Contains Nonbinding Recommendations 
 
Guidance for Industry 
Considerations Regarding Substances 
Added to Foods, Including Beverages and 
Dietary Supplements 
Additional copies are available from: 
Office of Food Additive Safety, HFS-200 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
       5001 Campus Drive
College Park, MD  20740 
(Tel) 240-402-1200 
http://www.fda.gov/FoodGuidances 
You may submit written comments regarding this guidance at any time.  Submit electronic 
comments to http://www.regulations.gov.   Submit written comments to the Division  of Dockets 
Management (HFA-305), Food and Drug Administration,  5630 Fishers Lane, rm. 1061, 
Rockville,  MD 20852.  All comments should be identified  with the docket number listed in the 
notice of availability  that publishes  in the Federal Register.  
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Food Safety and Applied Nutrition  
January 2014  Contains Nonbinding Recommendations 
 
Table of Contents 
I. Introduction
   
II. Background
   
III. Discussion
   
A.  Conventional Foods 
B.  Dietary Supplements 
IV. Conclusion
   
V. References
   
  Contains Nonbinding Recommendations 
Guidance for Industry1 
Considerations  Regarding Substances Added to Foods, Including 
Beverages and Dietary Supplements 
This guidance represents the Food and Drug Administration's  (FDA's) current thinking  on this 
topic.  It does not create or confer any rights for or on any person and does not operate to bind 
FDA or the public.  You may use an alternative approach if the approach satisfies the 
requirements of the applicable  statutes and regulations.  If you want to discuss an alternative 
approach, contact the FDA staff responsible for implementing  this guidance.  If you cannot 
identify the appropriate FDA staff, call the telephone number listed on the title page of this 
guidance.  
I.  Introduction 
We are issuing this guidance for two purposes.  The first purpose of the guidance is to remind 
manufacturers and distributors  of conventional  foods about the requirements of the Federal Food, 
Drug, and Cosmetic Act (the FD&C Act) regarding substances added to conventional  foods, 
including  beverages.  Substance is defined in FDAs food additive regulations  to include foods 
and food components consisting of one or more ingredients (21 CFR 170.3(g)).  Thus, a 
substance for purposes of the regulations and this guidance may be a food (e.g., an apple) that 
can be eaten on its own as well as used as an ingredient in other foods, or it may be a food that is 
used only as a component of other foods (e.g., flour).  A second purpose of the guidance is to 
remind dietary supplement manufacturers and distributors  that the same requirements apply to 
certain substances that are added to dietary supplements -- namely, those that are not dietary 
ingredients as defined in section 201(ff)(1) of the FD&C Act (21 U.S.C.  321(ff)(1)). 
FDA's guidance documents, including  this guidance, do not establish legally  enforceable 
responsibilities.   Instead, guidance describes the Agency's 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 guidance means that something is suggested or 
recommended, but not required.  
In this guidance, we refers to FDA and you refers to manufacturers and distributors  of foods, 
including  beverages and, where applicable,  dietary supplements (see Section III.B). 
                                              
1 This guidance has been prepared by the Office of Food Additive Safety in the Center for Food Safety and Applied 
Nutrition at the U.S. Food and Drug Administration.   Contains Nonbinding Recommendations 
 
