October 11, 2018

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Re: The Food and Drug Administration's Comprehensive, Multi-Year Nutrition Innovation  Strategy; Public Meeting; Request for Comments; Docket No. FDA-2018-N-2381

Food Marketing Institute (FMI) recognizes that FDA plays a critical role in promoting public health, including among other priorities, helping to ensure that food labeling allows consumers to make informed choices about the foods they purchase to promote good health through diet and nutrition.  On January 11, 2018, FDA released its 2018 Strategic Policy Roadmap (https://www.fda.gov/AboutFDA/ ReportsManualsForms/Reports/ucm591993.htm), which discusses the key priorities the Agency plans to pursue in order to advance its public health mission. On March 29, 2018, FDA announced a comprehensive Nutrition Innovation Strategy seeking to promote public health through improved nutrition, encourage industry innovation to create healthy products that consumers seek and address ways for consumers to identify those products. To help the Agency better understand how to  implement this Nutrition Innovation Strategy, FDA announced both a public meeting and opportunity for comment.

 

FMI appreciates the opportunity to provide comments on this important initiative.  Given that the key activities included in the Nutrition Innovation Strategy have the potential to greatly impact the entire food value chain, FDA is encouraged to engage with industry early and regularly throughout its implementation.  Also, as implementation will likely result in changes to food labels, FMI encourages  FDA to harmonize activities as much as possible to ensure consistency across regulations, messaging and recommendations.  Additionally, it is important for the Agency to establish reasonable compliance dates which will allow manufacturers to incorporate any changes with other planned label updates in order to reduce the number of label changes that need to be made.

 

Food Marketing Institute proudly advocates on behalf of the food retail industry, which employs nearly

5 million workers and represents a combined annual sales volume of almost $800 billion. FMI member

companies operate nearly 33,000 retail food stores and 12,000 pharmacies. FMI membership includes the entire spectrum of food retail venues; single owner grocery stores, large multi-store supermarket chains, pharmacies, online and mixed retail stores. Through programs in public affairs, food safety, research, education, health and wellness and industry relations, FMI offers resources and provides valuable benefits to almost 1,000 food retail and wholesale member companies and serves 85 international retail member companies. In addition, FMI has almost 500 associate member companies that provide products and services to the food retail industry. For more information, visit  www.fmi.org and for information regarding the FMI Foundation, visit  www.fmifoundation.org.

As part of its public meeting and request for comments, FDA indicated that it expects the following topics to be addressed.  FMI provides comments on each in more detail below:

 

1)    Considering using a standard icon to denote the claim “healthy” on food labels.

 

Food retailers often represent the last line of communication between consumers and their food choices, so transparency and clarity in labeling are extremely important to help customers select food items that contribute to a healthy diet.  As such, FMI would generally support any method of getting information to consumers that is clear, accurate and aligned with current, evidence-based dietary recommendations.  Although FMI believes such an icon could have merit, we would submit cautionary points for the Agency’s consideration.

 

First, for customers to have a clear and accurate understanding of what the standard icon means with regard to food choices it is necessary for FDA to first prioritize and finalize the rulemaking to update the criteria used to define the term “healthy.”  To that end, FMI commends the Agency for announcing during the July 26 public meeting that it is working on a proposed rule to modify the “healthy” definition, and we wish to reiterate on the “healthy” definition last year. Having a clear definition of “healthy” will help ensure that consumers, industry, and manufacturers all use consistent terminology to describe healthy foods. Moreover, to provide accurate and useful information to consumers so they can choose healthier diets, information must reflect modern science findings.  Updating the definition of “healthy” in a way that is consistent with the 2015-2020 Dietary G uidelines for Americans is important to ensure that consumers are provided with accurate information based on current science. FMI and its member companies value scientific data and information and recognize that nutrition science continues to advance and evolve over time.

 

Second, it is important that any icon selected to denote “healthy” be thoroughly informed by consumer research to maximize consumer understanding and utilization and to support consumer choices that build healthier eating patterns.  Given that food packages are already crowded with information and symbols, FDA should consider whether an additional icon would truly inform shoppers versus further cluttering and confusing the information already available on the package.  Consumer testing could help confirm whether the use of an icon would further the goal of consumer understanding.  Additionally, it  is important that any icon selected relay the appropriate information in a way that is both informative and consistently interpreted by consumers.  Consumer testing is also advisable for this aspect, as consistent interpretation is crucial for the proposed use of an icon to have utility in helping consumers make healthier food choices.  As an example, color choice may unintentionally imply that foods contain certain nutrients or characteristics, which could cause consumers to associate green with vegetables and high levels of fiber or folic acid, and orange could be associated with citrus and high levels of Vitamin C. Given the FDA would not want to imply foods utilizing any such symbol contain nutrients or characteristics when they do not, it is important that FDA study consumer perception of any potential icon before selecting it. This might include many characteristics of the icon, such as color, shape, placement, imagery, etc.

