Comments on issues 1 through 4 RE: Docket No. FDA-2014 ......changed. NHANES data indicate that...

GROCERY MANUFACTURERS ASSOCIATION 1350 I Street, NW, Ste 300, Washington, DC 20005 | Main: (202) 639-5900 | Fax: (202)639-5932 |

www.gmaonline.org

October 17, 2016

Division of Dockets Management (HFA-305),

Food and Drug Administration,

5630 Fishers Lane, Rm. 1061,

Rockville, MD 20852.

Filed electronically at Federal eRulemaking Portal: http://www.regulations.gov.

Comments on issues 1 through 4

RE: Docket No. FDA-2014-D-0055 for “Voluntary Sodium Reduction Goals: Target

Mean and Upper Bound Concentrations for Sodium in Commercially Processed,

Packaged, and Prepared Foods; Draft Guidance for Industry,” 81 Federal Register.

35363, June 2, 2016

Dear Sir or Madam:

The Grocery Manufacturers Associationi (GMA) respectfully provides the following general

comments and specific comments in response to issues 1 through 4 relating to short-term sodium

reduction goals.

Executive Summary

The Grocery Manufacturers Association (GMA) and its member companies are committed to

providing options to help consumers develop healthy diets.

Food and beverage companies have been voluntarily reducing sodium in products for decades.

Between 2008 and 2013, the collective impact of these voluntary sodium reduction efforts

resulted in a more than 16 percent decrease in purchased sodium levels, representing over 100

mg less sodium purchased per person per day.

At the same time, it is important to note that the U.S. food supply is complex and that sodium is

an essential ingredient that plays multiple important roles in our country's food and beverage

products, which underscores FDA’s challenge in attempting to set sodium reduction goals by

food category. FDA’s draft guidance divides the foods which are the major contributors to

dietary sodium intake into 150 categories and proposes short- and long-term reduction goals for

each category.

GMA recommends that FDA subdivide or merge certain categories and adjust the reduction

goals accordingly. While many of the short-term goals for gradual sodium reduction eventually

Draft Guidance for Industry: Voluntary Sodium Reduction Goals

Docket No. FDA-2014-D-0055

October 17, 2016

Page 2 of 74

can be achieved, we do not believe this can be done in the FDA’s proposed two-year time frame.

At least four years will be required due to the scope of product reformulations required to meet

the short-term sodium reduction goals and to permit the gradual changes necessary for

consumers to accept a lower-sodium taste in products. GMA recommends that FDA assess the

progress towards the short-term goals be undertaken after five years.

Here are the GMA’s main comments and recommendations:

Subdivide or Merge Certain Categories – Most of the draft categories are composed of

products with similar functional roles for sodium. GMA recommends that some be subdivided

based on the different roles that sodium plays within the category. Additionally, we recommend

that other categories be merged to decrease complexity and account for consumer use. In both

instances, the category changes provide the flexibility and clarity needed to help industry meet

the sodium reduction goals. We further request that, after FDA realigns the categories and

recalculates the baselines, the guidance be reissued in draft form to provide a short period to

comment on the modified categorization and associated goals. It is important to note that with

this recommendation, member’s work to further reduce sodium will continue throughout this

process.

Reduction Targets Not Achievable in Two Years – GMA appreciates FDA’s consideration for

gradual sodium reductions as it set the short-term goals. Many of the sales-weighted mean

(SWM) short-term goals provided by FDA in the draft guidance are achievable but only if the

timeframe is extended beyond the proposed two years. The two-year target is not a realistic

interval as some reformulations can take longer than two years, especially when safety is a

factor. Others present considerable challenges due to the absence of available technologies to

replace the functional roles of sodium and the need to move consumers gradually to accept a

different taste profile. This is especially true for iconic products in the marketplace for which

consumers have specific taste expectations. In these instances, alternative goals are proposed.

GMA members chose to use the available comment time to focus on the SWM goals because

these have the greatest impact on population sodium intake. We have not assessed the upper

bound concentration (UBC) short-term goals with the level of rigor required to recommend

alternative targets at this time. Additional time is required for a thorough analysis of the upper

bound approach. We request that FDA explicitly clarify that neither the SWM nor UBC goals be

interpreted to imply that any product poses a health concern by virtue of exceeding the

applicable target.

Needed Reformulations Will Require at Least Four Years – Reformulation of a large number

of products is required to meet the goals and this work needs to be staged and integrated into

each member’s reformulation portfolio to accommodate prototype development, scale-up, plant

trials, consumer research, ingredient procurement, national distribution, and inventory

management. We estimate that the scope of reformulation required to meet the short-term goals

will require at least four years. In addition, some of the short-term SWM goals are unachievable

in a four-year period because of a variety of factors. These include the need for a more gradual



October 17, 2016

Page 3 of 74

change than proposed, changing consumer use of products in the category, and/or the lack of

available technologies to replace the multiple functions of sodium - taste, texture, storage,

microbial control and stability. In these instances, GMA has proposed alternative SWM goals.

Monitoring Should be Conducted after Five Years - Additional time is required for products

to enter the food supply and become available to consumers. Therefore, GMA suggests that the

assessment of progress towards the short-term goals be undertaken after five years to adequately

reflect short-term changes in response to the final guidance.

GMA appreciates this opportunity to provide input to specific questions posed by FDA on its

draft guidance on voluntary sodium reduction goals. These comments focus on FDA’s proposed

categorization and short-term goals; input on the long-term goals will follow later.

Introduction

GMA members have been voluntarily lowering the sodium content of products for decades.

Early lessons from these initiatives are that most consumers generally reject low-sodium

products due to their perceived inferior taste, but that many consumers will over time accept

gradual reductions where the change in taste and texture is not discernible. Gradual changes are

resource intensive due to the need for relatively small (5% to 10%) incremental reductions, the

critical importance of consumer acceptance studies, and the need to assure that products are safe

under normal conditions of use. In addition, the changes need to be introduced slowly so that

consumers have time to adapt to the reformulated products. The following chart illustrates some

examples of past and ongoing member commitments to reduced sodium products.

Table 1. Summary of GMA Member Commitment to Voluntary Sodium Reduction

Company Past Achievements Future Commitments

Campbell Soup Company By 2012 more than 51% (208

products) of Campbell

portfolio had been reduced in

sodium or brought to market.

Today more than 792 products

in the US have been reduced

in sodium. The range of

reduction varies from 5-33%.

ConAgra Foods Between 2009 and 2015

sodium was reduced by 20%

across the ConAgra Foods

portfolio.



October 17, 2016

Page 4 of 74

General Mills Between 2010 and 2015,

General Mills met or exceeded

their stated 20% sodium

reduction goal in 7 of 10

categories, with reductions

across the 10 categories

ranging from 18 to 35 percent.

Hormel Foods Corporation By 2020, Hormel aims to

reduce sodium levels in select

branded products by 15% on

average.

Kellogg Company Kellogg began reducing

sodium in its most popular

cereals as early as

1998. Since that time, the

company has reduced sodium

in its most popular cereals by

as much as 70%.

By 2020, Kellogg will reduce

sodium on average by more

than 30 percent across all of

Kellogg's cereals. At least 85

percent of the company’s

cereals will have 150

milligrams or less of sodium

per 30 gram serving.

Kraft Heinz Company Between 2010 and 2012

decreased sodium by 10%

across Kraft portfolio;

Between 2010 and 2014,

decreased sodium between 10-

40% in key Heinz retail

products, including a 15%

reduction in ketchup.

Mars, Incorporated Between 2009 and 2012, Mars

Food reduced sodium by 25%

across the entire global

portfolio.

Mars Food aims for an

additional 20% reduction in

sodium globally by 2021.

McCormick & Company, Inc. Between 2009 and 2014

McCormick achieved a 19%

sodium reduction in the US

consumer portfolio

Mondelez International, Inc. Between 2010 and 2012

Mondelez achieved a 10%

reduction in sodium.

By 2020 Mondelez will

achieve an additional 10%

reduction.



October 17, 2016

Page 5 of 74

Nestlé USA, Inc. Between 2013 and 2016,

further reduce sodium by an

average of at least 10% in

those products that do not

meet the criteria defined in the

Nestlé Nutritional Profiling

System.

