Claim Category: Nutrient Content

Claim: Total Dietary Fiber

Graphics:
No more than 2x as prominent as statement of
identity
(21 CFR 101.13.n)
If a fiber claim is made and the food is not low
in total fat, then the label must disclose the
level of total fat per labeled serving.
(9 CFR 317.354.d) (21 CFR 101.54.d)
Associated Claim(s)
High Potency
(FDA only: food and dietary supplements)

Excellent
High
Rich In
Good Source of
Contains
Provides
Added
More Fortified
Enriched Extra Plus
(applies to food and dietary supplements)

Daily Value: 25 g

Graphics Requirements:
If dietary fiber claim, then you need a Nutrition Facts Panel with
percent daily value
(9 CFR 317.309.c)
The disclosure shall appear in immediate proximity to such claim
and be in a type size no less than one-half the size of the claim.
(9 CFR 317.354.d)
Regulation/Criteria

100% of the RDI for at least of vitamins and minerals with RDIs
present, must have 2% of RDI (multi-ingredient
food
product)

100% of the RDI per RACC (

dietary supplements
)
(21 CFR 101.54.f)

20% of DV per RACC

(9 CFR 317.354.b) (21 CFR 101.54.b)
10-19% of DV per RACC
(9 CFR 317.354.c) (21 CFR 101.54.e)

10% of DV per RACC than an appropriate reference food

(9 CFR 317.354.e) (21 CFR 101.54.e)

Docs required for:
Overall Information:
1. Using laboratory analyses, docs required to substantiate nutrient values:
a. Recipe/Product Formula
b. Laboratory contact information
c. Analytical worksheets (method used)
d. Statement signed and dated by the individual who can certify the information is complete and
accurate and that the establishment took reasonable steps to ensure that they adhered to the factors
on which its nutrient values were determined
2. Using information provided by other reasonable means, docs required to substantiate nutrient values:
a. Detailed description on how the nutrition information was determined
b. Recipe/Product Formula
c. Data derived in determining the nutrient values
d. Same as (d) above
Software Verification:
3. USDA/FDA Nutrition Analysis Database
Lab Analysis:
4. The AOAC Official Method 991.43 is used to determine the total dietary fiber content of a particular product.
Frequency Check (Docs & Database):
Upon new or updated product formulation

Supplementary Information:
4. AOAC Official Method 991.43
In order to determine fiber content in a food, enzymes are added to samples of dried foods in order to remove starch
and protein, mimicking the digestion process. For Total Dietary Fiber content determination, an alcohol (such as
ethanol) is added to the enzyme solution to form Soluble Dietary Fiber solids that are then filtered out to be included
in the total weight. Total Dietary Fiber residues are washed with alcohol, dried, and then weighed. Insoluble Fiber is
determined by washing the filtered residues with warm water, drying, and weighing. For total fiber calculations,
separate samples are ashed and crude protein calculations are performed (using the Kjeldahl method
= nitrogen 6.25) and combined to offset variable factors such as water loss or substances other than fiber.
5. Dietaryfiberfraction = (%originalsampleweight) (%ash) (%crudeprotein)
From Li, 2002 in the Journal of Food Composition & Analysis.
Resources:
Code of Federal Regulations
(9 CFR):
http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&tpl=/ecfrbrowse/Title09/9tab_02.tpl
(21 CFR):
http://www.ecfr.gov/cgi-bin/text-idx?rgn=div5;node=21:2.0.1.1.2#se21.2.101_154
1. Graphics Requirements:
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/LabelingNutrition/uc
m064894.htm
2. FDA Guidance:
http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm437403.htm#_V.B.
4
3. USDA/FDA Data Base:
http://ndb.nal.usda.gov/
4. AOAC 991.43:
http://acnfp.food.gov.uk/sites/default/files/mnt/drupal_data/sources/files/multimedia/pdfs/annexg.pdf
5. USDA Fiber Analysis Study:
http://www.ars.usda.gov/SP2UserFiles/Place/80400525/Articles/jfca15_715-723.pdf
6. AOAC Fiber Lab Analysis Study:
http://www.nutrientdataconf.org/pastconf/ndbc17/8-2_lee.pdf
7. FDA Field Science and Laboratories
http://www.fda.gov/ScienceResearch/FieldScience/ucm2025615.htm
8. FDA Lab
http://www.certified-laboratories.com/import.html

*****
FDAdoesnot"approve"healthcarefacilities,laboratories,ormanufacturers.FDAdoes
inspectproductmanufacturerstoverifythattheycomplywithgoodmanufacturingpractices.
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm047470.htm

**Health Claims associated with dietary fiber (CHD) included?

Requirements for Health Claims made in Labeling Resource:

http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/Labeling
Nutrition/ucm064919.htm