Definitions
A B C D E F G H I J K L M N O P Q R S T U V W Y Z
Note: The information in the database reflects what manufacturers print on their labels. The information is not edited or corrected. That is spelling errors may occur and the data are not reviewed for compliance with FDA regulations.
Amount Per Serving
The names and the quantitative amounts by weight of each dietary ingredient shall be presented under the heading "Amount Per Serving." When
the quantitative amounts by weight are presented in a separate column, the heading may be centered over a column of quantitative amounts,
described by paragraph, if space permits. A heading consistent with the declaration of the serving size, such as "Each Tablet Contains,"
or "Amount Per 2 Tablets" may be used in place of the heading "Amount Per Serving." Other appropriate terms, such as capsule, packet,
or teaspoonful, also may be used in place of the term "Serving."
SOURCE: FDA - Nutrition labeling of dietary supplements [21 CFR 101.36(b)(2)(i)(A)]
For the DSLD, the "amount per serving" field lists the amount of the specific dietary ingredient found within one serving (i.e. 50mg in one pill, 10 IU per teaspoon, etc.) as stated explicitly on the label.
Blended Ingredient Types
The following flags describe the two ways which blended ingredients, ingredients contained within a proprietary blends, are represented in the DSLD database. Since a proprietary blend may or may not include a Dietary Ingredient with RDIs or DRVs with it's individual weights declared.
Flag | Description |
---|---|
b | dietary ingredient is part of a blend, any quantity presented in the "Amount/Serving Size" and "% DV" columns are amounts related to the blend as a whole. |
c | dietary ingredient is part of a blend, with its own individual weight listed in the "Amount/Serving Size" and "% DV" columns. |
SOURCE: Dietary Supplement Labeling Guide: Chapter IV. Nutrition Labeling - 34. How must I list proprietary blends?
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Brand
Name given to a product by a manufacturer or distributor. For product descriptions in the DSLD, if no brand is identified, this field is coded as "generic". If a hard copy label is available, upper-and lower-case is preserved as it appears on the label.
Brand Intellectual Property (IP) Statement Information
Many products include after their brand name a symbol that indicates the Brand name, and often a specific statement about the product, are protected as corporate intellectual property (IP). Examples include symbols such as ©, ™, (SM), ® and wording such as "Quik-Sorb (R) is a registered trademark of Bio-Botanica (R) Inc.".
SOURCE: United States Patent and Trademark Office (USPTO)
CFSAN (Center for Food Safety and Applied Nutrition)
The Center for Food Safety and Applied Nutrition (CFSAN) in conjunction with the Food and Drug Administration's (FDA)
field staff, is responsible for promoting and protecting the public's health by ensuring that the nation's food supply is
safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled. CFSAN is one
of six product-oriented centers, in addition to a nationwide field force, that carry out the mission of the FDA.
SOURCE: Center for Food Safety and Applied Nutrition, FDA.
Contact Type
Contact type can be Distributor, Manufacturer, and/or Other depending on the self-describing text located above or before the company name and address for a product.
See: Distributor, Manufacturer, Other
Contact Type, Distributor
Can be an individual or an entity that is responsible for the distribution and/or marketing of products. A distributor may use an existing manufacturer's product label, affix their own label, or modify specific aspects of a manufacturer's label.
Contact Type, Manufacturer
The name of the company listed on the label. In the database, Manufacturer is used as the contact type when the label states "Manufactured or Formulated by."
Contact Types, Other
When the self-describing text say doesn't indicate that it's either a Distributor or a Manufacturer. For example: "Imported by" or "Contact us at"
Copyright Symbol
A copyright protects an original artistic or literary work. For product descriptions in the DSLD, "copyright symbol" indicates whether any trademark/copyright
symbols (e.g. ©, ™, (SM), ®) are associated with the product brand name or ingredient component (i.e., ingredient name or ingredient blend).
SOURCE: U.S. Patent and Trade Office
Country of Origin
"Country of Origin" is a product description field specific to this database. If country of origin is explicitly identified on the label, this field will contain a text descriptor of that item number exactly as it appears on the label. If a hard copy label is available, case will be preserved.
Database
The DSLD database contains the full label contents from dietary supplement products produced for distribution or sale. Dietary supplement products are grouped into three categories:
- DSLD On Market: a dietary supplement product or specific formulation of a dietary supplement product that is currently available on the market at the time the database was last updated.
- DSLD Off Market: a dietary supplement product or specific formulation of a dietary supplement product that was previously sold but is no longer available on the market.
- NHANES: Those products that were consumed by NHANES participants.
The categories of dietary supplement products can be searched together or independently in the DSLD via Advanced Search page.
Date - Entered into DSLD
The date on which the label information was entered into the DSLD after being verified through the contractor's quality control process.
Date - Off Market
The date on which the label went off market.
