Sub Chapter 525
Condiment Industry
Sec. 525.100 Whole and Ground Allspice
- Adulteration by Mold; Insect and Rodent Filth (CPG 7109.01)
REGULATORY ACTION GUIDANCE:
1. The following represents criteria for direct reference seizure to
Division of Compliance Management and Operations (HFC-210) and for direct
citation by District Offices:
Whole Allspice
The whole allspice contains an average of 5% or more moldy berries by
weight.
2. The following represents criteria for recommending legal action to
*CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*:
Ground Allspice
The ground allspice contains an average of 30 or more insect fragments
per 10 grams, or the average of rodent hairs is 1 or more per 10 grams.
NOTE: Determinations for all defects are made on a minimum of six (6)
ten (10) gram subsamples of ground allspice. See Microanalytical Procedures
Manual for weight and subsamples used in analyses of whole spices.
REMARKS:
Since the majority of spices are imported, determine that the lot in
question has not been previously examined and released by FDA as an import.
If the lot has been examined and released previously, submit all available
facts to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*
for seizure consideration in the usual manner.
SPECIMEN CHARGE:
Article (whole/ground allspice) adulterated (when introduced into and
while in interstate commerce)(while held for sale after shipment in interstate
commerce), within the meaning of 21 U.S.C. 342(a)(3), in that it consists
wholly or in part of a filthy substance by reason of presence therein of
(insects), (insect webbing), (insect excreta), (insect fragments), (insect
damaged whole/ground allspice), and (rodent hairs); and that it consists
in part of a decomposed substance by reason of presence therein of (moldy,
decomposed allspice).
NOTE: Only use direct citation authority when prosecution is anticipated
and evidence to support a prosecution is included with the adulteration
charge. Evidence necessary to support a prosecution is specified in existing
regulatory procedures issuances.
*Material between asterisks is new or revised.*
Issued: 10/1/80
Revised: 2/1/86, 3/95
Sec. 525.150 Bay (Laurel) Leaves Adulteration
by Insect Filth; Mold; Mammalian Excreta (CPG 7109.02)
REGULATORY ACTION GUIDANCE:
The following represents criteria for direct reference seizure to Division
of Compliance Management and Operations (HFC-210) and for direct citation
by District Offices:
1. Insect Filth:
The Bay Leaves contain an average of 5% or more insect infested pieces
by weight;
or
2. Mold:
The Bay Leaves contain an average of 5% or more moldy pieces by weight;
or
3. Excreta:
The Bay Leaves contain an average of 1 milligram or more mammalian excreta
per pound, after processing.
REMARKS:
Since the majority of spices are imported, determine that the lot in
question has not been previously examined and released by FDA as an import.
If the lot has been examined and released previously, submit all available
facts to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*
for seizure consideration in the usual manner.
SPECIMEN CHARGE:
Article (bay (laurel) leaves) adulterated (when introduced into and
while in interstate commerce)(while held for sale after shipment in interstate
commerce), within meaning of 21 U.S.C. 342(a)(3), in that it consists wholly
or in part of a filthy substance by reason of presence therein of (insects),
(insect webbing), (insect excreta), (insect damaged bay (laurel) leaves),
and mammalian excreta); and that it consists in part of a decomposed substance
by reason of the presence therein of (moldy, decomposed bay (laurel) leaves).
*Material between asterisks is new or revised.*
Issued: 10/1/80
Revised: 3/95
Sec. 525.200 Capsicum Pods, Ground Capsicums
Excluding Paprika, Ground Paprika - Adulteration with Insect and Rodent
Filth, Mold, Mammalian Excreta (CPG 7109.03)
REGULATORY ACTION GUIDANCE:
The following represents the criteria for direct reference seizure to
Division of Compliance Management and Operations (HFC-210) and for direct
citation by the District Offices:
1. Capsicum pods (includes all capsicums; chili peppers, paprika, etc.),
when analyzed using MPM V.8.A (Page V-32):
a. If the capsicum contains an average of more than 3% insect infested
and/or moldy pods by weight;
or
b. If the capsicum contains an average of more than 1 milligram of mammalian
excreta per pound (mammalian excreta should be identified as to source
when possible).
2. Ground capsicums (cayenne, red pepper, etc.), excluding paprika:
a. If the average mold count is more than 20% when analyzed using AOAC
915.94, 15th Ed.;
or
b. If the capsicum powder contains an average of more than 50 insect
fragments per 25 grams or an average of more than 6 rodent hairs per 25
grams using AOAC 978.22, 15th Ed.
3. Ground paprika:
a. If the average mold count is more than 20% when analyzed using AOAC
915.94, 15th Ed.;
or
b. If the ground paprika contains an average of more than 75 insect
fragments per 25 grams, or an average of more than 11 rodent hairs per
25 grams, when analyzed using 977.25B, 15th Ed.
REMARKS:
Since the majority of spices are imported, determine that the lot in
question has not been previously examined and released by FDA as an import.
If the lot has been examined and released previously, submit all available
facts to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*
for seizurie consideration in the usual manner.
SPECIMEN CHARGE:
Article (capsicum pods/ground capsicums/ground paprika) adulterated
(when introduced into and while in interstate commerce)(while held for
sale after shipment in interstate commerce), within meaning of 21 U.S.C.
342(a)(3), in that it consists wholly or in part of a filthy substance
by reason of presence therein of (insects), (insect webbing), (insect excreta),
(insect fragments), (insect damaged capsicum pods/ground capsicums/ground
paprika), and (mammalian excreta) (rodent hairs); and that it consists
in part of a decomposed substance by reason of presence therein of (moldy,
decomposed capsicum pods/ground capsicums/ground paprika).
