Comparison USFDA and GFCP Standards and Policies for Gluten-Free Claims
USFDA
1. Voluntary claim but needs to
be truthful
2. Gluten defined
3. Applies to what products
4. Effective date
5. Applies to consumer
products
6. Threshold for gluten
7. Intentional addition of
gluten containing ingredients
is a gluten-free food
8. Additional statements like:
made with no gluten-
containing ingredients, not
more than 10 ppm, etc.
9. Precautionary statements
like made in a factory that regulation such as <20 ppm
also processes wheat
products
10. Documented, validated and
audited procedures which
ensure consistent
compliance with the
regulation (i.e. <20 ppm) and
prevent failures
GFCP in USA
Same
Same except for uncontaminated oats which is
allowed
Only food excluding alcoholic beverages and
products covered by USDA namely meat,
poultry and egg products. Also excludes dietary
supplements and drugs for now.
August 1 2014 but misbranding rules that
already exist that parallel the regulation are
already in place
Yes
<20 ppm
Not allowed even if <20 ppm is achieved
o Dilution not a solution
Ingredient must be processed to remove
gluten to <20 ppm
Intentional addition excludes cross-
contamination
Allowed if true
Allowed but not an excuse to avoid the
such as <20 ppm
Not mandated. Facility or products may be
checked occasionally but surveillance programs
are very limited
Same
Same for USA and except for Canada where
uncontaminated oats is not allowed
All foods (including meat, poultry fish and egg
products) and beverages including natural health
products, dietary supplements and drugs. Other
products are possible like packaging, paper etc.
(TBD)
Can be applied now
Yes but also non-consumer products such as
ingredients for further processing (gate to plate.
< 10 ppm now but could change to < 20 ppm
Not allowed even if <20 ppm is achieved
o Dilution not a solution
Ingredient must be processed to remove
gluten to <20 ppm
Intentional addition excludes cross-
contamination
Allowed if true
Allowed but not an excuse to avoid the regulation
Mandated and each facility is audited annually (
Food products are treated like a food for special
dietary use meaning that it has been specially
processed or formulated to meet the particular
requirements of a person in this case for persons
with celiac disease and gluten sensitivity.
Comparison USFDA and GFCP Standards and Policies for Gluten-Free Claims
11. Testing required
12. Recommended testing
methods
13. Does not recognize any third
party inspection
14. Record keeping
15. Harmonization for all food
and beverage products
Not mandated but is expectation that
procedures should be in place to ensure
consistent compliance with the regulation (i.e.
<20 ppm)
USFDA correctly does not include
methodologies in regulation nor endorse any
specific test method but expects that
companies will seek out scientifically validated
method(s) for their products. (e.g. AOAC as
example are not valid for all food types. Best
advice would be to seek professionals who
provide this service)
True but no objection.
Not required
USFDA working with TTB and USDA to get them
onside but no guarantee. No mention of FTC
who handles advertising being consulted but it
needs to be onside too.
Testing based on risk is expected along with
documented and validated procedures which are
audited annually to ensure consistent compliance
with the regulation (i.e. <20 ppm). However,
gluten-free food are regulated as
GFCP does do not prescribe methodologies but
recommends that companies seek out
scientifically validated method(s) like ELISA-based
enzyme-linked immunosorbent assays. (Note:
AOAC listed tests are valuable but are not
validated for all food types. Best advice to
manufacturers would be to seek professionals
who provide this service)
Approved auditors may use any credible evidence
which can shed light on the level of conformance
to the requirements including internal and
external audits by others. However, audit reports
are made on GFCP documents and there are no
equivalency agreements with other standards like
GFSI standards whereby auditors are generally
not specifically trained and tested to ensure the
application of gluten-free as a food safety issue.
Mandated to support verification, validated and
audited
Covers all food, beverages and other products
where a gluten-free claim is relevant to protect
consumers. Advertising using the NFCA
trademark is controlled.