 

Finally, with an average of nearly 40,000 items carried in supermarkets, it is important to maintain flexibility and allow for a range of options that best suit each product in order to clearly and accurately communicate information to consumers.  These items vary significantly, ranging from large national brands of manufactured foods to unique local and seasonal offerings. Some are traditional grocery items and others are offered for sale in diverse ways and in varying packaging formats. In order to help protect the ability of stores to continue to market and offer a diverse variety of products, the use of an  icon to denote a “healthy” product should be voluntary and should not replace the option of simply utilizing the word “healthy” if the product meets the standard to be set by FDA. We also encourage the Agency to consider other methods of communication, which go beyond the food package, to further transparency and consumer understanding.  This might include methods such as more general signage to help consumers understand when they are in sections of a grocery store carrying healthy foods, such as the leafy greens area or a section carrying all varieties of apples, etc. This flexibility would allow  manufacturers and suppliers to choose the method that best suits the needs of their products, while still accurately communicating the information to purchasers.

2)    Creating a more efficient review strategy for evaluating qualified health claims on food labels.

 

FMI agrees that a more efficient review strategy for evaluating qualified health claims could help make useful product information more readily available to consumers; however, food safety and accuracy remain important priorities, and it is important that the scientific validity of the claim not be affected by any changes to the review process.  21 C.F.R. Section 101.14(b)(1) requires the relevance of the claim to be submitted to FDA in the context of the total daily diet.  In order to fully meet the goals of the Nutrition Innovation Strategy, it is important than any modifications to the review strategy still emphasize the importance of claims in relation to the total daily diet.  Additionally, to prove the validity of health claims, FDA currently requires both that the claim be supported by the “totality of publicly available scientific evidence” and that there is “significant scientific agreement among experts qualified by scientific training and experience.”  Although efficiency is important, it is not a substitute for valid scientific analysis of claims.  As such, it is important that any modifications to the review process not lessen the degree to which the scientific validity of health claims is analyzed.

 

3)    Discussing new or enhanced labeling statements or claims that could facilitate innovation to produce more healthful foods and more healthful consumer food choices.

As noted above, FMI members offer a large variety of products, ranging from popular national brands of manufactured foods to unique local and seasonal offerings. Some are traditional grocery items. Others are offered for sale in diverse ways and in varying formats, including, for example, made-to-order sandwiches packed by a store clerk in food-grade paper, customer-assembled salads eaten on-site in a reusable bowl, pasta salad sold by weight and packed by the retailer into a plastic container,  unpackaged bulk apples sourced from a farm down the road, among many others.  Consumers continue to demand a large variety of products to meet their convenience, nutritional, and other needs. Additionally, our data shows that consumers are increasingly looking for certain health claims with regards to these foods.

 

Based on this data, we agree that FDA can help meet growing consumer demand for information and facilitate innovation through new or enhanced labeling statements or claims. This innovation can help facilitate the production of more healthful foods and improve consumers’ ability to make good food choices. FMI supports keeping regulatory barriers low to encourage companies to invest in reformulation to healthier products and consumer research into new food offerings; however, we maintain that any new labeling statements or claims should still be consistent with the dietary guidelines and be truthful and evidence-based.

 

Additionally, we encourage FDA to consider new technology when considering new or enhanced statements or claims.  In particular, our data indicates that customers, particularly millennials, are  relying on smartphone apps and other tools in their shopping experiences more than ever before.  As an example, the  SmartLabel™ initiative gives customers easy and instantaneous access to detailed information about thousands of food, beverage, and other products. With FDA support, SmartLabel™ could be used by manufacturers to provide more information about their products and ingredients,

from health information and recipes to sourcing and production information. We encourage FDA to consider how new technology and resources like SmartLabel™ can be used to facilitate new statements or claims to better serve consumer needs.

 

4)    Modernizing the standards of identity to provide more flexibility for the development of healthier products, while making sure consumers have accurate information about these food products.


As part of its nutrition innovation strategy, FDA has indicated that that the Agency will be taking a closer look at standards of identity (SOI). In particular, FDA has indicated that it is interested in modernizing the SOI program in a way that will achieve three primary goals: (1) protecting consumers against economic adulteration; (2) maintaining the basic nature, essential characteristics, and nutritional integrity of food; and (3) promoting industry innovation and providing flexibility to encourage manufacturers to produce more healthful foods. We appreciate the opportunity to comment on this important topic.

As Commissioner Gottlieb noted in his July 26 statement, SOIs have been the subject of much discussion of late and warrant additional review and clarity. Of particular concern to the grocery industry are those products for which a definition and standard of identity do not exist under 21 C.F.R. Parts 131 through  169.  Where no federal preemption exists, states are free to set their own SOI standards for these products and have begun to do so. This is particularly important to grocery stores’ private brand products, which constitute thousands of SKUs and are positioned as lower cost alternatives to regional, national or international brands. Specifically, in 2016, private brands maintained a unit market share of  22.3% and dollar share of 18.4% in 2016.