*Material between asterisks is new or revised.*
Issued: 10/1/80
Revised: 3/95
Sec. 525.225 Whole Cassia or Whole Cinnamon,
*Ground Cinnamon* - Adulteration by Insect and Rodent Filth; Mold; Mammalian
Excreta (CPG 7109.04)
REGULATORY ACTION GUIDANCE:
1. The following represents criteria for direct reference seizure to
Division of Compliance Management and Operations (HFC-210) and for direct
citation by District Offices:
Whole Cassia and Cinnamon Bark:
a. Insect Filth:
The cassia or cinnamon bark averages 5% or more insect infested pieces
by weight;
or
b. Mold:
The cassia or cinnamon bark averages 5% or more moldy pieces by weight;
or
c. Mammalian Excreta:
The cassia or cinnamon bark contains an average of 1 milligram or more
of mammalian excreta per pound (mammalian excreta should be identified
as to source when possible).
2. The following represents criteria for recommending legal action to
*CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*:
Ground Cinnamon:
a. Insect Filth:
The cinnamon powder contains an average of 400 or more insect fragments
per 50 grams.
or
b. Rodent Filth:
The cinnamon powder contains an average of 11 or more rodent hairs per
50 grams.
NOTE: Determination for all defects are made on a minimum of six (6)
subsamples: 50-gram subsamples for the ground spice and 100-gram subsamples
for the whole spice.
REMARKS:
Since the majority of spices are imported, determine that the lot in
question has not been previously examined and released by FDA as an import.
If the lot has been examined and released previously, submit all available
facts to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*
for seizure consideration in the usual manner.
SPECIMEN CHARGE:
Article (whole cassia/whole cinnamon/ground cinnamon) adulterated (when
introduced into and while in interstate commerce) (while held for sale
after shipment in interstate commerce), within meaning of 21 U.S.C.
342(a)(3), in that it consists wholly or in part of a filthy substance
by reason of presence therein of (insects), (insect webbing), (insect excreta),
(insect fragments), (insect damaged whole cassia/whole cinnamon/whole cinnamon/ground
cinnamon), and (mammalian excreta), (rodent hairs); and that it consists
in part of a decomposed substance by reason of presence therein of (moldy,
decomposed cassia/cinnamon).
NOTE: Only use direct citation authority when prosecution is anticipated
and evidence to support a prosecution is included with the adulteration
charge. Evidence necessary to support a prosecution is specified in existing
regulatory procedures issuances.
*Material between asterisks is new or revised.*
Issued: 10/1/80
Revised: 2/1/86, 3/95
Sec. 525.250 Cloves - Adulteration with
Stems (CPG 7109.05)
REGULATORY ACTION GUIDANCE:
The following represents criteria for direct reference seizure to Division
of Compliance Management and Operations (HFC-210) and for direct citation
by District Offices:
The cloves contain an average of 5% or more stems by weight.
REMARKS:
Since the majority of spices are imported, determine that the lot in
question has not been previously examined and released by FDA as an import.
If the lot has been examined and released previously, submit all available
facts to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*
for seizure consideration in the usual manner.
SPECIMEN CHARGE:
Article adulterated while held for sale after shipment in interstate
commerce, within meaning of 21 U.S.C. 342(b)(2), in that clove stems have
been substituted wholly or in part for cloves.
*Material between asterisks is new or revised.*
Issued: 10/1/80
Revised: 3/95
Sec. 525.300 Condimental Seeds Other than
Fennel Seeds and Sesame Seeds - Adulteration by Mammalian Excreta (CPG
7109.06)
REGULATORY ACTION GUIDANCE:
The following represents criteria for direct reference seizure to Division
of Compliance Management and Operations (HFC-210) and for direct citation
by District Offices:
If the condimental seeds contain an average of 3 milligrams or more
of mammalian excreta per pound.
REMARKS
Since the majority of spices are imported, determine that the lot in
question has not been previously examined and released by FDA as an import.
If the lot has been examined and released previously, submit all available
facts to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*
for seizure consideration in the usual manner.
SPECIMEN CHARGE:
Article adulterated while held for sale after shipment in interstate
commerce, within meaning of 21 U.S.C. 342(a)(3), in that it consists wholly
or in part of a filthy substance by reason of presence therein of excreta.
*Material between asterisks is new or revised.*
Issued: 10/1/80
Revised: 3/95
Sec. 525.325 Cumin Seed - Adulteration
with Sand and Grit (CPG 7109.07)
REGULATORY ACTION GUIDANCE:
The following represents criteria for direct reference seizure to Division
of Compliance Management and Operations (HFC-210) and for direct citation
by District Offices:
The cumin seed contains an average of 9.5% or more ash and/or 1.5% or
more acid insoluble ash.
REMARKS:
Since the majority of spices are imported, determine that the lot in
question has not been previously examined and released by FDA as an import.
If the lot has been examined and released previously, submit all available
facts to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*
for seizure consideration in the usual manner.
SPECIMEN CHARGE:
Article adulterated while held for sale after shipment in interstate
commerce, within meaning of 21 U.S.C. as follows: 342(a)(3) in that it
is unfit for food by reason or presence therein of sand and grit; 342(b)(2)
in that sand and grit have been substituted wholly or in part for cumin
seed.