Date - Recalled by FDA
The date on which the label was recalled by the FDA.
Date - Recalled Voluntarily by Manufacturer
The date on which the label was recalled voluntary by the manufacturer.
Date - Rescan Requested
The date on which the label information was requested to be rescanned into the DSLD to be verified through the contractor's quality control process.
DS (Dietary Supplement)
In the U.S., the Dietary Supplement Health and Education Act (DSHEA, Public law 103-417, October 25, 1994, 103rd Congress) defines a dietary supplement product as
"a product (other than tobacco) intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an amino acid, an herb or other botanical; or a dietary substance for use to supplement the diet by increasing the total dietary intake; or a concentrate, a metabolite, a constituent, an extract, or a combination of any ingredient described above; and intended for ingestion in the form of a capsule, powder, softgel, or gelcap, and not represented as a conventional food or as a sole item of a meal or the diet."
DSHEA (Dietary Supplement Health and Education Act)
DSHEA amends the Federal Food, Drug, and Cosmetic Act of 1938 (FDCA) to alter the way dietary supplements are regulated
and labeled. DSHEA was enacted by Congress following public debate concerning the importance of dietary supplements in
promoting health, the need for consumers to have access to current and accurate information about supplements, and
controversy over the Food and Drug Administration's (FDA) regulatory approach to this product category.
SOURCE: Report of the Commission on Dietary Supplement Labels - Final Report
DSLD ID
The DSLD ID is a unique identifier specific to the DSLD database and different from the NHANES ID. The DSLD ID is assigned to a product with a Dietary Supplement Facts Panel that is unique in product name, net contents, ingredients and/or target group. IDs are assigned regardless of whether the product is on-market (currently produced) or off-market (no longer produced).
DSLD (Dietary Supplement Label Database)
The DSLD is a public use database designed to contain label information from virtually all dietary supplement products offered for sale in the US. The DSLD includes products on, off market, and those consumed by NHANES survey participants.
DRIs (Dietary Reference Intakes)
The Dietary Reference Intakes (DRIs) are nutrient reference values developed by the Institute of Medicine of The National Academies and Health Canada. They are intended to serve as a guide for good nutrition and provide the scientific basis for the development of food guidelines in both the United States and Canada. These nutrient reference values are specified on the basis of age, gender and life stage and cover more than 40 nutrient substances. The DRIs comprise four sets of values:
- Estimated Average Requirement (EAR) by age and gender. The EAR is at the midpoint, where 50 percent of the population would meet the end-point criterion.
- Recommended Dietary Allowance (RDA) based on the estimated average requirement. The RDA, calculated as two standard deviations above the EAR, is the intake level at which, theoretically, 97.5 percent of the population would meet that end point criterion.
- Adequate Intake (AI) level. AIs are set when data are insufficient to establish an EAR. The AI for a nutrient is a recommended average daily intake level based on observed or experimentally determined approximations or estimates of nutrient intake by a group (or groups) of apparently healthy people and is assumed to be adequate.
- Tolerable Upper Intake Level (UL) are defined as the highest level of daily nutrient intake that is likely to pose no risk of adverse health effects for almost all individuals in the specified life-stage group.
The DRIs are not used in labeling of dietary supplements and should not be confused with the daily values used in labeling.
SOURCE: IOM's, Dietary Reference Intake Reports
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DRI Life Stage Group(s)
Refers to dosage information specific to certain populations such as adults, children, mature adults, pre-natal, or infants. For supplements included in the DSLD, the formulation values are aggregated values to reference Dietary Reference Intake (DRI) values. When a formulation target group does not specify both gender and age group, the assumed target is an adult male, 19 to 30 years old.
The DRI Life Stage Groups are not used in labeling of dietary supplements and should not be confused with the intended target group based off the DV used in labeling.
SOURCE: IOM's, Dietary Reference Intake Reports
DV (Daily Value)
Daily Value comprises two sets of dietary standards established by the FDA for labeling purposes:
- Daily Reference Values (DRVs) and
- Reference Daily Intakes (RDIs)
SOURCE: FDA - Food Labeling Guide - Appendix F - Calculate the Perecent Daily Value for Nutrients
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DV Target Group(s) / Intended Target Group(s)
Refers to dosage information specific to certain populations such as adults, children, infants, etc. For supplements included in the DSLD, the values are based on Appendix B and C of the FDA Dietary Supplement Label Guide. Percent DVs are based on the values provided in these two appendices and are not based on the Dietary Reference Intakes (DRIs) established by the Institute of Medicine. The DVs for "Adults and Children 4 or More Years of Age" is also known as the Food Labeling Guide Reference Values. The DVs for "Infants," "Children Less Than 4 Years of Age," and "Pregnant and Lactating Women" when calculated are based on published values in the Federal Register. When a formulation target group does not specify for a gender and age group, the assumed target is "Adults and Children 4 or More Years of Age."
