Use of the Names of Dairy Foods in the Labeling of Plant-Based Products, 49103-49107 [2018-21200]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Notices]
[Pages 49103-49107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21200]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3522]


Use of the Names of Dairy Foods in the Labeling of Plant-Based 
Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or we) invites comments 
on the labeling of plant-based products with names that include the 
names of dairy foods such as ``milk,'' ``cultured milk,'' ``yogurt,'' 
and ``cheese.'' We are interested in learning how consumers use these 
plant-based products and how they understand terms such as, for 
example, ``milk'' or ``yogurt'' when included in the names of plant-
based products. We also are interested in learning whether consumers 
are aware of and understand differences between the basic nature, 
characteristics, ingredients, and nutritional content of plant-based 
products and their dairy counterparts. We are taking this action to 
inform our development of an approach to the labeling of plant-based 
products that consumers may substitute for dairy foods.

DATES: Submit either electronic or written comments on this document by 
November 27, 2018.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before November 27, 2018. The https://www.regulations.gov electronic filing system will accept comments until 
midnight Eastern Time at the end of November 27, 2018. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

[[Page 49104]]

     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2018-N-3522 for ``Use of the Names of Dairy Foods in the Labeling 
of Plant-Based Products.'' Received comments, those filed in a timely 
manner (see ADDRESSES), will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
https://www.regulations.gov or at the Dockets Management Staff between 
9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For more information about FDA's posting of comments to public dockets, 
see 80 FR 56469, September 18, 2015, or access the information at: 
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Mabel Lee, Center for Food Safety and 
Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740, 240-402-2371.

SUPPLEMENTARY INFORMATION: 

I. Background

A. Introduction

    Over the past several years, there has been an emergence and 
expansion of plant-based products labeled with names that include the 
names of dairy foods such as ``milk'' (e.g., ``soy milk,'' ``almond 
milk''), ``cultured milk'' (e.g., ``coconut kefir''), ``yogurt'' (e.g., 
``soy yogurt,'' ``almond milk yogurt''), and ``cheese'' (e.g., ``vegan 
mozzarella cheese''). These products are often packaged in the same 
kinds of cartons, tubs, or bottles as their dairy counterparts and 
sometimes are sold in or adjacent to the dairy display in stores. 
However, these plant-based products may not have the same basic nature, 
essential characteristics, and characterizing ingredients as their 
dairy counterparts and may differ in their performance characteristics 
(e.g., physical properties, flavor characteristics, functional 
properties, or shelf life) such that they are not suitable substitutes 
for certain uses. Some plant-based products also may contain less 
nutrients than their dairy counterparts and may not meet the 
recommendation for dairy food group intake in the ``2015-2020 Dietary 
Guidelines for Americans'' (Dietary Guidelines) (Ref. 1).
    We are interested in learning how consumers use these plant-based 
products and how they understand terms such as, for example, ``milk'' 
or ``yogurt'' when included in the labeling of plant-based products. We 
are interested in learning whether consumers are aware of and 
understand the basic nature, essential characteristics, characterizing 
ingredients, and nutritional differences between plant-based products 
and dairy foods.