*Materials between asterisks are new or revised*
Issued: 10/1/80
Revised: 3/95
Sec. 525.330 Curry Powder - Adulteration
by Insect and Rodent Filth (CPG 7109.08)
REGULATORY ACTION GUIDANCE:
The following represents the criteria for direct reference seizure to
Division of Compliance Management and Operations (HFC-210) and for direct
citation by the District Offices:
1. Insect Filth:
The curry powder contains an average of 100 or more insect fragments
per 25 grams;
or
2. Rodent Filth:
The curry powder contains an average of 4 or more rodent hairs per 25
grams.
REMARKS:
Since the majority of spices are imported, determine that the lot in
question has not been previously examined and released by FDA as an import.
If the lot has been examined and released previously, submit all available
facts to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*
for seizure consideration in the usual manner.
SPECIMEN CHARGE
Article curry powder adulterated (when introduced into and while in
interstate commerce), within meaning of 21 U.S.C. 342(a)(3), in that it
consists wholly or in part of a filthy substance by reason of presence
therein of (insects), (insect webing), (insect excreta), and (rodent hairs).
*Materials between asterisks are new or revised*
Issued: 10/1/80
Revised: 3/95
Sec. 525.350 Fennel Seed - Adulteration
by Mammalian Excreta; Insects (CPG 7109.09)
REGULATORY ACTION GUIDANCE:
The following represents the criteria for direct reference seizure to
Division of Compliance Management and Operations (HFC-210) and for direct
citation by District Offices:
1. Insects and Mammalian Excreta:
The fennel seed in 20% or more of the subsamples contain mammalian excreta
and/or insects;
or
2. Mammalian Excreta:
The fennel seed contains an average of 3 milligrams or more of mammalian
excreta per pound.
REMARKS:
Since the majority of spices are imported, determine that the lot in
question has not been previously examined and released by FDA as an import.
If the lot has been examined and released previously, submit all available
facts to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*
for seizure consideration in the usual manner.
SPECIMEN CHARGE:
Article fennel seed adulterated (when introduced into and while in interstate
commerce)(while held for sale after shipment in interstate commerce), within
meaning of 21 U.S.C. 342(a)(3), in that it consists wholly or in part of
a filthy substance by reason of presence therein of (insects), (insect
webbing), (insect excreta), (insect damaged fennel seed) and (mammalian
excreta).
*Materials between asterisks are new or revised*
Issued: 10/1/80
Revised: 3/95
Sec. 525.375 Whole Ginger - Adulteration
with Insect Filth; Mold; Mammalian Excreta (CPG 7109.10)
REGULATORY ACTION GUIDANCE
The following represents criteria for direct reference seizure to Division
of Compliance Management and Operations (HFC-210) and for direct citation
by District Offices:
1. Insect Filth and Mold:
The ginger contains an average of 3% or more moldy and/or insect infested
pieces by weight.
or
2. Mammalian Excreta:
The ginger contains an average of 3 milligrams or more of mammalian
excreta per pound.
REMARKS:
Since the majority of spices are imported, determine that the lot in
question has not been previously examined and released by FDA as an import.
If the lot has been examined and released previously, submit all available
facts to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*
for seizure consideration in the usual manner.
SPECIMEN CHARGE:
Article whole ginger, adulterated (when introduced into and while in
interstate commerce)(while held for sale after shipment in interstate commerce),
within meaning of 21 U.S.C. 342(a)(3), in that it consists wholly or in
part of a filthy substance by reason of presence therein of (insects),
(insect webbing), (insect excreta), (insect damaged whole ginger), and
(mammalian excreta); and that it consists in part of a decomposed substance
by reason of presence therein of (moldy, decomposed ginger).
*Material between asterisks is new or revised.*
Issued: 10/1/80
Revised: 3/95
Sec. 525.400 Hollandaise Sauce - Common
or Usual Name (CPG 7109.11)
BACKGROUND:
Traditionally hollandaise sauce has been made with butter and other
ingredients, but in recent years there has been substantial change in consumer
use and acceptance of margarine, *light butter, cream or sour cream* as
an alternative or supplementary ingredient for butter. A review of the
more commonly used cook books shows that many modern recipes for hollandaise
sauce call for use of either butter or margarine *(light butter, cream
or sour cream are also acceptable).* Egg yolk is the customary emulsifying
ingredient in hollandaise sauce. We have consistently expressed the opinion
that starch is not an appropriate ingredient.
POLICY:
In the absence of a standard of identity, "hollandaise sauce"
has been considered to be the common or usual name for an emulsion of butter,
egg yolk, acidifying ingredients such as lemon juice or vinegar, and seasoning
such as salt and pepper.
In view of the fact that *consumers* commonly substitute margarine for
butter and the fact that many modern recipes for hollandaise sauce provide
for use of either butter or margarine, the Food and Drug Administration
will not object to the use of margarine as the fat ingredient of hollandaise
sauce with appropriate label declaration. *Neither will FDA object to the
use of light butter, cream or sour cream to make a light version.*
Egg yolk is the customary emulsifying ingredient in hollandaise sauce.
Starch is not an acceptable ingredient.
Labels for hollandaise sauce must bear a listing of all ingredients
in accordance with Section 403(i)(2) of the Act. If margarine, *light butter,
cream or sour cream* is used, it should be declared as such in proper order
of predominance in the list of ingredients following in parenthesis by
a listing of the ingredients in the specific margarine *or other "fat"
ingredient* used.
*Material between asterisks is new or revised.*
Issued: 10/1/80
Revised: 3/95
Sec. 525.425 Hops - Adulteration Involving
Aphid Infestation (CPG 7109.12)
REGULATORY ACTION GUIDANCE:
The following represents the criteria for direct reference seizure to
Division of Compliance Management and Operations (HFC-210) and for direct
citation by District Offices:
The hops contain an average of 2500 or more aphids per 10 grams.
