Contains Nonbinding Recommendations 
 
Voluntary Labeling Indicating Whether 
Foods Have or Have Not Been Derived 
from Genetically Engineered Plants: 
Guidance for Industry   
 
 
Additional copies are available from:  
Office of Nutrition and Food Labeling 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5001 Campus Drive 
 
College Park, MD 20740
(Tel) 240-402-2371 
https://www.fda.gov/FoodGuidances 
 
You may submit either electronic or written comments regarding this guidance at any time.  Submit 
electronic comments to https://www.regulations.gov.  Submit written comments on the guidance to 
the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 
1061, Rockville, MD 20852.  All comments should be identified with Docket No. FDA-2000-D-
0075. 
 
 
 U.S. Department of Health and Human Services  
Food and Drug Administration  
Center for Food Safety and Applied Nutrition  
Center for Veterinary Medicine 
 
Issued November 2015   
Revised March 2019 
 
OMB Control No. 0910-0807  Contains Nonbinding Recommendations 
 
Table of Contents  
 
I.  INTRODUCTION
 
II.  BACKGROUND
 
III.  GUIDANCE
 
A. General principles
 
B.  Statements about foods that are not derived from genetically 
engineered plants
 
C.  Statements about foods that are derived from genetically 
engineered plants
 
D.  Substantiation of labeling statements
 
IV.  PAPERWORK REDUCTION ACT OF 1995
 
V.  REFERENCES
 
 
2 
 
  Contains Nonbinding Recommendations 
 
Voluntary Labeling Indicating Whether 
Foods Have or Have Not Been Derived 
from Genetically Engineered Plants:  
Guidance for Industry1 
 
 
 
This guidance represents the current thinking of the Food and Drug Administration (FDA or we) 
on this topic.  It does not establish any rights for any person and is not binding on FDA or the 
public.  You can use an alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible 
for this guidance as listed on the title page.  
 
 
 
I.  INTRODUCTION 
 
Manufacturers often voluntarily provide information on their labels beyond the information 
required by the Federal Food, Drug, and Cosmetic Act (the FD&C Act) or FDA regulations.  
Their reasons for doing so may have to do with marketing or providing information of specific 
interest to their customers.  This guidance addresses the voluntary labeling of plant-derived foods 
with information concerning whether the food was or was not produced using genetic 
engineering.2  Some consumers are interested in knowing whether a food was produced using 
                                                 
1 This guidance has been prepared by the Office of Nutrition and Food Labeling in the Center for Food Safety and 
Applied Nutrition and the Office of Surveillance and Compliance in the Center for Veterinary Medicine at the U.S. 
Food and Drug Administration.   
2  In July 2016, the National Bioengineered Food Disclosure Standard (NBFDS), PL 114-216, was signed into law.  
This law amended the Agricultural Marketing Act and charged the U.S. Department of Agricultures (USDA) 
Agricultural Marketing Service (AMS) with developing a national mandatory standard for disclosing the presence of 
bioengineered material in human food.  The term bioengineered as defined in that law includes products that are 
GE. The law primarily applies to human food derived from plants.  Therefore, FDA no longer has authority over 
voluntary labeling to indicate the presence of GE content in human foods including those derived from plants.  
FDA retains jurisdiction over labeling statements to indicate the absence of GE content in human food.  The NBFDS 
does not apply to animal food.  
In light of the NBFDS and its implementing regulations issued on December 20, 2018, FDA is reviewing this draft 
guidance to consider what additional or new recommendations may be needed for the kinds of products or 
statements, including claims of non-GE content, that are not covered by the NBFDS.  
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genetic engineering and some manufacturers want to respond to this consumer interest.  FDA is 
providing this guidance to assist food and feed manufacturers that wish to voluntarily label their 
plant-derived food products or ingredients (for humans or for animals) as having been made with 
or without bioengineering.  FDAs main concern within the context of this guidance is that such 
voluntary labeling be truthful and not misleading.  
 