 

It is important that our members are able to maintain this important sector of sales and continue to offer private brands as a lower cost alternative to many other brands; however, unlike national brands, private brand manufacturers do not invest considerable resources on advertising and label modifications. Infrequent label changes permit private brand manufacturers to purchase packaging in  bulk to minimize costs.  Any changes to a private brand label threaten the ability to keep packaging costs low and require significant additional resources in the form of planning and analyzing products, entering information into databases, new label and packaging designs, new printing plates, and queuing up in line with the printing company. Additionally, private brand products are often manufactured in a single location and shipped to stores in a number of states, such that non-uniform labeling rules greatly complicate logistics for distributing these products.

 

Any state legislation or regulations creating state specific SOIs threaten grocery retailers’ ability to maintain these important products as a low-cost alternative for consumers, as costs for labeling and distribution would increase significantly with a patchwork of SOI requirements. The ability to maintain  these low-cost products is further amplified by low net profit margins for food retailers, which at around  1 to 1.5%3, are significantly lower than those in many other industries. Because net profit margins are  so low, food retailers are often forced to pass any additional costs on to consumers.  Uniform product labeling standards, including uniform SOIs set by FDA, help food retailers better predict the costs associated with manufacturing, labeling and transportation and to keep those costs low for consumers.

Although FMI believes that modernizing SOIs is important for consumer clarity, we agree with FDA that any modifications must be truthful, not misleading, and reflective of consumer understanding and expectations. Again, food retailers serve as a direct line of communication between consumers and  their food choices.  As such, it is extremely important that food labels be clear and easy to understand as consumers make important nutrition and purchasing decisions.  While it is important that any modifications or additional SOIs be based on sound science, FMI agrees that the Agency should consider consumer understanding and expectations on a case-by-case basis. In particular, as the Agency has noted, sudden changes to longstanding product names may be confusing to consumers who have developed product expectations from years of purchasing history.

Additionally, the Agency has emphasized how consumers use information to make healthful choices, and how expectations of factors like nutritional content can influence these decisions.  Consumers also increasingly expect innovative products that fit their lifestyle and purchasing habits. Many of these innovative products are marketed as substitutes to existing items that provide unique value based individual customer preferences. Although it is important that any SOI’s maintain Federal preemption, it is also important that they be flexible enough to promote rather than hinder continuous innovation and introduction of new products. We also agree that it is important for FDA to consider consumer expectations and encourage the Agency to similarly consider changes made by product manufacturers

to meet these expectations. Specifically, consumer desires are extremely important to the food industry

such that products marketed as substitutes to longstanding products are generally fortified and modified to meet specific nutrition expectations. As one of the nutrition innovation goals is to encourage industry innovation and to encourage manufacturers to produce more healthful foods, it is important that the nutritional advancements already being made by industry be taken into account as FDA considers modifications to the SOIs.

5)    Providing opportunities to make ingredient information more helpful to consumers.

 

Retailers continuously strive to provide consumers with innovative ways to improve and maintain their health by making it easier for them to identify nutritious foods, so FMI greatly appreciates FDA’s consideration of changes that could make ingredient information more consumer friendly.  Consumer confusion when reading a food product’s ingredient list is an ongoing challenge, and opportunities to clarify the ingredient list could be beneficial in helping consumers understand what ingredients are used in products and why.  As with discussions around SOI, consumer understanding of ingredient

information is vital to making sure the information is useful in making healthy choices. As such, we encourage FDA to continue to emphasize consumer understanding during any considerations of ingredient information.

 

6)    FDA's educational campaign for consumers about the updated Nutrition Facts Label.

FDA has announced a major educational campaign for consumers surrounding the new nutrition information that consumers will be seeing in the marketplace. We appreciate the Agency’s recognition that this is a significant overhaul of the regulation, and that after more than 20 years, the changes warrant substantial education efforts for consumers. With approximately 30,000 products in the marketplace already carrying the revised Nutrition Facts Label (NFL), we encourage FDA to proceed with educational efforts as expeditiously as possible. We appreciate the efforts already made by the Agency, including the several guidance documents on issues such as fiber.

 

FMI member companies continue to work diligently to implement the updates to the NFL. As our industry embraces these new requirements, we support a consumer education campaign that will inform the public on the appropriate use of a new label and help consumers understand the meaning of the changes to the labels. We would encourage FDA to undertake consumer research before developing and deploying an NFL education campaign to determine effective messaging and strategies for teaching  consumers how to interpret the new label changes. FMI encourages FDA to use multiple outlet mediums to capture the broadest consumer audience and to collaborate with USDA to deliver one message to the public.

 

We also encourage the Agency to consider existing retailer resources in helping consumers both understand the updated NFL and meet their overall nutrition goals. Grocery retailers remain a trusted resource for their customers, and already utilize a number of communication vehicles to promote health and wellness. In particular, our 2017 Report on Retailer Contributions to Health and Wellness indicates that 52% of responding stores use on-site dieticians to assist customers and 85% utilize community outreach. Our member stores understand that healthy eating is important to customers, and are very willing to work with the Agency on ways in which these existing resources can be used to further FDA’s public health goals.

 

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If you have questions about these comments or would like additional information, please feel free to contact Stephanie Harris at sbharris@fmi.org or 202-220-0614.


Sincerely,

 

 

Stephanie K. Harris

Chief Regulatory Officer & Legal Counsel