REMARKS:
Since the majority of spices are imported, determine that the lot in
question has not been previously examined and released by FDA as an import.
If the lot has been examined and released previously, submit all available
facts to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*
for seizure consideration in the usual manner.
SPECIMEN CHARGE:
Article adulterated while held for sale after shipment in interstate
commerce, within meaning of 21 U.S.C. 342(a)(3), in that it consists wholly
or in part of a filthy substance by reason of presence therein of insects.
*Material between asterisks is new or revised.*
Issued: 10/1/80
Revised: 3/95
Sec. 525.500 Leafy Spices, Other than
Bay Leaves - Whole Oregano Leaves, Whole Marjoram, Whole Sage Leaves and
Whole Thyme Leaves - Adulteration with Insect Filth; Mold; Mammalian Excreta
(CPG 7109.13)
REGULATORY ACTION GUIDANCE:
The following represents criteria for direct reference seizure to Division
of Compliance Management and Operations (HFC-210) and for direct citation
by District Offices:
1. Insect Filth and Mold:
The spice contains an average of 5% or more insect infested and/or moldy
pieces by weight.
or
2. Mammalian Excreta:
The spice contains an average of 1 milligram or more of mammalian excreta
per pound, after processing (mammalian excreta should be identified as
to source when possible).
REMARKS:
Since the majority of spices are imported, determine that the lot in
question has not been previously examined and released by FDA as an import.
If the lot has been examined and released previously, submit all available
facts to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*
for seizure consideration in the usual manner.
SPECIMEN CHARGE:
Article (Leafy Spices (name specific spice)) adulterated (when introduced
into and while in interstate commerce) (while held for sale after shipment
in interstate commerce), within meaning of 21 U.S.C. 342(a)(3), in that
it consists wholly or in part of a filthy substance by reason of presence
therein of (insects), (insect webbing), (insect excreta), (insect damaged
spice), and (mammalian excreta) and in that it consists in part of a decomposed
substance by reason of presence therein of (moldy, decomposed spice).
NOTE: Only use direct citation authority when prosecution is anticipated
and evidence to support a prosecution is included with the adulteration
charge. Evidence necessary to support a prosecution is specified in existing
regulatory procedures issuances.
*Material between asterisks in new or revised.*
Issued: 10/1/80
Revised: 2/1/86, 3/95
Sec. 525.550 Mace - Adulteration with
Insect Filth; Mold; Foreign Matter; Mammalian Excreta (CPG 7109.14)
REGULATORY ACTION GUIDANCE:
The following represents the criteria for direct reference seizure to
Division of Compliance Management and Operations (HFC-210) and for direct
citation by the District Offices:
1. Insect Filth and Mold:
The mace contains an average of 3% or more insects infested and/or moldy
pieces by weight;
or
2. Mammalian Excreta:
The mace contains an average of 3 or more milligrams of excreta per
pound;
or
3. Foreign Matter:
The mace contains an average of 1.5% or more foreign matter through
a 20-mesh sieve.
REMARKS:
Since the majority of spices are imported, determine that the lot in
question has not been previously examined and released by FDA as an import.
If the lot has been examined and released previously, submit all available
facts to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*
for seizure consideration in the usual manner.
SPECIMEN CHARGE:
Article (mace) adulterated (when introduced into and while in interstate
commerce)(while held for sale after shipment in interstate commerce), within
meaning of 21 U.S.C. 342(a)(3), in that it consists wholly or in part of
a filthy substance by reason of presence therein of (insects), (insect
webbing), (insect excreta), (insect damaged mace), and (mammalian excreta);
and that it consists in part of a decomposed substance by reason of presence
therein of (moldy, decomposed mace); and is unfit for food by reason of
presence therein of (stones), (clay), and (sand); or 342(b)(2) in that
(stones), (clay), and (sand) have been substituted wholly or in part for
mace.
*Material between asterisks is new or revised.*
Issued: 10/1/80
Revised: 3/95
Sec. 525.575 Prepared Mustard - Composition (CPG 7109.15)
BACKGROUND:
No standard of identity for prepared mustard has been established under
the Federal Food, Drug, and Cosmetic Act. Prepared mustard and the mustard
seed ingredients used therein were defined in Food Inspection Decision
192, June 27, 1923. These definitions were adopted as a guide for purpose
of enforcement of the Food and Drugs Act of 1906 and with few changes have
continued in use as a guide for enforcement purposes under the Federal
Food, Drug, and Cosmetic Act of 1938. The latest revision of the definitions
appeared in Service and Regulatory Announcement F.D. No. 2, Revision 5,
November 1936.
POLICY:
In absence of a standard of identity for prepared mustard, we consider
the following definitions to be satisfactory guides for the composition
of prepared mustard for purposes of enforcement of the Federal Food, Drug,
and Cosmetic Act.
PREPARED MUSTARD: A paste composed of a mixture of ground mustard
seed and/or mustard flour and/or mustard cake, with salt, a vinegar, and
with or without sugar and/or dextrose, spices or other condiments. In the
fat-, salt-, and sugar-free solids it contains not more than 24 percent
carbohydrates, not more than 12 percent crude fiber, not less than 5.6
percent nitrogen, the carbohydrate being calculated as starch.
MUSTARD SEED: The seeds of Brassica hirta Moench.
*and Sinapis alba* (L.) (both known as white mustard), B.
nigra (L.) Koch (black mustard), B. juncea (L.) Cosson,
*(Chinese mustard)*, or varieties or closely related species of B.
nigra and B. juncea. (In S.R.A. F&D No. 2, the
name Sinapis alba (L.) was used. a
B. hirta (white mustard) contains no appreciable amount
of volatile oil. It contains not more than 5 percent of total ash nor more
than 1.5 percent of ash insoluble in hydrochloric acid.
