost for determining nutrition information for each item alone can be up to $1,000, so in order to limit the burden on customers it is extremely important to limit compliance efforts to only items definitively covered by the rule.  Some examples of challenges regarding the scope of foods that are covered by the rule are discussed in more detail below.

a.   Restaurant Type Foods vs. Grocery Items

In the Final Rule, FDA states that the definition of a restaurant-type food is intended to cover those items that are most like the food sold in restaurants and should not cover foods that are more commonly considered to be groceries. Although grocery stores often sell items that are clearly grocery items or clearly ready-to-eat items, there are also many food options that cannot be clearly categorized as one or the other given the current definition.  As such, one major challenge  has  been  determining  which  foods  are  restaurant  type  items  that  are  potentially covered by the rule versus grocery items which would not be subject to the requirements.

Section 101.11 defines restaurant type food as:

Restaurant-type food means food that is: (i) Usually eaten on the premises, while walking away, or soon after arriving at another location; and (ii) Either: (A) Served  in  restaurants  or  other  establishments  in  which  food  is  served  for
 
immediate human consumption or which is sold for sale or use in such establishments; or (B) Processed and prepared primarily in a retail establishment, ready for human consumption, of the type described in paragraph (ii)(A) of this definition, and offered for sale to consumers but not for immediate human consumption in such establishment and which is not offered for sale outside such establishment.

In working to comply with the rule FMI members have encountered multiple scenarios where a food item could meet the definition of restaurant-type food, but is meant to be a grocery item. For example, produce sections of grocery stores commonly offer pre-cut vegetables, fruit parfaits and seven layer dip for customer convenience.  Based on the definition above, this item could be inaccurately categorized as a restaurant type food.

As noted above, determining nutrition information for each item is estimated to cost $1,000, with significant additional expenses on top of that for labeling and recordkeeping.   While it is important to our members to be able to offer these convenience items, these additional and unnecessary costs are likely to make these items unprofitable for stores.  As such, it is important to FMI and its members that FDA clarify that grocery items sold by the store simply packaged for customer convenience would not be considered restaurant type food and are not covered by the rule.

Confusion is also common with bakery-type items, particularly those sold in bulk.  Section I3 of FDA’s Questions and Answers on the Menu and Vending Machines Nutrition Labeling Requirements discusses how restaurant-type food is defined and some of the key exemptions:

Foods that would generally not be covered under the definition of “restaurant- type” food include certain items purchased in a grocery store or other similar retail food establishment that are eaten over several occasions or stored for later use (e.g., a whole cake, a loaf of bread, bags/boxes of rolls), foods that are typically  intended  for  more  than  one  person  to  eat  or  require  additional preparation before consuming (e.g., pounds of deli meats and cheeses, large-size deli salads), and certain foods bought from bulk bin cases in grocery stores (e.g., nuts, dried fruits, olives from bulk bins) (emphasis added).

There are similar statements made in the preamble to the final rule.  This guidance indicates that in most cases bulk bread or rolls sold in the bakery section of stores would generally be excluded from the rule, as these are commonly sold from bulk bins where customers can hand select rolls to pack into bulk bags provided onsite.  However, although they are designed to be purchased in bulk, there is nothing preventing consumers from purchasing a single roll, either for immediate or  later  consumption.    More  specifically,  grocery  stores  understand  that  families  come  in different sizes and generally offer pricing by the roll so that families of one, families of eight, etc. can purchase the appropriate number of rolls or other bakery items for the week.

FDA staff has informally indicated that bulk items, such as rolls, could be considered restaurant type foods when consumers have the option to purchase a single roll for immediate use (e.g., a consumer  might  purchase  a  single  roll  from  the  bulk  bin  for  use  in  their  soup).    This
 
interpretation is inconsistent with the language in the final rule.  In most cases, a customer has the option of choosing the quantity they would like to purchase—this has no bearing on whether an item is a restaurant-type food. It would be next to impossible to apply such an arbitrary distinction  in the bakery/bulk  item  category.    As  noted above,  costs  associated with  menu labeling compliance are extremely high for each individual item.  Section 101.11 of the Menu Labeling rule makes clear that it only applies to “each standard menu item listed on the menu or menu board” and that a standard menu item “means a restaurant-type food that is routinely included on a menu or menu board or routinely offered as a self-service food or food on display” (emphasis added).  As such, it is not the intent of the rule to cover grocery type items simply because there is a possibility, however remote, that a customer could purchase a single one for immediate use.  Because labeling these bulk grocery items is extremely costly to stores and does not support the intent of the Menu Labeling rule, FMI requests that the Agency make clear that bulk items are always exempt from the rule, whether or not a consumer might purchase a single item for immediate consumption.

