Contains Nonbinding Recommendations 
 
Guidance for Industry 
Distinguishing Liquid Dietary Supplements 
from Beverages 
Additional copies are available from: 
Office of Nutrition, Labeling and Dietary Supplements, HFS-800 
Center for Food Safety and Applied Nutrition 
Food and Drug Administration 
5100 Paint Branch Parkway 
College Park, MD  20740 
(Tel) 240-402-2373 
http://www.fda.gov/FoodGuidances 
Or 
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. Beverages Are Conventional Foods That May Not Be Marketed as 
Dietary Supplements 
B. Factors that Distinguish Beverages from Liquid Dietary Supplements 
C.  Powdered Premix Products and Liquid Concentrates May Be 
Dietary Supplements 
D. Regulatory Requirements for Ingredients of Beverages and Liquid 
Dietary Supplements 
E. Regulatory Requirements for the Labeling of Beverages and Liquid 
Dietary Supplements 
IV.  References  Contains Nonbinding Recommendations 
 
Guidance for Industry1 
Distinguishing Liquid Dietary Supplements from Beverages 
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 to help dietary supplement and beverage manufacturers and 
distributors determine whether a product in liquid form is properly classified as a dietary 
supplement or as a beverage. This guidance describes the factors that distinguish liquid products 
that are dietary supplements from those that are conventional foods.  Further, this guidance 
reminds manufacturers and distributors of dietary supplements and beverages about the 
requirements of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) regarding their 
respective ingredients and labeling. 
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 
dietary supplements and beverages. 
                                                 
1 This guidance has been prepared by the Office of Nutrition, Labeling, and Dietary Supplements and the Office of 
Food Additive Safety in the Center for Food Safety and Applied Nutrition at the U.S. Food and Drug 
Administration.  
  1  Contains Nonbinding Recommendations 
 
II.  Background 
We have observed an increase in the marketing of liquid products with a wide array of 
ingredients and intended uses.  Some of these products are marketed as dietary supplements, and 
others as conventional foods.  Some products may be misbranded because their labeling or other 
representations made about them are inconsistent with the product category under which they are 
being marketed.  In addition, products may be excluded from the dietary supplement category 
because of representations that they are for use as conventional foods.  This guidance is intended 
to describe the factors to consider when determining whether a liquid product should be 
marketed as a dietary supplement or a conventional food. 
III.  Discussion 
A. Beverages Are Conventional Foods That May Not Be Marketed as 
Dietary Supplements 
Under section 201(ff)(2)(B) of the FD&C Act (21 U.S.C. 321(ff)(2)(B)), the term dietary 
supplement means a product that, among other requirements, is not represented for use as a 
conventional food or as a sole item of a meal or the diet.  Beverages are conventional foods 
under the FD&C Act.  Even when the label of a product characterizes it as a dietary supplement, 
the product may not in fact be a dietary supplement.  Products in liquid form can be represented 
as conventional foods as a result of factors such as their product or brand name, packaging, 
serving size and total recommended daily intake (i.e., the volume in which they are intended to 
be consumed), composition, recommendations and directions for use, statements or graphic 
representations in labeling or advertising, and other marketing practices.   
B. Factors that Distinguish Beverages from Liquid Dietary Supplements 
The most obvious representations about a products use are claims made for the product in its 
labeling and advertising.  However, a products name, packaging, serving size, recommended 
daily intake and other recommended conditions of use, and composition, as well as marketing 
practices and representations about the product outside its labeling and advertising, can also be 
important determinants of whether the product is represented as a conventional food (and, thus, 
may not be marketed as a dietary supplement).  Below, we discuss some of these factors in more 
detail.  Although in some circumstances a single factor may be determinative of whether the 
product is represented as a conventional food (see, e.g., the discussion below regarding product 
name), in most circumstances a combination of factors would determine whether the product is 
represented as a conventional food.  
  Labeling and advertising. FDA considers statements and graphics on product labels, labeling, 
and advertising, including Web sites and social media, when the agency evaluates the 
intended use of the product and how it is represented. For example, a product that bears a 
Supplement Facts panel may still be a conventional food if it also bears statements that the 
product is intended to refresh or rehydrate because such statements represent the product 
  2  Contains Nonbinding Recommendations 
 