PepsiCo, Inc. On a global average per

serving basis, PepsiCo

reduced sodium by more

than10% and removed over

1,800 metric tons from key

global food brands between

2006 and 2014

Between 2006 and 2020

PepsiCo will reduce the

average amount of sodium per

serving in key global food

brands by 25%

Unilever By 2010, achieved a 25%

reduction

Ambition to reduce salt by a

further 15-20% on average to

meet the target of 5g salt per

day. By 2020, 75% of

Unilever Foods portfolio will

meet salt levels to enable

intakes of 5g per day

Despite manufacturer efforts, sodium intake by the U.S. population does not appear to have

changed. NHANES data indicate that sodium intake in the U.S. population, measured by dietary

surveys, has remained relatively constant over the past decade or more. Therefore, GMA

conducted a study in 2014 to assess the collective impact of member voluntary sodium reduction

initiatives and quantitatively measure the changes in sodium purchased from member products

between 2008 and 2013. The results indicate that consumers purchased 16% less sodium from

GMA member products in 2013 than they did in 2008. This decrease represents over 100 mg

less sodium purchased per person per day and is probably large enough to be detectible in

NHANES surveys. Over the period of this survey, however, consumers were also shifting their

eating patterns and consuming more foods away from home. This illustrates that sodium

reduction initiatives need to have sufficient flexibility to adjust to ever-changing consumer

behaviors.

Issue 1 – Categorization

The ways in which products are grouped into categories and the resulting baseline sales-

weighted means (SWM) are the foundation for FDA’s sodium reduction guidance. Therefore, a

clear and shared understanding of the categories between FDA and the food industry is critical

for success of the sodium reduction goals. GMA appreciates the complexity of the task and



October 17, 2016

Page 6 of 74

FDA’s efforts to provide flexibility and address the multiple functions of sodium in various food

groups. However, FDA has not made available all the information that members need to fully

assess the categories and resolve apparent inconsistencies between the category descriptions, the

histograms and baseline SWMs. FDA has identified many discrete and specific categories, but

has not been consistent as other categories encompass a diverse range of products.

GMA believes that while some categories are too broad and should be refined, others could be

merged and expanded. Furthermore, GMA requests additional details on the categories

themselves in order to better understand which products are targeted under the guidance and

which fall into non-target categories. This clarification of the categories is also important to

enable industry to place potential new innovations in the appropriate category and apply sodium

reduction goals during their development.

The grouping of products into categories is central to all aspects of the sodium reduction

guidance. GMA requests that FDA realign and clarify categories as illustrated by some

examples below and further detailed in Appendix 1. Consultation with industry, beyond

submitted comments, could further help assure that product complexity and use are more

adequately addressed in the categorization. A category revision will result in different baselines

and changes to both short- and long-term goals. GMA requests that the guidance be reissued in

draft form with an opportunity to comment on the modified categories and revised baselines and

goals. This reissue of the draft guidance will not delay initiation of work towards the overall

goal as GMA members will continue their sodium reduction efforts during the process.

FDA Question: Are there categories where foods have been grouped together that should be

separated on the basis of different manufacturing methods or technical effects relating to the

potential for sodium reduction?

GMA found some categories to be excessively broad and encompass many different types of

foods that do not share similar characteristics or potential for sodium reduction. For example,

Nuts and Seeds (31) has no explanation of the category so it is assumed that it currently

encompass all types of nuts and seeds with and without shells. However, there is a significant

difference in the sodium concentrations of seeds with shells and those without shells due to

differing manufacturing processes and labeling requirements.

GMA members believe there are some categories that should be further separated on the basis of

different manufacturing methods and storage conditions. For example, Frozen/Refrigerated

Dough and Batter (79) includes products that are leavened with and without yeast. Sodium salts

are important for flavor and dough development in both types of product, but have additional

leavening roles in non-yeast leavened products. The latter products have a higher sodium

concentration. A second example is Unflavored/Flavored Potato and Vegetable Chips (109, 110)

where sodium contributes taste and in pellet or “re-formed” products has an additional functional

role. The re-formed products require sodium in the dough or base in order to functionally enable

expansion to make the finished product and consequently have a higher sodium concentration



October 17, 2016

Page 7 of 74

than products made with sliced vegetables. We recommend that re-formed products be removed

from categories 109 and 110 and included in a combined “puffed snacks” category including

products made from potato, vegetables or grains (i.e. the current Puffed Corn Snacks (113) and

Puffed Rice Snacks (114)) to better accommodate the roles of sodium in these products.

GMA members also noted categories where it would be more appropriate to differentiate

products by storage condition as safety considerations impose constraints leading to different

sodium concentrations in frozen, refrigerated and shelf-stable products. In the Processed Cheese

category (3) shelf-stable products require more sodium for food safety than refrigerated products.

However, in the Pickled Vegetables category (23), shelf-stable (cooked) products require less

sodium than their refrigerated counterparts. Based on these different needs, a subdivision is

recommended in each category.

Products with filling may also have significantly different sodium concentrations from their

unfilled counterparts (e.g. Crackers, 72) due to a difference in required water activities (Aw) for

shelf stability between filled and unfilled crackers. Using salt as a functional ion, the water

activity in these products is lowered to an acceptable level for stability, safety, and quality. These

highlighted examples demonstrate the need for further category differentiation and new target

setting to more accurately reflect the technical functions of sodium in these products.

In addition to the examples GMA notes above, there are additional categories that should be

separated or split. Please refer to Appendix 1 for a complete list.

FDA Question: Are there categories which could be merged due to similar sodium functionality

and potential for reduction?

GMA members recommend that several proposed categories to be merged based on functional

similarities. First, members request that the FDA consider combining Ready-to-Eat Cereal,

Flakes (54) and Ready-to-Eat Cereal, Puffed (55) categories. These categories consist of a

relatively homogeneous group of products where sodium has a similar functional role in each

case. In addition, it is unclear from the descriptions provided where FDA considers ready-to-eat

cereal products that are neither flaked nor puffed (e.g. latticed) or products using a combination

of technologies and components (e.g. clusters). Combining these categories provides clarity to

industry and also accounts for the similar roles of sodium (flavor, safety, color, etc.) across the

products.

FDA’s draft guidance introduces complexity in the Snacks major food category by proposing

nine separate categories (109 – 117) for a type of product that consumers purchase for a single

eating occasion. Consumers seek high variety and enjoyment in the snacks category, perhaps

choosing a flavored chip one day, and pretzels the next. However, past experience with salt

reductions in the snacks category has demonstrated that only small (5% to 10%) sodium

reductions are acceptable to consumers who will substitute brands or flavors before sacrificing

taste.



October 17, 2016

Page 8 of 74

FDA proposed a detailed approach to the salty snack categories, requiring manufacturers to

assess their portfolios in a fragmented manner and identify sodium reduction strategies in

specific leading products for each category. Market leading products may or may not actually be

the largest contributors to sodium in the overall salty snacks category, and focusing on them

specifically may result in less impactful results. A more effective approach toward success is to

allow manufacturers to make small, incremental reductions across many products. A greater

overall sodium reduction is possible by making more reductions across a wide range of products,

mirroring diverse consumer purchasing patterns while retaining consumer acceptance.

In addition to the categories noted above, there are additional categories that should be merged.

Please refer to Appendix 1 for a complete list and detailed rationales.

FDA Question: Are there foods that contribute to sodium intake that we have not effectively

captured?

The level of detail provided by FDA in the draft guidance is not sufficient for GMA to fully

respond to some of the proposed categories such as some bakery categories and mixed ingredient

dishes (category 129) and their respective goals. When attempting to assess portfolios against

the guidance, members were unable to place some common foods into the proposed categories.

GMA requests that additional detail be provided on all categories. One suggestion is to have the

same level of detail for each sodium reduction category as FDA has provided for Reference

Amounts Customarily Consumed (RACCs)1.

Issue 2 – Baseline

FDA Question: Are the baseline sodium concentration values reasonably representative of the

state of the food supply in 2010? For categories that do not appear representative, what food

products are not adequately represented? Are there situations in which our method of

quantification could lead to unrepresentative baseline values?