In this guidance, we use the terms genetic engineering and bioengineering to describe the 
use of modern biotechnology.  Modern biotechnology means the application of in vitro nucleic 
acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of 
nucleic acid into cells or organelles, or fusion of cells beyond the taxonomic family, that 
overcome natural physiological reproductive or recombinant barriers and that are not techniques 
used in traditional breeding and selection of plants (Ref. 1).  The term modern biotechnology 
may alternatively be described as recombinant DNA (rDNA) technology (Ref. 2), genetic 
engineering (Ref. 3), or bioengineering.  These terms are often used interchangeably by 
industry, federal agencies, international bodies, and other interested stakeholders and are used in 
this guidance to refer to foods derived from new plant varieties developed using modern 
biotechnology.  The term genetic modification is also sometimes used to refer to the use of 
modern biotechnology (e.g., Ref. 4), although FDAs longstanding position, as discussed later in 
this guidance, is that such use of the term is less accurate because the term encompasses the 
broad spectrum of genetic alterations that can be made in plants (see, e.g., Ref. 5).  
 
Because technically it is the plant that is genetically engineered rather than the food, for 
simplicity we use the term food derived from genetically engineered plants in this guidance to 
refer to products that are derived from genetically engineered plants.  (For reasons discussed in 
more detail later in this guidance, FDA does not use the terms genetically modified or 
genetically modified organism (GMO) when referring to foods derived from genetically 
engineered plants.)    Because section 201(f)(1) of the FD&C Act defines food in relevant part 
as articles used for food or drink for man or other animals, the food derived from genetically 
engineered plants addressed in this guidance include plant-derived foods for animals as well as 
such foods for humans. 
 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the agencys current thinking on a topic and should 
be viewed only as recommendations, unless specific regulatory or statutory requirements are 
cited. The use of the word should in agency guidances means that something is suggested or 
recommended, but not required. 
 
II.  BACKGROUND  
 
The FD&C Act prohibits the introduction or delivery for introduction into interstate commerce 
of any food that is misbranded.  21 U.S.C.  331(a).  Under section 403(a)(1) of the FD&C Act, 
a food is misbranded if its labeling is false or misleading in any particular.  21 U.S.C. 
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 343(a)(1).  Section 201(n) of the FD&C Act (21 U.S.C. 321(n)) provides that labeling is 
misleading if, among other things, it fails to reveal facts that are material in light of 
representations made or suggested in the labeling, or material with respect to consequences that 
may result from the use of the food to which the labeling relates under the conditions of use 
prescribed in the labeling, or under such conditions of use as are customary or usual.  21 U.S.C. 
 321(n).  In a 1992 Statement of Policy: Foods Derived from New Plant Varieties (1992 
Policy) (Ref. 5) FDA explained its interpretation of the FD&C Act with respect to foods derived 
from new plant varieties, including varieties developed using bioengineering.  In the 1992 
Policy, FDA stated that it was not aware of any information showing that bioengineered foods 
differ from other foods in any meaningful or uniform way, or that, as a class, foods developed by 
the new techniques present any different or greater safety concern than foods developed by 
traditional plant breeding (Ref. 5). Further, FDA concluded that the method of development of a 
new plant variety (including the use of new techniques such as rDNA technology) is generally 
not material information within the meaning of section 201(n) of the FD&C Act, and would not 
usually be required to be disclosed in the labeling for the food.  This determination was reviewed 
and upheld by the court in Alliance for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166, 17879 
(D.D.C. 2000) (finding that FDAs determination that genetic engineering, alone, is not a 
material fact that warrants food labeling was entitled to deference) (Ref. 10).  Labeling provided 
by manufacturers on a wholly voluntary basis regarding whether a food was or was not 
bioengineered as described in this guidance is acceptable to FDA, provided that such labeling is 
truthful and not misleading.  Some consumers are interested in the information provided in such 
labeling.   
 
The FD&C Act does not define the term material within the context of section 201(n) of the 
FD&C Act.  Historically, the agency has interpreted the term, within the context of food, to mean 
information about the attributes of the food itself.  For example, FDA has required special 
labeling in cases where the absence of such material information may:  (1) pose special health 
risks (e.g., a warning statement on protein products used in very low calorie diets (21 CFR 
101.17(d)) (Ref. 6), or a caution statement not to feed animal food products that contain animal-
derived protein to cattle or other ruminants (21 CFR 589.2000(c)(1)(i)) (Ref. 7)); (2) mislead the 
consumer in light of other statements made on the labeling (e.g., a requirement for quantitative 
nutrient information when certain nutrient content claims are made about a product (21 CFR 
101.13(j)) (Ref. 8)); or (3) in cases where a consumer may assume that a food, because of its 
similarity to another food, has nutritional, organoleptic (e.g., taste, smell, or texture), or 
functional characteristics of the food it resembles when in fact it does not (e.g., a statement that 
reduced fat margarine is not suitable for frying (21 CFR 101.13(d)(1)) (Ref. 9).  Further, section 
403(i) of the FD&C Act and FDA regulations require that each food bear a common or usual 
name or, in the absence of such a name, an appropriately descriptive term (21 U.S.C.  343(i); 21 
CFR 101.3, 501.3).  For example, if oil from a genetically engineered canola plant has a 
significantly different amount of lauric acid such that the fatty acid composition of the oil is 
significantly changed compared to traditional canola oil, the term canola oil no longer 
adequately identifies or describes the nature of the oil or its characterizing properties, particularly 
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since oils are distinguished by their fatty acid profiles.   
 