Brassica nigra (black mustard) and B. juncea
yield 0.6 percent of volatile mustard oil (calculated as allylisothiocyanate).
The varieties and species closely related to the types of B. nigra
and B. juncea yield not less than 0.6 percent of volatile
mustard oil, similar in character and composition to the volatile oils
yielded by B. nigra and B. juncea. These mustard
seeds contain not more than 5 percent of total ash, nor more than 1.5 percent
of ash insoluble in hydrochloric acid.
GROUND MUSTARD SEED, MUSTARD MEAL: Unbolted, ground mustard seed
conforming to the standards for mustard seed.
MUSTARD CAKE: Ground mustard seed, mustard meal, from which a
portion of fixed oil has been removed.
MUSTARD FLOUR, GROUND MUSTARD, "MUSTARD": The powder
made from mustard seed with the hulls largely removed and with or without
the removal of a portion of the fixed oil. It contains not more than 1.5
percent starch, nor0 more than 6 percent of total ash.
CHARLOCK, Brassica kaber (DC.) L.C. Wheeler, according
to available information, does not yield mustard oil. Therefore, charlock
is not a suitable ingredient in prepared mustard. Its use in prepared mustard
may serve to adulterate the article. Charlock is not generally recognized
as safe and no regulation has been promulgated establishing safe conditions
of use in accord with the Food Additives Amendment.
aPrepared mustard must be labeled with a listing of its ingredients
in accord with section 403(i)(2) of the Federal Food, Drug, and Cosmetic
Act. The ingredients should be listed in order of decreasing predominance
in accord with 21 CFR 101.4
*Material between asterisks is new or revised.*
Issued: 10/1/80
Sec. 525.600 Whole and Ground Nutmeg -
Adulteration with Insect Filth; Mold; Rodent Filth (CPG 7109.16)
REGULATORY ACTION GUIDANCE:
1. The following represents the criteria for direct reference seizure
to Division of Compliance Management and Operations (HFC-210) and for direct
citation by the District Offices:
Whole Nutmeg
The whole nutmeg contains an average of 10% or more insect infested
and/or moldy pieces by count.
2. The following represents the criteria for recommending legal action
to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*:
Ground Nutmeg
The nutmeg powder contains an average of 100 or more insect fragments,
or the average of rodent hairs is 1 or more per 10 gram sample.
NOTE: Determination for all defects are made on a minimum of six (6)
subsamples; 10 gram subsamples for ground nutmeg and 100 nuts by count
subsamples for whole nutmeg.
REMARKS:
Since the majority of spices are imported, determine that the lot in
question has not been previously examined and released by FDA as an import.
If the lot has been examined and released previously, submit all available
facts to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*
for seizure consideration in the usual manner.
SPECIMEN CHARGE:
Article (whole/ground nutmeg) adulterated (when introduced into and
while in interstate commerce)(while held for sale after shipment in interstate
commerce), within meaning of 21 U.S.C. 342(a)(3), in that it consists wholly
or in part of a filthy substance by reason of presence therein of (insects),
(insect webbing), (insect excreta), (insect fragments), (insect damaged
nutmeg), and (rodent hairs); and that it consists in part of a decomposed
substance by reason of presence therein of (moldy, decomposed nutmeg).
*Material between asterisks is new or revised.*
Issued: 10/1/80
Revised: 2/1/86, 3/95
Sec. 525.625 *Whole and Ground Pepper
- Adulteration with Insect and Rodent Filth; Mold; Mammalian Excreta; Foreign
Matter* (CPG 7109.17)
REGULATORY ACTION GUIDANCE:
1. The following represents the criteria for direct reference seizure
to Division of Compliance Management and Operations (HFC-210) and for direct
citation by District Offices:
Whole Pepper
a. Insect Filth and Mold
The pepper contains an average of 1% or more insect infested and/or
moldy pieces by weight.
or
b. Mammalian Excreta
The pepper contains an average of 1 milligram or more of mammalian excreta
per pound.
or
c. Foreign Matter
The pepper contains an average of 1% or more pickings and siftings
2. The following represents criteria for recommending legal action to
*CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*:
Ground Pepper
a. Insect Filth
The ground pepper in six or more subsamples contains an average of 475
or more insect fragments per 50 grams.
or
b. Rodent Filth
The ground pepper in six or more subsamples contains an average of 2
or more rodent hair fragments per 50 grams.
REMARKS:
Since the majority of spices are imported, determine that the lot in
question has not been previously examined and released by FDA as an import.
If the lot has been examined and released previously, submit all available
facts to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)
for seizure consideration in the usual manner*.
SPECIMEN CHARGE:
Article (whole/ground pepper) adulterated (when introduced into and
while in interstate commerce) (while held for sale after shipment in interstate
commerce), within meaning of 21 U.S.C. 342(a)(3), in that it consists wholly
or in part of a filthy substance by reason of presence therein of (insects),
(insect webbing), (insect excreta), (insect fragments), (insect damaged
pepper), and (mammalian excreta), (rodent hairs); and that it consists
in part of a decomposed substance by reason of presence therein of (moldy,
decomposed pepper); and is unfit for food by reason of presence therein
of (stones), (clay), and (sand); or 342(b)(2) in that (stones), (clay),
and (sand) have been substituted wholly or in part for (whole/ground) pepper.