for use as a beverage, i.e., a conventional food.  Graphics (e.g., symbols, vignettes, pictorial 
serving suggestions) can also represent a product as a conventional food.  For example, an ad 
or label with a picture of a liquid product being poured onto a green salad would represent 
the product as a salad dressing.   
  Product name.   Product or brand names that use conventional food terms such as 
beverage, drink, water, or soda represent the product as a conventional food. 
Examples of other terms that generally would be considered to represent a liquid product as a 
conventional food when used in the products name are beverage names such as orange 
juice, apple cider, bottled water, iced tea, and coffee. For example, calling a 
product bottled water represents the product as a conventional food because bottled 
water is a term identifying a specific category of conventional food that is defined in a food 
standard regulation (see 21 Code of Federal Regulations (CFR) 165.100).   In some 
instances, the mere use of such a term in a product name or brand name may be sufficient to 
establish that a product is represented for use as a conventional food.  However, in other 
situations (e.g., where the term is not associated exclusively with conventional foods), the 
use of such a term in the product name likely would be evaluated in the broader context of 
other factors.  This would be the case, for example, for products described as teas.    
  Product packaging.  Packaging is used to market a product as well as to contain, hold, and 
preserve the product.  Packaging can convey messages about how the product is to be used.  
Packaging characteristics that should be considered include the size, shape, color, and design 
of the container or other packaging, the volume of liquid it holds, whether it is reclosable or 
designed to be consumed in a single serving, and the similarity of the packaging to packaging 
used for common beverages.  For example, packaging a liquid product in a red twelve-ounce 
pop-top aluminum can bearing a silver stripe with the name cola supplement printed in 
script on the can could be considered an implied representation that the product is a cola-
flavored soft drink that is intended to be consumed in a single serving like other canned soft 
drinks.  However, there may be situations where other factors (such as labeled serving size 
and recommended daily intake, discussed in next bullet) support a determination that the 
product is not represented as a conventional food, even if its container is similar to a 
beverage container. 
  Serving size and recommended daily intake.  Based on data from the 2005-2006 National 
Health and Nutrition Examination Survey on daily intake of drinking water and other 
beverages in the United States, we estimate the average total daily drinking fluid intake per 
person to be about 1.2 liters (1200 ml) (Ref. 1).  Liquid products that suggest through their 
labeled serving size and/or recommended daily intake (e.g., Drink up to three 16-ounce 
bottles per day) that they are intended to be consumed in amounts that provide all or a 
significant part of the entire daily drinking fluid intake of an average person in the United 
States are effectively being represented as conventional foods.  Even if a product is not 
expressly represented as an alternative to a beverage, when the practical result of the labeled 
serving size and/or total recommended daily intake is that the product is used as a beverage 
or replaces beverages that serve as ordinary sources of drinking fluid, FDA would generally 
consider the product to be represented for use as a conventional food.  
  3  Contains Nonbinding Recommendations 
 
  Recommendations and directions for use.  Dietary supplements are defined as products that, 
among other requirements, are intended to supplement the diet.  (See section 201(ff)(1) of the 
FD&C Act [21 U.S.C. 321(ff)(1)].)  In contrast, beverages generally are intended, for 
example, to quench thirst or otherwise provide a source of fluids (e.g., water, soda), provide 
nutritive value (e.g., milk, orange juice), or provide taste and aroma (e.g., hot cocoa).  
Recommendations or directions to use a product as a thirst quencher can be considered 
recommendations or directions to use that product as a beverage, replacing other beverages 
such as fruit juice, water, or soda, and thus represent the product as a conventional food.  In 
contrast, recommendations or directions to use a liquid product to supplement the diet in a 
manner consistent with other dietary supplements (e.g., by taking one tablespoon three times 
a day) could be a factor in determining that the product is not represented as a conventional 
food, even if the packaging is similar to packaging used for beverages.   
  Marketing practices.  Examples of marketing practices that may represent a product in liquid 
form as a conventional food include labeling, advertising, or other promotional activities that 
favorably compare the product to a category of beverages (e.g., sodas), market the product as 
an accompaniment to a meal, or market the product based on typical beverage criteria like 
taste, refreshment, and thirst-quenching ability; the use of metatags2 that result in the 
products appearing in the results of an electronic search for sodas, juices, or other beverages; 
and paying for the product to be displayed in the beverage section of retail stores.  However, 
simply recommending that a liquid product be taken with a meal would not generally be 
considered to represent the product as a conventional food, as many dietary supplements 
should be taken with food for best absorption.  Moreover, promoting a product as a substitute 
for a beverage would not always represent the product as a conventional food.  For example, 
a labeling or advertising statement promoting a liquid vitamin C supplement as a quick and 
easy alternative to drinking orange juice would not represent the product as a conventional 
food because it would be promoting the supplement as a more convenient source of vitamin 
C, not as a beverage to quench thirst, provide fluids, or wash down a meal.  
 
