0817 Gluten RIA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Food Labeling; Gluten-Free Labeling of
Fermented or Hydrolyzed Foods
Docket No. FDA-2014-N-1021

Final Regulatory Impact Analysis
Final Regulatory Flexibility Analysis
Unfunded Mandates Reform Act Analysis

Economics Staff
Office of Economics and Analysis
Office of Policy, Legislation, and International Affairs
Office of the Commissioner

1

Table of Contents
I. Introduction and Summary .............................................................................................. 3 
A. Introduction ............................................................................................................................ 3 
B. Summary of Costs and Benefits ............................................................................................. 4 
C. Comments on the Preliminary RIA and Our Responses ........................................................ 6 
D. Summary of Changes ............................................................................................................. 6 
II. Final Regulatory Impact Analysis .................................................................................. 7 
A. Background ............................................................................................................................ 7 
B. Market Failure Requiring Federal Regulatory Action ............................................................ 7 
C. Purpose of the Rule................................................................................................................. 8 
D. Baseline Conditions................................................................................................................ 8 
E. Costs of the Rule ..................................................................................................................... 8 
a. Testing Costs...................................................................................................................... 10 
b. Cost of Development and Implementation of Measures to Prevent Cross-Contact .......... 12 
c. Relabeling Costs ................................................................................................................ 14 
d. Paperwork Costs ................................................................................................................ 16 
e. Total Costs ......................................................................................................................... 18 
F. Benefits of the Rule............................................................................................................... 18 
a. Number of Individuals with Celiac Disease on a Gluten-Free Diet .................................. 18 
b. Estimating Baseline Gluten Consumption......................................................................... 19 
c. QALY Loss from Baseline Consumption and Social Cost................................................ 23 
d. Gluten Consumption with Rule ......................................................................................... 26 
e. Other Potential Benefits ..................................................................................................... 26 
f.  Break-even Analysis ....................................................................................................... 28 
G. Distributional Effects ........................................................................................................... 29 
H. International Effects ............................................................................................................. 29 
I. Uncertainty and Sensitivity Analysis ..................................................................................... 29 
J. Analysis of Regulatory Alternatives ...................................................................................... 32 
1. Prohibit the “Gluten-Free” Claim on Fermented and Hydrolyzed Foods ......................... 32 
2. Limit the Requirements of the Rule to a Subset of Fermented and Hydrolyzed Foods .... 33 
III. Small Entity Analysis .......................................................................................................... 33 
A. Description and Number of Affected Small Entities............................................................ 34 
B. Description of the Potential Impacts of the Rule on Small Entities ..................................... 35 
IV. References................................................................................................................... 36 

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I. Introduction and Summary
A. Introduction
We have examined the impacts of the final rule under Executive Order 12866, Executive Order
13563, Executive Order 13771, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess
all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and equity). Executive Order 13771
requires that the costs associated with significant new regulations “shall, to the extent permitted by law,
be offset by the elimination of existing costs associated with at least two prior regulations.” This rule is
not an economically significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize
any significant impact of a rule on small entities. Because small firms may have annualized costs that do
not exceed one percent of their annual revenue, we certify that the proposed rule will not have a
significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written
statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that
includes any Federal mandate that may result in the expenditure by State, local, and tribal governments,
in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in
any one year.” The current threshold after adjustment for inflation is $156 million, using the most
current (2019) Implicit Price Deflator for the Gross Domestic Product. This rule would not result in an
expenditure in any year that meets or exceeds this amount.

3

B. Summary of Costs and Benefits
This rule requires that, for foods that are fermented or hydrolyzed or contain one or more
fermented or hydrolyzed ingredients, and bear any of these claims: “gluten-free,” “no gluten,” “free of
gluten,” or “without gluten,” the manufacturer must have records that demonstrate adequate assurance
that the food, or fermented or hydrolyzed ingredient(s), is “gluten-free” in compliance with 21 CFR
101.91(a)(3). In addition, the rule requires documentation by the manufacturer that any potential for
gluten cross-contact has been adequately assessed, and where such potential has been identified, that the
manufacturer has implemented measures to prevent the introduction of gluten during the manufacturing
process. The rule also provides that we will evaluate compliance of distilled foods, such as distilled
vinegar, by verifying the absence of protein using scientifically valid analytical methods that can
reliably detect the presence of protein or protein fragments in the food.
The costs of this rule are the costs to manufacturers of covered foods for testing ingredients for
gluten, evaluating any potential for cross-contact, developing and carrying out written standard
operating procedures (SOPs) for preventing gluten cross-contact if necessary, relabeling products that
cannot be brought into compliance, and maintaining records of these activities for FDA inspection. We
estimate total annualized costs of $7 million to $11 million for the 3% discount rate and annualized costs
ranging from $7 million to $11 million at 7% discount rate. All costs are computed in 2018-dollar
values.
The benefits of this rule are health gains for people with celiac disease using “gluten-free”
labeled foods while maintaining a gluten-free diet. To examine the potential scope of these benefits, we
simulate the harm done by dietary gluten intake from a gluten-free diet before and after the rule. Due to
uncertainty in this simulation analysis, we describe benefits qualitatively. For the rule to break even with
costs, the annualized benefits would need to be at least $8.8 million at a 3% discount rate and $9.1
million at a 7% discount rate. Based on our simulation analysis, the rule would break even with primary
cost estimates discounted at 7% if at least 0.07% of estimated individuals with celiac disease following a
gluten-free diet benefit from the rule each year.

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Table 1. Summary of Benefits, Costs, and Distributional Effects of Final Rule (Millions)

Category
Annualized
Monetized
$millions/year
Annualized
Quantified
Qualitative
Benefits

Costs

Transfers

Effects

5

Primary
Estimate

Low
Estimate

High
Estimate

Year
Dollars
2018
2018

Units
Discount Period
Rate
Covered
7%
10
3%

10

7%
3%
The benefits of this rule are health gains for people
with celiac disease using “gluten-free” labeled foods
while maintaining a gluten-free diet. For the rule to
break even with costs, the annualized benefits would
need to be at least $8.8 million at a 3% discount rate
and $9.1 million at a 7% discount rate. Based on our
simulation analysis, the rule would break even with
primary cost estimates discounted at 7% if at least
0.07% of estimated individuals with celiac disease
following a gluten-free diet benefit from the rule
each year.
$9.09
$7.34
$11.46
2018
7%

10

$10.94

10

Annualized
Monetized
$7.14
$millions/year $8.76
Annualized
Quantified
Qualitative
Federal
Annualized
Monetized
$millions/year
From/ To
From:
Other
Annualized
Monetized
$millions/year
From/To
From:
State, Local or Tribal Government:
Small Business:
Wages:
Growth:

2018

3%
7%
3%
7%
3%

To:
7%
3%
To:

Notes

In line with Executive Order 13771, in Table 2 we estimate present and annualized values of
costs and cost savings over an infinite time horizon based on 2016-dollar values. Based on these costs,
this final rule would be considered a regulatory action under EO 13771.
Table 2. EO 13771 Summary Table (in $ Millions 2016 Dollars, Over an Infinite Time Horizon)

Item
Present Value of Costs
Present Value of Cost Savings
Present Value of Net Costs
Annualized Costs
Annualized Cost Savings
Annualized Net Costs

Primary
Lower
Upper
Estimate
Estimate
Estimate
(7%)
(7%)
(7%)
$107.12
$89.37
$130.02
0
0
0
$107.12
$89.37
$130.02
$7.50
$6.26
$9.10
0
0
0
$7.50
$6.26
$9.10

C. Comments on the Preliminary RIA and Our Responses
The Agency did not receive any comments on the preliminary regulatory impact analysis.
D. Summary of Changes
While we received no public comments on the preliminary economic analysis, we have made the
following change to our final analysis: We previously computed monetized health benefits based on a
simulation analysis. Due to underlying uncertainty in this analysis, we now describe these benefits as
simulated and exclude them from our total accounting. Instead, we highlight the impact of the final rule
by discussing how these simulated benefits could break even with estimated costs.
Compared to the preliminary analysis, the final regulatory impact analysis updates inputs into
our simulated benefits analysis and costs model with more recent data. The analysis now uses wage,
population, and QALY data from 2018. The final analysis also incorporates updated peer-reviewed
estimates of celiac disease prevalence and accounts for potential changes to baseline consumption of
covered products following publication of the 2013 gluten-free final rule.