Food Labeling Guide Reference Values |
LanguaL Code | LanguaL Description |
---|---|---|
Adults and Children 4 or More Years of Age | P0250 | Four years and above |
Children Less Than 4 Years of Age | P0192 | Children 12 mths - < 4 Years |
Infants | P0266 | Infants/Children < 12 mths (1 yr.) |
Pregnant and Lactating Women | P0253 | Pregnant and lactating women |
SOURCE: FDA - Dietary Supplement Labeling Guide - Appendix B , FDA - Dietary Supplement Labeling Guide - Appendix C , Møller A., and Ireland J - LanguaL 2014 Thesaurus - Danish Food Information
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FDA (Food and Drug Administration)
The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human
and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that
emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make
medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based
information they need to use medicines and foods to improve their health.
SOURCE: Food and Drug Administration
FDA Disclaimer Statement
By law, the Food and Drug Administration (FDA) requires the following language on a dietary supplement label if the label also includes a structure/function claim: "This (These) statement(s) have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."
The wording of these disclaimers cannot be modified.
SOURCE: U.S. Government Printing Office via GPO Access - 21 CFR 101.93(c)
FDA Statement of Identity
A Statement of Identity is required on all dietary supplement products. The statement of identity for a dietary supplement is its common or usual name or an appropriately descriptive term, as specified by Federal law or regulation. It must be placed on the principal display panel and on alternate principal display panels, if present.
SOURCE: FDA Labeling Guide - Chapter II. Identity Statement, U.S. Government Printing Office via GPO Access - 21 CFR 101.1![Exiting NLM Site](images/exitdisclaimer.gif)
Dietary supplements shall be identified by the term 'dietary supplement' as a part of the statement of identity, except that the word 'dietary' may be deleted and replaced by the name of the dietary ingredients in the product (e.g., calcium supplement) or an appropriately descriptive term indicating the type of dietary ingredients that are in the product (e.g., herbal supplement with vitamins).
SOURCE: U.S. Government Printing Office via GPO Access - 21 CFR 101.3(g)![Exiting NLM Site](images/exitdisclaimer.gif)
Hence if a structure/function claim is included on the product label then the Food and Drug Administration (FDA) requires a statement that specifically identifies the product as a vitamin, mineral, herbal/botanical or dietary supplement.
Examples include: dietary supplement, calcium supplement, vitamin supplement.
Ingredient Categories
There are several ingredient categories in the DSLD database such as: amino acid, botanical, carbohydrate, fat, fatty acid, fiber, mineral, other, protein, and vitamin. These will eventually be categorized based on LanguaL.
Ingredient Category, Amino Acid
This term is being used to categorize dietary ingredients in this database. Amino acids are biologically important organic compounds. They are alpha-amino carboxylic acids (composed of amine (-NH2) and carboxylic acid (-COOH) functional groups), along with a side-chain specific to each amino acid.
Ingredient Category, Enzyme
(The FDA has not defined what is an enzyme as a dietary ingredient) Enzymes are proteins that act as a catalyst in biochemical processes. This term is being used to categorize dietary ingredients in this database.
Ingredient Category, Mineral
This term is being used to categorize dietary ingredients in this database. A solid homogeneous crystalline chemical element or compound that results from the inorganic processes of nature.
SOURCE: NLM - MedlinePlus
Ingredient Category, TBD
To be determined. This term is being used to temporarily categorize dietary ingredients in this database, pending further review for final classification.
Ingredient Category, Vitamin
Any of various organic substances that are essential in minute quantities; act especially as coenzymes and precursors
of coenzymes in the regulation of metabolic processes, but do not provide energy or serve as building units; and are present
in natural foodstuffs or are sometimes produced within the body.
SOURCE: MedlinePlus
Ingredient Name
For each dietary supplement product in the DSLD, the ingredients names are stored into the database as they appear on the label.
A "dietary ingredient" is an ingredient that adds further value to (supplement) the diet. A "dietary ingredient" may be one, or any combination, of the following substances:
- a vitamin
- a mineral
- an herb or other botanical
- an amino acid
- a dietary substance for use by people to supplement the diet by increasing the total dietary intake
- a concentrate, metabolite, constituent, or extract of one of the ingredients listed above
SOURCE: FDA Basics on what is a dietary supplement
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The Dietary Supplement Health and Education Act defines a dietary supplement as containing "dietary ingredients." Examples of dietary ingredients include vitamins, minerals, botanicals, and amino acids. The term "other ingredient" also refers to substances that are not dietary ingredients such as binders, colors, excipients, fillers, flavors, sweeteners, OR are the source of the dietary ingredient.