Since the commercial introduction of bioengineered crops in the United States in 1996, the use of 
bioengineered crops has accelerated and such crops are now widely used (Ref. 11).  In 2013, in 
the United States, bioengineered soybeans made up 93 percent of the acreage of planted 
soybeans, bioengineered cotton made up 90 percent of the acreage of planted cotton, and 
bioengineered corn varieties made up 90 percent of the acreage planted corn (Ref. 11).  In 
addition, bioengineered sugar beets accounted for 95 percent of the acreage of planted sugar 
beets in the 2009-2010 crop year (Ref. 11).   
 
III.  GUIDANCE 
 
A. General principles 
 
In determining whether a food is misbranded, FDA generally reviews labeling statements under 
sections 403 and 201(n) of the FD&C Act, and if applicable, other sections of the FD&C Act.  
Under section 403(a)(1) of the FD&C Act, a food is misbranded if its label or labeling is false or 
misleading in any particular.  For example, the label on a chocolate bar may not declare that the 
chocolate contains ingredients, such as walnuts and coconut oil, if those ingredients are not 
actually present in the chocolate.   
 
Under section 201(n) of the FD&C Act, both the presence and the absence of information are 
relevant to whether labeling is misleading.  Put another way, food labeling may be misleading if 
it makes or suggests certain representations, or if it fails to disclose facts that are material in light 
of representations made or suggested about a food or facts that are material with respect to the 
consequences that may result from use of the food.  In determining whether a labeling statement 
about a food is misleading under sections 201(n) and 403(a)(1) of the FD&C Act, FDA takes 
into account all labeling for that food, including the label on the food itself (e.g., all words used 
on the label including the brand name of the product, vignettes, logos or any of its containers or 
wrappers and other information accompanying the food, such as labeling for the food that is on 
the internet. Labeling means all labels and other written, printed, or graphic matter (1) upon any 
article or any of its containers or wrappers, or (2) accompanying such article.  21 U.S.C. 321(m) 
(section 201(m) of the FD&C Act).  Firms should be aware that labeling may extend to 
information beyond that included on containers or wrappers.  For example, in certain 
circumstances, information that is disseminated over the internet by, or on behalf of, a regulated 
company meets the definition of labeling in section 201(m) of the FD&C Act and is subject to 
applicable requirements.  See, e.g., Guidance for Industry and FDA: Dear Manufacturer letter 
Regarding Food Labeling, January 2007, available at: 
http://wwwfdagov/Food/GuiddanceRegulation/GuidanceDocumentsRegulatoryInformation/Labe
lingNutrition/ucm053425.htm. These general principles apply in evaluating a food labeling 
claim, including a statement about whether a food is or is not developed using modern plant 
biotechnology. 
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  Contains Nonbinding Recommendations 
 
 
B.  Statements about foods that are not derived from genetically engineered plants  
 
Food manufacturers may voluntarily label their foods with information about whether the foods 
were not produced using bioengineering, as long as such information is truthful and not 
misleading.  In general, an accurate statement about whether a food was not produced using 
bioengineering is one that provides information in a context that clearly refers to bioengineering 
technology.  Examples of such statements include: 
 
  Not bioengineered. 
  Not genetically engineered. 
  Not genetically modified through the use of modern biotechnology.  
  We do not use ingredients that were produced using modern biotechnology. 
  This oil is made from soybeans that were not genetically engineered. 
  Our corn growers do not plant bioengineered seeds. 
 