The level of transparency and detail provided by FDA in the draft guidance is not sufficient for

GMA to fully respond to FDA’s questions about the adequacy of the baseline. When members

attempted to assess their portfolios against the 2010 baseline, they found that, in some categories,

products they considered to be category leaders were missing from FDA’s 2010 baseline sales

weighted mean and from the category histograms. It is unclear if FDA considered the products

to be in different categories or accounted for the products in a more fragmented way so they

would count in the bottom 20% of sales for a given category (and therefore not be represented).

In some categories, the number of products collectively represented in the histograms appears to

underestimate member understanding of products accounting for 80% of category sales. GMA

acknowledges that questions surrounding the baseline may be addressed by additional detail

1

http://www.fda.gov/downloads/food/guidanceregulation/guidancedocumentsregulatoryinformation/labelingnutrition/

ucm513820.pdf, Accessed 10/5/2016.

http://www.fda.gov/downloads/food/guidanceregulation/guidancedocumentsregulatoryinformation/labelingnutrition/ucm513820.pdfhttp://www.fda.gov/downloads/food/guidanceregulation/guidancedocumentsregulatoryinformation/labelingnutrition/ucm513820.pdf



October 17, 2016

Page 9 of 74

about the categories themselves as requested above. The baseline SWMs are a key component in

the establishment of FDA’s category goals, so a shared understanding is critical for progress

towards sodium reduction.

GMA understands the proprietary nature of the Nielsen ScanTrack and other source data used by

FDA to develop baseline information. Nevertheless, as discussed above, it is important for FDA

to provide greater detail in the category descriptions so that manufacturers have a clearer

understanding of what is and is not included in each category. This transparency in turn will

enable a clearer understanding of the baseline and its relationship to the category goals.

Additionally, we request that FDA provide greater detail on the sales data used to calculate the

sales weighted means and upper bound concentrations, particularly if it includes all sales such as

through Walmart, mass merchandise and convenience (drug and gas) channels. Consumers

purchase different product mixes from these channels than from conventional grocery stores.

The histogram plots that FDA made available after publication of the original draft guidance are

helpful. However, the histograms of the 2010 baseline only show the number of products at

particular sodium concentrations in market, not their relative sales weighting. A reader is

expected to infer relative sales from the 2010 baseline sales weighted mean. It would be more

helpful if relative sales data were presented for each of the sodium concentration groupings.

This becomes important to better assess the sales impact (and by inference consumer

acceptability) of products at the lowest and highest end of the range, especially in broad

categories. GMA requests the histograms be revised to show the relative sales at each level of

sodium concentration in addition to the number of products.

GMA has concerns with how FDA accounted for food service data in developing sales-weighted

averages. Data are readily available for retail sales, but less so for food service. Food service

product information would not be available through sources such as Gladson and Mintel. The

sodium concentration of commercial (restaurants, etc.) and institutional (healthcare, schools,

etc.) food service products differs from retail food products and do not appear to be represented

in the 2010 baseline data. In the U.S., the share of food service (“away-from-home”) sales have

steadily increased and recently surpassed those of retail (“at-home”) food sales2 and thus make

substantial contributions to population sodium intake.

Bacon is another category where the baseline is not clear. The draft guidance provides a 2010

baseline SWM for Uncooked Bacon (88.a), but the labeled sodium values for packaged bacon

are based on cooked values. It is therefore unclear how the raw bacon data was obtained and

why there are no 2010 baseline data for Cooked Bacon (88.b). Given that sodium is not labeled

for raw bacon, we recommend that this category be removed and that the baseline and goals be

based on cooked bacon.

2 U.S. Department of Agriculture. Economic Research Service. Food Expenditure Series, “Food-at-home and

away-from-home expenditures in the United States, 1960-2014” Accessed at: http://www.ers.usda.gov/data-

products/chart-gallery/detail.aspx?chartId=40091&ref=collection&embed=True&widgetId=39734

http://www.ers.usda.gov/data-products/chart-gallery/detail.aspx?chartId=40091&ref=collection&embed=True&widgetId=39734http://www.ers.usda.gov/data-products/chart-gallery/detail.aspx?chartId=40091&ref=collection&embed=True&widgetId=39734



October 17, 2016

Page 10 of 74

The 2010 baseline has limited value is setting goals against which future progress is measured in

instances where there have been significant market changes. The food market is dynamic and

the 2010 baseline includes products that are no longer in the market today and products that have

been reformulated. Furthermore, it does not include new product innovations introduced in the

last six years. As an example, sodium reduction in 64 soup products by a market leader in the

Canned, Ready-to-Eat Soup category (34) would have been captured in 2010 baseline sodium

concentrations. About a year later, products had to be reformulated to partially add back the

sodium to address consumer complaints. The current sales weighted average for canned, ready-

to-eat soups is higher than the 2010 baseline; a factor than needs to be considered in the short-

and long-term sodium reduction goals.

The Popcorn category (115) is an additional example where the 2010 baseline does not reflect

the mix of products frequently consumed by consumers today. Over the past six years there has

been a significant shift in popularity and availability of ready-to-eat (RTE) popcorn snacks,

which have a higher sodium concentration than un-popped (microwave) product. In 2012 the

market mix was approximately 30% RTE and 70% microwave. The current mix is about 50%

RTE, 50% microwave. The category goals for these categories should be adjusted to account for

these changes.

Issue 3 - Feasibility of Short-term Goals – Sales-weighted Means

FDA Question: Are there categories for which the 2-year target concentration goals are

infeasible? If so, why are these targets not feasible, e.g. , for technical reasons? What goals

would be feasible in the short-term(2-year), and why?

GMA members have reviewed the SWM short-term goals and conclude that the majority are not

achievable in the short-term, if short-term is defined as 2 years as in FDA’s draft guidance. FDA

did not specify if the 2 years was for reformulation work alone or if it should also include the

additional time necessary for sodium-reduced products to become dominant in the market and be

measurable in Nielsen sales data. As discussed below in greater detail, we are recommending

that the time for short-term reformulations be 4 years to provide adequate time to achieve our

proposed targets for the needed sodium reductions. Therefore, our comments on the short-term

goals are based on adequate time being available to conduct the reformulations (4 years) and for

the reformulations to become visible in the market (1 year).

An appropriately detailed assessment of the short-term goals for many categories was not

possible due to uncertainty about the products encompassed in the category. In those categories

where we could conduct an evaluation, some of the category goals are not feasible primarily due

to lack of available technology and inability to achieve the indicated change in sodium

concentration while maintaining consumer product preference or acceptability. We will address

research needs in later comments, but want to highlight here that the sodium taste receptor is



October 17, 2016

Page 11 of 74

much less understood than sweet, bitter, and umami receptors. A greater understanding is

required to help reach the draft achievable short-term goals.

Throughout the draft guidance and supplementary memos, FDA identified ingredients such as

potassium chloride, calcium chloride, and magnesium chloride as alternatives for sodium or

sodium chloride. While FDA acknowledges the limited applicability of some of these options,

the overall conclusion inferred from the Agency’s draft guidance is that alternatives are widely

available and widely used. In fact, most of the available substitutions have already occurred to

the degree that they can be made without affecting consumer acceptability. Potassium,

magnesium and calcium chlorides are potential salt alternatives, but all three significantly reduce

“salty” taste while enhancing both bitter and metallic tastes. A simple replacement is not

possible and as higher levels of the alternatives are used to achieve the desired saltiness, the

product becomes unpalatable to the consumer. Increased use of these alternatives in some cases

is no longer possible due to “off-flavors” and in those instances where it is possible must be

made gradually otherwise consumers will reject the lower sodium products and choose those

with higher sodium. The average amount of salt that can be removed short-term is between 5%

and 10%. The short-term goals are infeasible in the categories outlined in the following table

(Table 2), largely because draft short-term goal is 15% to 20% lower than baseline. The reasons

for the proposed alternative goals are more fully explained in the Appendix.