  Composition.  FDA recognizes that there are areas of overlap between the ingredients of 
some dietary supplements and conventional foods.  For example, amino acids, proteins, 
vitamins, water, and certain plant ingredients are commonly used in both.  However, in light 
of Congresss findings in the Dietary Supplement Health and Education Act of 1994 
(DSHEA), which focused on the value of dietary supplements in improving nutrition, 
promoting long-term health and quality of life, and reducing the risk of chronic diet-related 
diseases, the agency does not believe that Congress intended the overlap in composition 
between dietary supplements and conventional foods to be total.3  Moreover, the dietary 
supplement provisions of the FD&C Act (added by DSHEA) are premised on the concept of 
dietary supplements as products that are marketed and consumed for nutrition and health 
benefits, and specifically authorize supplements to be marketed for those purposes (see 
section 403(r)(6) of the FD&C Act [21 U.S.C. 343(r)(6)]).  Given that some conventional 
foods are consumed primarily for taste rather than for nutrition or health-related purposes, it 
                                                 
2 A metatag is an HTML tag that contains descriptive information about a Web page.  Although the metatag does not 
appear when the Web page is displayed in a browser,  searching for a word that is one of the Web pages metatags 
will cause that Web page to turn up in the search results (Ref. 2).   
3 Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417,  2, 108 Stat. 4325, 4325-26.  
  4  Contains Nonbinding Recommendations 
 
would strain common sense to interpret DSHEA as authorizing the creation of a dietary 
supplement whenever any dietary ingredient is added to any conventional food.  Such an 
interpretation would make the dietary supplement and conventional food universes co-
extensive, differentiated only by labeling, advertising, and other marketing practices.  In 
addition, if a manufacturer could create a dietary supplement simply by adding a dietary 
ingredient to any pre-existing conventional food and labeling the resulting product as a 
supplement, firms could easily evade the requirement that ingredients in conventional foods 
be generally recognized as safe (GRAS) or approved for their intended use (see section 
III.D.1, below).   
 
When a product marketed as a dietary supplement consists in significant part of conventional 
food components unrelated to its claimed nutritional or health benefit as a supplement and 
the product is essentially a copy of a common beverage with a dietary ingredient added, FDA 
intends to consider whether the composition, along with other factors, represents the product 
as a conventional food.  Merely adding an ingredient listed as a dietary ingredient in section 
201(ff)(1) of the FD&C Act to a product universally recognized as a beverage does not by 
itself transform that beverage into a dietary supplement.  For example, adding a botanical 
such as ginkgo to kool-aid or non-alcoholic eggnog would not automatically create a product 
that could be marketed as a ginkgo supplement.    
 
It should be noted that a dietary ingredient that is lawful for addition to dietary supplements 
may or may not also be lawful for addition to conventional foods.  To be lawful for use in a 
conventional food, the ingredient must be used in conformity with a food or color additive 
regulation prescribing the conditions of its use in food, be GRAS for its intended use in food, 
or qualify for one of the other exceptions to the food additive definition. For example, a firm 
that makes or distributes a liquid dietary supplement containing yohimbe bark extract should 
not assume that yohimbe bark extract may be added to a carbonated soft drink. Unless the 
intended use of yohimbe bark extract in the soft drink meets the GRAS eligibility criteria 
described in the FD&C Act or another exception to the food additive definition applies, this 
use of yohimbe bark extract would be unlawful without a food or color additive regulation 
prescribing safe conditions of use. 
 