SOURCE: FDA - Supplement Labeling Guide - Chapter V. Ingredient Labeling, Public Law 103-417, 60 Federal Register 67194 on page 67199 (December 28, 1995)
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Ingredient Name - Location
There are several locations where an ingredient is listed within a label. Ingredients can be listed within the Supplement Facts panel or below (or outside of) the Supplement Facts panel, or elsewhere on the label. Then an ingredient may contain additional information like Source Ingredients, Alternative Names, Blend Ingredients, and etc.
Location Options | Description |
---|---|
Supplement Facts Panel | Includes the dietary ingredients, alternative names, and proprietary blends found within the supplements facts panel. If the row says "Vitamin B1 (Thiamin)" either name is used since they are alternative names for each other. |
Ingredient / Other Ingredient Listing | The ingredient list on dietary supplements is placed outside of the supplement facts panel |
Dietary Ingredient Source | Additional information on the source of a dietary ingredient, found within the supplement facts panel or other ingredients statement. See source definition |
Blended Ingredient | Primarily refers to ingredients contained within a proprietary blends.
See blended definition |
SOURCE: FDA - 21 CFR 101.36 (b)(2), FDA - Supplement Labeling Guide - Chapter V. Ingredient Labeling
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Ingredient Name - Alternate Names
There is a separate table that stores an ingredients synonym or alternative name. This may be identified within the supplement facts label in parentheses immediately following or indented beneath the name of a dietary ingredient.
SOURCE: FDA - 21 CFR 101.36(b)(2)
Example:
Ingredient Name - Blend
Primarily refers to "Proprietary Blend" or other appropriately descriptive term or fanciful name which may be highlighted by bold type.
Which lists all of the dietary ingredients it contains in descending order of predominance in a column or linear fashion.
On the same line of the Proprietary Blend Name, the total weight is of all the dietary ingredients contained within the blend.
SOURCE: FDA - 21 CFR 101.36(c) and (b)(2) (c)(3)
, Dietary Supplement Labeling Guide: Chapter IV. Nutrition Labeling - 34. How must I list proprietary blends?
Example:
Ingredient Name - Blended
Dietary ingredients contained in a proprietary blend. Which are listed in descending order of predominance in a column or linear fashion, and indented under the term "Proprietary Blend" or other appropriately descriptive term.
SOURCE: FDA - 21 CFR 101.36(c)(2) and (b)(3)(i)
Example:
Ingredient Name - Source
The source ingredient that supplies a dietary ingredient may be identified within the supplement facts label in parentheses immediately following or indented beneath the name of a dietary ingredient and preceded by the words "as" or "from," e.g., "calcium carbonate" as the source for "Calcium (as calcium carbonate)."
SOURCE: FDA - 21 CFR 101.36(d)
Example:
Ingredient - Group
This term and ID is being used to group related dietary ingredients in the database together.
Ingredient - Fact Sheet(s)
Links to journal articles or other information sources provided as supplemental information about the dietary ingredient.
Ingredient - Nutrient CAS #
Chemical Abstract Service (CAS) Registry Number for the ingredient. The chemical forms in which the nutrient can be found. CAS Registry Numbers (often referred to as CAS RNs or CAS Numbers) are universally used to provide a unique, unmistakeable identifier for chemical substances. A CAS Registry Number itself has no inherent chemical significance but provides an unambiguous way to identify a chemical substance or molecular structure when there are many possible systematic, generic, proprietary or trivial names.
SOURCE: Chemical Abstracts Service
Ingredient - Nutrient Identity(as)
The chemical forms in which the nutrient can be found.
Ingredient - Nutrient IUPAC nomenclature
The International Union of Pure and Applied Chemistry's Standardized naming of inorganic and organic chemistry.
SOURCE: International Union of Pure and Applied Chemistry (IUPAC)
Ingredient - Nutrient Name
A nutritive substance or ingredient.
SOURCE: Medline Plus
Label Statements, Formulation
Label statements that describe the cultivation, collection, manufacturing, or processing of the ingredients contained in the dietary supplement product. Formulation subtypes include Kosher, contains or does not contain, Type( i.e. specific age, gender, or life stage group or multiple groups), Organic, or Vegetarian/Vegan. Warnings are coded under Label Statements, Precautions.
Label Statements, Precautions
These label statements contain cautions, special conditions for use (e.g. instructions for the safe and responsible use of the dietary supplement product) and for unexpected reactions or interactions with foods or other ingested products. These statements may be general in nature or specified for age groups (children, elderly etc.), life stages (pregnancy, lactation), interactions with prescription medication, presence or potential contact with specific known allergens during product production, or any other precautions for a specific sub-group or actions to take if adverse effects are perceived after ingestion.
Examples include: "Avoid this product during pregnancy and lactation"; "Avoid this product if you are allergic to yeast"; "DO NOT USE IF SEAL IS BROKEN"; "
Discontinue use and consult a doctor if adverse reactions occur".