Table 2. Proposed Alternative Short-Term Targets for Categories of Concern

FDA Categories FDA 2010 Baseline

SWM*

FDA Target SWM*

GMA Proposed SWM Target for 4-year short

term goals*

Dairy-Cheese

1

Blue/Blue-Veined Cheese (Semi-soft)

1240 1080 1200

3 Processed Cheese/Cheese Food (Semi-soft)

1358 1210 Separate out shelf stable:

1280

9 Feta Cheese 1171 1120 1200

Nuts and Seeds

31

Nuts and Seeds 413 350 Separate categories: Seeds

in Shell: 6000; Nuts and Seeds, no shell: 530

Soups

33 Canned, Condensed Soup

581 520 536

34 Canned, Ready-to-Eat Soup

265 230 280

37 Frozen Soup 259 230 280



October 17, 2016

Page 12 of 74

FDA Categories FDA 2010 Baseline

SWM*

FDA Target SWM*

GMA Proposed SWM Target for 4-year short

term goals*

Sauces, Gravies, Dips, Condiments, and Seasonings

49 Cream-based Dips 654 590 Separate shelf-stable: 640

50 Bean-based Dips 525 470 Separate shelf-stable: 590

51 Vegetable/fruit-based Dips

716 500 Separate shelf-stable: 740

52 Dry Seasoning and Dry Sauce Mixes

22460 18000 20214

Bakery Products

72 Crackers 905 750 Separate Filled Crackers:

950

77 Cookies 360 300 Separate w/Alkalized

Cocoa: 330

78.a Frozen/Refrigerated Breakfast Bakery Products

565 420 510

Snacks

109 Unflavored Potato and Vegetable Chips

585 500 Sliced only, combined with

(110): 600 110

Flavored Potato and Vegetable Chips

774 630

111 Unflavored Grain Chips 438 390 Combined with (112): 590

112 Flavored Grain Chips 674 590

113 Puffed Corn Snacks 1075 870 Combined with (114) and parts of (110) and includes

all puffed and extruded: 900

114 Puffed Rice Snacks 941 750

115 Popcorn 846 680 940

Mixed Ingredient Dishes

128 Frozen Meals/Entrees 332 280 Separate Cheese-based Frozen Meals/Entrees:

300mg *All data in mg sodium/100 g product

A further consideration with many alternative ingredients for lowering sodium is that many

consumers look for simple or clean labels and will not purchase products with ingredients that

appear to be “chemicals” or have had negative press (e.g. monosodium glutamate). Salt is a

simple and familiar ingredient to consumers and most of the substitutions require a combination

of ingredients which results in a longer ingredient statement which does not appeal to consumers.



October 17, 2016

Page 13 of 74

As a result the options available for lowering sodium are in fact fewer than in the past. Sodium

is in contrast to sugar where there are many substitutes available which are appropriate for

diverse product formats and consumer needs.

Throughout the draft guidance and supplementary memos, FDA implies that if a product in a

category has a lower sodium concentration, then all other products placed in the same category

should have no trouble in reducing sodium to that level. However, each product has a unique

flavor profile and ingredient list. The inherent ingredients and other flavorings determine the

role that sodium plays in masking bitterness and producing a rounded flavor. In addition, in

many categories sodium plays unique structural roles which differ from product to product.

In those categories where spoilage or pathogen growth is an issue, sodium has an important and

unique role to prevent microbial growth. In four of the six studies reviewed by FDA, the

ineffectiveness of sodium alternatives against Clostridium botulinum is documented.3 This is a

major concern because C. botulinum is often the most difficult microorganism to control and one

of the most dangerous. While other ions can replace sodium to help control microbial growth in

some situations, they impart flavor characteristics that are not acceptable to most consumers so

their use has to be carefully calibrated. Lower sodium products can have a shorter shelf life

which in turn increases food waste and disposal costs. Manufacturers also have to consider

consumer use of products such as dips. They can be set out for consumption and refrigerated

many times resulting in the potential for microbial growth in the absence of adequate amounts of

sodium.

Uses of many techniques proposed by FDA to enhance preservation of products have major

limitations. High pressure, microfiltration, pulsed electric fields processing are only applicable

to fluid products. High intensity light is only effective on smooth-surface products. Irradiation,

however, is an effective technique in some situations, but its use is limited because of consumer

misinformation and misplaced concerns about radiation.

Issue 3 - Feasibility of Short-term Goals – Upper Bound Concentrations

Analyzing the feasibility and potential impact of FDA’s proposed SWM concentration approach

has been time and resource intensive. For that reason, GMA has not had an opportunity to fully

analyze the feasibility and potential impact of the proposed upper bound concentration (UBC)

approach. We believe it is critical that FDA provide additional time for the submission of

comments that include a robust analysis of the UBC approach. Below we offer our preliminary

comments, which focus on our concern that the UBC approach is especially prone to

misinterpretation and misuse. Our preliminary comments on the UBC approach should not be

interpreted as an endorsement of that approach.

The goal of the Draft Guidance is to “reduce sodium intake in the general population to 2,300

mg/day.”4 This objective is based on FDA’s selection of scientific evidence that “supports the

3 Survey of Microbiological Issues in FDA-Regulated Products at 8.

4 Draft Guidance at 8 (emphasis added).

https://www.regulations.gov/contentStreamer?documentId=FDA-2014-D-0055-0008&disposition=attachment&contentType=pdf



October 17, 2016

Page 14 of 74

value to public health of reducing sodium intake in the general population.”5 Further, as noted

in FDA’s response to the CSPI citizen petition on sodium, “the public health concern with

sodium consumption is based on the overall consumption of sodium in the diet, rather than

any with specific uses of it in food.”6 Given these premises, the agency must ensure that any

UBC-type approach included in any final guidance is not misinterpreted and misapplied to

suggest that public health concerns can be attributed to specific foods or to specific uses of

sodium in foods. As currently drafted, the Draft Guidance does not accomplish this task.

On one hand, the Draft Guidance proposes the UBC targets as part of a flexible and voluntary

approach aimed at reducing the overall consumption of sodium, and the Supporting

Memorandum explicitly disclaims any intent to require any particular goal framework.7 Thus,

the UBC targets should be viewed as points of reference for a manufacturer interested in sodium

reduction to consider in evaluating that manufacturer’s product portfolio. The fact that the

sodium content of a specific product exceeds the corresponding UBC target cannot serve to call

into question the safety or regulatory status of that product, nor does it speak to a manufacturer’s

commitment to voluntary, gradual, overall sodium reduction.

On the other hand, the Draft Guidance includes statements suggesting that the UBC targets are

intended to function as de facto regulatory limits on levels of use.8 For example, the Draft

Guidance states: “The goals are a reference for industry members when considering the

following questions: ‘Are each of my products below the highest level recommended for its

category?’”9 Further, the Draft Guidance refers to the UBC targets as “standards,” and the

Supporting Memorandum characterizes them as providing “a clear reference point for assessing

individual products.”10

The Supporting Memorandum further states that the targets as a whole

will give the agency “the ability to see which manufacturers are the greatest offenders of using

excess sodium in foods.”11

There is a high likelihood that statements such as those quoted above will be misinterpreted and

misused to suggest that the UBC targets speak to the safety and/or regulatory status of individual

products that exceed those targets. This could needlessly result in substantial consumer

confusion, as well as a wave of frivolous litigation that could divert industry resources already

taxed by other recent regulatory initiatives (e.g., FSMA implementation and revised nutrition

labeling). As acknowledged in FDA’s response to the CSPI petition, the mere fact that the

sodium content of a specific product exceeds the corresponding UBC target cannot serve as

5 Id. at 7 (emphasis added).

6 See Steven Musser’s letter to Michael F. Jacobson denying CSPI’s citizen petition (FDA-2005-P-0196), June 1,

2016, at 3 (emphasis added) 7 Supporting Memorandum at 28 (“Nothing in this document should be construed to imply that any goal framework

is required.”) 8 Any such limits would have to be established through notice-and-comment rulemaking.