B. Legal Authority

1. What is FDA's statutory and regulatory authority relating to the 
naming of food?
    The Federal Food, Drug, and Cosmetic Act (FD&C Act) provides for 
two general categories of food: Standardized food and nonstandardized 
food. (See sections 401 and 403(g), (h), and (i) of the FD&C Act (21 
U.S.C. 341 and 343(g), (h), and (i)).) Both standardized foods and 
nonstandardized foods are generally named by their common or usual 
names. When a food is standardized, the standard is promulgated in a 
regulation under the common or usual name of the food under section 401 
of the FD&C Act. The common or usual name of the food must be declared 
on the principal display panel of the label when the food is in package 
form. (See Sec.  101.3(b)(1) (21 CFR 101.3(b)(1).) Foods that are not 
standardized are also required to bear the common or usual name of the 
food on their labels when such a name exists (section 403(i)(1) of the 
FD&C Act and Sec.  101.3(b)(2)). The common or usual name of a food is 
the name by which it is known to the American public and is generally 
established by common usage (Sec.  102.5(d) (21 CFR 102.5(d)).
    However, in certain instances where the common or usual name of a 
nonstandardized food is found to be misleading or to cause 
confusion,\1\ we have established a new common or usual name by 
regulation (see 21 CFR part 102, subpart B). When establishing the 
name, we consider the principles set forward in Sec.  102.5(a) through 
(c), such as whether the name accurately identifies the food or 
describes its basic nature or characterizing properties or ingredients. 
We also consider whether the name is uniform among similar products and 
is not confusingly similar to the name of any other food that is not 
reasonably encompassed within the same name. The common or usual name 
established by regulation is then the name required to be declared on 
the label of the food (Sec.  101.3(b)(1)).
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    \1\ The FD&C Act prohibits labeling that is false or misleading 
(sections 403(a)(1) and 201(n) of the FD&C Act).
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2. What is FDA's statutory and regulatory authority regarding food 
standards?
    Our authority to establish food standards is set forth in section 
401 of the FD&C Act, which provides, in part, that to promote honesty 
and fair dealing in the interest of consumers we can promulgate 
regulations fixing and establishing for any food, under its common or 
usual name so far as practicable, a reasonable definition and standard 
of identity, a reasonable standard of quality, or reasonable standards 
of fill of container.
    Under section 403(g) of the FD&C Act, a food is misbranded if it 
purports to be or is represented as a food for which a definition and 
standard of identity has been prescribed by regulation, unless it 
conforms to such definition and standard. Misbranded food is prohibited 
from introduction or delivery for introduction into interstate commerce 
(section 301(a) of the FD&C Act) (21 U.S.C. 331(a))). The factors 
considered

[[Page 49105]]