b.  Substitutions

Limiting food waste and utilizing ingredients that are fresh and ripe is important to food retailers and the products they offer.   Food retailers may offer berry smoothies with different types of berries and other fruit, depending on what is in season and in stock.  Specifically, if the general recipe includes blackberries and strawberries, but the blackberries have not been ripe, the store may substitute them with raspberries.  Additionally, in order to reduce food waste, retailers often modify certain recipes to utilize excess stock.  For example, if a retailer has a surplus of carrots one week, they may substitute another vegetable in their ready-to-eat vegetable soup to limit the potential for any waste.

With potentially thousands of restaurant-style foods produced in a grocery store, change is inevitable and occurs at a rapid pace due to formulation modifications, ingredient and recipe changes, and/or supplier changes. While we understand that slight substitutions or modifications to a recipe based on available ingredients would not be considered standard menu items when they are offered for less than a total of 60 days per calendar year, there is still concern as to how these scenarios would be addressed by state and local inspectors, as inspectors could take the view that the number of days during which these items are offered needs to be recorded and made available for review upon request of a regulator.

Based on informal conversations with the Agency, we understand that FDA would not expect grocery stores to provide the modified calorie and nutrition information for the temporarily substituted item.  Specifically, FDA has recognized that there may be occasional disruptions in the market, with regard to the availability of certain ingredients in standard menu items, and this may lead  to  a short-term  ingredient  substitution.   The Agency has  indicated that,  should  a concern be raised about the accuracy and reasonable basis for a disclosure when a temporary substitution is in place, FDA would take this circumstance into account; however, there is no written guidance discussing this point.  And to the contrary, FDA’s written guidance states that establishments should contact the Agency to discuss a situation where the menu will not be updated in a way that coincides with a change to a menu item (Section 6.22).
 
In the supermarket setting, inspectors should understand these changes occur weekly, and it takes time to implement signage and menu board changes throughout potentially thousands of stores. We request the FDA and any state and local jurisdictions that inspect for regulatory compliance provide flexibility for the accuracy of displayed calorie information after reformulations or recipe changes of standard menu items.  We also request that FDA make clear that in such cases, there is no requirement to keep records of the number of days or which the item is offered, provided a responsible individual at the covered establishment is able to affirm that the item meets the definition of a temporary menu item.   This type of flexible approach would appropriately limit the amount of burdensome recordkeeping that ultimately would be unhelpful to consumers.  Additionally, while FDA indicates in guidance that contacting the FDA to discuss the scenario on a case-by-case basis would be an option, it is simply not be feasible to do so in a supermarket setting where substitutions and modifications are sometimes made on a daily basis based on the availability of ingredients.

As such, FMI requests that FDA provide additional clarification on such temporary substitutions, including what the Agency considers to be temporary substitutions and steps to take should a question be raised regarding the need for or accuracy of calorie or nutrient disclosure for an item containing a temporary substitution to ensure state and local inspectors have adequate guidance.

c.   FDA Should Clarify that Whole Cakes are Exempt

The Agency makes it clear in the preamble to the final rule that whole cakes are foods to be eaten over several eating occasions or stored for later use, and therefore do not fall within the definition of “restaurant-type foods” requiring menu labeling.  Specifically, in FDA’s chart in the preamble including “[e]xamples of foods that generally would not be considered restaurant-type food” the agency lists “[f]oods to be eaten over several eating occasions or stored for later use (e.g., loaves of bread, bags or boxes of dinner rolls, whole cakes, and bags or boxes of candy or cookies);” however, subsequent informal FDA correspondence and private consultations with the Agency have potentially expanded the scope of the rule to cover whole cakes on a menu or menu board, even though whole-cakes are clearly not covered based on the Rule’s preamble language and guidance statements.