9 Draft Guidance at 11 (emphasis added).

10 Guidance at 15; Supporting Memorandum at 32.

11 Supporting Memorandum at 52.



October 17, 2016

Page 15 of 74

evidence to support any conclusion that the product poses any risk to health by virtue of its

sodium content, or that its regulatory status is open to question.12

The above-identified risk of misinterpretation and misuse also exists with respect to the SWM

targets, although perhaps to a lesser degree. We therefore ask that FDA explicitly acknowledge

in any final guidance that neither the UBC nor SWM targets speak to the safety or regulatory

status of any product that exceeds the UBC or SWM targets. It is critical that such language be

included in the final guidance and not be relegated to another document because the guidance

would be the document most likely to be read and referenced by all stakeholders going forward.

For example, a final guidance could state:

“The public health concern with sodium consumption is based on the overall

consumption of sodium in the diet, rather than any with specific uses of it in food.

Therefore, the voluntary target concentrations identified in Table 1 should not be

interpreted to imply that any product poses a health concern by virtue of exceeding the

applicable target.”

Further, to the extent that any UBC goals are included in any final guidance , we ask that FDA

revise the first of the questions for manufacturers on p. 11 of the Draft Guidance to state “What

is the sodium level of my products relative to the highest level recommended for their category?”

(as opposed to “Are each of my products below the highest level recommended for its

category?”). We believe our suggested language more accurately captures the flexibility that

FDA intends to preserve with its approach, and avoids any implication that the highest level

recommended for a category is intended to function as a regulatory limit.

Issue 4 - Time Frame for Short-term Goals

FDA Question: Are the short-term (2-year) timeframes for these goals achievable? If the

timeframes are not achievable, what timeframes would be challenging, but still achievable?

The short-term goals are not achievable in the proposed two-year timeframe. We estimate that it

will take four years for short-term sodium reductions across all the categories in the guidance to

become available for market introduction. Reformulations to reduce sodium are complex

because they require new technology and multiple rounds of consumer testing to assure that

reformulated products will be acceptable in the market. As a result, reformulations often involve

many cycles to find a formulation that meets consumer expectations for flavor and other

characteristics dependent on sodium. The larger the sodium decrease the greater the likelihood

of needing multiple attempts to get the formulation right. In some cases, consumers may reject

the sodium reduction outright either during product development or after introduction to the

market. In addition, in products where sodium has a preservative function, additional time is

12

See supra fn. 3, and also p. 4 of the supporting memorandum (“[A]t this time we do not consider setting limits on

salt or sodium content by food additive regulation to be the most effective or sustainable path to the improvement of

public health by reducing population sodium intake.”)



October 17, 2016

Page 16 of 74

required to conduct the necessary real-time stability testing. The typical duration of a sodium

reduction project is three to four years.

Products such as frozen dinners consist of many components and changes to any one component

affect the entire meal. Thus, reductions made by the supplier of each ingredient need to be

integrated and orchestrated to assure that final meals are acceptable. Additionally, products that

are packed fresh annually, such as canned vegetables, must allow for up to a year-long lag time

between planning sodium reduction and receiving the reduced product. If the vegetable has an

additional ingredient such as peppers, pimentos, etc., the time frame to allow the supplier of that

ingredient to produce an adequate amount to test can add up to another year to the timeline.

These more complex reductions can take longer than the typical duration mentioned above.

Most large manufacturers have many products to reformulate to achieve the short-term goals, but

do not have the capacity or resources to initiate all the reformulations at the same time.

Therefore sodium reductions need to be staggered to allow for capacity issues regarding

availability of resources from functions including supply chain, procurement, product

development, engineering and consumer testing, in addition to capacity for plant trials. Such

sodium reductions also need to be integrated with other necessary product development activities

and regulatory initiatives. Therefore, sodium reductions across a portfolio of products in many

categories requires at least 4 years.

In order to assess short term progress towards sodium reduction using category SWM

concentrations, the reformulated products have to be on the market long enough to achieve

market penetration and pick-up by Nielsen. It will take at least a year for reformulated products

to gain full distribution and acceptance by consumers. Some products with longer shelf life can

remain on the market for many years.

Encouraging Adoption of Voluntary Sodium Reduction Goals

GMA appreciates FDA’s intent to “level the playing field” for sodium reduction but FDA’s

proposed approach, which focuses heavily on successful lower sodium products may have

unintended consequences. FDA’s proposal explicitly targets market leaders. However, by

admission in FDA’s own examples a reduction in sodium is accompanied by a decline in sales

(Reference 17, page 31). This assumption is supported by GMA member experience, which

shows that reductions that are too ambitious too quickly can significantly impact overall sales.

In addition, consumers also have the option of seeking foods from other outlets which have

higher sodium concentrations or adding sodium at the point of consumption. Market share may

be lost by companies that reduce sodium and gained by those outlets that have not taken action,

thereby having minimal impact on population sodium intake. Our recommendations above and

in the Appendix are intended to prevent such a scenario, but we offer the following additional

suggestions for ways that FDA could increase the likelihood that the guidance will decrease

population sodium intakes.



October 17, 2016

Page 17 of 74

Consumer Education

Consumer education could encourage greater consumer acceptance of low or lower sodium

products. Consumers currently perceive lower sodium products as having inferior taste and in

the absence of compelling reasons to follow a lower sodium diet mot will choose products based

on taste. In addition, sodium-reduced products, particularly if developed aggressively, could

have shorter shelf life, cost more, and have a less appealing appearance. The degree to which

consumers are led to accept sodium reduced products will dictate the ultimate success and time

frame for efforts to lower sodium concentration in the food supply. Effective consumer

education sponsored by the Agency is one way to ensure manufacturer efforts to reformulate are

rewarded and sustainable. Consumer education will be critical to ensure that consumers seek

products with lower sodium and refrain from adding salt at the table. In doing so, FDA can help

ensure progress is made toward lowering sodium intake.

GMA appreciates FDA’s recognition of the importance of education in its draft guidance noting,

“the overall sodium reduction initiative will also include an essential education component.”13

We recommend that FDA begin consumer education with an assessment of current consumer

attitudes towards reduced sodium. GMA further encourages FDA to consider working with

industry to clarify roles and responsibilities of various stakeholders and the development of

impactful consumer education.

Claims

Following an education campaign to encourage consumers to purchase lower sodium options,

FDA should consider revising the criteria for nutrient content claims relating to sodium to permit

communication of sodium reductions of all magnitudes. Regulatory claims for reductions

require a minimum of a 25% decrease compared to an appropriate reference product. Some

flexibility regarding appropriate reference products and the ability to communicate changes of a

lesser magnitude, even as low as 5%, could help encourage purchase of reduced sodium

products. FDA should consider amendments to the regulations to allow reduction claims against

the sodium goals that both inform consumers and encourage industry action.

Clean Label

GMA suggests FDA work with industry to revise ingredient statement requirements to allow

manufacturers to reformulate products for lower sodium, while retaining the option for a “clean

label.” Clean labels are increasingly desired by consumers and are a key consumer attribute for

many brands. Salt is a simple ingredient easily understood by consumers, but potential

replacements such as “potassium chloride” or “monosodium glutamate” are not favorably

viewed by consumers. Consumers are increasingly demanding “cleaner” product labels without

“chemical-sounding” ingredients. New functional ingredients that replace sodium containing

ingredients or salt can have poor consumer acceptability once declared on a label. Manufacturers

13

Supplementary Memorandum to Draft Guidance, page 2



October 17, 2016

Page 18 of 74

need to balance the desire to decrease salt and sodium content with the simultaneous consumer

demand for fewer “chemical-sounding” ingredients. Therefore, FDA should expedite evaluation

of citizen petitions requesting more consumer-friendly common or usual names for ingredients

that can partially replace salt, e.g. potassium chloride to be renamed potassium salt.

FDA Monitoring

GMA has concerns over the lack of specificity and detail in FDA’s plans to monitor industry

progress in meeting the sodium reduction goals. GMA recognizes that many factors will affect a

category’s SWM sodium concentration that will be outside of both the Agency’s and the food

industry’s control. Consumer buying patterns are dynamic, driven by a wide range of factors

including taste, availability, convenience, variety and cost, and will undoubtedly impact category

SWMs. As category leaders reduce sodium in their products consumers may switch to higher

sodium brands from smaller and/or regional manufacturers, creating shifts in the marketplace.