in determining whether a food purports to be or is represented as a 
standardized food are not limited to the name or labeling of the food; 
other factors (for example, location in the grocery store or appearance 
of the package or container) may be relevant.
3. FDA's Standard of Identity Regulations for Certain Dairy Foods: 
Milk, Cultured Milk, Yogurt, and Cheese
    Standards of identity are established for milk and cream in 21 CFR 
part 131, subpart B. Each of these standards requires the use of milk 
or ingredients derived from milk (e.g., cream, nonfat milk). In this 
document, we discuss the standards of identity for milk, cultured milk, 
yogurt, lowfat yogurt, and nonfat yogurt for illustration purposes. We 
also discuss 21 CFR part 133, which sets forth definitions and 
standards of identity for cheeses and related cheese products.
    Milk is a standardized food and is described in Sec.  131.110(a) 
(21 CFR 131.110(a)), in part, as the lacteal secretion, practically 
free of colostrum, obtained by the complete milking of one or more 
healthy cows. Generally, milk serves as a dietary source of protein, 
calcium, vitamin A, and potassium. The standard of identity permits 
optional fortification with vitamins A and D to increase nutrient 
content (Sec.  131.110(b)). The common or usual name of food that 
purports to be or is represented as milk and conforms to the standard 
of identity is ``milk.''
    Cultured milk is a standardized food and is produced by culturing 
cream, milk, partially skimmed milk, and/or skim milk with 
characterizing microbial organisms (Sec.  131.112(a) and (c) (21 CFR 
131.112(a) and (c))). The standard of identity permits optional 
fortification with vitamins A and D to increase nutrient content (Sec.  
131.112(b)). The common or usual name of a food that purports to be or 
is represented as cultured milk and conforms to the standard of 
identity is ``cultured milk.'' However, the name of the food may be 
accompanied by a declaration such as the traditional name of the food 
or the generic name of the organisms used, thereby indicating the 
presence of the characterizing microbial organisms or ingredients, 
e.g., ``kefir cultured milk'' (Sec.  131.112(f)).
    Yogurt is a standardized food produced by culturing cream, milk, 
partially skimmed milk, and/or skim milk with a characterizing 
bacterial culture (Sec.  131.200(a) (21 CFR 131.200(a))). The common or 
usual name of a food that purports to be or is represented as yogurt 
and conforms to the standard of identity is ``yogurt.'' Lowfat yogurt 
and nonfat yogurt are also standardized foods produced by culturing 
cream, milk, partially skimmed milk, and/or skim milk with a 
characterizing bacterial culture (Sec.  131.203(a) and Sec.  131.206(a) 
(21 CFR 131.203(a) and 131.206(a))); their common or usual names are 
``lowfat yogurt'' and ``nonfat yogurt,'' respectively. We note that 
certain provisions of the standards of identity for yogurt, lowfat 
yogurt, and nonfat yogurt have been stayed (47 FR 41519, September 21, 
1982). We also note that, in the Federal Register of January 15, 2009 
(74 FR 2443), we issued a proposed rule that would amend the standard 
of identity for yogurt and revoke the standards of identity for lowfat 
yogurt and nonfat yogurt. Revocation of the standards of identity for 
lowfat yogurt and nonfat yogurt would result in lower fat yogurt 
products being covered under the general standard in Sec.  130.10 (21 
CFR 130.10).
    Standards of identity are established for cheeses and related 
cheese products in 21 CFR part 133, subpart B. Each of these standards 
requires the use of milk or ingredients derived from milk (e.g., cream, 
nonfat milk). Milk is defined in Sec.  133.3(a) (21 CFR 133.3(a)), in 
part, as the lacteal secretion, practically free of colostrum, obtained 
by the complete milking of one or more healthy cows. However, some 
standardized cheeses (e.g., Caciocavallo siciliano cheese (Sec.  
133.111 (21 CFR 133.111)) and mozzarella cheese (Sec.  133.155 (21 CFR 
133.155)) allow for the use of milk from other mammals like sheep, 
goat, or water buffalo. When cheese is made from sheep's milk, goat's 
milk, or water buffalo's milk, the animal source of the milk is often 
declared on the label in conjunction with the name of the cheese (e.g., 
see Sec.  133.111(e)). The common or usual name of a food that purports 
to be or is represented as a standardized cheese or cheese product and 
conforms to the standard of identity is the name specified in the 
corresponding standard (e.g., cheddar cheese, provolone cheese, and 
swiss cheese).
    Standardized foods that have been modified in accordance with a 
nutrient content claim defined by regulation (e.g., ``low fat,'' 
``skim'') and that substitute for the standardized food are subject to 
the general standard under Sec.  130.10. If the modification results in 
loss of essential nutrients, the general standard requires the 
nutrients to be restored so that the modified food is not nutritionally 
inferior to the standardized food (Sec.  130.10(b)). Both the nutrient 
content claim and the name of the standardized food are included in the 
name of the modified food (e.g., ``low fat milk,'' ``skim milk''). In 
general, a standardized food that has been modified in accordance with 
a nutrient content claim defined by regulation and that substitutes for 
the standardized food is subject to the general standard under Sec.  
130.10, unless a specific standard of identity related to the 
modification exists (e.g., lowfat yogurt, nonfat yogurt, low sodium 
cheddar cheese).
    Plant-based products that resemble dairy foods, such as milk, 
cultured milk, yogurt, and cheese do not have standards of identity, 
and therefore are nonstandardized foods. Thus, these foods are subject 
to section 403(i)(1) of the FD&C Act and their labels must bear the 
common or usual name of the food.

II. Additional Issues for Consideration and Request for Information

    We invite comment, particularly data and other evidence, about: (A) 
The current market conditions and labeling costs of plant-based 
products; (B) consumer understanding, perception, purchase, and 
consumption of plant-based products, particularly those manufactured to 
resemble dairy foods such as, for example, milk, cultured milk, yogurt, 
and cheese; (C) consumer understanding regarding the basic nature, 
characteristics, and properties of these plant-based products; (D) 
consumer understanding of the nutritional content of plant-based 
products and dairy foods and the effect, if any, on consumer purchases 
and use; and (E) the role of plant-based products and dairy foods in 
meeting the recommendations in the Dietary Guidelines (Ref. 1). 
Specifically, we are interested in responses to the following 
questions. In responding to these questions, please identify the 
question by its associated letter and number (such as ``B.1'') so that 
we can easily associate your response with a specific question.