This informal guidance runs counter to the clear FDA statements in the preamble that whole cakes are not covered and the implication that they are now subject to the calorie labeling requirements merely because they are listed on a menu or menu board is arbitrary and capricious and inconsistent with the intent of the rule.  As such, we request that the Agency be consistent in its interpretation and make clear that whole cakes and other items to be eaten over several occasions are not covered by the Menu Labeling rule regardless of whether they are being offered  for  sale  within  the  grocery  store  or  on  a  menu  or  menu  board  because  in  all circumstances such whole cakes sold by a grocery store are not restaurant-type foods.

d.  FDA Should Limit the Scope of the Rule to Items Sold in the Prepared Foods
Area of a Grocery Store

As discussed above, to be considered a restaurant-type food the item must be eaten on the premises, while walking away, or soon after arriving at another location.  Many items that are offered outside of the ready-to-eat section of a grocery store could meet this definition but are not intended to be consumed in this way.  For example, as noted above, produce sections of grocery stores commonly offer pre-cut vegetables, fruit parfaits and seven layer dip packed for customer convenience.  That is, the items are still designed to be stored in the refrigerated for later use and often eaten over multiple occasions like a typical grocery-type food – but are cut/repackaged by the store for added convenience.  Based on the current definition of restaurant type food, however, these items could potentially be considered a restaurant type food. This arbitrary and unclear distinction is problematic and clearly inconsistent with the intent of the law—to apply the rule to restaurant-type foods.  Because there is no clear distinction or guidance on how stores can demonstrate that foods are intended as grocery items and not covered, they may provide the information regardless at a significant expense.

In revisiting the final rule, issuing guidance, and providing oversight of state and local menu labeling  enforcement,  FDA  should  follow  the  premise  that  covered  restaurant-type  foods designed to be eaten on the premises, while walking away, or soon after arriving at another location are displayed and marketed within the ready-to-eat section of the grocery store. Therefore, regulatory oversight and inspections of a store should be limited to the areas within the store that are marketed in such a way as to evidence the intent that the food be consumed in a way similar to restaurant foods.  This distinction will help provide clarity for covered grocery stores about which items are covered and alleviate concerns that state/local inspectors will apply the law inconsistently.  To provide clarity and consistency, FMI urges the Agency to clarify that foods outside of the ready-to-eat section of a grocery store would not be considered restaurant- type foods and, thus, are exempt from the menu labeling requirements.  Items that are being sold with traditional groceries are clearly not intended to be restaurant-type foods.

e.   Alcoholic Beverages

The Menu Labeling rule applies to alcoholic beverages, except for alcoholic beverages that are foods on display that are not self-service foods.  The preamble and FDA’s guidance, however, provide only limited examples of how this exemption would apply, particularly in a grocery context.  While many grocery stores offer alcoholic beverages for sale, the ways in which these beverages are marketed and sold vary widely between stores.  As such, there has been some confusion regarding which alcoholic beverages are covered by the rule.

Clearly standard menu item alcoholic beverages listed on a menu or menu board that could be consumed on the premises would be covered by the rule; however, alcoholic beverages that are sold as grocery items, such as a build your own six-pack, would not be subject to the menu labeling requirements.  As another example, we expect that a “fill your own growler” offering would not be covered because it is not a restaurant-type food. A growler would be an item typically stored for later use and consumed on multiple occasions rather and therefore would not meet the restaurant-type food definition.

FMI seeks clarification in this area, and requests that FDA clearly communicate that an alcoholic beverage must be listed on a menu or a menu board and sold for immediate consumption on the premises to be subject to the calorie disclosure requirements.
 


IX. Exception from the Requirement to Provide the Two Written Statements for Grab- and-Go Items that Bear a Nutrition Facts Panel

Section 5.96 of FDA’s guidance document indicates that “if an establishment voluntarily chooses to use a Nutrition Facts label that meets the requirements under 21 CFR 101.9, the Nutrition
Facts label would meet the menu labeling requirements for calorie declaration and additional written nutrition information.”9  While we appreciate this flexibility, unanswered questions remain surrounding its use in complying with the Menu Labeling rule.