Furthermore, products are constantly introduced to and removed from the marketplace. GMA

encourages FDA to provide a specific detailed plan for how it intends to monitor changes in

sodium in the food supply and GMA hopes to have the opportunity to provide input. In the

meantime, GMA puts forth the following points for FDA’s consideration as it develops its plans.

Changes in sodium concentration

GMA believes that FDA should focus its monitoring efforts to assess overall changes in sodium

in each category. It was not clear from FDA’s brief description of its monitoring plans whether

FDA would attempt to track like-for-like products from the baseline to the monitoring date.

However, members recommend that FDA reassess the category as a whole. Doing so would

capture line extensions and successful introduction of new, lower sodium products, in addition to

gradual reformulations in existing products.

Similarly, “low-sodium” products should not be excluded from future monitoring efforts. FDA

excluded “low-sodium” products from the 2010 baseline, “Baselines and targets do not include

products labeled low/reduced sodium products.”14

However, the exclusion of low-sodium

products from future monitoring does not provide an incentive for industry to develop and

promote such products in their efforts to meet the desired decreased sodium concentration in the

food supply. Manufacturers offer a range of products and consider these low-sodium options to

be part of strategies to reduce sodium across their portfolio and they should not be disregarded.

Changes in intake

GMA believes the evaluation of progress towards sodium reduction will require assessment of

24-hour sodium excretion in a larger sample than is in NHANES. If public health is to be

14

Explanation of Appendix Table 1. Voluntary Sodium Reduction Goals: Target Mean and Upper Bound

Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods, page 19.

http://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM504014.pdfhttp://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM504014.pdf



October 17, 2016

Page 19 of 74

improved with lower sodium in processed foods, it will be important to check if consumers are

adding more table salt to home-cooked foods or consuming more foods outside the home where

sodium concentration is less defined and more uncertain. Evidence from clinical studies is that

consumers revert to usual sodium intakes after the study is over. In addition, population wide

decreased sodium intake below levels typical in the U.S. has not been demonstrated anywhere.

Sodium intake, rigorously measured by urinary sodium excretion, did decrease in the UK at the

time point measured, but the starting levels were higher than in the US. Whether those lower

levels of intake have been sustained is yet unknown.

Monitoring timeframe

The timeframe for FDA’s assessment of SWM sodium concentration by category should be

clearly defined. In order for this assessment to reflect changes to the food supply in response to

the guidance, adequate time will be required for the reformulations to happen and for the

reformulated products to have a significant presence in the market. Reassessment of SWM for

the short-term targets should be at least 5 years after finalization of the guidance.

Continued progress

GMA believes the results of monitoring will be critical to informing future iterations of the

guidance. Issuance of the long-term goals should wait until the results of the short-term targets

have been assessed. In the past, significant reductions in sodium purchased from member

products have not resulted in corresponding changes in average intake. GMA members would

likely need to know if intake has changed in the ways FDA has modeled in the draft guidance

before they could assess further long-term goals.

Finally, while industry is optimistic it can meet the short-term goals with the changes proposed

in these comments, GMA believes it is important to recognize and reward all reductions,

including those that may not yet meet their respective target.

Conclusion

In conclusion, GMA appreciates this opportunity to provide comments on the categorization and

short-term goals included in FDA’s draft guidance on voluntary sodium reduction goals. As

discussed above, the broad sodium reductions included in the draft will take considerable effort

and time to implement in ways that do not erode consumer acceptance of packaged foods and

beverages. Sodium reduction in complex and we look forward to continued dialogue with FDA

as our comments are evaluated. In particular, since many comments address the fundamental

categorization proposed by FDA, an opportunity for further formal comment on a reissuance of

modified draft guidance is critical.



October 17, 2016

Page 20 of 74

Sincerely,

Leon H. Bruner, DVM, PhD

Executive Vice President for scientific and Regulatory Affairs and

Chief Science Officer

Grocery Manufacturers Association

i The Grocery Manufacturers Association (GMA) is the trade organization representing the world’s

leading food, beverage and consumer products companies and associated partners. The U.S. food,

beverage and consumer packaged goods industry has facilities in 30,000 communities, generates $1

trillion in sales annually, contributes $415 billion in added value to the economy every year and is the

single largest U.S. manufacturing industry with 1.7 million manufacturing workers. Founded in 1908,

GMA has a primary focus on product safety, science-based public policies and industry initiatives that

seek to empower people with the tools and information they need to make informed choices and lead

healthier lives. For more information, visit gmaonline.org.

Appendix 1. GMA Category Response

FDA requested information on the categorization, technical issues, alternative targets and alternative durations. GMA’s detailed

response to these requests for each category may be found below.

For some categories, GMA believes FDA has provided sufficient detail for GMA to propose changes to the categorization and a sales-

weighted mean (SWM). However, there are some categories for which changes to categorization or requests for clarification are

provided, but not proposals for alternative SWMs. In these cases, GMA believes either FDA did not provide sufficient detail about

the products that comprise the category or the changes in categorization proposed by GMA significantly change the category make-up,

such that a new baseline and new SWM should be re-issued by FDA. As noted above, GMA requests a reissuance of the guidance in

draft form to allow stakeholders an opportunity to review any changes that may have been made to the categories and subsequent

baselines and goals.

Finally, GMA’s feedback, particularly the SWM, is based on the assumption that FDA will extend the timeframe for short-term

changes from two to four years, with an additional year for market penetration. A detailed explanation on the importance of using

four years for the short-term goals is provided in the full text of the comment above.

FDA Category

FDA Description

and/or SWM Target

for Short-Term

Goals

GMA Proposed

Description and/or

SWM Target for 4-

year Short-Term

Goals

GMA Rationale

Dairy Cheese

(1) Blue/Blue-Veined Cheese

(Semi-soft)

SWM: 1180mg/100g SWM: 1200mg/100g GMA requests additional clarification on the products that

comprise these categories as the 2010 baseline values appear too

high. Current Blue cheeses available through a major

manufacturer are 10% higher than the reported 2010 baseline.

Therefore, GMA proposes a SWM of 1200mg/100g.

Salt interacts with lipase enzymes to provide characteristic

flavor for these cheeses.



October 17, 2016

Page 22 of 74

15

Taormina, P. (2010) Implications of Salt and Sodium Reduction on Microbial Food Safety. Critical Reviews in Food Science and Nutrition: 50 (3).

(3) Processed

Cheese/Cheese

Food (semi-

soft)

Pasteurized

processed non-

spreadable cheeses,

e.g. American cheese

slices and processed

cheese loaf.

SWM: 1210mg/100g

3a. Shelf Stable

Processed

Cheese/Cheese Food

(semi-soft)

Shelf stable pasteurized

processed non-

spreadable cheeses, e.g.

American cheese slices

and processed cheese

loaf.

SWM: 1280mg/100g

3b. Refrigerated

Processed

Cheese/Cheese Food

(semi-soft)

Refrigerated

pasteurized processed

non-spreadable

cheeses, e.g. American

cheese slices and

processed cheese loaf.

SWM: 1210mg/100g

Shelf stable products should be separated from refrigerated

products. Cheeses are considered an acidified and low-acid

canned food, and require the use of sodium both during and after

processing to control the growth of microorganisms such as C.

botulinum.15

While safety is the greatest obstacle for all

processed cheeses, it is even more critical for shelf stable items

that cannot rely on refrigeration to control microbial growth.

Shelf stable cheeses are already lacking one barrier to microbial

growth (refrigeration), which is typically combined with sodium,

pH and chemical preservation. Lowering sodium to the same

degree as a refrigerated product would negatively impact the

food safety of shelf stable cheese. Currently, the difference in

sodium between these two processed cheese categories is 365

mg/100g.

Additionally, options to reduce sodium in processed cheese

include use of reduced-sodium natural cheese, potassium-based

emulsifying salts, and use of hydrocolloids which have shown

mixed results. These modifications require sequential analysis of

each replacement to ensure acceptable safety, functionality and

taste. Micro studies alone typically take 12-18 months

depending on the shelf-life of the product. New innovations in

sodium replacement technology and micro-challenge study data

would both be needed to meet the original FDA target as

proposed.