Label Statements, Product Specific Information (i.e. Storage Instructions)
Label statements are included in this category if they provide information about the appropriate method for storage and handling of the dietary supplement product; i.e., control of temperature, sunlight, moisture, etc.
Example: "Avoid leaving in direct sunlight", "keep refrigerated" or "store in a cool, dry place."
Label Statements, Other
Any label statements that assert claims, such as structure/function statements, or assert specific advertising and/or simplified scientific or clinical language related to the dietary supplement product. These statements may also assert the quality of the dietary supplement product, or other customer-specific and manufacturing information.
Label Statements, Seals / Symbols
On the label there may be specific information and an image presented as a formal seal with related language asserting a quality parameter or certification organization associated with the dietary supplement product. The presence of such a seal does not have to be approved by any government agency nor are any assertions that accompany such a seal necessarily verified by a government agency.
Label Statements, Suggested/Recommended/Usage/Directions:
These label statements provide information related to the daily amount, timing and other usage instructions for the dietary supplement product.
Example: "SUGGESTED USE: One capsule daily with a meal, as a dietary supplement."
LanguaL
LanguaL stands for "Langua aLimentaria" or "language of food." LanguaL is a structured, controlled vocabulary for describing foods, in a systematic organization that simplifies retrieval of information for data analysis. It is based on the principle that items within a database (whether they are dietary supplements or conventional food products) can be described by a combination of uniform terms chosen from "facets" that characterize various mutually exclusive attributes of these products. These facets include food groupings, main ingredient source, physical attributes, other ingredients and processing, packaging and packaging materials, dietary uses, and other miscellaneous characteristics.
SOURCE: Saldanha LG, Dwyer JT, Holden JM, Ireland JD, Andrews KW, Bailey RL, Gahche JJ, Hardy CJ, Møller A, Pilch SM, and Roseland JM.
A Structured vocabulary for indexing dietary supplements in databases in the United States.
J Food Composition and Analysis. 2012 24:226-233.
; Møller A., and Ireland J - LanguaL 2014 Thesaurus - Danish Food Information
LanguaL, Dietary Claim or Use
The categorization of label statements using the LanguaL related to Dietary Claims or Use [P0023]. More than one may be applicable if the has one or more of the following claims listed.
LanguaL Code | LanguaL Description |
---|---|
P0065 | Nutrition-Related Claim or Use When adjectives and descriptors like "High", "Good Source", "Enriched" and etc are applied to nutrients for which a daily value (DV) has been established. |
P0124 | Health-Related Claim or Use Characterizes the relationship between a substance and its ability to reduce the risk of a disease or health-related condition. For which only three are approved:
|
P0264 | Qualified Health Claims Qualified health claims differ from health claims [P0124] in that they must be accompanied by a disclaimer or otherwise qualified. As they are claims that do not meet the significant scientific agreement (SSA) standard. For example:
|
P0265 | Structure/Function Claim Claims that describe the effect that a substance has on the structure or function of the body and does not make reference to a disease. Given there is no pre-approved FDA list for these types of claims it must carry the disclaimer, like the following example "Calcium builds strong bones. This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease." |
P0115 | Other Ingredient- or Constituent-Related Claim or Use All other claims, like "not intended for ---", warning statements, allergen related, and etc. |
P0276 | No Dietary Claim or Use |
SOURCE: Saldanha LG, Dwyer JT, Holden JM, Ireland JD, Andrews KW, Bailey RL, Gahche JJ, Hardy CJ, Møller A, Pilch SM, and Roseland JM.
A Structured vocabulary for indexing dietary supplements in databases in the United States.
J Food Composition and Analysis. 2012 24:226-233.
; Møller A., and Ireland J - LanguaL 2014 Thesaurus - Danish Food Information - Dietary Claims or Use [P0023]
, FDA - Guidance for Industry on Implementation of "Qualified Health Claims" Q&A
LanguaL, Product Type
The categorization of products based on the content within the Supplement Facts box using the following LanguaL codes under Product Type for Dietary Supplement [A1298].