On the one hand, the Agency has indicated in guidance that an establishment may voluntarily choose to use a Nutrition Facts label that meets the requirements under 21 CFR §101.9 to meet the menu labeling requirements for calorie declaration and additional written nutrition information.  On the other hand, FDA has on other occasions stated that the statement designed to enable consumers to understand the significance of the calorie information in the context of a total daily diet (i.e.,”2,000 calories a day is used for general nutrition advice, but calorie needs vary”) must still be displayed so that it is visible when the customer is making the selection. Specifically, FDA affirms in Sections 5.94 and 5.95 of its guidance document that disclosing calorie information on a grab-and-go item is a sufficient means to comply with the Menu Labeling rule.  However, the guidance goes on to say if the label does not provide the full additional nutrition information that must be available upon request (i.e., the information on 11 nutrients), the succinct statement and the statement of availability of additional written nutrition information (along with separate additional written nutrition information) would still be required for this “grab and go” item.

Nutrition Facts labels are likely to be used as a means to comply with the Menu Labeling rule in settings where developing and adhering a menu board or other menu might be difficult and cost prohibitive, given space restraints, etc.  A common example of this is pre-made sandwiches in a grab-and-go refrigerated case.  These cases are often tightly packed and have an outer rim of approximately 2 inches in width.  This leaves grocery retailers very little room to provide signage to communicate additional information.  This means of compliance becomes far less practical, however, when the two additional statements must be placed next to or in close proximity to the item.   Stores must identify an appropriate place to provide the signage when they have chosen this method of compliance precisely because it is not practical to use signage in this situation.  In the grab-and-go sandwich example above, the grocery store might have to outsource an expensive customer hanging sign just to add the succinct statement above that cooler.

FDA should provide an exception from the requirements to post the succinct statement and statement on additional written nutrition information when calories are disclosed directly on the


9 Although it FDA has indicated during multiple public meetings that it will accept both the old or new format for the Nutrition Facts label, the Agency should confirm this point in writing so that there is a clear understanding across industry that either version of the Nutrition Facts label is an appropriate means to comply with the Menu Labeling rule.
 
label of a grab-and-go item.  Requiring additional stickers or signage for these items is incredibly costly, burdensome, and of little value since consumers will invariably have access to the
succinct statement in multiple other locations throughout the prepared foods areas of grocery stores. Providing an exemption from the requirement to display the two written statements will allow companies to utilize the calorie disclosure on the labels of grab-and-go items to reduce the financial burden in situations where signs or other types of menus might be prohibitively expensive.  We see no reason to provide the statements in multiple locations throughout a grocery store.

X. Recordkeeping and Enforcement

FMI and its members share a number of concerns regarding compliance with and enforcement of the Menu Labeling rule.  These are discussed in greater detail below.

a.   Records Documenting Eligibility for Exemptions from the Rule

FMI’s members sell many ready-to-eat items that are not subject to the rule, such as a temporary pumpkin muffin for October or a new side item that the chef has decided to test for two-weeks. While these items are clearly not covered by the rule, the Agency has provided only limited guidance as to records in this regard.  As noted above, recordkeeping is already estimated to cost
$2,000,000 per chain annually.  In order to alleviate the burdens imposed by the rule, FMI requests that the Agency clarify that records documenting eligibility for an exemption are not required.  In other words, food retailers should only be required to keep records for covered items, and no recordkeeping should be required for items not covered by the rule. Clarification on this point would alleviate confusion as to the types of records that are required under the rule.

b.  Signed Statement by an Responsible Individual Employed at the Covered Establishment

In the final rule, FDA states that a covered establishment must provide to FDA, within a reasonable period of time upon request, information substantiating nutrient values including the method and data used to derive these nutrient values.  This information must include, among other things, (1) a statement signed and dated by a responsible individual, employed at the covered establishment or its corporate headquarters or parent entity, who can certify that the information contained in the nutrient analysis is complete and accurate; and (2) a statement signed and dated by a responsible individual employed at the covered establishment certifying that the covered establishment has taken reasonable steps to ensure that the method of preparation (e.g., types and amounts of ingredients in the recipe, cooking temperatures) and amount of a standard menu item offered for sale adhere to the factors on which its nutrient values were determined.