  Other representations about a product.  Other representations about a product include, for 
example, representations in publicly available documents, such as statements made in filings 
with government agencies such as the U.S. Securities and Exchange Commission or the U.S. 
Patent and Trademark Office.  For example, a filing describing a product as a type of bottled 
water or coffee drink would represent the product as a conventional food.  However, an 
isolated representation of this type generally would not be enough for FDA to conclude that 
the product is not a dietary supplement.  FDA intends to consider all relevant factors in 
context when determining whether a product is represented as a conventional food. 
C.  Powdered Premix Products and Liquid Concentrates May Be 
Dietary Supplements  
Powdered premix products that are intended to be added to water or other liquids have long been 
marketed as dietary supplements.  If properly labeled as a dietary supplement, a product of this 
  5  Contains Nonbinding Recommendations 
 
type is unlikely to be confused with beverage mixes or used as a substitute for a beverage mix.  
Powdered premixes may bear directions recommending that the premix be added to a liquid as a 
convenient delivery system, for other reasons of convenience or stability (e.g., if the ingredients 
are not stable in aqueous solutions), or to mask the taste of certain ingredients.  We generally do 
not view such products as beverages when they are labeled as dietary supplements, provided that 
they are not otherwise represented as being for beverage use or as alternatives to beverages.  
Likewise, we generally would not view liquid concentrates that are added to water or other 
liquids as beverages when they are labeled as dietary supplements, provided that they are not 
otherwise represented for beverage use or as alternatives to beverages. An example of a product 
represented for beverage use would be chocolate syrup labeled with the statement Delicious in 
milk or over ice cream.  In addition, a product labeled as a powdered lemonade mix would be 
considered to be a conventional food because lemonade is a beverage.   
D. Regulatory Requirements for Ingredients of Beverages and Liquid 
Dietary Supplements 
It is your responsibility to ensure that any beverage or liquid dietary supplement you market 
complies with all applicable regulatory requirements for substances added to the product. 
1. Substances intentionally added to beverages 
Many substances intentionally added to beverages are food additives, which require premarket 
approval by FDA. (See section 409 of the FD&C Act [21 U.S.C. 348] and 21 CFR Part 171.)  A 
substance is exempt from the definition of a food additive, and thus from pre-market approval, if 
it is generally recognized as safe by qualified experts under the conditions of its intended use in 
food (see 21 CFR 170.30), or if it falls under another exception to the food additive definition in 
section 201(s) of the FD&C Act (21 U.S.C. 321(s)).   
The Ingredients, Packaging & Labeling Web page on the FDA Web site (Ref. 3) includes links 
to regulatory requirements and recommendations that apply to substances intentionally added to 
beverages and other conventional foods.  A guidance document entitled Considerations 
Regarding Substances Added to Foods, Including Beverages and Dietary Supplements (Ref. 4) 
is particularly relevant to beverages containing ingredients that have not previously been used in 
conventional foods, that are now being added to beverages at levels in excess of their traditional 
use levels, or that are now being added to new beverages.  
2. Dietary ingredients in dietary supplements 
Substances that are dietary ingredients under section 201(ff)(1) of the FD&C Act (21 U.S.C. 
321(ff)(1)) must not adulterate the dietary supplement to which they are added (see section 402 
of the FD&C Act [21 U.S.C. 342]).  In addition, dietary ingredients that were not marketed in the 
United States before October 15, 1994, are new dietary ingredients subject to the requirements 
of section 413 of the FD&C Act (21 U.S.C. 350b) and 21 CFR 190.6.  Our Web pages entitled 
Dietary Supplements (Ref. 5), New Dietary Ingredients in Dietary Supplements - Background 
for Industry (Ref. 6), and New Dietary Ingredients Notification Process (Ref. 7) include links 
to regulatory requirements and recommendations that apply to new dietary ingredients.  
  6  Contains Nonbinding Recommendations 
 