LanguaL Code | LanguaL Description |
---|---|
A1302 | Vitamin Contains only vitamins, which includes: vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, pantothenic, biotin, and choline. |
A1299 | Mineral (or Element) Contains only minerals (or elements). Examples include: calcium, chromium, copper, fluoride, iodine, iron, magnesium, manganese, molybdenum, phosphorus, selenium, zinc, potassium, sodium, and chloride. |
A1305 | Amino acid/protein Contains only amino acid(s) and/or protein containing products |
A1326 | Other Nutritive Contains only nutrients for which the IOM/FNB has established Dietary Reference Intakes (DRIs); not coded as a vitamin, mineral (or element), or amino acid. Examples include fiber, carbohydrates, fatty acids (lipids), omega-3‘s, or combination of any of these. |
A1310 | Other Nutritive > Fatty Acid or Fat/Oil Is a narrower term for Other Nutritive [A1326] for products that only contain something like fatty acids (lipids), omega-3‘s, fish oil, evening primrose, or etc. |
A1306 | Herb/Botanical Contains only herb(s)/botanical(s): plant and plant part, extracts (native, dry/solid, and liquid/tincture). |
A1309 | Non-Nutrient/Non-Botanical Contains only non-nutrient bioactives and nutrients for which there is no DRI is established like Metabolite, constituent, extract, isolate, or combination of any of these |
A1313 | Combination Combination of any of the above ingredients listed above. Examples include: vitamin(s) + mineral(s), vitamin(s) + botanical(s), vitamin(s) + mineral(s) + omega-3s, etc. |
A1315 | Multi-Vitamin and Multi-Mineral Is a narrower term for Combination Supplements [A1313] that only contain the combination of vitamin(s) + mineral(s) |
A1316 | Single-Vitamin and Single-Mineral Is a narrower term for Combination Supplements [A1313] that only contain the combination of vitamin + mineral e.g., Calcium + Vitamin D |
A1317 | Botanical with Vitamin/Mineral Is a narrower term for Combination Supplements [A1313] that only contain the combination of botanical(s) and nutrients like botanical(s) + vitamin(s), botanical(s) + mineral(s), botanical(s) + vitamin(s) + mineral(s) |
A1325 | Other Combination Is a narrower term for Combination Supplements [A1313] for all other combinations. |
SOURCE: Saldanha LG, Dwyer JT, Holden JM, Ireland JD, Andrews KW, Bailey RL, Gahche JJ, Hardy CJ, Møller A, Pilch SM, and Roseland JM.
A Structured vocabulary for indexing dietary supplements in databases in the United States.
J Food Composition and Analysis. 2012 24:226-233.
; Møller A., and Ireland J - LanguaL 2014 Thesaurus - Danish Food Information - Product Type - Dietary Supplement [P1298]
LanguaL, Supplement Form
The categorization of the supplement's physical state, shape or form using the following LanguaL codes under Supplement Form [E0154].
LanguaL Code | LanguaL Description |
---|---|
E0164 | Bar |
E0159 | Capsule |
E0161 | Softgel capsule Is the narrower term for Capsules [E0159], when a label describes the capsule to be a softgel |
E0165 | Liquid |
E0174 | Lozenge |
E0162 | Powder |
E0176 | Gummy |
E0155 | Tablet (will cover pill) |
E0172 | Supplement Form, Other (e.g. tea bag,) |
E0177 | Supplement Form, Unknown |
SOURCE: Saldanha LG, Dwyer JT, Holden JM, Ireland JD, Andrews KW, Bailey RL, Gahche JJ, Hardy CJ, Møller A, Pilch SM, and Roseland JM.
A Structured vocabulary for indexing dietary supplements in databases in the United States.
J Food Composition and Analysis. 2012 24:226-233.
; Møller A., and Ireland J - LanguaL 2014 Thesaurus - Danish Food Information - Supplement Form [E0154]
MedlinePlus®
MedlinePlus directs users to information that helps answer health questions by bringing together authoritative
information from National Library of Medicine (NLM), the National Institutes of Health (NIH), and other government agencies and health-related organizations.
Preformulated MEDLINE searches are included in MedlinePlus and give easy access to medical journal articles.
MedlinePlus also has extensive information about drugs, an illustrated medical encyclopedia, interactive
patient tutorials, and latest health news.
SOURCE: NLM - MedlinePlus
MedWatch
MedWatch, the FDA Safety Information and Adverse Event Reporting Program, serves both healthcare professionals and the
medical product-using public. MedWatch provides important and timely clinical information about safety issues involving
medical products, including prescription and over-the-counter drugs, biologics, medical and radiation-emitting devices,
and special nutritional products (e.g., medical foods, dietary supplements and infant formulas).
SOURCE: FDA - MedWatch
MeSH®
MeSH is the National Library of Medicine's (NLM) controlled vocabulary thesaurus. It consists of sets of terms naming
descriptors in a hierarchical structure that permits searching at various levels of specificity.
SOURCE: National Library of Medicine
Multi-Pack ID
Is the DSLD ID which relates products together that contain two or more separately packaged dietary supplements that differ in content
from each other. For example if the product has a packet of supplements to be taken in the morning and a different packet to be taken
in the afternoon or taken at the same time, such as a prenatal multi-vitamin and mineral and a prenatal DHA supplement.
This is illustrated in paragraph 21 CFR 101.36(e)(10)(iii) where the quantitative amounts and percent of Daily
Value may be presented as specified in this paragraph in one aggregate nutrition label Supplement Facts panel or individual nutrition
labels Supplement Facts panels.