Other terms are sometimes used by manufacturers in food labeling regarding whether a food was 
not derived from genetically engineered plants, including not genetically modified and claims 
using the acronym GMO (genetically modified organism).   For the reasons discussed in the 
remaining paragraphs of this section, FDA recommends terms such as not bioengineered, not 
genetically engineered, and not genetically modified through the use of modern 
biotechnology.  However, FDA does not intend to take enforcement action against a label using 
the acronym GMO in a statement indicating that the product (or an ingredient) was not 
produced through the use of modern biotechnology, as long as the food is, in fact, not derived 
from a genetically engineered plant and the foods labeling is not otherwise false or misleading, 
as further discussed in this guidance.  Similarly, we do not intend to take enforcement action 
against a label using the acronym GMO in a statement indicating that the product (or an 
ingredient) was produced through the use of modern biotechnology, as long as the statement was 
true and the foods labeling is not otherwise false or misleading. 
 
As stated, FDA encourages manufacturers to use labeling claims that state that a food product (or 
its ingredients, as appropriate) was not developed using bioengineering, genetic engineering, or 
modern biotechnology such as the claims included above.   
 
Not genetically modified or Non-genetically modified.  As noted above, the term genetic 
modification encompasses a broad range of methods that can be used to alter the genetic 
composition of a plant.  FDA's longstanding position has been that the term has traditionally 
been used broadly to signify the alteration of the genotype of a plant using any technique, new or 
traditional (See, for example, Refs. 5 and 12).  The term modification, in this context means 
the alteration in the genetic composition of a plant that results from adding, deleting, or changing 
hereditary traits, irrespective of the method (Refs. 3, 5).  Modifications may be minor, such as a 
7 
 
  Contains Nonbinding Recommendations 
 
single mutation that affects one gene, or major alterations of genetic material derived from 
conventional breeding (e.g., selection) that affect many genes.  Because the term genetically 
modified can encompass any alteration to the genetic composition of a plant, including 
alterations achieved through traditional hybridization or breeding techniques, that term could 
apply to most cultivated food crops since most food crops are the product of selective breeding 
(Ref. 13).  An example of a food that is derived from a plant that has not been subject to any 
form of selective breeding might be berries collected from wild plant varieties.   
 
FDA encourages food manufacturers to ensure that labeling terminology concerning the use of 
modern biotechnology in the production of a food or its ingredients be accurate and consistent 
and that the integrity and meaning of scientific terminology be preserved to help ensure clear 
communication in food labeling.  Thus, FDA encourages manufacturers to use labeling claims 
that state that a plant-derived food product or its ingredients, as appropriate, was not developed 
using bioengineering, genetic engineering, or modern biotechnology.  Alternatively, FDA 
encourages that the terms bioengineering, genetic engineering, or modern biotechnology be used 
in conjunction with claims using the term genetically modified or genetic modification to 
indicate that a plant-derived food has not been genetically engineered or bioengineered (e.g., 
not genetically modified through the use of modern biotechnology).   
 
GMO free, GE free, does not contain GMOs, non-GMO, and similar claims.  The 
term free conveys zero or total absence unless a regulatory definition has been put in place in a 
specific situation (Refs. 14, 15).  The potential challenges of substantiating a free claim are 
described in Section III.D of this guidance, and in light of these challenges FDA recommends 
that manufacturers not use food labeling claims that indicate that a food is free of ingredients 
derived through the use of biotechnology.  Instead, FDA recommends that manufacturers 
consider the use of other types of statements to indicate that a plant-derived food has not been 
produced using bioengineering, as described above and below.   
 
The O in the acronym GMO refers to the word organism. Most foods do not contain 
entire organisms (foods such as yogurt that contain microorganisms are exceptions); however, in 
some formulations this acronym may be read as meaning that the food was not derived from a 
genetically engineered organism, such as a plant that has been genetically engineered.  In light of 
potential confusion regarding the meaning of the acronym GMO, FDA encourages 
manufacturers to consider the use of other types of statements to indicate that a plant-derived 
food has not been produced using bioengineering, as described above.  For example, a statement 
that our tomato growers do not plant bioengineered seeds or this oil is made from soybeans 
that were not genetically engineered could be used.   
 
Context.  As noted above, under section 403(a)(1) of the FD&C Act, a food is misbranded if its 
labeling is false or misleading in any particular.  Both the presence and absence of information 
on labeling can be misleading.  Regarding the absence of information, section 201(n) of the 
FD&C Act provides in relevant part that labeling is misleading if it fails to reveal facts that are 
8 
 
  Contains Nonbinding Recommendations 
 
material in light of representations made or suggested in the labeling, or material with respect to 
consequences that may result from the use of the food to which the labeling relates under the 
conditions of use prescribed in the labeling, or under such conditions of use as are customary or 
usual.  
 