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II. Final Regulatory Impact Analysis

When presenting our estimates of input values, we use average values for readability. All results
presented are for average values of inputs, rounded to the nearest 100th significant figures in the text.
The “Uncertainty and Sensitivity Analysis” section presents the probability distributions of inputs and
the Monte Carlo simulation that we use to form our final estimates.
A. Background
Gluten is a protein found in wheat, barley, rye, and their crossbred hybrids [1]. Wheat gluten is
generally recognized as safe [2], and gluten-containing grains are staples in the food supply [3]. Because
of this, many foods contain gluten-containing grains or ingredients derived from them. Additionally,
many foods contain gluten, even though they do not contain any gluten-containing ingredients, because
of cross-contact with these ingredients [3]
People with celiac disease may be harmed by consuming gluten. The way for them to avoid harm
is to maintain a gluten-free diet [1]. Many foods bear a “gluten-free” labeling claim to advertise that
their food is safe for individuals with celiac disease.
B. Market Failure Requiring Federal Regulatory Action
Before FDA published a final rule defining the term “gluten-free” and establishing requirements
for the voluntary use of the term in labeling1, approximately 5% of foods labeled “gluten-free” contained
more than 20 ppm of gluten [4]. Due to testing limitations specific to fermented and hydrolyzed foods,
additional requirements for these foods are needed to help ensure that individuals with celiac disease are
not misled and receive truthful and accurate information when these foods are labeled “gluten-free.”
Although it is not possible to verify this with testing, we estimate that one percent of fermented and
hydrolyzed foods contain more than 20 ppm of gluten. As we show below in the detailed analysis in
section II.F.b., Estimating Baseline Gluten Consumption, this means that about 4,326 individuals
diagnosed with celiac disease consume such foods daily and are at risk of harm due to a 50 mg daily
gluten intake from such food represented to be “gluten-free.” We use the term “harm” in this analysis to

1

This rule, now codified at 21 CFR 101.91, published in the Federal Register on August 5, 2013 at 78 FR 47154.
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reflect the morphological damage that 50 mg of gluten per day has been shown to cause in those with
celiac disease [5, 6]. This rule would reduce or eliminate that morphological damage by limiting the
“gluten-free” label to foods that are manufactured in a way that minimizes their gluten content.
C. Purpose of the Rule
In the Federal Register of August 5, 2013 (78 FR 47154), we published a final rule that defines
the term “gluten-free” and establishes requirements for the voluntary use of the term in food labeling.
The rule is codified at 21 CFR 101.91 (the gluten-free food labeling final rule). This rule is a response to
limitations of analytical method technology for enforcement of 21 CFR 101.91 when “gluten-free”
claims are made about certain foods.
Our regulation at 21 CFR 101.91 helps protect individuals with celiac disease by setting several
requirements, one of which is that foods that bear a “gluten-free” labeling claim must have less than 20
parts per million (ppm) of gluten due to the unavoidable presence of gluten or from an ingredient
derived from gluten-containing grain that has been processed to remove gluten. This regulation states
that FDA will enforce the 20 ppm requirement using a valid test method that can reliably detect the
presence of 20 ppm gluten in a variety of food matrices. At this time, there is uncertainty in interpreting
the results of current gluten test methods for fermented and hydrolyzed foods on a quantitative basis that
equates the test results in terms of intact gluten. Thus, FDA does not have the ability to test such foods
to determine their compliance with 21 CFR 101.91.
D. Baseline Conditions
The baseline for this economic analysis is full compliance with 21 CFR 101.91 for all foods that
are not fermented or hydrolyzed, and the current market situation for foods that are fermented or
hydrolyzed. We estimate how the rule might change health status and manufacturer costs from this
baseline.
E. Costs of the Rule
In order to demonstrate that the food is gluten-free before fermentation or hydrolysis, we expect
that most manufacturers would test their incoming ingredients or obtain Certificates of Analysis from
their ingredient suppliers. While testing is not required nor even expected in all circumstances, it is a
reliable way to demonstrate that an ingredient is gluten-free, so we include estimates for the costs of

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testing. To the extent that some manufacturers rely on other appropriate verification regarding their
ingredients, this analysis may overestimate the total cost. Once a manufacturer evaluates its
manufacturing process, if it determines that there is the potential for gluten cross-contact, it must
document its implementation of measures to prevent gluten cross-contact and maintain these records so
they can be made available to FDA. For the purpose of this analysis, we are calling the entire process of
evaluating the potential for gluten cross-contact, and development and implementation of measures to
prevent cross-contact “developing written standard operating procedures (SOPs) for preventing gluten
cross-contact.” Some manufacturers may decide not to maintain the “gluten-free” label on their products
and, instead, relabel the product to remove this claim.
Therefore, for the purpose of this analysis, the costs of this rule are represented as those costs
necessary to test the ingredients for gluten, evaluate the potential for gluten cross-contact and, if
necessary, develop written SOPs for preventing gluten cross-contact, relabel products that cannot be
brought into compliance, and maintain records of these activities for FDA inspection.
Our estimates of the numbers of manufacturers are based on the number of food products that
would be covered by the rule. In November 2017 we searched the FoodEssentials database recently
rebuilt and renamed Label Insight [7] for foods that are hydrolyzed, fermented, or contain fermented or
hydrolyzed ingredients, and bear the claim “gluten-free,” “no gluten,” “free of gluten,” or “without
gluten” and found about 2,500 products that would be affected by the rule. Based on our understanding
of the market and experience with the percentage of the food market covered by this database, we
estimate that it has at least half of all products that would be covered by the rule, so that there would
likely be, at most, 5,000 products affected by the rule.
We do not have data that would allow us to determine how many products are produced in each
facility, so we assume that each product and its production line would be tested separately and would
require a separate evaluation and SOP. If multiple products are produced in the same facility and can
share testing, evaluation, SOPs, and paperwork, then costs would be less than these estimates.
We do not know how many of these products are already being manufactured using gluten-free
ingredients and/or with a process designed to prevent gluten introduction through cross-contact. A 2011
survey of food industry practices [8] shows that about 45% of all food production facilities have a
written allergen control plan, and about 39% require certificates of analysis for ingredients. Given that

9

manufacturers of foods labeled “gluten-free” are marketing to customers who care more about gluten
cross-contact, we estimate that about 75% of the 5,000 foods with a “gluten-free” labeling claim already
have a written plan for preventing the introduction of gluten into the food product that includes the
testing of ingredients and also procedures for evaluating and preventing gluten cross-contact. Therefore,
we estimate that testing and SOP development costs would be incurred for about 1,250 products. Even
facilities that already have an allergen control plan would need to make records available to FDA for
inspection and copying, so we estimate that these costs would be incurred for about 5,000 products.
a. Testing Costs
As described above, to demonstrate that food is gluten-free before fermentation or hydrolysis, we
expect that most manufacturers would test their incoming ingredients or obtain Certificates of Analysis
from their ingredient suppliers. Gluten testing can be done by sending ingredient samples to a testing
company and by using test kits on site. Test kits must first undergo method validation for the testing
situation in which they are to be used [9]. We assume that a manufacturer that begins a program of
testing the gluten content of an ingredient would start by sending several samples to a lab and obtaining
method validation for a test kit for the ingredient. This is a one-time cost.
After paying the startup cost, the manufacturer would then use test kits to test the ingredient on a
regular basis and may also send one or two samples a year to an outside lab for testing. This is a
recurring annual cost. We estimate that an average of two ingredients per universal product code (UPC)
would be tested in this manner. Most foods affected by this rule are those that contain a single
hydrolyzed or fermented ingredient, and an ingredient supplier would complete testing before
fermentation or hydrolysis of the ingredient. Other products contain several ingredients that would be
tested before fermentation or hydrolysis.
It is also possible that manufacturers would obtain a Certificate of Analysis from their ingredient
supplier showing that the ingredient does not contain gluten instead of testing the ingredients
themselves. To the extent that a single supplier can provide tested ingredients to multiple manufacturers,
the cost of the rule would be lower than our estimates.
Testing companies charge between $68 and $110 per sample, with a best estimate of about $75
[10, 11]. The average of these estimates is about $84 ([68+75+110]/3=84.33), and we also estimate that