FMI has concerns with the requirement to provide upon request a statement signed by a responsible individual at the store-level, as it is overly burdensome and provides no corresponding benefit.  The Menu Labeling rule’s compliance standard already requires establishments to “take reasonable steps to ensure that the method of preparation (e.g., types and amounts of ingredients, cooking temperatures) and amount of a standard menu item offered for sale adhere to the factors on which its nutrient values were determined.”  Grocery stores already provide their own training programs to ensure that consistent serving sizes and preparation methods are used.  This is done not only to comply with the “reasonable steps” requirement but also for business reasons to ensure that items are consistent in preparation and size across stores. There is no added benefit to consumers from requiring an individual at the covered establishment to certify that the “reasonable steps” requirement has been followed.  It is simply an exercise in paperwork that adds costs, time, confusion, and burden.

For example, some employees may be hesitant to provide a signed statement for fear of repercussions in the event there was an issue outside their control.  Some union employees have voiced significant concerns with these requirements.

Additionally, in the event the calorie and other nutrition information is not accurate, the foods would be considered misbranded and subject to the same penalties that misbranded packaged foods are subject to under the FD&C Act, regardless of whether there are sworn statement at the corporate or store-level.  FMI does not believe the store-level signed statement requirement is necessary to ensure compliance.  Instead, it creates an additional burden and costs for covered establishments and store employees alike.

c.   Corrective Action Period

As FDA is aware, ready-to-eat items sold in grocery stores differ vastly from those sold in traditional chain restaurants.  Food items are often rearranged geographically within stores, the multitude of self-service items means that signage may be accidentally moved by customers, and items may be replaced with different items depending on availability and sales.  For example, many stores use individual standing tags on a salad bar, or magnetic placards outside of the case for items that might need to be changed regularly depending on flavors offered, like donuts. Based on these differences and the additional complexities in a grocery store setting, corrective actions may take additional time and financial resources.  For example, if signs on a salad bar or these magnetic placards are being continuously bumped and moved by customers, the store may need time and additional funding in order to replace the movable tags or placards with more permanent boards or to develop another appropriate solution.

As discussed above, FMI believes that FDA and other regulatory officials should provide an appropriate period of time for food retailers to remedy a violation of the regulation, which will provide stores sufficient time to analyze the least burdensome way to come into compliance.  For example, in the scenario addressed above the stores might need time to get cost estimates from multiple suppliers of more permanent signs, or to bring in an employee to analyze space availability.  FMI asks that FDA provide a 90-day period to correct a violation of the Menu Labeling rule with no enforcement action, including issuing a Warning Letter or untitled letter, from the date the Agency notifies the covered establishment of the violation.  Specifically, we would suggest the following language:

OPPORTUNITY TO CORRECT VIOLATIONS—Any restaurant or similar retail food establishment that the Agency determines is in violation of this clause shall have 90 days after receiving notification of the violation to correct the violation.  The Agency shall take no enforcement action, including issuance of any public letter, for violations that are corrected within such 90-day period.

d.  Consistent Enforcement

Consistent enforcement of the Menu Labeling rule is extremely important to FMI and our members, as it can affect personnel training and implementation procedures in many ways.  In order to assure our member stores that oversight will be consistent, we ask that the Agency further clarify the ways in which it plans to uniformly train and inform states and municipalities that may be enforcing the FDA rule or an identical state or local rule.  We would also ask that FDA issue and make any Memoranda of Agreement publicly available prior to allowing or delegating authority to other government entities so that any understanding reached between these entities is clear to those subject to the rule.

e.   Federal Preemption

Given the revised compliance date and current RFI, FMI strongly urges FDA to clarify that – during the time before the compliance date – states and local governments are preempted from enforcing their own rules, even if those rules are identical to the Dec. 1, 2014 rule.  The IFR strongly signals that FDA will be revising the Menu Labeling rule in a significant way. Since the IFR was released, some states are attempting to impose nutrition-labeling standards that are in conflict with the provisions of existing federal law. Given this incredibly problematic development, we strongly urge FDA to take action to reinforce the preemption of any state law, regulation, or other requirement that is not identical to the federal standard for nutrition labeling. The federal preemption provision in the statute is clear: states, cities, and other local governments only have the power to pass or implement nutrition-labeling requirements that are the same as the federal requirements, and may only pass or implement different requirements if they request and obtain specific permission from FDA.  This also includes effective and compliance dates.  As demonstrated by a July 14, 2017 letter from House Energy and Commerce Committee Chairman Greg Walden and Health Subcommittee Chairman Michael Burgess, Congress supports FDA taking “action to reinforce the preemption of any state or municipal law, regulation or other requirement that is not identical to the federal standard” for menu labeling, which “includes the effective and compliance dates of the requirements.”10  We appreciate FDA’s recognition and willingness to reconsider the serious concerns with implementing the Menu Labeling rule as part of the implementation, it is critical that FDA publicly issue a statement expressing its jurisdiction over these issues and that the law preempts conflicting state laws. Failure to do so will lead to confusion among retail food providers and consumers, and will thwart the purpose of the statute to create a uniform system.