A. The Current Market Conditions and Labeling Costs of Plant-Based 
Products

    1. How many different types of plant-based products that are 
manufactured to resemble dairy foods such as, for example, milk, 
cultured milk, yogurt, and cheese, are on the market? Please provide 
any data or evidence to support your answer.
    2. What percentage of each subclass (e.g., soy or almond) of plant-
based products is marketed as a substitute for its dairy counterpart 
(e.g., milk, cultured milk, yogurt, or cheese)? What percentages of 
each subclass of plant-based products are marketed with names that 
include the name of a dairy

[[Page 49106]]

food (e.g., ``milk'') versus names that include another term (e.g., 
``beverage'' or ``drink'')? Please provide any data or evidence to 
support your answer.
    3. What are the costs associated with label changes? How often are 
labels revised?
    4. How are plant-based products displayed in stores? For example, 
are they sold in grocery stores next to or mixed with their dairy 
counterparts or are they sold in areas of the store that are separate 
or distinct from the areas where their dairy counterparts are sold? 
Does the packaging or display of these plant-based products affect 
consumers' perception or expectation about the nutritional properties 
or performance of these products?

B. Consumer Understanding, Perception, Purchase, and Consumption of 
Plant-Based Products, Particularly Those Manufactured To Resemble Dairy 
Foods Such as, for Example, Milk, Cultured Milk, Yogurt, and Cheese

    1. Why do consumers purchase and consume these types of plant-based 
products? How do they use these products? Specifically, do consumers 
purchase these plant-based products for use as substitutes for their 
dairy counterparts, or do consumers purchase these plant-based products 
for distinct uses? If consumers use these plant-based products as 
substitutes for dairy foods (for example plant-based beverages as 
alternatives to milk), what are their reasons? Do consumers think they 
are healthier, and if so, why? Are consumers purchasing these plant-
based products because they may be allergic to dairy or are lactose-
intolerant? Are consumers purchasing these plant-based products for 
reasons related to their personal consumption habits, such as a vegan 
diet? If consumers do not use these plant-based products as substitutes 
for dairy foods, what are their reasons for choosing these products? 
(For example, do these products provide unique taste, flavor, or 
texture?) Does consumer purchasing behavior differ if the consumer is 
purchasing the product for himself/herself as opposed to purchasing the 
product for a family member? Please provide any data or evidence to 
support your answer.
    2. Do consumers perceive these plant-based products to be more 
nutritious, as nutritious, or less nutritious than their dairy 
counterparts? If consumers perceive these plant-based products to be 
more nutritious or as nutritious as their dairy counterparts, to what 
extent does this affect their decision to buy plant-based products? 
Please provide any data or evidence to support your answer.
    3. Do consumers perceive or expect these plant-based products to 
perform in the same manner as their dairy counterparts? For example, 
milk can be an ingredient in preparing other foods. Do consumers expect 
plant-based beverage products to perform in the same manner as milk 
when preparing other foods or in recipes that use milk? Please provide 
any data or evidence to support your answer.
    4. How do consumers perceive or understand labeling of these plant-
based products? For example, do consumers perceive the labeling as 
suggesting that these plant-based products are equivalent to or can be 
substituted for their dairy counterparts? Do consumers perceive the 
labeling as suggesting that plant-based products are different or 
distinct from their dairy counterparts? Please provide any data or 
evidence to support your answer.
    5. We are aware that some plant-based beverage manufacturers use 
the term ``milk'' as part of the name of these foods while other 
manufacturers use terms such as ``beverage'' or ``drink'' as part of 
the name of these foods. Do consumers perceive plant-based beverages to 
be different if the term ``milk'' is used instead of ``beverage'' or 
``drink''? For example, how do consumers perceive or understand ``soy 
milk'' in comparison to ``soy-based beverage'' or ``soy drink''? Please 
provide any data or evidence to support your answer.