10

manufacturers would spend about $28 per sample to collect the ingredient and mail it to the lab,2 for a
total cost per lab test of $112 (84.33+27.81=112.14).
Manufacturers would test between 2 and 12 samples of each ingredient [9], for an average of 7
samples and an average testing cost of $ (112.14*7=784.99). Method validation costs between $1,000
and $10,000, with a most likely cost of $2,500 [12], for an average cost of $4,500 ([1+2.5+10]/3=4.5).
This results in an average total one-time cost of $5,285 per ingredient tested (785+4,500=5,285).
We use Excel’s PMT function to annualize this cost over ten years with a cost of capital of 7% and find
that the annualized cost is $752 per year per ingredient. If the cost of capital was 3%, the annualized cost
would be approximately $620 per ingredient.
Test kits cost about $11 each and take 10 minutes to use [10]. The average wage rate in the food
manufacturing industry is $37.34 after adding benefits and overhead [11] which means that the total cost
of using a test kit is about $17.22 (11+[37.34*10/60]=17.22). We estimate that manufacturers would use
test kits between twice a year and once a week, with a best estimate of once a month, per ingredient. We
therefore use a triangular distribution with minimum 2, maximum 50, and peak 12. This yields an
average of about 21 ([2+12+50]/3=21.3) test kits used per year, at an annual cost of $367.43 per
ingredient (17.22*21.33=367.43). In addition to using test kits, companies would send between zero and
two samples of each ingredient annually to an outside lab, for an average annual cost of $112
(112*[0+2]/2 = 112). Adding up these two costs yields total recurring costs of $480 per ingredient on
average (367+112=480).
Adding the average recurring costs to the average annualized one-time costs yields total annual
testing costs of $1,232 per ingredient at a 7% cost of capital and $1,099 at a 3% cost of capital that can
be attributed to this rule.
With the average estimate of 1,250 UPCs requiring testing, and an average of two ingredient
tests per UPC, we estimate the total economic costs of testing that result from this rule to be about $3.0
million at a 7% cost of capital and $1.5 million at a 3% cost of capital.

2

A USPS Medium Flat Rate Box costs $12.35 and will hold most food samples. The cost of the food ingredient sent
for testing will be about $10. Ten minutes of labor at $32.75 an hour will be required to mail the sample.
12.35+10+(32.75x10/60) =27.81
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Table 2 summarizes the variables and the results of the calculations explained above, using mean
values for all variables:
Table 2. Testing Cost Summary
Per Ingredient

Total

7
$785
$4,500
$5,285

$13,200,000

Startup
Initial tests
Testing Cost
Method Extension
Total One-time
Annualized
3% Cost of Capital
7% Cost of Capital
Recurring
Number of kits used
Cost of Kits
Number of Lab Tests
Cost of Lab Tests
Total Recurring

$620
$752

$1,500,000
$1,900,000

21
$367
1
$112
$480

$1,200,000

Total Annual Cost of Testing: 3%
Total Annual Cost of Testing: 7%

$1,099
$1,232

$2,700,000
$3,000,000

b. Cost of Development and Implementation of Measures to Prevent Cross-Contact
We have estimates for the time and expense of developing allergen control procedures for
facilities producing one product. We use these estimates as the cost of evaluating gluten cross-contact
risk and developing gluten control procedures for a single UPC. To the extent that multiple UPCs can be
made in the same controlled facility, these estimates overstate the expected cost of the rule.
Based on our expert elicitation, we estimate that it would take six to eight hours to develop and
implement facility-specific procedures for gluten control. This would require the time of professional
staff, at a cost of $119 per hour (this amount includes benefits and overhead costs) [11]. We also
estimate that companies would spend between $0 and $2,000 on allergen control equipment, for a perUPC average estimate of $1,834 (7*119+1,000=1,834) [13]. This is a one-time cost. We use Excel’s
PMT function to annualize this cost over ten years with a cost of capital of 7% and find that the

12

annualized cost is $261 per year per UPC. If the cost of capital was 3%, the annualized cost would be
approximately $215 per UPC.
Facilities without pre-existing procedures would require regular training in the proper use of the
procedures. We estimate that it would take approximately two hours per year to train an employee in the
correct use of the procedures. This would require two hours of manager time and two hours per
employee, with five to 15 employees being trained. We also estimate that it would take an additional 0.7
hours of manager time per year to update the procedures. This yields an average annual training cost of
$1,068 per UPC ((2.7*119.12) +(2*10*37.34) =1,068).
Adding the average recurring costs to the average annualized one-time costs yields total annual
SOP costs of about $1,329 per UPC at a 7% cost of capital (261+1,068=1,329) and $1,283 per UPC at a
3% cost of capital (215+1,068=1,283) that can be attributed to this rule.
With the average estimate of 1250 UPCs requiring the development and implementation of
measures to prevent the introduction of gluten into fermented or hydrolyzed food, we estimate the total
economic costs of SOP development and implementation that result from this rule to be about $1.7
million at a 7% cost of capital (1,329*1,250=1,661,902) and $1.6 million at a 3% cost of capital
(1,283*1,250=1,604,257).
Table 3. SOP Cost Summary
Startup
Hours for Development
Equipment Cost
Total One-time
Annualized
3% Cost of Capital
7% Cost of Capital
Recurring
Manager Hours for Updating
Manager Hours for Training
Worker Hours for Training
Total Recurring
Total Annual Cost of Testing: 3%
Total Annual Cost of Testing: 7%

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Per UPC

Total

7
$1,000
$1,834

$2,300,000

$215
$261

$269,000
$326,000

0.7
2
20
$1,068

$1,300,000

$1,283
$1,329

$1,600,000
$1,700,000

c. Relabeling Costs
Some manufacturers may decide that it is not possible or economical to make their product in a
way that complies with this rule. They may also discover that the products are still not gluten-free after
they start a program aimed at compliance with this rule. In either case, they would then remove the
“gluten-free” label from the product.
Testing of foods with “gluten-free” claims has shown that 5% of such foods contain more than
20 ppm of gluten [4, 14, 15]. Therefore, we estimate, as an upper bound, that 5% of foods covered by
this rule would be relabeled.
According to the FoodEssentials database [7] in 2018, there were 2,514 of 271,872 UPCs had a
“gluten-free” claim affected by this rule, so we estimate that 0.9% of all foods have such a “gluten-free”
claim (2,514/271,872=0.9%). Because 5% of foods covered by this rule might have to be relabeled, we
estimate that 0.05% of all foods would need to be relabeled (0.9%*5%=0.046%).
We believe that removing the claim in response to this final rule will impose minimal, if any,
reformulation costs because the least costly way to comply with the rule will be relabeling. However, it
is possible that producers may make the business decision to start using an allergen control plan to
eliminate gluten cross-contact, instead of relabeling. This would involve incurring costs to change the
production process, train workers, and possibly test ingredients and change suppliers. However, we
estimate that producers would engage in these activities only when profits from doing so are higher than
the profits from relabeling and abandoning the market for “gluten-free” labeled foods. We believe the
same reasoning applies to reformulation, which producers may decide to undertake by substituting
ingredients used before hydrolyzation/fermentation.
We cannot predict what proportion of manufacturers might decide to pursue allergen control or
reformulation, which depends on a product’s market as well as how the product introduces gluten into
its production process. However, because we estimate relabeling would apply to 0.05% of foods affected
by this rule and because we expect the majority of manufacturers to relabel, the proportion of foods
pursuing either allergen control or reformulation would be <0.025% (less than 50% of 0.05%). This
proportion is relatively small and, given that we do not know the division between allergen control and
reformulation, we refrain from making additional estimates which may be highly uncertain.

14

We used FDA’s Labeling Cost Model [16] to calculate the potential new labeling costs implied
by the rule. The model calculates the cost of a new label based on the product type, label type,
compliance time, and inflation. The compliance costs of labeling laws are lower if the required changes
can be coordinated with planned label changes. Manufacturers will have one year to comply with the
rule. The Labeling Cost Model uses a three- to four-year timeline for normally scheduled redesign,
which means that only some of the labeling changes required by this rule can be coordinated with
planned labeling changes.
The costs per UPC of relabeling depend on the exact printing method, the amount of packaging
in inventory, the labor costs of managing the relabeling process and other variable factors. Because these
costs cannot be known with certainty, the Labeling Cost Model reports a low and high cost estimate for
any required label change. The lowest estimated cost for relabeling during a 12-month compliance
period is $150 per label UPC for branded products. The highest estimated cost for a 12-month
compliance period is $13,230 per label UPC for private label products. And, the midpoint of average
estimated cost, adjusting for inflation, is about $7,000 per UPC.
We entered the value of 0.05% of all foods requiring relabeling into the Labeling Cost Model,
and the result was that it calculated relabeling costs for 347 UPCs.
With a 12-month compliance period, the Labeling Cost Model estimates that 89% of branded
product labels and 95% of private label product labels of labels using the claim would have to change
their labels earlier than planned. If 347 labels are affected, the rule would affect 317 unscheduled label
changes and 30 scheduled label changes. The midpoint of estimated label cost per UPC for a 12-month
compliance period is $7,101 for unscheduled changes and $289 for scheduled changes. The higher cost
reflects both discarded inventory and overtime or rushed order charges.
With 89% to 95% of the 347 UPCs incurring the full cost, and the remainder incurring lesser
costs, the cost of relabeling due to the rule, adjusted for inflation to 2019, is estimated to be
approximately $2.4 million (347*$7,101*92% ≈ $2.4 million). This is a one-time cost. We use Excel’s
PMT function to annualize this cost over ten years with a cost of capital of 7% to estimate that the rule
would, if finalized, cost approximately $340,000 per year due to label changes. If the cost of capital was
3%, the annualized cost would be approximately $280,000.