XI. Areas Where FDA Has Provided Appropriate Flexibility and Clarification

There are a number of areas where FDA has provided useful clarification and flexibility.  We would like to take the opportunity to applaud the Agency in the following areas, and request that FDA continue to consider these points as it makes any modifications to the Menu Labeling rule.

a.   Clarification regarding Internet Sales

Earlier this year, FMI posed a number of difficult questions to FDA regarding the Menu Labeling rule.  One important question addressed whether grocery items offered for sale online are covered under the rule.  We posed this question in light of question 3.23 of the menu labeling guidance, which indicates that a menu or menu board can include specialty menus such as “menus on the internet,” but does not specify how that would apply to a website strictly designed as a means to order groceries in advance.  We provided FDA an example where a website offers a means for ordering grocery items.  The grocery website in the example offered the same items that are available in the store, which the customer can either order online for later in-store pick- up or delivery, such as baby food, paper towels, packaged foods, produce, etc.  Customers can also select items that would not be covered by the Menu Labeling rule were they offered in-store, such as whole cakes/pie.  We asked that FDA clarify that this online platform for ordering groceries would follow the same rules as for in-store sales.  Specifically, use of the online platform would not result in items that are not covered when sold in-store would be automatically be considered restaurant-type foods when sold via the online platform.

In its response to FMI, FDA confirmed that the online platform strictly for ordering grocery items would follow the same rules as for items offered for sale in-store.  That is, examples might be:

A whole grab and go pie: This pie would not be covered in-store or online (same rules apply in-store and to this platform- it is designed to be eaten over multiple eating occasions and, thus, not subject to the rules)

A hot pizza: A hot pizza would be covered both in-store and online (same rules apply- this is a restaurant type food item designed to be eaten immediately)

We appreciate FDA’s willingness to resolve this question and applaud the Agency for offering a consistent interpretation in this regard.

b.  Grocer Cooperatives and Marketing Alliances

In the final rule, FDA states that independent businesses that are cooperatives, even those that are similarly named, are not covered establishments if, for example, they are only connected insofar as they take advantage of economies of scale when procuring goods and services, or for marketing and advertising purposes, but are not ‘‘offering for sale substantially the same menu items.’’  FDA further notes that given the way in which cooperatives generally are structured, it does not expect that two cooperatives would be offering for sale substantially the same menu items.  FMI agrees with FDA’s determination that cooperatives and marketing alliances do not generally offer for sale substantially the same menu items and are, therefore, not covered under the rule.

A number of food retailers are members of cooperatives or marketing alliances.  These business structures allow independent retailers to take advantage of economies of scale for supply chain and joint marketing, among other things; however, members of the co-op remain separate corporate entities that operate more or less independently and have their own recipes and prepared food offerings.  While a co-op may be comprised of 100 stores operating under the same banners, it may actually be a grouping of 50 separate owners that operate two stores each. Store owners enjoy—and exercise—vastly more independence than owners of franchise restaurants.  Stores in co-ops may operate under completely different banners, may have different banners but display a common logo, or may share all aspects of the same banner.  FMI believes stores that belong to a co-op but are independently operated do not meet the definition of a covered establishment.

In our informal discussions with the Agency, we provided FDA with numerous examples of grocer cooperatives and marketing alliances that might be utilized in the food retail business. One example as it relates to ready-to-eat foods is provided for reference below:

Hypothetical: There are currently 83 stores operating under the same name.  They are all named “Big Food Mart”, although some of them add a name on the front to indicate the owner or owner group (e.g., Bob’s Big Food Mart, Anderson’s Big Food Mart, YKZ Big Food Mart, etc.).  Of those 83 stores, there are 25 different owners:

1 owner owns 50 stores; 1 owner owns 8 stores; 2 owners own 2 stores each; 21 owners own 1 store each

While they might offer similar restaurant type food to other Big Food Marts that are not owned or operated by them (e.g., fried chicken, vegetable soup, grab and go sandwiches or yogurt parfaits, doughnuts, etc.), they do not share recipes, preparation instructions, formulations, etc. with any other Big Food Marts.