C. Consumer Understanding Regarding the Basic Nature, Characteristics, 
and Properties of Plant-Based Products

    1. What do consumers believe to be the basic nature, 
characteristics, or properties of plant-based products manufactured to 
resemble dairy foods such as, for example, milk, cultured milk, yogurt, 
and cheese? Is consumer understanding of the basic nature of plant-
based products influenced by inclusion of terms such as milk, cultured 
milk, yogurt, and cheese in the names in the labeling of these 
products? Do consumers expect plant-based products labeled with such 
names to have physical characteristics, performance characteristics, or 
properties of their dairy counterparts? If so, in what ways? Please 
provide any data or evidence to support your answer.
    2. What do consumers believe are the main ingredients of plant-
based products? What do consumers understand/think about the different 
protein sources being used to make these plant-based products? Do they 
understand that some of these plant-based products contain proteins 
from more than one plant source (e.g., almond and pea protein)? Are 
these beliefs or understanding influenced by the inclusion of dairy 
food names, particularly ``milk,'' ``cultured milk,'' ``yogurt,'' or 
``cheese,'' in the product name? Please provide any data or evidence to 
support your answer.
    3. What is consumers' understanding of the amount or proportion of 
plant-based ingredient(s) relative to other ingredients in plant-based 
products? Are consumers aware that other ingredients (e.g., 
emulsifiers, thickeners, sweeteners, and added nutrients such as 
vitamins and minerals) are used in the manufacture of these plant-based 
products? How does the use of these ingredients impact consumer 
perception of these products? Please provide any data or evidence to 
support your answer.
    4. Do these plant-based products vary in ingredients, even when 
manufactured using the same type of plant source (e.g., soy or almond)? 
If so, how? What are consumers' expectations regarding the ingredients 
of different brands of each subclass (e.g., soy or almond) of plant-
based products? What impact, if any, does the compositional variation 
have on purchase and consumption decisions? Please provide any data or 
evidence to support your answer.

D. Consumer Understanding of the Nutritional Content of Plant-Based 
Products and Dairy Foods and the Effect, if Any, on Consumer Purchases 
and Use

    1. Dairy foods, such as milk, cultured milk, yogurt, and cheese, 
may differ in nutritional content compared to plant-based products 
manufactured to resemble these dairy foods. What nutrients, if any, do 
consumers believe to be provided from dairy foods such as milk, 
cultured milk, yogurt, and cheese? What nutrients, if any, do consumers 
believe to be in plant-based products that resemble dairy foods, such 
as milk, cultured milk, yogurt, and cheese? Do consumers expect certain 
nutrients to be present in both plant-based products and their dairy 
counterparts, and, if so, what nutrients do they expect? Do these 
expectations change depending on the terms included in the names of 
plant-based products, e.g., ``milk,'' ``beverage,'' ``drink,'' 
``yogurt,'' ``yogurt alternative,'' ``vegan cheddar cheese,'' ``cheese 
shreds''? Please provide any data or evidence to support your answer.
    2. Do parents and caregivers who purchase these plant-based 
products for young children or other family members

[[Page 49107]]

believe that these plant-based products are nutritionally equivalent to 
their dairy counterparts and can replace them as a food choice? Are 
expectations of nutritional equivalency a factor in parents' and 
caregivers' decisions to purchase these plant-based products as part of 
young children's or other family members' balanced diet? Please provide 
any data or evidence to support your answer.
    3. Do these plant-based products vary in nutrient composition, even 
when manufactured using the same type of plant ingredients (e.g., soy 
or almond)? If so, how? What are consumers' expectations regarding the 
nutrient compositions of different brands of each subclass (e.g., soy 
or almond) of plant-based products? What impact, if any, does the 
compositional variation have on purchase and consumption decisions? 
Please provide any data or evidence to support your answer.
    4. We are aware that the United States Department of Agriculture's 
National Nutrient Database for Standard Reference (USDA Nutrient 
Database) provides information about the nutritional content of dairy 
foods as well as some plant-based products that resemble dairy foods 
(Ref. 2). However, we believe the USDA Nutrient Database may not be a 
full representation of all the varieties of dairy foods, including 
milk, cultured milk, yogurt, cheese, and of the plant-based products 
manufactured to resemble these dairy foods, currently in the United 
States marketplace. We are interested in any data regarding the 
nutritional profiles of different dairy foods, such as, for example, 
milk, modified milk, cultured milk, yogurt, and cheese products, and 
any data regarding the nutritional profiles of the various plant-based 
products that resemble dairy foods, including fortified versions of 
those plant-based products. We are particularly interested in obtaining 
data that compares the amounts of protein, calcium, vitamin D, and 
potassium in these plant-based products and their dairy counterparts.
    5. How do the protein qualities of plant-based products compare to 
their dairy counterparts? How does the variation, if any, impact 
consumer perception, and purchasing and consumption decisions? Please 
provide any data or evidence to support your answer.