15

d. Paperwork Costs
The rule would require manufacturers to maintain records showing that their food products meet
the requirements of the rule. The manufacturers would need to make these records available to FDA for
inspection and copying.
We estimate that the manufacturers would satisfy the recordkeeping requirements of this rule by
maintaining records of their tests or other appropriate verification procedures, their evaluation of the
potential for gluten cross contact, and their standard operation procedures for preventing gluten crosscontact. It is also possible that manufacturers would comply with this rule by obtaining Certificates of
Analysis or test results from their suppliers instead of conducting the testing themselves. In that case, the
suppliers rather than the manufacturers would incur the paperwork burdens related to collecting samples
for the tests, and the manufacturers would still incur the paperwork burdens related to maintaining
records of the tests, in the form of the Certificates of Analysis or test results themselves. If one supplier
provides ingredients for multiple manufacturers, then the paperwork burden would be less than these
estimates.
The estimates presented here are averages. We anticipate that the records kept would vary based
on the type of ingredients used. Some manufacturers, such as those producing fermented dairy products,
would likely maintain fewer records, because one bulk ingredient can be used for many UPCs. Other
manufacturers, such as those producing foods with fermented or hydrolyzed grains, legumes, or seeds,
would likely maintain more extensive records, because those products contain more ingredients and a
greater variety of ingredients.
The costs of testing are detailed earlier in section II.E.a. of this analysis. We estimate that, in
addition to these costs, the rule would require 30 minutes of work per test to process and file the test
results so that they can be made available to FDA. The average wage rate in the food manufacturing
industry is about $37.34 after adding benefits and overhead [11], so this work would cost $37 per hour,
for an additional paperwork cost of $18.50 per test.
The one-time method extension requires an estimated average of seven tests per ingredient, so
with two ingredients per product, the associated paperwork cost would be $259 per UPC
(7*0.5*37*2=259). This is a one-time cost. We use Excel’s PMT function to annualize this cost over ten

16

years with a cost of capital of 7% and find that the annualized cost is $37 per year per UPC. If the cost
of capital was 3%, the annualized cost would be approximately $31 per UPC.
We estimate that the manufacturers would use 21 test kits annually on average, per ingredient so
the associated paperwork cost would be $777 per UPC (21*0.5*37*2=777). We estimate that the
manufacturers would conduct one outside test annually on average per ingredient, so the associated
paperwork cost is $37 per UPC (1*0.5*37*2=37).
The costs of developing and updating SOPs are detailed earlier in section II.E.b. of this analysis.
We estimate that, in addition to these costs, the rule would require one hour of work per UPC to
maintain the updated SOP records, for a cost of $37 per year.
The total annualized paperwork costs per UPC from testing and SOP development are $896 at a
7% cost of capital and $889 at a 3% cost of capital.
While we estimate that 3,750 manufacturers already have testing programs and written
procedures in place for gluten control (5,000-1,250=3,750), it is not clear that these manufacturers are
maintaining these test results and written procedures a way that would align with the requirements.
Therefore, we estimate that all 5,000 UPCs would incur these paperwork costs, for a total cost of $4.5
million per year with a cost of capital of 7% and $4.4 million per year with a cost of capital of 3%.
Table 4. Paperwork Cost Summary

17

Per UPC

Total

$259

$1,300,000

Startup
Method Extension Records
Annualized
3% Cost of Capital
7% Cost of Capital
Recurring
SOP Update Records
Test Kit Records
Lab test Records
Total Recurring

$31
$37

$150,000
$186,000

$37
$777
$35
$807

$187,000
$4,000,000
$187,000
$4,300,000

Total Annual Cost of Paperwork: 3%
Total Annual Cost of Paperwork: 7%

$889
$896

$4,450,000
$4,480,000

e. Total Costs
The total annualized cost of the testing, evaluation, SOPs, relabeling, and paperwork is $9.0
million at a 7% cost of capital and $8.7 million at a 3% cost of capital.
F. Benefits of the Rule
To examine the potential scope of the benefits of the rule, we simulate the harm done by dietary
gluten intake from a gluten-free diet before and after the rule. We simulate the number of people harmed
under the baseline (full compliance with the existing 21 CFR 101.91 for other products) and the amount
by which they are harmed. We then compare the results of these simulated benefits to the costs of the
rule using a break-even approach.
a. Number of Individuals with Celiac Disease on a Gluten-Free Diet
According to a study based on the 2009 to 2014 National Health and Nutrition Examination
Survey of non-institutionalized civilian population in the U.S. [17, 18], 0.21% of the population have
been told by a medical professional that they have celiac disease.3 In December of 2018, the Census
estimated the civilian non-institutionalized population aged over 6 years to be about 298.6 million, so
we multiply the population by the percentage of individuals with celiac disease to estimate that there are
about 627,000 people diagnosed with celiac disease in the U.S. (298,600,000*0.21%=627,000).
We do not know the harm that is caused by foods that contain 20 ppm or more gluten and bear
the “gluten-free” claim in individuals with celiac disease who are only partially compliant with the
gluten-free diet. Therefore, we must exclude them from the analysis. There have been many estimates
of the percentage of individuals with celiac disease who fully comply with the gluten-free diet. The
estimates of compliance range from 45% to 80%. Recent studies where nutritionists interviewed caretakers or children aged 2-19 years and adult patients aged above 18 years of age concluded that about 79
to 82% of celiac patients had good or excellent adherence with a gluten-free diet, meaning that they
knowingly eat gluten once a month or less. The two separate studies focused on patient categories that
were either children (2-19 years) or adults patients who were aged above 18 years [19, 20]. For the study

3

This weighted prevalence estimate is the difference between the percent of population with diagnosed and
undiagnosed celiac disease (0.72%) and the percent of population with undiagnosed celiac disease (0.51%). In the Analysis
of Uncertainty, we show how we generated a probability distribution to reflect uncertainty in this estimate.
18

focusing on children below 19 years old, 66 children were followed for two years beginning August 1,
2014 to July 31, 2016. These children were included if they had a confirmed diagnosis of celiac disease
and a standardized evaluation of adherence by a registered dietitian (M.D.R.) with expertise in pediatric
celiac disease. The second study had a sample of 29 adults diagnosed with celiac disease before they
were 4 years old and their adherence to celiac disease diet was compared with patients diagnosed with
celiac disease as adults.
Owing to the small size of these studies we use a triangular distribution with minimum 45%,
maximum 82%, and a peak of 79%. This yields an estimated average of ~69% compliance
([45+82+79]/3=68.7). Multiplying this percentage by the number of individuals diagnosed with celiac
disease, we find that there are approximately 432,600 individuals diagnosed with celiac disease
complying with a gluten-free diet (627,000*69%=432,600).
This does not include people who choose to remain on a gluten-free diet for reasons other than
medically diagnosed celiac disease. There are many individuals with celiac disease without a medical
diagnosis of celiac disease. Many of these people may have self-diagnosed and chosen to eat a glutenfree diet, which means that they would also benefit from the rule. We do not have enough data to
include them in the core analysis, but we discuss how the benefits of the rule increase if they are
included in section II.F.e, Other Potential Benefits.
b. Estimating Baseline Gluten Consumption
To estimate the baseline gluten intake, we used gluten testing results of food currently labeled
“gluten-free,” data on diets from the NHANES survey [21], and data on the percentage of “gluten-free”
foods that have fermented or hydrolyzed ingredients to simulate gluten-free diets and the daily gluten
intake from those diets. These simulated diets consisted of a random selection from fermented or
hydrolyzed “gluten-free” foods, non-fermented or hydrolyzed “gluten-free” foods, and inherently
gluten-free foods not labeled as “gluten-free” and therefore not covered by these rules, such as raw
agricultural commodities, in random amounts matching the observed distribution of serving sizes.
Comments from the Celiac Sprue Association to the gluten-free rulemaking [4] included test
results for 1,000 food products labeled “gluten-free.” The amount of gluten detected, if any, was
reported for each individual food. Of these, 49 had levels of gluten above 20 ppm. A more recently
published article cited a study that retrospectively examined information from product packaging for
19