An example of a statement that might by itself be truthful, but could be misleading when 
evaluated in the context of the entire labeling might be a statement that a particular ingredient in 
the food was not bioengineered, where there is another ingredient in the food that was 
bioengineered, about which the labeling is silent.  For example, on a product made largely of 
flour derived from genetically engineered corn and a small amount of non-genetically engineered 
soybean oil, a claim that the product does not contain bioengineered soybean oil could be 
misleading if consumers believe that the entire product, or a larger portion of it than is actually 
the case, is free of bioengineered material.  It may be necessary to carefully qualify the statement 
in order to ensure that consumers understand its significance.  
 
Another example of a statement in food labeling that may be false or misleading could be the 
statement None of the ingredients in this food is genetically engineered on a food where some 
of the ingredients are incapable of being produced through genetic engineering (e.g., salt).  It 
may be necessary to carefully qualify the statement where modern biotechnology is not used to 
produce a particular ingredient or type of food.   
 
Further, a statement may be false or misleading if, when considered in the context of the entire 
label or labeling (as noted in Section IIIA. above), it suggests or implies that a food product or 
ingredient is safer, more nutritious, or otherwise has different attributes than other comparable 
foods because the food was not genetically engineered.  For example, the labeling of a bag of 
specific type of frozen vegetables that states that they were not produced through modern 
biotechnology could be misleading if, in addition to this statement, the labeling contains 
statements or vignettes that suggest or imply that, as a result of not being produced through 
modern biotechnology, such vegetables are safer, more nutritious, or have different attributes 
than other foods solely because the food was not produced using modern biotechnology.  
 
Common or usual name.  Section 403(i)(2) of the FD&C Act requires that, for a food that is 
made from two or more ingredients, each ingredient must be declared on the food label by its 
common or usual name.  Accordingly, FDA regulations require (among other things) that 
ingredients required to be declared on the label or labeling of a food must be listed on either the 
principal display panel or information panel of the food subject to certain exceptions.  21 CFR 
101.4(a)(1). Further, FDA regulations provide that ingredients required to be declared on the 
label or in the labeling of food must be listed by their common or usual name and without 
intervening material.  See 21 CFR 101.2(e), 101.4(a)(1), 501.2(e) and 501.4(a).  In general, FDA 
has interpreted a term used to describe an ingredient in the list required by FDAs regulations 
(typically in an ingredient statement) that is not part of the ingredients common or usual name 
(e.g., pure, fresh, certified non-GE) to be intervening material that violates FDA 
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regulations (Ref. 16).  However, elsewhere on the label, other than in the ingredient statement, 
terms that are not a part of the common or usual name of an ingredient may accompany the name 
of the ingredient provided it is done in a manner that is truthful and not misleading and otherwise 
in accordance with the FD&C Act and applicable regulations.  For example, the principal display 
panel on a bottle of soybean oil made from soybeans that were not bioengineered could say 
Made from certified non-GE soybeans, provided that (1) the text does not obscure information 
required to be on the principal display panel, such as the statement of identity; and (2) the 
ingredient (i.e., soybean oil) is listed in the ingredient list by its common or usual name and 
without intervening material.  This statement could also appear on the information panel of the 
food product, provided that it does not appear in the ingredient list.  In this example, for the 
ingredient soybean oil, the ingredient list may only list such ingredient as soybean oil as that 
term is the common or usual name for the ingredient.  
 
C.  Statements about foods that are derived from genetically engineered plants 
 
As explained in section III.A above, food labeling may be misleading if, among other things, it 
makes or suggests certain representations, or if it fails to disclose facts that are material in light 
of representations made or suggested in the labeling, or material with respect to the 
consequences that may result from use of the food to which the labeling relates under the 
conditions of use prescribed in the labeling, or under such conditions of use as are customary or 
usual.  In general, an accurate statement about whether a food was produced using 
bioengineering is one that provides information in a context that refers to bioengineering 
technology.  Examples of such statements include: 
 
  Genetically engineered or This product contains cornmeal from corn that was 
produced using modern biotechnology. 
   Some of our growers plant soybean seeds that were developed through modern 
biotechnology to be drought tolerant. 
 
These kinds of simple statements that a food was developed using bioengineering are not likely 
to be misleading.   
 