We asked FDA to confirm that the owners in the example above who are operating fewer than 20 stores are not subject to the Menu Labeling rule.  In its email response, FDA provided a clear explanation of the necessary analysis to answer this question.  Specifically, the Agency indicated that final rule defines a covered establishment as a restaurant or similar retail food establishment that meets the following four criteria:


• Being part of a chain with 20 or more locations (with the term location referring to a fixed position or site)
• Doing business under the same name (regardless of the  type of ownership, such as individual franchises).  When the term “name” refers to the name of the establishment presented to the public, the term “same” includes names that are slight variations of each other,  due  to  things  such  as  the  region,  location,  or  size  (e.g.,  “ABC”  and  “ABC
Express”).
 
• Selling substantially the same menu items
• Selling restaurant  type  foods (defined,  in  part,  as  food that  is  usually eaten  on  the premises, while walking away, or soon after arriving at another location)

Additionally, FDA confirmed that in the example above, the owners operating fewer than 20 stores would not be subject to the rule because they do not appear to be selling substantially the same menu items and, therefore, would not meet all of the criteria.

We appreciate FDA’s clear response in this matter, and willingness to review specific examples and concerns.  We ask that in modifying the rule the Agency continue to make clear that establishments are not covered where they are not part of a chain with 20 or more locations selling substantially the same menu items.

c.   Reasonable Basis

As indicated by Section 101.11(c)(1) of the final rule and FDA’s guidance document, covered establishments subject to the rule must have a reasonable basis for determining the values for calorie and other nutrient information provided for standard menu items.  This determination may be made using any one of a number of means, including:

• Calculations based on nutrient databases such as the USDA National Nutrient Database for Standard Reference
• Values listed in a cookbook
• Laboratory analysis of your menu items
• Other reasonable means such as:
o Use of Nutrition Facts on the labels of packaged foods that comply with the nutrition labeling requirements of section 403(q)(1) of the FD&C Act and 21 CFR
101.9;
o FDA’s nutrient values for raw fruits and vegetables (Appendix C of 21 CFR part
101; or
o FDA’s nutrient values for cooked fish (Appendix D of 21 CFR part 101). Further details about using these methods are discussed in questions 6.6-6.20. (21 CFR
101.11(c)(1))

We appreciate this flexibility and agree with FDA that the reasonable basis standard is more flexible and appropriate for the menu labeling rule than the “80/120” standard.  We ask that in modifying the rule the Agency continue to uphold the reasonable basis standard and its flexibility.

XII. Future Compliance

As previously noted, our members operate under business models that vary significantly from store to store and chain to chain.  Our members also seek to achieve varying consumer experiences, including providing the latest technology, meeting consumer demands for convenience, or providing a consistent consumer experience across all stores.  As such, it is important that FDA remain cognizant of these different models and business objectives when making any modifications to the rule.  First, we ask that the FDA be aware that any additional changes to the rule in the near future will have a significant effect on those businesses who value consistency in both their business model and in-store signage.  As noted above, compliance costs for the Menu Labeling rule are extremely high, so stores who value consistency will strive to utilize existing menus and signage for as long as possible to reduce burdens and maintain uniformity in stores.  Second, we ask that FDA recognize the alternative (i.e., those who emphasize technology and evolving customer needs) and modify the rules in ways that will allow for these changes in the future.  Specifically, stores may increasingly seek to utilize electronic menus and boards, and the rule should be written in a manner that allows the rule to be adapted
to such technologies.

XIII. Conclusion

Once again, FMI appreciates the opportunity to submit comments to FDA regarding the Menu Labeling rule, and ways in which the Agency can reduce the regulatory burden and provide additional flexibility.  We look forward to our continued collaboration with FDA on the Menu Labeling rule.

If you have questions about these comments or would like additional information, please feel free to contact me at (202) 220-0614 or sbarnes@fmi.org.

Sincerely,

Stephanie K. Barnes
Chief Regulatory Officer & Legal Counsel