*Material between asterisks is new or revised.*
Issued: 10/1/80
Revised: 2/1/86, 3/95
Sec. 525.650 Labeling of Seasonings (CPG
7109.18)
BACKGROUND:
The Agency has considered the labeling of multi-ingredient products
used as seasoning. The labeling of two of these products is discussed to
provide guidance on the status and labeling. One was a "Pizza Seasoning"
containing principally salt, a dried cheese preparation, dextrose and paprika
and smaller amounts of tomato powder, onion powder, garlic powder, ground
oregano, butylated hydroxyanixole, citric acid, propylene glycol, propyl
gallate and oleoresin sweet basil. The cheese preparation contained dehydrated
cheddar cheese with added sodium phosphate, salt, lactic acid and certified
color. The other product was a "Barbecue Seasoning" containing
principally salt, dextrose, sugar, hydrolyzed yeast and lesser amounts
of paprika, monosodium glutamate, onion powder, ground cumin, tricalcium
phosphate, oleoresin celery and a "smoke" flavor. The "smoke"
flavor contained oil of coriander, oil of juniper, isoeugenol, isolates
from wood distillates and propylene glycol. Our comments were in part as
follows:
POLICY:
Section 403(i)(2) requires naming of individual spices, flavorings or
coloring ingredients only in case of articles sold as such. These two articles
do contain spices and flavorings but they are not either spices or flavorings
sold as such. They belong in a broader category of foods, which for want
of a better term might be called "seasonings." There are many
substances whose effect on the taste of food is an important consideration
in their use, which are neither "spices" or "flavorings"
and which we have consistently refused to sanction being declared as "spices"
or "flavorings" when used as ingredients. Examples are the dextrose,
tomato powder, onion powder, garlic powder, citric acid, salt, cane sugar,
hydrolyzed yeast, monosodium glutamate, and tricalcium phosphate in these
products. True spices and flavorings comprise a relatively small percentage
by weight of these two products. Since the products are not spices or flavorings
sold as such the collective term "spices" can be used to declare
the spice ingredients (i.e., oleoresins of sweet basil, celery, etc. and
the spice oils, and isoeugenol). The nonspice and nonflavoring ingredients
are declared by their common or usual names. Wood distillates (pyroligneous
acid) should be declared as "artificial flavor" or "artificial
smoke flavor" in accordance with 21 CFR 101.22(h)(6).
Issued: 10/1/80
Sec. 525.700 Sesame Seeds - Adulteration
with Insect Filth; Decomposition; Mammalian Excreta; Foreign Matter (CPG
7109.19)
REGULATORY ACTION GUIDANCE:
The following represents the criteria for direct reference seizure to
Division of Compliance Management and Operations (HFC-210) and for direct
citation by the District Offices:
1. Insect Filth and Decomposition
The sesame seeds contain an average of 5% or more insect infested or
decomposed seeds by weight;
or
2. Mammalian Excreta
The sesame seeds contain an average of 5 milligrams or more of excreta
per pound;
or
3. Foreign Matter
The sesame seeds contain an average of 0.5% or more foreign matter by
weight.
REMARKS:
Since the majority of spices are imported, determine that the lot in
question has not been previously examined and released by FDA as an import.
If the lot has been examined and released previously, submit all available
facts to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*
for seizure consideration in the usual manner.
SPECIMEN CHARGE:
Article (sesame seeds) adulterated (when introduced into and while in
interstate commerce)(while held for sale after shipment in interstate commerce),
within meaning of 21 U.S.C. 342(a)(3), in that it consists wholly or in
part of a filthy substance by reason of presence therein of (insects),
(insect webbing), (insect excreta), (insect damaged sesame seeds), and
(mammalian excreta); and that it consists in part of a decomposed substance
by reason of presence therein of (moldy, decomposed sesame seeds); and
is unfit for food by reason of presence therein of (stones), (clay), and
(sand); or 342(b)(2) in that (stones), (clay), and (sand) have been substituted
wholly or in part for sesame seeds.
*Material between asterisks is new or revised.*
Issued: 10/1/80
Revised: 3/95
Sec. 525.750 Spices - Definitions (CPG
7109.20)
BACKGROUND:
No definitions for standards of identity for spices have been established
in accordance with Section 401 of the Federal Food, Drug, and Cosmetic
Act. Advisory standards were issued in 1918 as Food Inspection Decision
(FID) 172, under the Food and Drugs Act of 1906. These defined the collective
term "spices" and described a number of specific foods classified
as spices. These underwent several revisions, the latest having appeared
as Service and Regulatory Announcement (SRA) F.D. No. 2, Revision 5, November
1936. These advisory standards provided substantial guidance to the food
industry concerning acceptable labeling of spices or flavorings, and foods
in which these were used. At the same time they were useful as guides to
regulatory officials, under both the 1906 Food and Drugs Act and 1938 Food,
Drug, and Cosmetic Act.
These advisory standards were considered in connection with preparation
of the list of "generally recognized as safe" (GRAS) spices and
other natural flavorings in 21 CFR 182, and the promulgation of regulations
concerning food labeling in 21 CFR 101.22.
After consultation with the American Spice Trade Association, the list
has been brought up-to-date, and information from other sources has been
added.
POLICY:
In the absence of definitions and standards of identity for spices,
the following descriptions provide guidance concerning acceptable names
for use in labeling spices and foods in which they are used. Only the commonly
used spices are included; specific questions about other substances which
may be considered as spices within the general definition may be referred
to the Food and Drug Administration.
DEFINITIONS:
1. SPICES - General Definition - Aromatic vegetable substances, in the
whole, broken, or ground form, whose significant function in food is seasoning
rather than nutrition. They are true to name and from them no portion of
any volatile oil or other flavoring principle has been removed.