Multi-ingredient foods.  Where a benefit from a bioengineered ingredient in a multi-ingredient 
food is voluntarily described in the labeling for a food, the statement should be worded so that it 
addresses the ingredient and not the food as a whole; for example, This product contains laurate 
canola from bioengineered canola that may be used as an alternative to palm kernel oil.  In 
addition, the amount of the bioengineered ingredient in the food may be relevant to determine 
whether the statement is misleading.  This would apply especially where the bioengineered 
difference is characterized as a functional improvement.  For example, it may be misleading to 
make a statement about a functionally improved ingredient (e.g., in this example, that the oil may 
be used as an alternative to palm kernel oil in high temperature cooking applications) in a food 
that contains only a small amount of the ingredient, if such statement implies that the foods 
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overall functional quality is significantly improved when the amount of the ingredient present is 
not sufficient to confer the properties indicated.  Research suggests that the presence of a 
statement on a product label regarding a specific benefit associated with the product can create a 
more favorable overall perception of a product. (Refs. 17, 18, and 19).   
 
The labeling requirements that apply to foods generally, some of which are described above, also 
apply to food produced using genetic engineering.  Foods from some genetically engineered 
crops, like food from non-genetically engineered crops, may have characteristics that are 
materially different from those of comparable foods.  Such foods would require labeling under 
existing provisions to disclose such material differences.  
 
Based on sections 403(a)(1), 201(n), and 403(i) of the FD&C Act: 
 
  If a food derived from genetically engineered plants is significantly different from its 
traditional counterpart such that the common or usual name or existing statement of 
identity no longer adequately identifies or describes the new food, the name of the new 
food must be changed to a term that accurately identifies or describes the new food.  For 
example, if oil from a genetically engineered plant has a significantly different amount of 
lauric acid such that the fatty acid composition of the oil is significantly changed 
compared to that of conventionally produced oil, the standard name for the oil no longer 
adequately identifies or describes the nature of the oil or its characterizing properties, 
particularly since oils are distinguished by their fatty acid profiles.  See 21 CFR 102.5, 
502.5.  Under sections 403(a)(1), 201(n), and 403(i) of the FD&C Act, a word or phrase 
like laurate is required to appear as part of the new name to appropriately identify or 
describe the food.  See also 21 CFR 101.3, 501.3.  
  If a genetically engineered food or one of its constituents differs from its traditional 
counterpart regarding how the food is used or the consequences of its use (for example, if 
the genetically engineered food behaves differently than its traditional counterpart when 
used in a comparable way, such as in frying or canning), a statement must be made on the 
label to describe the difference(s) in use or the consequence(s) of its use.  Therefore, in 
this case, under sections 403(a)(1) and 201(n) of the FD&C Act, the fact that such food 
behaves differently when canned or fried must be disclosed in the labeling for the food.   
  If a food derived from genetically engineered plants has a significantly different 
nutritional property compared to its traditional counterpart, its label must describe such 
difference.  For example, if (hypothetically) a vegetable has been bioengineered to 
contain vitamin B12, the fact that the vegetable contains vitamin B12 and that non-
bioengineered versions of that vegetable do not contain vitamin B12 is material.  Thus, in 
this instance, under sections 403(a)(1) and 201(n) of the FD&C Act, the fact that the 
vegetable contains vitamin B12 would have to be disclosed in the labeling for the 
vegetable.  
  If a food derived from genetically engineered plants contains an allergen that consumers 
would not expect to be present in the food based on the name of the food, the presence of 
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that allergen must be disclosed on the label.  The presence of such allergen in the food 
would be material information.  Under sections 403(a)(1), 201(n) and potentially, in some 
circumstances, section 403(w) of the FD&C Act, the labeling for such food is required to 
disclose the presence of such allergen. 
 
D.  Substantiation of labeling statements  
 
A manufacturer that claims that a food product or its ingredients, including foods such as raw 
agricultural commodities, is bioengineered or is not bioengineered should substantiate that the 
claim is truthful and not misleading.  We note that when selecting a method to substantiate a 
claim, a manufacturer should consider the specifics of the claim as one method might 
substantiate one kind of claim, but not another.  The following methods may be used to 
substantiate that a claim, within this context, is truthful and not misleading: 
 