3. Substances (other than dietary ingredients) intentionally added to 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). See the 
discussion in section III.D.1 of this guidance and References 3 and 4. 
E. Regulatory Requirements for the Labeling of Beverages and Liquid 
Dietary Supplements  
It is your responsibility to ensure that your dietary supplement or beverage complies with all 
applicable labeling requirements. 
1. General prohibition on false or misleading labeling  
All claims, statements, and graphics in the labeling of foods, including beverages and liquid 
dietary supplements, are subject to section 403(a)(1) of the FD&C Act (21 U.S.C. 343(a)(1)), 
which provides that a food is misbranded if its labeling is false or misleading. The FD&C Act 
further provides in section 201(n) (21 U.S.C. 321(n)) that affirmative representations are not the 
only factor relevant to whether labeling is misleading. In determining whether the labeling of an 
article is misleading, there shall be taken into account (among other things) ... the extent to 
which the labeling fails to reveal facts material in the light of such representations or material 
with respect to consequences which may result from the use of the article to which the labeling 
relates under the conditions of use prescribed in the labeling thereof or under such conditions of 
use as are customary or usual.  21 U.S.C. 321(n). 
2. Health claims  
Beverages and liquid dietary supplements may bear health claims, which characterize the 
relationship between a substance (food or food component) and a disease or health-related 
condition (see 21 CFR 101.14(a)(1)). For more information about health claims, including 
procedures for our review of health claims and examples of authorized health claims, we refer 
you to the following: 
  Sections 403(r)(1)(B), (r)(3), (r)(4), and (r)(5) of the FD&C Act (21 U.S.C. 343(r)(1)(B), 
(r)(3), (r)(4), (r)(5));  
  21 CFR 101.14; 
  21 CFR 101.70;   
  21 CFR 101.72101.83; and 
  References from FDAs Web site  
  7  Contains Nonbinding Recommendations 
 
  Label Claims. General Information (Ref. 8) 
  Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of 
Health Claims (Ref. 9)  
  Qualified Health Claims (Ref. 10) 
  FDA Modernization Act (FDAMA) Claims (Ref. 11) 
  Summary of Qualified Health Claims Subject to Enforcement Discretion (Ref. 12). 
3. Nutrient content claims  
Liquid dietary supplements and beverages may bear nutrient content claims, which characterize 
the level of a nutrient in a food (see 21 CFR 101.13(b)).  For more information about nutrient 
content claims, including procedures for our review of nutrient content claims and examples of 
authorized nutrient content claims, we refer you to the following: 
  Sections 403(r)(1)(A), (r)(2), (r)(4), and (r)(5) of the FD&C Act (21 U.S.C. 343(r)(1)(A), 
(r)(2), (r)(4), (r)(5)); 
  21 CFR 101.13;  
  21 CFR 101.69; 
  21 CFR 101.54101.67; and 
  References from FDAs Web site  
  Label Claims. General Information (Ref. 8) 
  FDA Modernization Act (FDAMA) Claims (Ref. 11).   
4. Structure/function claims for conventional foods  
Conventional foods, including beverages, may bear certain kinds of claims about effects on the 
structure or function of the body (structure/function claims).  The FD&C Act defines drug to 
include articles intended to affect the structure or function of the body. This provision contains 
an exception for foods, which affect the structure and function of the body by virtue of providing 
nutrition to sustain life and health. See section 201(g)(1)(C) of the FD&C Act (21 U.S.C. 
321(g)(1)(C)). Food is defined in section 201(f) of the FD&C Act (21 U.S.C. 321(f)) as (1) 
articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used 
for components of any such article.  
Consistent with case law interpreting the other than food exception as applying to articles 
consumed primarily for taste, aroma, or nutritive value, FDA does not intend to regulate 
conventional foods that bear structure/function claims in their labeling as drugs if the claimed 
structure/function effect derives from the products character as a foodits taste, aroma, or 
nutritive value. See Nutrilab v. Schweiker, 713 F.2d 335 (7th Cir. 1983). However, if a 
structure/function claim promotes a product for a use other than providing taste, aroma, or 
nutritive value, such as blocking the absorption of carbohydrates in the gut, the claim may cause 
the product to be a drug under section 201(g)(1)(C) of the FD&C Act by changing its primary 
use. In other words, because of the use promoted in the claim, the product may no longer be 
consumed as a foodprimarily for taste, aroma, or nutritive valuebut rather as a drug for 
some other physiological effect.  Further, if a labeling claim about the effect of a conventional 
food on the structure or function of the body also states or implies that the product is useful in 
treating, mitigating, curing, or diagnosing a disease, the claim causes the product to be a drug 
  8  Contains Nonbinding Recommendations 
 