2. ALLSPICE (Pimenta) - The dried, nearly ripe fruit of fficinalis
Lindl. The whole berries are globular in form, dark reddish-brown in color,
have a eugenol-like odor and a strong aromatic, pungent taste. The quality
characteristics are measured by the volatile oil, total and acid insoluble
ash, and moisture.
3. ANISE (Aniseed) - The dried, ripe fruit of Pimpinella anisum
L., an annual herb of the parsley family. The dried seeds are greenish-gray
in color, crescent shaped, and possess a strong licorice-like odor. The
principal active ingredient of the volatile oil is anethole. The quality
characteristics are measured by the volatile oil and total and acid insoluble
ash.
4. BASIL - Also known as sweet basil; the dried leaves of Ocimum
basilicum L. The glossy leaves are grayish-green underneath and
when crushed, have a delicate, sweet, warm, highly aromatic odor. The quality
characteristics are measured by the total and acid insoluble ash and freedom
from stems.
5. BAY LEAVES - The dried leaves of Laurus nobilis L. The pale
green to green and occasionally brown-hued leaves are stiff and brittle
and have a smooth and slightly shiny surface. The underneath part of the
leaf appears dull in color. When crushed, the leaves have a delicate aromatic
odor and an aromatic, bitter taste. The principal active ingredient is
cineole. The quality characteristics are measured by the volatile oil,
total and acid insoluble ash, moisture, and freedom from stems.
6. CARAWAY SEED - Caraway seed is the dried fruit of Carum carvi
L. The small, hard seeds have an aromatic, pleasant, warm, sharp taste.
The principal active ingredient of the volatile oil is d-carvone.
The quality characteristics are measured by the volatile oil, total and
acid insoluble ash, and moisture. Caraway N.F. must comply with the monograph
in National Formulary XIV.
7. CARDAMOM (or Cardamon) - The dried, nearly ripe fruit or seed of
Elettaria cardamomum L. Maton. The fruit pods consist of
a husk which is either green or white (bleached) and in which the seeds
are contained. The husk and consequently the whole pod has very little
odor until it has been crushed. The hard, wrinkled, light reddish-brown
to dark reddish-brown seed has a pleasant aromatic odor and a characteristic
warm, slightly pungent, highly aromatic taste. The quality characteristics
are measured by the volatile oil, total and acid insoluble ash and moisture.
8. CELERY SEED - The dried fruit of a biennial herb, Apium graveolens
L. The light brown to brown-colored seeds have a characteristic celery
aroma and a warm, bitter taste. The quality characteristics are measured
by the volatile oil, non-volatile ether extract, total and acid insoluble
ash.
9. CHERVIL - A small, low-growing annual of the parsley family. Anthriscus
cerefolium L. Hoffm. It is similar in appearance to parsley, but
sweeter and more aromatic. It has an anise-like fragrance with a slight
hint of pepper flavor. Its quality characteristics are measured by total
and acid insoluble ash and freedom from stems.
10. CINNAMON (Cassia) - The dried bark of Cinnamomum zeylanicum
Sees (Ceylon cinnamon), Cinnamomum cassia Blume (Chinese
cinnamon), or Cinnamomum loureirii Nees (Saigon cinnamon).
It is brown to reddish-brown in color. The principal active ingredient
in the volatile oil is cinnamaldehyde, which is responsible for the characteristic
odor. The quality attributes are measured by volatile oil, aldehyde content
of the volatile oil, non-volatile ether extract, total and acid insoluble
ash, and moisture. Cinnamon N.F. is made from the dried bark of Cinnamomum
loureirii, and must conform to the monograph in the National Formulary
XIV.
11. CLOVES - The dried, unopened flower buds of Eugenia caryophyllus
(Sprengel) Bullock et. Harrison (formerly Eugenia Caryophyllata
Thunberg). The dried buds resemble a round-headed nail, are dark reddish-brown
in color, have a strong aromatic odor, and a hot pungent, aromatic taste.
The principal active ingredient in the volatile oil is eugenol. The quality
characteristics are measured by volatile oil, total and acid insoluble
ash, moisture, and freedom from clove stems.
12. CORIANDER SEED - The dried ripe seed of Coriandrum sativum
L. The globular, yellowish-brown seed has a slightly fragrant odor and
a pleasant aromatic taste. The quality characteristics are measured by
the total and acid insoluble ash.
13. CUMIN SEED - The dried seed of Cuminum cyminum L. The yellowish-brown
seeds have a strong, distinctive aromatic odor and a warm, aromatic taste.
The quality attributes are measured by the volatile oil, total and acid
insoluble ash, and moisture.
14. DILL SEED - The dried, ripe fruit of Anethum graveolens L.,
an annual herb of the parsley family. The quality characteristics are measured
by total and acid insoluble ash.
15. FENNEL SEED - The clean, dried, ripe fruit of Foeniculum
vulgare Mill. The green or yellowish-tan colored seeds have a pleasant
aromatic odor and possess a sweet anise-like taste. The quality characteristics
are measured by the volatile oil, total and acid insoluble ash, and moisture.
16. FENUGREEK - The clean, dried ripe fruit of Trigonella foenum-graecum
L. The hard, brownish-yellow colored seeds have a strong, pleasant, burnt
sugar-like odor and possess a farinaceous, slightly bitter taste. The quality
characteristics are measured by the total and acid insoluble ash, and moisture.
17. GINGER - The dried, or decorticated and dried, rhizome of Zingiber
officinale Rosc. The roots are irregular, varying from tan to a
pale brown color, or white if limed, and have agreeable, aromatic, slightly
pungent odor, and an aromatic, pungent, biting taste. The principal active
ingredient is zingiberene, which is largely responsible for the pungency.