  Documentation of handling practices and procedures.  Manufacturers that have control 
over growing, harvesting, storing, and distribution should consider appropriate 
recordkeeping to document whether foods are or are not produced using bioengineering 
including segregation procedures, to ensure that a foods labeling is not false or 
misleading. Manufacturers not engaged in these activities may rely on certifications or 
affidavits from farmers, processors, and others in the food production and distribution 
chain to document whether foods are or are not produced using bioengineering.  If a 
farmer, distributor, or manufacturer dealt only in plant-derived foods that were not 
bioengineered, they could have records attesting to this fact for all ingredients entering 
their distribution chain.  For example, a farm could certify that it does not plant 
bioengineered seeds and keep records of handling practices for that crop to substantiate 
that the crop was not bioengineered.  Similarly, a distributor could certify that it only 
purchases foods from farmers that do not plant bioengineered seeds and keep records to 
substantiate such certifications.   
  Use of certified organic food.  The Department of Agriculture's (USDA) Agricultural 
Marketing Service administers the National Organic Program, which enforces laws and 
regulations regarding certified organic foods.  Foods that comply with 7 CFR part 205 
(USDA organic regulations) would meet criteria to be labeled as not produced or handled 
using bioengineering.  USDA regulations on organic food production and handling 
provide in relevant part that in order for a food to be sold or labeled as 100% organic, 
organic or made with organic (specified ingredients or food group(s)),  the food must 
be produced and handled without the use of such excluded methods as these methods 
are defined in 7 CFR 205.2.  Compliance with USDA's requirements at 7 CFR 205.105 
can therefore be used to support food labeling claims about the production of food 
without the use of bioengineering.3  Documentation of compliance with the USDA 
                                                 
3 USDA regulations cited in this section refer to the subject regulations as they existed as of the date of this guidance 
document. 
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organic certification requirements and recordkeeping requirements for certified 
operations (7 CFR 205.100, 7 CFR 205.103 and 205.400 et seq.) would be sufficient to 
substantiate a food labeling claim that a food was not produced using bioengineering. 
(Ref. 20) 
  Use of validated test methods. Validated analytical methods may be useful in confirming 
the presence of bioengineered material in food derived from genetically engineered plants 
or food ingredients.  Where tests have been validated and shown to be reliable, they may 
be used to confirm the presence of bioengineered material in support of a claim that a 
food has been bioengineered.  For many foods, however, particularly for highly 
processed foods such as oils, it may be difficult to differentiate, through validated 
analytical methods, between plant-derived food developed through bioengineering and 
plant-derived food developed using traditional breeding methods.  Tests may be less 
useful in demonstrating the absence of bioengineered material in food derived from 
genetically engineered plants or food ingredients.  It would be very difficult to identify all 
test methods that might be necessary to support an analysis-based statement that a 
particular food does not contain any material from each variety of bioengineered plant in 
the marketplace.  In addition, the specific analytical methods necessary to detect 
bioengineered material likely will change as new bioengineered plant varieties are 
introduced to the marketplace, so firms may have to update tests and then routinely and 
methodically (e.g., shipment by shipment or lot by lot) analyze their ingredients or 
products for bioengineered material.  If validated test methods are not available or 
reliable because of the way a plant-derived food is produced or processed, it may be more 
practical to substantiate a claim for such foods differently, such as documenting handling 
practices and procedures.  For example, statements indicating that a food has not been 
produced using bioengineering could be substantiated through documentation of practices 
and handling procedures or documentation of compliance with USDA organic 
certification requirements (7 CFR 205.100 and 205.400 et seq.) and recordkeeping 
requirements for certified operations (7 CFR 205.103) as described above. 
 
IV.  PAPERWORK REDUCTION ACT OF 1995 
 
This guidance refers to previously approved collections of information.  These collections of 
information are subject to review by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (44 U.S.C.  3501-3520).  The collections of information have 
been approved under OMB control number 0910-0807. 
V.  REFERENCES 
 
The following references marked with an asterisk (*) are on display at the Dockets Management 
Staff, Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and 
are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
13 
 
  Contains Nonbinding Recommendations 
 
Friday; they are also available electronically at https://regulations.gov.  References without 
asterisks are not on public display at https://regulations.gov because they have copyright 
restriction.  Some may be available at the website address, if listed.  References without asterisks 
are available for viewing only at the Dockets Management Staff.  FDA had verified the website 
addresses, as of March 6, 2019, but websites are subject to changes over time. 
 