GMA proposes a SWM target of 1280 mg/100g for shelf-stable

cheese, which represents a 10% reduction from current market

leading shelf-stable processed cheese.



October 17, 2016

Page 23 of 74

16

Mistry VV, Kasperson KM. 1998. Influence of salt on the quality of reduced fat cheddar cheese. Journal of Dairy Science. 81(5):1214-21. 17

Guinee, T.P. and Kilcawley, K.N. 2010. Strategies for low-fat, reduced-sodium cheese. Proceedings of ‘Dairy Foods Symposium: Microbiology and flavor of

cheese: Impact of Lower Salt-In-Moisture Content of Low Fat and Reduced Sodium Cheeses’, July 12, 2010, Denver, CL, 2010. Journal of Animal Science 88,

E-Suppl. 2/Journal of Dairy Science. 93, E-Suppl. 1/Poultry Science 89, E-Suppl. 1

(4) Monterey

Jack and Other

Semi-Soft

Cheese

For most natural cheeses, the salt to moisture (S/M) ratios are

critical to both the safety and the quality of the cheese. Cheddar,

for example, has been shown to have an optimal S/M ratio of

4.5%.16

Also, reducing the content of sodium in cheese

adversely affects the development and release of key compounds

associated with flavor.17

Sodium plays an integral role in the cheese making process, such that minor changes can have

significant impact on functionality, and ultimately consumer

acceptance.

Also, in standard cheeses are unable to use sodium replacers (eg,

KCl) and remain within the SOI.

(6) Cheese

Spreads/Other

Spreadable

Cheese (Soft)

Pasteurized

spreadable cheeses,

pimento spreads, and

other cheese spreads.

GMA members request

a clarification of the

categorization and

baseline values for this

category

GMA members do not believe the 2010 baseline adequately

accounts for current leaders in the market for this category.

FDA has proposed a short-term SWM of 710mg/100g. This

goal is significantly below (by greater than 50%) what members

identify as in-market levels of 2 leading cheese spreads, which

roughly range from 1,600mg to 1,800mg/100g.

GMA requests clarification on the products that comprise this

category. Depending on the outcome of this clarification,

pimento spread may need to be separated from this category as it

has significantly different levels of sodium from other cheese

spreads in this category.

Depending on the outcome of this clarification or revised

baseline, a reduction of 10% below current in-market levels may



October 17, 2016

Page 24 of 74

be feasible in 4 years.

(8) Pasta Filata

Cheese (Soft)

Feta is inherently a brined/pickled cheese with a salty

characteristic, such that sodium reduction would significantly

alter the functionality and standard of identity. Standardized

cheeses are unable to use sodium replacers (eg, KCl) and remain

within the current Standard of Identity.

For this category, and most cheeses in general, one consequence

of sodium reduction is the need to increase cheese solids, which

would increase total/sat fat content. Furthermore, salt interacts

with lipase enzymes to provide characteristic flavor for these

cheeses.

(9) Feta

Cheese (Soft)

SWM: 1120mg/100g SWM: 1200mg/100g

GMA requests additional clarification on the products that

comprise these categories as the 2010 baseline values appear too

high. Current Feta cheeses available through a major

manufacturer are 10% higher than the reported 2010 baseline.

Therefore, GMA proposes a SWM of 1200mg/100g.

(11) Cheddar

and Colby

Cheese (Hard)

The natural cheese making process is dependent on live bacteria,

which are impacted by the sodium level. Minor changes in the

sodium level can have a significant impact on functionality,

flavor and the rate of spoilage, which would affect consumer

acceptance.

Lower sodium levels could also impact product safety. Lower

sodium products would need to be developed and evaluated over

shelf life for performance, quality and safety. This development

process alone typically takes longer than 2 years.

(12) Swiss and

Swiss-type

Cheese (Hard)

The sodium reduction targets for the Swiss and Swiss-Type

Cheeses seem extremely low based on other product categories

and experience.



October 17, 2016

Page 25 of 74

Fats, Oils, Dressings

(14) Butter Sodium in salted butter products acts as a preservative,

preventing the growth of undesirable organisms. This is essential

for the safety and quality of these products, especially those with

a longer shelf life. Reducing sodium in salted butter, margarine

and spreads could have a safety and/or spoilage impact. Lower

sodium products would need to be developed and evaluated over

shelf life for stability, performance, quality and safety.

(15) Margarine

and Vegetable

Oil Spreads

GMA members believe there may be consumer safety issues for

some products in this category.

Sodium in margarine and spreads products acts as a

preservative, preventing the growth of undesirable organisms.

This is essential for the safety and quality of these products,

especially those with a longer shelf life. Reducing sodium in

salted butter, margarine and spreads could have a safety and/or

spoilage impact. Lower sodium products would need to be

developed and evaluated over shelf life for stability,

performance, quality and safety.

(16)

Mayonnaise

and Other

Sandwich

Spreads

The need for new technologies, micro challenge studies and

consumer testing makes industry’s ability to meet 2-y targets

infeasible. GMA members believe a 4-y timeframe is more

appropriate to account for the added time needed to reformulate,

carry out the appropriate laboratory and consumer tests,

manufacture and scale-up and conduct microbiological

challenge and open shelf-life studies.

Salt replacers and bitter blockers would need to be developed

and tested. Companies have already reduced sodium across

categories.



October 17, 2016

Page 26 of 74

Fruits, Vegetables, and Legumes

(23) Pickled

Vegetables

Pickled vegetables,

e.g. peppers,

cucumbers, and

beets. Excludes

sauerkraut (see 20)

and olives (see 21

and 22).

(23.a)

Pickled Vegetables-

Shelf-Stable

Pickled vegetables that

are cooked during

processing e.g.

peppers, cucumbers,

and beets. Excludes

sauerkraut (see 20) and

olives (see 21 and 22).

(23.b)

Pickled Vegetables-

Uncooked/Refrigerate

d

Pickled vegetables that

are not cooked during

processing and must be

constantly refrigerated

e.g. peppers,

cucumbers, and beets.

Excludes sauerkraut

(see 20) and olives (see

21 and 22).

This category should be subdivided further, as there are a variety

of methods used to pickle vegetables. The source of sodium in

pickles is the brine, which requires salt to preserve the pickle,

especially in the case of refrigerated pickles that have not been

cooked. Lowering sodium in raw/refrigerated pickles would be

more challenging from a food safety perspective. GMA

proposes two subcategories to account for the differences

between pickled vegetables that are uncooked and refrigerated

versus those that are cooked and shelf-stable.

It is also unclear why this category uses 100 mL instead of

weight for a product that is labeled by weight (such as pickles).

(26) Fried

Potatoes

without

Toppings

Likely, a combination of simple sodium/salt reduction coupled

with sodium reduction technology (potassium chloride, flavors)

in formed and flavored products would be necessary to meet

these targets. The level of reductions proposed by FDA are

significant at approximately a 30% reduction in sodium. The

goals for this category would be challenging to meet in a short

time frame while retaining consumer acceptance.



October 17, 2016

Page 27 of 74

(29) Potato

Side Dishes

Potato side dishes,

e.g. mashed potatoes

with gravy or sauce,

scalloped potatoes,

and baked potatoes

with toppings such as

cheese. Excludes

fried potatoes (see

26), mashed potatoes

(see 30.a and b), and

hash brown and

home fries (see 28).

(29.a) Potato Side

Dishes-Refrigerated

Refrigerated potato

side dishes, e.g.

mashed potatoes with

gravy or sauce,

scalloped potatoes, and

baked potatoes with

toppings such as

cheese. Excludes fried

potatoes (see 26),

mashed potatoes (see

30.a and b), and hash

brown and home fries

(see 28).

(29.b) Potato Side

Dishes-Frozen

Frozen potato side

dishes, e.g. mashed

potatoes with gravy or

sauce, scalloped

potatoes, and baked

potatoes with toppings

such as cheese.

Excludes fried potatoes

(see 26), mashed

potatoes (see 30.a and

b), and hash brown and


There are multiple varieties of potato sides that entail various

degrees of sodium use for preservation, functionality and flavor.

Sodium replacers and alternate processing/packaging

technologies are necessary in order to meet the proposed targets.