328 foods tested for gluten content by Gluten Free Watchdog, LLC that only looked at products labeled
gluten-free. Of the products reviewed, 297 did not include an allergen advisory statement for wheat or
gluten on product packaging and only 31 products included such a statement. Of the 297 without
allergen advisory statement, 39 contained quantifiable gluten at or above 5 ppm with 12 products testing
at 20 ppm or above[22]. This is the best source of data we have of foods labeled “gluten-free”; we lack
the information that would allow us to ensure a representative sample of all “gluten-free” foods and of
fermented and hydrolyzed foods. Other studies [14, 15] have reported a slightly larger percentage of
foods whose gluten content exceeds 20 ppm, but they were not as comprehensive and did not report data
for individual food products.
Because we currently know of no scientifically valid analytical method effective in detecting and
quantifying with precision the gluten protein content in fermented and hydrolyzed foods in terms of
equivalent amounts of intact gluten proteins, we assume that the distribution of gluten content in these
foods is similar to the distribution of gluten content in tested foods. It is possible that the lack of testing
has resulted in a situation where fermented and hydrolyzed foods have a greater chance of containing 20
ppm or more gluten than foods that can be tested. In this case, the benefits of this rule would be greater
than the benefits we calculate. Based on data from 2014, the NHANES Total Nutrient Intakes tables
show that the average consumer consumed 15 servings of food and drink daily. The NHANES
Individual Foods data show the grams of each food or beverage that was consumed. Serving sizes of
beverages are larger than serving sizes of foods, and there were many outliers of very large serving sizes
from beverages. While we recognize the issue of gluten in beer, most beverages are rarely a source of
gluten. Using the serving sizes of both foods and beverages to estimate the distribution of serving sizes
of “gluten-free” food would have caused the serving sizes to be biased upwards, which would cause us
to overestimate gluten intake. Therefore, we removed water, beverages, juices, milk, and raw
watermelon from the data, which resulted in a mean serving size of about 82 grams. We then fit a
gamma distribution to these values.4
We then simulated 100,000 gluten-free diets using the @RISK program [23]. Each diet consisted
of a mix of inherently gluten-free unlabeled foods and foods labeled “gluten-free”. Foods labeled

4

The gamma distribution was chosen because the data were extremely right-skewed, with many small values but no
negative values, and the gamma distribution is flexible enough to fit such data without truncation. We found that the
distribution of food serving sizes had a shape parameter of approximately 0.86 and a scale parameter of approximately 95.
20

“gluten-free” consisted of foods that met the requirements of 21 CFR 101.91 and the tested “gluten-free”
foods.
We do not know what proportion of the average gluten-free diet comes from inherently glutenfree unlabeled foods and foods labeled “gluten-free”, but we do know that some consumers rely on their
own research of safe foods and others purchase products with “gluten-free” labels almost exclusively.
We therefore drew the proportion of labeled food in each diet from a uniform distribution with a
minimum of 0 and a maximum of 1. Each diet consisted of 15 random draws of an inherently gluten-free
unlabeled food or a food labeled “gluten-free”, according to that diet’s proportion of labeled foods. The
amount of each food eaten was drawn from the previously defined gamma distribution.
To determine the fraction of foods labeled “gluten-free” that are fermented or hydrolyzed or have
fermented or hydrolyzed ingredients, we searched the FoodEssentials database [7], a comprehensive
survey of food products sold in nationwide in the U.S., for foods with claims about gluten that would be
affected by the rule: “gluten-free,” “no gluten,” “free of gluten,” and “without gluten.” The search also
included variations of these claims within larger sentences, such as “No milk, soy, or gluten.” We refer
to all such claims as “gluten-free” claims. We found 11,108 such foods in November 2017.
We then searched the foods with “gluten-free” claims for ingredients that are fermented or
hydrolyzed. For the purposes of this search, we considered autolyzed yeast extract to be a hydrolyzed
food, based on the text of 21 CFR 102.22. We searched for foods with one or more of the following
words in the ingredients list: hydrolyzed, autolyzed, yeast extract, fermented, beer, brandy, cheese,
cider, fish sauce, kimchi, kombucha, miso, pepperoni, pickle, salami, sauerkraut, vinegar, vodka,
whisky, wine, and yogurt. We found 2,514 such foods, which means that approximately 23% of all
foods with a “gluten-free” claim contain one or more ingredients that are fermented or hydrolyzed
(2,514/11,108=0.226). We lack information that would allow us to further refine this percentage;
therefore, we assume that 23% of all labeled “gluten-free” foods consumed are fermented or hydrolyzed
or contain fermented or hydrolyzed ingredients.
We modeled all products covered by 21 CFR 101.91 as containing up to 19.9 ppm gluten
(uniform distribution between 0 and 19.9). We assumed zero gluten from inherently gluten-free food and
from sources other than food. Changing this assumption to add trace amounts of gluten from these foods

21

or other sources would have increased the percentage of diets that contained more than 50 mg gluten.
This would have inflated the estimate of the number of people harmed at the baseline.
The highest amount of gluten that can be safely consumed each day by individuals with celiac
disease is not known and is likely to vary from person to person. For the purposes of the economic
analysis, we choose a value for harm of 50 mg of gluten per day because this amount has been shown to
cause morphological damage to most individuals with celiac disease in a double-blind, placebocontrolled challenge study [5]. This choice produces a tendency toward underestimation of the true
scope for benefits of the rule, because it underestimates the baseline harm. As we explain in section
II.F.b., Other Potential Benefits, individuals with celiac disease are probably harmed by consuming
smaller amounts of gluten daily, and this rule would also reduce intake at those levels.
The simulation results in roughly 1.6% (1,600) of the simulated diets containing more than 50
mg of gluten. This result is not significantly affected by our choice of the gamma distribution to model
the amount of each food consumed. A simulation where people consumed exactly 82 grams of all foods
resulted in about 1.8% (1,800) of diets containing more than 50 mg of gluten. We choose the gammadistribution simulation because it is a more accurate model and lessens the chance of overestimating the
benefits of the rule. However, since the publication of the gluten-free final rule (published in the Federal
Register on August 5, 2013 at 78 FR 47154, now codified at 21 CFR 101.91), consumption patterns of
fermented and hydrolyzed foods may have changed. In particular, consumers may have reduced their
consumption of these products since they may not have had confidence in the labeling of hydrolyzed and
fermented products bearing the “gluten-free” claim due to the issues with evaluating compliance.
Because we do not have information that would allow us to estimate changes in consumption of
fermented and hydrolyzed foods over time, we model this parameter as a triangular distribution with
minimum 0.5%, peak 1%, and maximum 1.6%.5 We use a wide range with 1.6% as a maximum to
account for potential decreases in consumption of covered products that may have followed the first
gluten-free final rule.

5

Due to the dearth of reliable data, we use probability distributions at multiple points in the analysis. Given that less
than 2% of the simulated diets reach the 50 mg threshold, the tails of distributions have outsized importance. Fairly small
deviations from uniformity could produce quite different estimates of how many diets exceed the threshold, so it is unclear
whether the 1.6% estimate is meaningful.
22

We multiply the estimate of the percentage of gluten-free diets with 50 mg or more of gluten
daily by the number of individuals with celiac disease on a gluten-free diet to produce an estimate of
approximately 4,326 individuals with celiac disease harmed by the consumption of fermented or
hydrolyzed foods carrying the “gluten free” label and containing 20 ppm or more gluten as part of their
diet (1%*432,600=4,326). For purposes of this analysis, this assumes that each of these diets contains
daily consumption of at least some fermented or hydrolyzed products labeled as “gluten-free.”[24]6
c. QALY Loss from Baseline Consumption and Social Cost
Our approach to estimating the benefits of being in good health (health benefits) involves the use
of Quality-Adjusted Life Years (QALYs). QALYs can be used to measure the loss of well-being that an
individual suffers due to a disease or condition. The QALY calculation does not include the cost of
medical expenditures caused by the illness in question. QALYs range from 0 to 1, where 0 is equivalent
to death and 1 is equivalent to perfect health for one year.
A number of methods have been constructed to measure QALYs. The studies that we reference
use the EQ-5D health index to calculate changes in QALY as a result of celiac disease. The EQ-5D
index allows us to estimate an individual’s disutility from being ill in terms of the number of QALYs
lost due to that illness. As shown in Table 5, the EQ-5D scale consists of five domains, with 3 levels for
each domain, that assess an individual’s mobility, ability to perform self-care activities, ability to
perform usual activities (such as going to work or school), level of pain and discomfort, and level of
anxiety and depression as a result of their medical condition.
Table 5. EQ-5D Health Status Classification System
Domain
Mobility

Attribute
Level
1
2
3

Description
I have no problems walking about
I have some problems walking about
I am confined to bed

6
Implicit in this approach is the assumption that no consumers with celiac disease who comply with strict diets
would be confused by claims (e.g., ‘processed to remove gluten’) that are permitted for products that do not meet the
requirements of this rule and thus might contain more than 20 ppm of gluten. Providing support for this assumption is
consumer research that shows that people with celiac disease insist on words or symbols that say ‘gluten-free’ and distrust
other claims.