under section 201(g)(1)(B) of the FD&C Act (21 U.S.C. 321(g)(1)(B)). The same is true for a 
disease prevention claim in the labeling of a conventional food, unless the claim is an authorized 
health claim about reducing the risk of a disease or health-related condition.   
As with all claims in food labeling, structure/function claims for conventional foods may not be 
false or misleading. See section 403(a)(1) of the FD&C Act (21 U.S.C. 343(a)(1)). 
5. Structure/function claims and related claims for dietary supplements 
Structure/function claims in the labeling of dietary supplements are subject to section 403(r)(6) 
of the FD&C Act (21 U.S.C. 343(r)(6)) and our regulation in 21 CFR 101.93, as are dietary 
supplement labeling claims about general well-being and benefits related to a classical nutrient 
deficiency disease.  For more information about these claims for dietary supplements, see Ref. 8. 
As with conventional foods, if a labeling claim about the effect of a dietary supplement on the 
structure or function of the body also states or implies that the product is useful in treating, 
mitigating, curing, or diagnosing a disease, the claim causes the product to be a drug under 
section 201(g)(1)(B) of the FD&C Act (21 U.S.C. 321(g)(1)(B)); see also 21 CFR 101.93(g).  
The same is true for a disease prevention claim in the labeling of a dietary supplement, unless the 
claim is an authorized health claim about reducing the risk of a disease or health-related 
condition.   
6. General food labeling requirements  
Mandatory labeling for beverages and other conventional foods differs in many respects from 
mandatory labeling for dietary supplements.  For example, beverages must show nutrition 
information in the Nutrition Facts format (see 21 CFR 101.9), but dietary supplements must 
show nutrition information in the Supplement Facts format (see 21 CFR 101.36).  Generally, all 
ingredients in a beverage must be declared in the ingredient statement by their common and 
usual names,4 in descending order of predominance; however, for dietary supplements, only 
ingredients not listed in Supplement Facts have to be listed in the ingredient statement.  In 
addition, a beverage or other conventional food should not be labeled with the FDA disclaimer 
that is required on dietary supplement labels that bear structure/function claims or other claims 
described in section 403(r)(6)(A) of the FD&C Act (21 U.S.C. 343(r)(6)(A)).  
FDAs general food labeling requirements, including those that apply to dietary supplements, are 
in 21 CFR Part 101.    
IV.  References  
We have placed the following references on display in the Division of Dockets Management, 
Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You may 
see them at that location between 9 a.m. and 4 p.m., Monday through Friday. 
                                                 
4 There are a few exceptions for ingredients that are exempt from declaration (e.g., processing aids) or that may be 
declared collectively (e.g., spices and flavorings).  See 21 CFR 101.4(b), 101.22, 101.100(a).   
  9  Contains Nonbinding Recommendations 
 
1.  Memorandum from Jannavi Srinivasan, FDA, Center for Food Safety and Applied Nutrition, 
Office of Food Additive Safety, to Barbara Schneeman, FDA, Center for Food Safety and 
Applied Nutrition, Office of Nutrition, Labeling, and Dietary Supplements.  Daily Drinking 
Fluid Intake Estimate (Aug. 31, 2009). 
2.  Metatag. Dictionary.com. The American Heritage Science Dictionary. Houghton Mifflin 
Company. Available at http://dictionary.reference.com/browse/metatag. Accessed May 31, 
2013. 
3.  FDA. Ingredients, Packaging & Labeling.  Available at 
http://www.fda.gov/Food/IngredientsPackagingLabeling/default.htm 
4.  FDA. Guidance for Industry:  Considerations Regarding Substances Added to Foods, 
Including Beverages and Dietary Supplements (2014).  Available at 
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/d
efault.htm 
5.  FDA. Dietary Supplements.  Available at 
http://www.fda.gov/Food/DietarySupplements/default.htm 
6.  FDA.  New Dietary Ingredients in Dietary Supplements - Background for Industry.  
Available at http://www.fda.gov/Food/DietarySupplements/ucm109764.htm 
7.  FDA.  New Dietary Ingredients Notification Process.  Available at 
http://www.fda.gov/Food/DietarySupplements/NewDietaryIngredientsNotificationProcess/de
fault.htm 
8.  FDA. Label Claims. General Information. Available at 
http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm2006873.htm 
 
9.  FDA. Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of 
Health Claims (2009).  Available at 
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/L
abelingNutrition/ucm073332.htm 
10. FDA. Qualified Health Claims. Available at 
http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm2006877.htm 
11. FDA. FDA Modernization Act (FDAMA) Claims.  Available at 
http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm2006874.htm 
12. FDA. Summary of Qualified Health Claims Subject to Enforcement Discretion. Available at 
http://www.fda.gov/Food/IngredientsPackagingLabeling/LabelingNutrition/ucm073992.htm 
  10  Contains Nonbinding Recommendations 
 
  11