E. The Role of Plant-Based Products and Dairy Foods in Meeting the 
Recommendations in the Dietary Guidelines

    The Dietary Guidelines contain nutritional and dietary information 
and guidelines for the public. The Dietary Guidelines are based on the 
preponderance of current scientific and medical knowledge and are 
intended to help individuals ages 2 years and older consume a healthy, 
nutritionally adequate diet. As part of these recommendations, the 
Dietary Guidelines refer to several ``food groups,'' including a 
``dairy group,'' which includes fortified soy beverages. [Note: 
Although the Dietary Guidelines refer to a ``dairy group,'' as 
indicated in section I.A., by ``dairy foods,'' FDA is referring to 
foods such as milk, cheese, and yogurt, and not to their plant-based 
counterparts.]
    The Dietary Guidelines state that healthy eating patterns in the 
dairy group include fat-free and low-fat (1 percent) dairy, including 
milk, yogurt, cheese, or fortified soy beverages (see Ref. 1 at page 
23). The Dietary Guidelines explain that soy beverages fortified with 
calcium, vitamin A, and vitamin D, are included as part of the dairy 
group because they are similar to fortified low- and non-fat milk based 
on nutrient composition and in their use in meals. The Dietary 
Guidelines also state that other plant-based beverages sold as 
``milks'' (such as almond, rice, coconut, and hemp ``milks'') are not 
included as part of the dairy group because their overall nutritional 
content is not similar to that of milk and fortified soy beverages 
(id.).
    According to the Dietary Guidelines, the key nutrient contributions 
in the dairy group include calcium, phosphorus, vitamin A, vitamin D 
(in products fortified with vitamin D), riboflavin, vitamin B12, 
protein, potassium, zinc, choline, magnesium, and selenium (id.).
    1. Do consumers understand that certain plant-based products might 
have a nutritional content that is not adequate to place them in the 
dairy group as described in the Dietary Guidelines? How does this 
influence their purchasing behavior with respect to plant-based 
products and dairy foods? Please provide any data or evidence to 
support your answer.
    2. Do consumers who purchase or consume plant-based products 
instead of dairy foods, such as yogurt or cheese, believe that these 
plant-based products meet the dairy group recommendation described in 
the Dietary Guidelines? Please provide any data or evidence to support 
your answer.

III. References

    The following references are on display at the Dockets Management 
Staff (see ADDRESSES) and are available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also 
available electronically at https://www.regulations.gov. FDA has 
verified the website addresses, as of the date this document publishes 
in the Federal Register, but websites are subject to change over time.

1. U.S. Department of Health and Human Services and U.S. Department 
of Agriculture. ``Dietary Guidelines for Americans, 2015-2020.'' 
Eighth Edition. December 2015. Accessed online at https://health.gov/dietaryguidelines/2015/guidelines/.
2. U.S. Department of Agriculture. National Nutrient Database for 
Standard Reference (Release 23), Food items with NDB Numbers: 01077, 
01079, 01082, 01085, 16222, 16229, 16230, 14091, and 14639 accessed 
online at https://www.nal.usda.gov/fnic/foodcomp/search on August 1, 
2018.

    Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21200 Filed 9-27-18; 8:45 am]
 BILLING CODE 4164-01-P