23

1
Self-Care
2
3
1
Usual Activities
2
3
1
Pain/Discomfort
2
3
1
Anxiety/Depression 2
3

I have no problems with self-care
I have some problems washing or dressing myself
I am unable to wash or dress myself
I have no problems with performing my usual activities
I have some problems with performing my usual activities
I am unable to perform my usual activities
I have no pain or discomfort
I have moderate pain or discomfort
I have extreme pain or discomfort
I am not anxious or depressed
I am moderately anxious or depressed
I am extremely anxious or depressed

We found three articles that reported EQ-5D scores for individuals with celiac disease [25-28].
These studies either compared the reported health outcomes of celiac who did not follow a gluten-free
diet to those who adhered to a gluten-free diet, or they compared the change in health outcomes for
patients newly diagnosed celiac who switched to a gluten-free diet after their diagnosis. The reported
increases in EQ-5D scores as a result of adhering or switching to a gluten-free diet were 0.20, 0.21, and
0.27. Given that treatment for celiac disease is the removal of gluten from the diet, we conclude that
exposing an individual with celiac disease to the levels of gluten in the average diet results in a mean
QALY loss of 0.23 ([0.2+0.21+0.27]/3=0.227).
We do not have dose-response relationships for gluten in people with celiac disease, so we do
not know how the QALY loss that such individuals experience from consuming 50 mg of gluten daily
compares with the QALY loss from consuming a non-gluten-free diet. Given the morphological changes
caused by 50 mg of gluten [7], we assume a low estimate that 50 mg of gluten causes 5% of the harm a
non-gluten-free diet would cause.
We have an estimate that inadvertent partial compliance with the gluten-free diet causes a QALY
loss of 0.09 [26]. We use this to generate a high estimate that 50 mg of gluten causes 30% of the harm a
non-gluten-free diet would cause.
We have studies showing that prolonged exposure to amounts of gluten smaller than 50 mg daily
causes some individuals with celiac disease to report symptoms that lower their quality of life [29, 30],

24

but these studies do not provide EQ-5D scores. We use these studies to generate a best estimate that 50
mg of gluten causes 10% of the harm a non-gluten-free diet would cause.
The mean of the triangular distribution generated by these estimates is 15% ([5+30+10]/3=15).
This means that, on average, an individual with celiac disease who consumes more than 50 mg of gluten
daily as a result of exposure to gluten from foods carrying the “gluten free” label that contain 20 ppm or
more gluten suffers a QALY loss of 0.035 (0.23*15%=0.0345).
Multiplying the estimate of the number of individuals with celiac disease harmed by the estimate
of the QALY loss of the harm produces an estimate of approximately 160 QALYs lost each year from
“gluten-free” food with levels of gluten of 20 ppm or higher (4,326*0.035=151.4).
We monetize this QALY value using the guidelines for regulatory impact analyses from the U.S.
Department of Health and Human Services [31]. The central 2018 value of a QALY, at a 7% discount
rate, is $871,000 and $524,000 at 3% discount rate. Using this value, the current social loss from food
labeled “gluten-free” with 20 ppm or more gluten is approximately $131.5 million annually
(151*$871,000=$131,521,000) at 7% discount rate, and $79 million annually
(151*$524,000=$79,124,000) at 3% discount rate. Dividing the annual estimate of social loss by
potential total number of persons with celiac disease (i.e. 4,326), the estimated cost per person ranges
between $18,000 and $30,000 per person per year. Since these costs are relatively high, it may be
unlikely that morbidity of such magnitude would fail to prompt consumers to shift to less-painful food
options even in the absence of the rule. For this reason, we are hesitant to describe the results of our
simulated analysis as quantitative. We instead use a break-even discussion to qualitatively compare
these simulated benefits to costs of the rule.
Table 6 summarizes the variables and the results of the calculations explained above, using mean
values for all variables:
Table 6. Baseline Harm Calculation Summary
Variable
Non-institutionalized Civilian Population Over 5 Years Old
Percent of Population Diagnosed with Celiac Disease (CD)
Individuals Diagnosed with CD
Percent of CD-Diagnosed Individuals on “gluten-free” Diet

25

Mean Value
298,600,000
0.21%
627,000
69%

CD-Diagnosed Individuals on “gluten-free” Diet
Percent of “gluten-free” Diets Above 50 mg *
CD-Diagnosed Individuals on “gluten-free” Diet Consuming >50 mg
of gluten *
QALY Loss for Untreated Celiac Disease *
Severity of 50 mg Compared to Untreated *
QALY Loss for >50 mg of gluten *
Annual QALY Loss from High-gluten Food *
Value of QALY loss (3% Discount rate) *
Value of QALY loss (7% Discount rate) *
Total Annual Baseline Harm (3% Discount rate) *
Total Annual Baseline Harm (7% Discount rate) *
* Simulated analysis; results not claimed as regulatory baseline.

432,600
1.0%
4,326
0.23
15%
0.035
151
$524,000
$871,000
$79,000,000
$131,500,000

d. Gluten Consumption with Rule
Next, we simulated gluten-free diets after the rule. We assumed full compliance with the rule.
Even under the unlikely worst-case scenario where all “gluten-free” labeled products contain up to 19.9
ppm gluten and people consume those products exclusively rather than inherently gluten-free unlabeled
food, not one of 100,000 simulated diets contained more than 50 mg of gluten daily. The average diet
had 12 mg of gluten daily. Therefore, for the purpose of this simulated analysis, we assume that all harm
associated with the consumption of more than 50 mg of gluten daily by individuals with celiac disease,
who comply with a gluten-free diet, would be ended by the rule even under the worst-case scenario.
If the rule results in some foods that previously bore a “gluten-free” claim no longer being able
to bear the “gluten-free” claim, consumers who are seeking “gluten-free” packaged foods may change
their consumption away from those products. To the extent that consumers preferred those products to
the gluten-free products they may now choose instead, our analysis should consider the possibility of
consumers’ lost pleasure from such substitution. We lack the information to quantify this effect,
because among other reasons, consumers’ behavior may be driven by habit, and their preferences may
not be consistent over time. As a result, consumers may make different choices regarding products they
like that may have negative consequences for their health over time. Due to this uncertainty about
consumer behavior, the health benefits simulated above do not account for potential lost utility, thus
increasing overall uncertainty in our total simulated benefits.
e. Other Potential Benefits

26

NHANES survey data from 2009 to 2014 show that 1.11% of the U.S. civilian noninstitutionalized population is on a gluten-free diet without a diagnosis of celiac disease [17]. As
previously noted, 0.21% of individuals have been told by a medical professional that they have celiac
disease. However, after including undiagnosed individuals who test positive for celiac disease with a
serological test, the estimated prevalence of celiac disease in the U.S. population of both diagnosed and
undiagnosed individuals is 0.72% [17]. This estimate suggests there are many undiagnosed individuals
with celiac disease in the population. As a result, we believe that many of these people would gain the
same benefit from a gluten-free diet as individuals diagnosed with celiac disease.
Individuals with undiagnosed celiac disease on a gluten-free diet would suffer the same harm
from foods carrying the “gluten free” label that contain 20 ppm or more gluten as individuals with
diagnosed celiac disease, but we do not know how many people on a gluten-free diet actually have
celiac disease and how closely they comply with the diet. It is possible that a significant percentage of
people on a gluten-free diet are individuals with undiagnosed celiac disease who have good compliance
with the diet. If this were the case, then the harm done by foods carrying the “gluten free” label that have
20 ppm or more gluten would be much greater than we estimate in the preceding simulation analysis.
As discussed above, 0.14% of the U.S. population consists of people with diagnosed celiac
disease who comply with a gluten-free diet (0.21%*68%=0.14%). For example, chosen for ease of
presentation, if one-sixth of the people on a gluten-free diet were individuals with undiagnosed celiac
disease with good compliance, then there would be an additional 0.1% of the population benefiting from
the rule (0.68/6=0.103).
In addition to eliminating diets with more than 50 mg of gluten per day, the rule would reduce
the percentage of diets with levels of gluten that might cause lesser harm. About 1.7% of simulated
baseline gluten-free diets have between 20 mg and 50 mg of gluten per day. After the rule is in place,
about 0.9% of diets have between 20 mg and 50 mg of gluten per day. If levels of gluten between 20 mg
and 50 mg per day cause health problems for individuals with celiac disease, then those health problems
would be reduced as a result of the rule.
The distribution of gluten in the simulated diets is extremely right-skewed. Over two-thirds of all
diets with more than 50 mg of gluten per day had over 100 mg of gluten per day. In our simulation
analysis, we assumed that all diets with more than 50 mg of gluten per day cause the same harm.