GMA proposes to sub-divide the category based on type of

storage; refrigerated versus frozen versus shelf stable.



October 17, 2016

Page 28 of 74

(29.c) Potato Side

Dishes-Shelf-Stable

Shelf-stable potato side

dishes, e.g. mashed

potatoes with gravy or

sauce, scalloped

potatoes, and baked

potatoes with toppings

such as cheese.

Excludes fried potatoes

(see 26), mashed

potatoes (see 30.a and

b), and hash brown and


(30.b) Mashed

Potatoes, Dry

Mix

Dry mix mashed

potatoes with or

without additions.

(30.b) Potatoes, Dry

Mix

Dry mix potatoes (e.g.

mashed, scalloped,etc.)

with or without

additions

This category would ideally expand dried, mashed potatoes to

include dried/dehydrated potato side dishes beyond "mashed",

e.g. casserole potatoes such as scalloped potatoes (from dry

mix). If these products are already included in the category as

proposed, GMA suggests clarification in the category

description to reflect this fact.

Nuts and Seeds

(31) Nuts and

Seeds

Nuts and seeds.

SWM: 350 mg/100g

(31.a)

Nuts, and Seeds-

Without Shells

Nuts, and seeds

without their shells,

seasoned/salted.

Excludes all

unseasoned varieties.

SWM: 530mg/100g

There is a significant difference in sodium levels of seeds with

shells and those without. GMA members have identified the

need for this category to be separated into two distinct

categories; 1) nuts and seeds without shells and 2) seeds with

shells. There is a significant difference in sodium levels of

seeds with shells and seeds without shells. Seeds without shells

are more similar to nuts. GMA proposes a SWM of

530mg/100g for the unshelled category and 6000mg/100g for

the shelled category.



October 17, 2016

Page 29 of 74

18 Bao, Ying, Jiali Han, Frank B. Hu, Edward L. Giovannucci, Meir J. Stampfer, Walter C. Willett, and Charles S. Fuchs. "Association of Nut Consumption with Total and Cause-Specific Mortality." New England Journal of Medicine N Engl J

Med 369.21 (2013): 2001-011. Web

(31. b)

Seeds with Shells

Seeds with their shells,

seasoned/salted.

SWM: 6000mg/100g

Sodium is derived from seasoning, therefore the solution is to

either use less seasoning or include salt replacers. Significant

work to reduce sodium in this category has already taken place.

Consumer acceptance is the largest barrier, and increased

consumption of nuts and seeds as a source of healthy

unsaturated fats is typically encouraged. According to 2005-

2006 NHANES data, this category contributes



October 17, 2016

Page 30 of 74

reductions with gap years to measure consumer acceptance are

necessary to be successful in the long term. GMA’s proposed

SWM of 536mg/100g is still very challenging but could be

achieved with adequate time for reformulation (i.e. 4 years).

(34) Canned,

Ready-to-Eat

Soup

SWM: 230mg/100g SWM: 280mg/100g Due to the diversity of products in this category, there are a

number of different technological challenges that must be

balanced to maintain taste, texture, appearance and overall

product integrity.

There is currently no consumer acceptable, one-for-one

substitute for salt. There is a not a singular solution that can be

applied across all categories of soup and maintain the same taste,

meeting consumer expectations. The ability to use potassium

chloride is limited due to metallic off-taste. There is also a lack

of consumer acceptability for salt substitutes as a clean label

ingredient.

Every SKU will need to be re-formulated with a unique solution.

For example, sodium phosphate is a highly functional ingredient

in emulsified/creamy soups and acts as an emulsifier, giving

creamy soups their appearance and texture. It is also used in

meats to contribute to the texture and flavor that consumers

desire. Sodium phosphate can contribute a significant portion of

the sodium, particularly in creamy soups. New technology

needs to be developed to replace sodium phosphate.

Finally, the baseline data from 2010 includes 42 varieties of

ready-to-serve soups that were reformulated to sodium levels

above the current sales weighted average but still received

consumer complaints on taste. Therefore, the 2010 baseline is

artificially low and does not reflect the current average. To meet



October 17, 2016

Page 31 of 74

the short-term target as proposed, a greater than 10% reduction

would be necessary and not achievable. GMA proposes a SWM

of 280mg/100g to account for this change in the market. This

proposal aligns with GMA’s proposal for (33) Canned,

Condensed Soup, on a RACC basis.

(35) Dry Mix

Soup

SWM: 1640mg/100g GMA suggests FDA

reconsider the short-

term mean, accounting

for presence of

multiple dilution

factors.

FDA baseline numbers and draft short term goals for this

category appear quite low based on GMA member assessment of

the marketplace.

Consumers enjoy a bowl of soup regardless of packaging or

storage conditions (ready-to-eat, condensed, a dry mix,

refrigerated or frozen). However, dilution factors may vary

across these different categories, and particularly within the dry

mix category. This variation in dilution factor should be

accounted for when setting the baseline and subsequent

reduction goals.

GMA does not believe it is appropriate to establish sodium

concentration using a single dilution factor. The example below

shows two dry mix soups with widely varying sodium

concentrations as-packaged but yet very similar sodium

concentrations when prepared according to package directions.

GMA disagrees with FDA’s assumption of a standard dilution

factors for all soups. Members observe a wide range of dilution

factors; anywhere from 5 to 17.

Product Sodium (mg/100

g as packaged)

Sodium (mg/100 g

as prepared)

Rehydration Factor

Dry soup mix A 1422 235 6

Dry soup mix B 3498 241 14.5



October 17, 2016

Page 32 of 74

For this category, GMA is unable to propose a sodium

concentration target on an as packaged basis due to the wide

range of dilution factors (i.e., the ratio of dry mix to water).

(36) Shelf

Stable Liquid

Broth and

Stock

Shelf stable liquid

stocks and broths,

e.g. chicken, beef,

and vegetable-based

stocks and broths.

(36) Shelf Stable

Liquid Broth and

Stock

Shelf stable liquid

stocks, broths (e.g.

chicken, beef, and

vegetable-based stocks

and broths), bouillon

cubes, bouillon

powders, stock

pastes/concentrates/jell

ies and bases used to

prepare stock or soup.

GMA members note that this category description appears too

narrow as it does not account for bouillon cubes, bouillon

powders, stock pastes/concentrates/jellies and bases used to

prepare either stock or soup.

Furthermore, this category only accounts for the ready to use

liquid formats of broth and stock and does not allow for an

assessment of concentrated versions of stock/broth, which may

have varying dilution factors. GMA proposes clarification or

further separation of this category.

(37) Frozen

Soup

SWM: 230mg/100g SWM: 280mg/100g To a leader in this category, it appears that frozen condensed and

all private label products were not included in the calculation of

the 2010 sales-weighted mean. Most products in this category

are for commercial- and non-commercial foodservice including

restaurants and institutions. It is unclear if any of those products

were assessed by FDA. The current sales-weighted mean

calculated by a manufacturer is 17% higher than the baseline.

Therefore, manufactures have a higher starting point for

reformulations. Foods that were included in analysis of this

category and had to be reconstituted include frozen condensed

soup, and frozen concentrated stocks and broths.

Furthermore, sodium reduction efforts in the form of alternatives

would go against the primary consumer/customer interest in

clean label. The level of reformulation necessary greatly exceeds



October 17, 2016

Page 33 of 74

26% reduction target in some cases. Therefore, GMA proposes

a SWM of 280mg/100g.

Sauce-Gravy-Dip-Condiment-Seasoning

(42) Pesto

Pesto sauces, e.g.

standard pesto, basil

sauce, and sun-dried

tomato pesto sauce.

(42.a) Pesto-Shelf-

Stable

Shelf-stable pesto

sauces, e.g. standard

pesto, basil sauce, and

sun-dried tomato pesto

sauce.

(42.b) Pesto-

Refrigerated

Refrigerated pesto

sauces, e.g. standard

pesto, basil sauce, and

Comments on issues 1 through 4 RE: Docket No. FDA-2014 ......changed. NHANES data indicate that...

Documents

Transcript of Comments on issues 1 through 4 RE: Docket No. FDA-2014 ......changed. NHANES data indicate that...