1. Codex Alimentarius Commission.  2003. Amendments in 2008, 2011.  Principles for the Risk 
Analysis of Foods Derived From Modern Biotechnology CAC/GL 44-2003. 
http://www.codexalimentarius.net/download/standards/10007/CXG_044e.pdf.   
2. Codex Alimentarius Commission.  2003. Amendments in 2008. Guideline for the Conduct of 
Food Safety Assessment of Foods Derived from Recombinant-DNA Plants CAC/GL 45-2003 
http://www.codexalimentarius.net/download/standards/10021/CXG_045e.pdf.   
3. National Research Council. Safety of Genetically Engineered Foods: Approaches to Assessing 
Unintended Health Effects. Washington, DC: The National Academies Press, 2004. 1; ix and 
194. http://www.nap.edu/openbook.php?record_id=10977&page=R1. 
4. United States Department of Agriculture. Glossary of Agricultural Biotechnology Terms. 
http://www.usda.gov/wps/portal/usda/usdahome?navid=BIOTECH_GLOSS&navtype=RT&pare
ntnav=BIOTECH.*   
5. Food and Drug Administration. 1992. Statement of Policy: Foods Derived from New Plant 
Varieties; Notice Federal Register, Vol. 57, May 29, 1992, pp. 22984-23005.* 
6. Food and Drug Administration. 1984. Food Labeling: Protein Products; Warning Labeling 
Federal Register, Vol. 49, pp. 13679 at 13685, April 6, 1984.*   
7. Food and Drug Administration. 1997. Substances Prohibited From Use in Animal Food or 
Feed; Animal Proteins Prohibited in Ruminant Feed Federal Register, Vol. 62, pp. 30936 at 
30977, June 5, 1997.*   
8. Food and Drug Administration. 1993. Food Labeling:  Nutrient Content Claims, General 
Principles, Petitions Definition of Terms; Definitions of Nutrient Content Claims for Fat, Fatty 
Acid, and Cholesterol Content of Food Federal Register, Vol. 58, pp. 2302 at 2365, January 6, 
1993.* 
9. Food and Drug Administration. 1993. Food Standards:  Requirements for Foods Named by 
Use of a Nutrient Content Claim and a Standardized Term Federal Register, Vol. 58, pp. 2431 
at 2437, January 6, 1993.* 
10. See Alliance for Bio-Integrity v. Shalala, 116 F. Supp. 2d 166, 17879 (D.D.C. 2000). 
14 
 
  Contains Nonbinding Recommendations 
 
11. United States Department of Agriculture, Economic Research Service. Adoption of 
Genetically Engineered Crops in the U.S. Updated July 16, 2018. https://www.ers.usda.gov/data-
products/adoption-of-genetically-engineered-crops-in-the-us.* 
12. Executive Office of the President, Office of Science and Technology Policy. 1986. 
Coordinated Framework for Regulation of Biotechnology Federal Register, Vol. 51, pp. 
23302, June 26, 1986.* 
13. Doebley, J. F., Gaut, B.S. and Smith, B.D. (2006) The Molecular Genetics of Crop 
Domestication.  Cell 127:1309-1321. 
14. Food and Drug Administration. 2007. Food Labeling:  Gluten-Free Labeling of Foods.  
Federal Register, Vol. 72, pp. 2795 at 2799, January 23, 2007.* 
15. Food and Drug Administration. 2005. CPG Sec. 510.400 Dealcoholized Wine and Malt 
Beverages  Labeling.  
http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm074430
.htm.*  
16. Food and Drug Administration.  2007.  November 7, 2007 Letter from Emma R. Singleton, 
Director, Florida District, to John D. Miller, Marjon Specialty Food, Inc. http://wayback.archive-
it.org/7993/20170111020117/http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2
007/ucm076569.htm.*  
17. Carpenter, G.S., Glazer, R., and Nakamoto, K. (1994).  "Meaningful brands from 
meaningless differentiation: the dependence on irrelevant attributes."  Journal of Marketing 
Research 31: 229-350. 
18. Lin, C.-T J (2008) "How do consumers interpret health messages on food labels?"  Nutrition 
Today 43(6) 267-272. 
19. Roe, B, Levy, A.S. and Derby, B.M. (1999).  "The impacts of health claims on consumer 
search and product evaluation outcomes: results from FDA experimental data."  Journal of 
Public Policy and Marketing 18 (1); 89-105. 
20. United States Department of Agriculture, Agricultural Marketing Service, National Organic 
Program (NOP) Policy Memo 11-13, Miles McEvoy, Deputy Administrator to Stakeholders and 
interested parties, April 15, 2011. 
http://www.ams.usda.gov/sites/default/files/media/OrganicGMOPolicy.pdf.* 
 
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