27

However, diets with larger amounts of gluten, such as 100 mg per day, may cause substantially more
harm.
Untreated celiac disease can cause premature mortality in addition to losses in quality of life [1].
We do not have any information on the mortality effects of smaller doses of gluten, but it is possible that
prolonged exposure to 50 mg of gluten or more also causes premature mortality. By removing this
source of gluten, the rule may benefit individuals with celiac disease by preventing early death in
addition to the benefit from improved quality of life.
In addition to the harm done to quality of life, untreated celiac disease can cause increased
medical expenses. However, we do not know the additional medical expenses incurred by people who
are complying with a gluten-free diet but who are exposed to gluten from hydrolyzed or fermented foods
currently labeled “gluten-free.” We believe that these medical costs are small compared to the QALY
loss, but reducing these medical costs is an additional benefit of this rule.
There are many people who choose a gluten-free diet for reasons other than celiac disease. For
example, people who do not suffer from celiac disease but who are allergic to wheat often use the
“gluten-free” label to quickly identify foods that are free from the wheat proteins that trigger their
allergic reactions. These people would also benefit from the rule. Anyone who is on a gluten-free diet
for any reason would benefit from the reduction in search costs, if they start using and trusting the
“gluten-free” label as a result of this rule.
f. Break-even Analysis
Our simulated benefits analysis showed that the primary annualized benefits of this rule could
potentially range from $71.9 million at a 3% discount rate to $119.2 million at a 7% discount rate. For
the rule to break even with costs, the annualized benefits would need to be at least $8.8 million at a 3%
discount rate and $9.1 million at a 7% discount rate. Put differently, the simulated benefits would have
to be overestimated thirteen-fold before they would fail to offset the costs of the rule at a 7% discount
rate. Of the estimated population of 432,600 individuals with celiac disease complying with a glutenfree diet, the rule would break even with primary costs discounted at 7% if at least 0.07% of these
individuals benefited each year ($9.1 million/$30,000 = 303 individuals; 303/432,600 = 0.07%). While
these results should be interpreted with caution given the uncertainty underpinning our simulated

28

benefits, they suggest that the health benefits would need to be minimal for the final rule to fail to break
even with costs.
G. Distributional Effects
We do not anticipate any significant distributional effects as a result of this regulation. The costs
are split between consumers and business owners or shareholders, while the benefits go to the subset of
consumers who are currently suffering from health problems.
H. International Effects
We do not anticipate any significant effects of this regulation on international trade. Domestic
and foreign manufacturers pay equal compliance costs for each product they sell in the US.
I. Uncertainty and Sensitivity Analysis
In Tables 3, 4, 5, and 6 of this document and elsewhere, we present point estimates. While this is
a convenient way to summarize the effects or potential scope of the rule and explain our calculation, the
use of point estimates neglects the large degree of uncertainty intrinsic to the underlying analysis. In
Table 7 of this document, we present the results of a Monte Carlo simulation of uncertainty for the final
estimates of annual costs of the rule and for the simulated analysis regarding the scope of potential
benefits.
All parameters are defined as probability distributions. In our Monte Carlo simulation, we use
samples from the probability distributions rather than using the mean values. The randomly chosen
numbers are used to form a final estimate. This procedure is repeated 10,000 times, and the results are
ranked from lowest to highest. We report the distribution for each input parameter, and the 5th percentile,
mean, and 95th percentile of the simulated results.
We relied on NHANES survey estimates of 22,277 people for a prevalence estimate of 0.21% of
the population diagnosed with celiac disease. The standard error of this sample will be approximately
0.03% ((0.21%*99.862%/22,277) ^ 0.5=0.029%). Therefore, we use a normal distribution with a mean
of 0.21% and a standard deviation of 0.03%. We truncate this distribution at zero, because there cannot
be a negative percentage of individuals with celiac disease.

29

As we described above, the estimate for compliance with a gluten-free diet is a triangular
distribution with minimum 45%, peak 79%, and maximum 80%.
Our 100,000 simulations of the diets before the rule were split into ten simulation runs of 10,000
diets each. The percentage of diets with more than 50 mg of gluten before the rule varied from 1.4 to 1.8
across simulation runs, with most results clustered around 1.6. We describe this parameter as a triangular
distribution with minimum 0.5%, peak 1%, and maximum 1.6%. We use a wide range with 1.6% as a
maximum to account for potential decreases in consumption of covered products that may have followed
since the final rule on gluten-free labeling of food published in 2013 (codified at 21 CFR 101.91).
As described above, three estimates of QALY loss from untreated celiac disease are 0.20, 0.21,
and 0.27. We draw the QALY loss from a triangular distribution with minimum 0.20, peak 0.21, and
maximum 0.27. We draw the percentage harm that 50 mg of gluten causes compared to a non-glutenfree diet from a triangular distribution with minimum 5%, peak 10%, and maximum 30%.
We drew the cost of lab tests from a triangular distribution with minimum $96, peak $103, and
maximum $138, reflecting the sum of testing and handling costs. We drew the number of products
requiring new testing from a discrete uniform distribution with minimum 0 and maximum 2500.
We drew the number lab tests ordered in the first year from a discrete uniform distribution with
minimum 2 and maximum 12. We drew the cost of method extension from a triangular distribution with
minimum $1,000, peak $2,500, and maximum $10,000.
We drew the annual number of test kits used per UPC from a triangular distribution with
minimum 2, peak 12, and maximum 50. We drew the annual number of lab tests ordered from a discrete
uniform distribution with minimum 0 and maximum 2.
We drew the number of products requiring new SOPs from a discrete uniform distribution with
minimum zero and maximum 2500. We drew the cost of allergen control equipment from a uniform
distribution with minimum $0 and maximum $2,000.
The labeling cost model produced low, midpoint, and high estimates. Annualized at a 7% cost of
capital, these are $0.19 million, $0.34 million, and $0.56 million, respectively. We drew labeling costs
from a triangular distribution with low, peak, and high values equal to these low, mid, and high
estimates.

30

Table 7 shows these results. The “Low” column shows the low estimates for the inputs and the
5th percentile of the simulation results. The “Median” column shows the medians for the inputs and
simulation results. The “High” column shows the high estimates for the inputs and the 95th percentile of
the simulation results. All results are rounded to the nearest million for clarity and to prevent a false
impression of precision.
Table 7. Analysis of Uncertainty Summary
Variable
Low Median
High
Cost of Lab Test
$96
$103
$138
Products Requiring New Testing
0
1,250
2,500
Products Requiring New SOP
0
1,250
2,500
Allergen Control Equipment Costs
$0
$1,000
$2,000
Initial Lab Tests
2
7
12
Method Extension Cost
$1,000
$2,500
$10,000
Number of Test Kits Used Annually
2
21
50
Number of Annual Lab Tests
0
1
2
Annualized Relabeling Costs (Millions)
$0.19
$0.34
$0.56
Annual Costs: 3% discount (Millions)
$7
$9
$11
Annual Costs: 7% discount (Millions)
$7
$9
$11
Percent of Population Diagnosed with CD
0.16%
0.21%
0.26%
Percent of CD Diagnosed People on “gluten-free”
45%
69%
80%
Diet
Percent of “gluten-free” Diets Above 50 mg *
0.5%
1%
1.6%
QALY Loss for Untreated Celiac Disease *
0.2
0.227
0.27
Average Severity of 50 mg Compared to Untreated *
5%
15%
30%
Value of QALY: 3% discount rate *
$244,000 $524,000 $ 797,600
Value of QALY: 7% discount rate *
$407,000 $871,000 $1,326,000
Annual Benefits: 3% discount (Millions) *
$31
$72
$152
Annual Benefits: 7% discount (Millions) *
$53
$119
$254
* Simulated analysis; results not claimed as benefits of the rule.