SOURCE: FDA - Nutrition labeling of dietary supplements [21 CFR 101.36(e)(8)]
Multivitamin/multimineral
Dietary supplement products in which each serving contains two or more vitamins and minerals.
NCCIH (National Center for Complementary and Integrative Health)
Formally the National Center for Complementary and Alternative Medicine (NCCAM). The National Center for Complementary and Integrative Health (NCCIH)
is the Federal Government's lead agency for scientific research on complementary and integrative health approaches. NCCIH conducts and supports research
and provides information about complementary health products and practices.
The mission of NCCIH is to define, through rigorous scientific investigation, the usefulness and safety of complementary and integrative health interventions
and their roles in improving health and health care.
SOURCE: NCCIH
NCHS (National Center for Health Statistics)
The National Center for Health Statistics (NCHS) is part of the Centers for Disease Control and Prevention (CDC) and has the responsibility for producing vital and health statistics for the Nation. The mission of the NCHS is to provide statistical information that will guide actions and policies to improve the health of the American people. As the Nation's principal health statistics agency, NCHS leads the way with accurate, relevant, and timely data.
SOURCE: National Center for Health Statistics
NCI (National Cancer Institute)
The National Cancer Institute (NCI) is a component of the National Institutes of Health (NIH), one of eight
agencies that compose the Public Health Service (PHS) in the Department of Health and Human Services (DHHS). The
NCI, established under the National Cancer Institute Act of 1937, is the Federal Government's principal agency for
cancer research and training. The National Cancer Act of 1971 broadened the scope and responsibilities of the NCI
and created the National Cancer Program. Over the years, legislative amendments have maintained the NCI authorities
and responsibilities and added new information dissemination mandates as well as a requirement to assess the incorporation
of state-of-the-art cancer treatments into clinical practice.
SOURCE: National Cancer Institute
Net Contents Quantity/Units
For the DSLD, the "net contents quantity" field within the product description is equal to the total number of units included in the container as explicitly stated on the label. Values must be greater than zero, and must be whole numbers when serving size unit (see below) is discrete (e.g. tablets, capsules, softgels), but may contain decimals when serving size unit is measured in non-discrete units (e.g. milliliters, ounces).
NHANES (National Health and Nutrition Examination Survey)
The National Health and Nutrition Examination Survey (NHANES) is a program of studies designed to assess the health and nutritional status of adults and children in the U.S. The survey is unique in that it combines interviews and physical examinations. NHANES is conducted by the Centers for Disease Control and Prevention (CDC), National Center for Health Statistics (NCHS).
NHANES collects data on use of vitamins, minerals, herbals, and other dietary supplements from all survey participants. Product labels are obtained for all products reported by survey participants. The DSLD includes product labels reported by NHANES participants starting with the 2011-2012 NHANES survey. We include this supplement-level label information on the DSLD site. For more information on how NHANES collects information on participants' usage of dietary supplements, please see the NHANES website: www.cdc.gov/nchs/nhanes.htm
SOURCE: NHANES
NHANES [Supplement] ID
NHANES labels have unique identifiers assigned to them by NCHS. While NHANES labels are assigned a DSLD ID, the NHANES supplement ID is also included so that label information may be linked with NHANES participant data by the NHANES supplement ID, DSDSUPID. For more information on how NCHS assigns NHANES ID's, please see the 'Data Processing and Editing' section of the Data Documentation, Codebook, and Frequencies for any given years survey
SOURCE: NHANES Dietary Supplement Database documentation, Dietary Supplement Database: Product Information (DSPI Doc)
NIH (National Institutes of Health)
NIH is the primary Federal agency for conducting and supporting medical research. Its mission is science in pursuit
of fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to extend
healthy life and reduce the burdens of illness and disability. NIH is a part of the U.S. Department of Health and Human
Services.
SOURCE: National Institutes of Health
NLM® (U.S. National Library of Medicine)
The National Library of Medicine (NLM), on the campus of the National Institutes of Health in Bethesda, Maryland,
is the world's largest medical library. The Library collects materials and provides information and research services
in all areas of biomedicine and health care.
SOURCE: National Library of Medicine
ODS (Office of Dietary Supplements)
The mission of ODS is to strengthen knowledge and understanding of dietary supplements by evaluating
scientific information, stimulating and supporting research, disseminating research results, and educating
the public to foster an enhanced quality of life and health for the U.S. population.
SOURCE: Office of Dietary Supplements
Outer Packaging
"Outer Packaging" is a product description field specific to the DSLD. This field will have the response selection of "present/not present" and identify whether the dietary supplement product container is marketed with an outer carton of any type.