II.  Background 
We have seen a growth in the marketplace of beverages and other conventional  foods that 
contain novel substances, such as added botanical ingredients  or their extracts.  Some of these 
substances have not previously  been used in conventional  foods and may be unapproved food 
additives.  Other substances that have been present in the food supply for many years are now 
being added to beverages and other conventional  foods at levels in excess of their traditional  use 
levels, or in new beverages or other conventional  foods.  This trend raises questions regarding 
whether these new uses are unapproved food additive uses.   
III.  Discussion 
A.  Conventional Foods 
If a substance is not generally recognized as safe (GRAS) by qualified  experts for its intended 
use in food and does not qualify for any of the other exemptions from the food additive 
definition,2  it is a food additive.  Many substances intentionally  added to beverages and other 
conventional  foods are food additives.  Food additives require premarket approval based on data 
demonstrating  safety. Usually, these data are submitted to us in a food additive petition,  although 
we may also approve a food additive  on our own initiative  without first receiving a petition.  We 
issue food additive regulations specifying  the conditions  under which an additive has been 
demonstrated to be safe and, therefore, may be lawfully  used.  Any unapproved food additive 
used in a beverage or other conventional  food causes the food to be adulterated under section 
402(a)(2)(C) of the FD&C Act (21 U.S.C. 342(a)(2)(C)).  Adulterated foods cannot be legally 
imported or marketed in the United States. 
If a substance is GRAS under the conditions  of its intended use in food, it is exempt from the 
definition  of a food additive,  and thus, from pre-market approval.  (See section 201(s) of the 
FD&C Act (21 U.S.C.  321(s))).  For a particular use of a substance to be GRAS, there must be 
both evidence of safety and a basis to conclude that this evidence is generally known and 
accepted by qualified  experts.  In other words, the GRAS standard first requires that the 
scientific evidence about the substance establish that the intended use of the substance is safe; 
i.e., that there is a reasonable certainty in the minds of competent scientists that the substance is 
not harmful under its intended conditions  of use (21 CFR 170.3(i)).   In addition,  under the 
second part of the GRAS standard, the scientific evidence to establish the safety of the substance 
for its intended use must be generally available, and there must be a basis to conclude that 
consensus exists among qualified  experts about the safety of the substance for its intended use 
(see 21 CFR 170.30(a)-(c)).   
                                              
2 Under section 201(s) of the FD&C Act (21 U.S.C.  321(s)), the following types of substances are excluded from 
the food additive definition:  (1) pesticide chemical residues in or on a raw agricultural commodity or processed 
food; (2) pesticide chemicals; (3) color additives; (4) substances used in accordance with a prior sanction (i.e., a 
sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the FD&C 
Act, the Poultry Products Inspection Act, or the Meat Inspection Act; (5) new animal drugs; and (6) dietary 
ingredients in or intended for use in a dietary supplement.   
  4  Contains Nonbinding Recommendations 
 
We are concerned that some of the novel substances that are being added to conventional  foods, 
including  beverages, may cause the food to be adulterated because these added substances may 
not be GRAS for their intended use and are not being used in accordance with a food additive 
regulation  prescribing conditions  of safe use.  In addition,  some substances that have been 
present in the food supply for many years are now being added to conventional  foods at levels in 
excess of their traditional  use levels or in new types of conventional  foods.  This trend raises 
questions as to whether these higher levels and other new conditions  of use are safe. 
B.  Dietary Supplements 
Section 201(s) of the FD&C Act (21 U.S.C.  321(s)) exempts dietary ingredients used in dietary 
supplements from the food additive definition.   Although a dietary ingredient used in a dietary 
supplement must not adulterate the supplement under section 402(f) of the FD&C Act (21 U.S.C. 
 342(f)), it does not have to be GRAS for its intended use in the supplement.  However, other 
ingredients intended for use in dietary supplements, such as binders, excipients,  and fillers, are 
not exempt from the food additive definition  and must meet the same requirements as substances 
added to conventional  foods.  In other words, non-dietary ingredients added to a dietary 
supplement must be used in accordance with a food additive regulation or be GRAS for their 
intended use (unless they qualify for another exception to the food additive definition).3      
IV.  Conclusion   
It is your responsibility  to ensure that substances added to foods you manufacture or distribute, 
including  non-dietary ingredients  in dietary supplements, comply with all applicable regulatory 
requirements for substances added to food.  The Ingredients,  Packaging and Labeling page on 
FDAs Web site (Ref. 1) includes links to regulatory requirements and recommendations that 
apply to such substances.  
V.  References  
We have placed the following  reference on display in the Division  of Dockets Management, 
Food and Drug Administration,  5630 Fishers Lane, rm. 1061, Rockville,  MD 20852. You may 
see it at that location between 9 a.m. and 4 p.m., Monday through Friday. 
1.  FDA. Ingredients, Packaging & Labeling.  Available  at 
http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm.   
 
                                              
3 See list in footnote 2. 
  5