Because many uncertainties could not be measured, Table 7 should not be seen as a complete
characterization of the uncertainty underlying the analysis.
A big driver of uncertainty is likely to be the fact that there is a wide range of sensitivity to
gluten among individuals with celiac disease. If each individual has a unique “dose-response” to gluten
exposure, then there would also be individual variability with respect to QALY loss. There is no

31

research that defines the distribution of gluten sensitivity across the population [32], so our simulated
benefits analysis reflects averages from small and limited studies.
J. Analysis of Regulatory Alternatives
We have identified two regulatory alternatives:
1. Prohibit the “gluten-free” claim on all fermented and hydrolyzed foods; and
2. Limit the requirements of the rule to a subset of fermented and hydrolyzed foods.
1. Prohibit the “Gluten-Free” Claim on Fermented and Hydrolyzed Foods
Another regulatory alternative is to prohibit the “gluten-free” claim on all fermented and
hydrolyzed foods, due to the uncertainty in interpreting the results of current gluten test methods for
fermented and hydrolyzed foods on a quantitative basis that equates the test results in terms of intact
gluten in order to verify their compliance with the 20 ppm requirement.
This alternative would mean that manufacturers who are making good-faith attempts to produce
gluten-free fermented or hydrolyzed foods, or foods that contain such ingredients, would not be able to
distinguish these products from ordinary products by using the “gluten-free” claim. While manufacturers
could develop statements that might be informative about gluten content, these statements may not be
helpful for consumers without a clear a regulatory standard. Without certainty about gluten content,
celiac consumers might avoid such products to decrease their risk of gluten exposure. Moreover, without
a regulatory standard, firms may not be able to differentiate themselves adequately by offering “glutenfree” products. This alternative would reduce the incentives for manufacturers to market such products.
They would not have the option of demonstrating compliance by documenting appropriate ingredients
and processes and may be forced to bear relabeling costs if they currently make a “gluten-free” claim. If
we assume that all affected products would incur no other costs but those to relabel, the annualized cost
of the rule at a 7% discount rate is $0.3 million.
This alternative could reduce the chances that individuals with celiac disease are exposed to
potentially harmful gluten fragments from fermented and hydrolyzed foods if individuals avoid these
foods entirely. However, the removal of such products from the “gluten-free” market would reduce the
dietary options and/or increase the search costs of people with celiac disease. Alternatively, celiac

32

consumers may continue consuming such products at risk to their health due to lack of labeling clarity.
This could reduce their compliance with a gluten-free diet and result in health problems.
2. Limit the Requirements of the Rule to a Subset of Fermented and Hydrolyzed Foods
Another regulatory alternative is to make the requirements of this rule apply only to a subset of
fermented and hydrolyzed foods containing ingredients deemed to be at high risk of gluten crosscontact, for example legumes, grains, and seeds. This alternative would have lower costs than the rule,
but also lower benefits.
According to the FoodEssentials database [7], approximately one-fifth of all fermented or
hydrolyzed foods labeled “gluten-free” contain legumes, grains, and seeds,7 and, according to FDA
subject matter experts, these foods are at a higher risk of gluten cross-contact than vegetables, meats,
and dairy due to the way they are typically transported and stored. We estimate that the total annualized
costs of this alternative (if the rule only applied to foods that are or contain hydrolyzed legumes, grains,
or seeds) would be about $7.2 million less than the total costs of the rule ($9 million * 0.8 = $7.2
million). 
III. Small Entity Analysis
The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would
minimize any significant impact of a rule on small entities. Because small firms may have annualized
costs (over ten years at a seven percent discount rate) that do not exceed one percent of their annual
revenue, we certify that the proposed rule will not have a significant economic impact on a substantial
number of small entities. This section serves as the Final Regulatory Flexibility Analysis, as required
under the Regulatory Flexibility Act.

7

This figure excludes distilled vinegar.

33

A. Description and Number of Affected Small Entities
The Small Business Administration (SBA) publishes size standards for industry categories of
firms defined by North American Industry Classification System (NAICS) codes. SBA defines each
NAICS code’s small business threshhold either in terms of sales revenue or number of employees of a
firm. Using the 2019 SBA size standards8 in conjunction with the Statistics of U.S. Businesses (SUSB)
counts of firms in each NAICS code by revenue and employment size,9 we estimate the numbers of
covered small firms by industries that may be affected by the final rule. Our first step is to broadly
identify the number of affected industries by different sizes using annual total receipts and number of
employees. Table 8 lists these industries by both annual receipts and number of employees based on
broad three- and four-digit NAICS code categories.
Next we estimate proportion of small industries that will be affected by the rule. We determine
that between 97 to to 98 percent of industries coverd by this rule are composed of small businesses by
SBA standards (number of employees). We do not have information that would allow us to estimatethe
proportion of firms in each industry involved in the production of fermented and hydrolyzed foods.
Table 8 shows estimated counts of small firms that may be affected by the rule.

Table 8: Summary of Potential Industry Sectors Affected by the Rule
2012
NAICS
Code

NAICS
Industry Description

Number of
Employees

Number
of Firms

Total
Annual
Revenue
($ millions)

Revenue per
Firm
($ millions)

Size
Standard
(Number of
Employees)

311

Food Manufacturing

<10

12,500

10,658

0.85

500

311

Food Manufacturing

10-19

3,439

10,526

3.1

500

311

Food Manufacturing

20-99

3,849

54,954

14.3

500

311

Food Manufacturing

100-499

1,291

116,558

90.3

500

311

Food Manufacturing

500+

542

646,864

1,193

500

3121

Beverage Manufacturing

<10

2,943

2,015

0.68

750

8

Small Business Association. Table of Size Standards. Aug 19, 2019. Available from:
https://www.sba.gov/document/support--table-size-standards
9
We use the 2012 SUSB, the last release that contained revenue data, and inflate revenues to 2019-dollar values
using the GDP deflator. Available from: https://census.gov/data/datasets/2012/econ/susb/2012-susb.html
34

3121

Beverage Manufacturing

10-19

606

1,817

3.0

750

3121

Beverage Manufacturing

20-99

592

5,988

10.1

750

3121

Beverage Manufacturing

100-499

133

10,479

78.8

750

3121

Beverage Manufacturing

500+

79

94,651

1,198

750

B. Description of the Potential Impacts of the Rule on Small Entities
We calculate costs to small firms based on our primary estimates. Table 9 breaks down the
annual cost of implementing the rule per UPC per firm. A key assumption we make in this analysis for
small businesses is that each firm may incur compliance costs for one UPC product only. We assume
that all covered small entities would incur one-time costs to validate the gluten free tests. Some covered
small entities may also incur a one-time capital investment cost and a one-time SOP training cost, as
well as recurring annual testing and labeling costs. In our assessment of one-time costs, most of these
would be less than $500 per UPC per firm, and these costs may not be incurred for all small businesses.
Table 9: Annual Cost of Complying to Gluten Free Rule per Firm per Product
Compliance Activities
Gluten Testing and Validation
Standards of Operating Procedures (SOP)
Relabeling
Paperwork
Annualized total cost per UPC product

Primary Estimate
$2,464
$1,330
$978
$896
$5,667

We use 2019-inflated annual firm receipts from the 2012 SUSB. The firm receipts are used to
estimate the magnitude of costs as a percent of the revenues of potentially affected small firms. We
consider costs per firm exceeding one percent of annual revenues to be a substantial impact. Table 10
shows our estimate of the annual costs as a percentage of revenue for small firms, broken down by broad
industry categories expected to be affected by the rule. We expect costs as a percentage of annual
revenue to range from about 0% to 0.8% for each of the industries that would potentially be affected by
the rule. These percentages are likely overestimates for firms with <10 employees, because our cost
estimates assume that at least ten employees will require training.
Table 10: Annual costs of rule compliance per firm as a percentage of small firm annual revenue

35

2012
NAICS
Code

NAICS
Industry Description

Number of
Employees

Costs as a percent
of annual revenue
(primary)

311

Food Manufacturing

<10

0.7%

311

Food Manufacturing

10-19

0.2%

311

Food Manufacturing

20-99

0.0%

311

Food Manufacturing

100-499

0.0%

311

Food Manufacturing

500+

0.0%

3121

Beverage Manufacturing

<10

0.8%

3121

Beverage Manufacturing

10-19

0.2%

3121

Beverage Manufacturing

20-99

0.1%

3121

Beverage Manufacturing

100-499

0.0%

3121

Beverage Manufacturing

500+

0.0%

C. Alternatives to Minimize the Burden on Small Entities
Based on annual firm receipts and number of employees per firm, most firms in potentially
affected industries would qualify as small entities. Our analysis shows that small firms would not be
impacted significantly. Nevertheless, since the rule requires the firms to voluntarily declare whether or
not their products are gluten-free, it also allows flexibility on how firms can integrate proposed changes
into their business plans. For example, firms could coordinate labeling changes with already-scheduled
relabelling activities, which may reduce annual costs per UPC by nearly 40 percent.

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38