Product
Any item produced for distribution or sale. Dietary supplement products included in the DSLD are
grouped into two categories:
- those products currently available on the market at the time the database was last updated: DSLD On Market
- those products that were once on the market (historic database) but are no longer made available for sale by the manufacturer: DSLD Off Market
- those products that were consumed by NHANES participants
The categories of dietary supplement products can be searched together or independently in the DSLD.
Product Name
For each dietary supplement product in the DSLD, the product name is identified from the main label panel. In a separate field in the database, but linked to the name, is the product Brand. The user can search the DSLD for all products with a specific brand and/or by the product names.
Product Trademark
Product trademark is a distinctive symbol used to identify that the products for which the trademark appears originate from a unique source, and to distinguish products of one entity from those of other entities. A trademark is a type of intellectual property.
SOURCE: U.S. Patent and Trade Office
PubMed Dietary Supplement Subset
ODS and the National Library of Medicine (NLM) partnered to create this Dietary Supplement Subset of NLM's PubMed. PubMed provides access to citations from the MEDLINE database and additional life science journals. It also includes links to many full-text articles at journal Web sites and other related Web resources.
SOURCE: ODS - PubMed Dietary Supplement Subset
PubMed®/MEDLINE®
PubMed is a service of the U.S. National Library of Medicine (NLM) that includes over 23 million citations from MEDLINE
and other life science journals for biomedical articles dating from the 1950s. PubMed includes links to full text articles
and other related resources.
SOURCE: NLM - PubMed
Serving Size
One serving of a dietary supplement equals the maximum amount recommended, as appropriate, on the label for consumption per eating occasion, or in the absence of recommendations, 1 unit (e.g., tablet, capsule, packet, teaspoonful, etc). For example, if the directions on your label say to take 1-3 tablets with breakfast, the serving size would be 3 tablets.
21 CFR 101.12(b) Table 2 in the Miscellaneous Category
SOURCE: FDA Dietary Supplement Labeling Guide
, Dietary Supplement Labeling Guide: Chapter IV. Nutrition Labeling - Serving Size Section
, U.S. Government Printing Office via GPO Access - 21 CFR 101.12(b)
For product descriptions in the DSLD, "serving size" refers to the total number of units in a single serving as identified in the Supplement Facts Panel. Values must be greater than zero, and must be whole numbers when serving size unit is discrete (e.g., tablets, capsules, softgels), but may contain decimals when serving size unit is measured in non-discrete units (e.g., milliliters, ounces).
In any given product, there may be more than one serving size or a range of servings per container on the label if the product is formulated and specified for more than one age, gender, or life stage group. When defining serving size, if there is a range of serving sizes, the highest value will be recorded in the database, and the range will be recorded as a note.
Serving Size (Alternate)
When a label includes multiple serving sizes (e.g, "Serving Size 1 Bottle(s) (18 fl oz)"), then the primary is defined as the one that appears first or at the top-left and the rest would be considered alternates. When an alternative serving size is specified on the label, it gets stored in the text descriptor for the first serving size exactly as it appears on the label.
Serving Size Unit
A description of one serving's form (e.g., tablet, capsule, ml). Specific regulations govern the terms used to
describe one serving's form. Also called "serving size declaration."
SOURCE: FDA Dietary Supplement Labeling Guide
Servings per Container
On the dietary supplement product label, the manufacturer indicates the number
of servings of the dietary supplement product that can be found in the product container. This number of
servings is dependent upon the manufacturer recommended number of product units for use. In any given
product there may be more than one number, or a range of servings per container shown on the label if the
product is formulated and specified for more than one age, gender, or life stage group.
SOURCE: FDA Dietary Supplement Labeling Guide
SKU
SKU or "stock keeping unit" is a ten digit unique identifier for a product and not to be confused with the DSLD ID.
Supplement Facts Panel
The Supplement Facts Panel is required for all dietary supplements. The panel must show the manufacturer's
suggested serving size, information on nutrients present in significant levels, percent Daily Value where applicable,
and all other dietary ingredients present in the product, including botanicals and amino acids. Small businesses and low volume selling
products are except if they filed for an exemption and have met the exemption criteria.
SOURCE: FDA Dietary Supplement Labeling Guide
Tracking Information
Complete list of the dates related to the label.
See: Entry Date, Off-Market Date, FDA Recall
, Manufacturer Recall, Rescan Requested
TBD
To be determined. A definition for this term is temporarily unavailable, pending further review.
Unit Type, IU (International Unit)
The amount of specific physiological activity of a standardized preparation (as of a vitamin) that is agreed upon as an international standard especially for comparison with other biologicals containing the substance in impure form or with a related biologically active substance; also : the amount of the biologically active substance in the standard amount of the preparation producing this activity.
SOURCE: Medline Plus Medical Dictionary
Unit Type, mcg (microgram)
One millionth of a gram.
SOURCE: NLM - MedlinePlus Dictionary
Unite Type, mg (milligram)
One thousandth of a gram.
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