The quality characteristics are measured by the volatile oil, total and
acid insoluble ash, crude fiber, and moisture.
18. HORSERADISH - The root of Armoracia lapathifolia Gilib.
Horseradish is a hardy perennial plant of the mustard family. It is generally
dehydrated and when wet, emits a characteristic highly pungent, penetrating
odor, plus volatile oils that may cause tears to flow. This is due to the
glycoside sinigrin, which, decomposing by enzymatic action, liberates an
acrid volatile oil similar to mustard oil in taste and properties.
19. MACE - The dried outer membrane of Myristica fragrans
Houtt. It is yellowish-tan to reddish-tan in color, is flat, with horn-like
branched, shiny pieces. It has a fragrant, nutmeg-like odor, and an aromatic,
slightly warm taste. Its quality characteristics are measured by volatile
oil, total and acid insoluble ash, non-volatile ether extract, and moisture.
20. MARJORAM (Sweet Marjoram) - The dried leaves, with or without a
small proportion of the flowering tops of Marjorana hortensis
Moench. The round, light green to light gray-green leaves possess a pleasant,
aromatic odor and have a warm, aromatic, slightly bitter taste. The quality
characteristics are measured by the volatile oil, total and acid insoluble
ash, and moisture.
21. MUSTARD SEED - The seed of Brassica hirta Moench (white
mustard), Brassica nigra (L) Koch (black mustrad), Brassica
juncea (L.) Coss., or varieties or closely related species of the
types of Brassica nigra and B. juncea. Except
for Brassica hirta Moench, which contains no appreciable
volatile oil, the quality characteristics are measured by the volatile
oil, total and acid insoluble ash, and moisture.
22. MUSTARD FLOUR ("Mustard") - The powder made from mustard
seed with the hulls largely removed and with or without the removal of
a portion of the fixed oil. Its quality attributes are measured by volatile
oil, total and acid insoluble ash, starch and moisture.
23. NUTMEG - The dried seed of Myristica fragrans Houtt.,
deprived of its testa, with or without a thin coating of lime (CaO). The
surface of the seed kernels is furrowed in an irregular pattern; they are
spheroidal (some nearly spherical nuts), grayish-brown to brown in color
if unlimed; they have a characteristic, strong, aromatic odor; and an aromatic,
warm, slightly bitter taste. The quality characteristics are measured by
the volatile oil, non-volatile ether extract, total and acid insoluble
ash, and moisture.
24. OREGANO - The dried leaves of Origanum vulgare L.
or Origr Lippia spp. (Mexican oregano). The light green-colored
leaves, when crushed, have a strong camphoraceous aroma and a warm, pungent,
and slightly bitter taste. The quality characteristics are measured by
volatile oil, total and acid insoluble ash, and moisture.
25. PAPRIKA - The sweet, non-pungent, or, if specified, slightly pungent,
dried, ground, red, ripe fruit of Capsicum annum L. The quality
characteristics are measured by extractable color, total and insoluble
ash, and moisture.
26. PARSLEY LEAVES - The leaves and seeds from a biennial herb, Petroselinum
crispum (Mill.) Mansf.
27. PEPPER, BLACK - The dried, immature berries of Piper nigrum
L. The deep dark brown to black, deep-set wrinkled berries, when ground,
have a characteristic, penetrating odor, and a hot, biting and very pungent
taste. The principal active ingredient is piperine, which is responsible
for the pungency. The quality characteristics are measured by the volatile
oil, non-volatile methylene chloride extract, piperine, total and acid
insoluble ash, crude fiber, and moisture.
28. PEPPER, RED (Capsicum, Cayenne) - The red, dried fruit of any variety
of Capsicum frutescens L. or C. annuum L. It
has the characteristic red to brown-red color and a sharp pungency. The
principal active ingredient is capsaicin, which is responsible for the
pungency. The quality characteristics are measured by the pungency rating
(Scoville units), total and acid insoluble ash, and moisture.
29. PEPPER, WHITE - The dried, mature berries of Piper nigrum
L., from which the outer covering or outer and inner coverings have been
removed. As with black pepper, piperine is the principal active ingredient.
The quality characteristics are measured by volatile oil, non-volatile
methylene chloride extract, total and acid insoluble ash, crude fiber,
and moisture.
30. ROSEMARY - The clean, whole dried leaves of Rosmarinus officinalis
L. The shiny, dark green to brownish-green colored, rolled, margined leaves
have the shape and appearance of pine needles. It has a tea-like fragrance;
when crushed, they have a slight camphoraceous odor. The quality characteristics
are measured by the volatile oil, total and acid insoluble ash, moisture,
and freedom from stems.
31. SAFFRON - The dried stigma of Crocus sativus L., a
perennial plant of the iris family. The quality characteristics are measured
by the total and acid insoluble ash.
32. SAGE - The dried leaves of Salvia officinalis L. The
green to gray-green colored, oblong to lanceolate leaves, covered with
fine, short hairs possess a strong, fragrant and aromatic odor relatively
free of any camphoraceous note, and free of objectionable terebinthic odor.
The quality characteristics are measured by the volatile oil, total and
acid insoluble ash, moisture, and freedom from stems.
33. SAVORY - The dried leaves and flowering tops of Satureia
(Satureja) hortensis L. The pale brownish-green leaves have
a fragrant aromatic odor and a warm, aromatic, slightly sharp taste.
34. STAR ANISEED - The dried, ripe fruit of Illicium verum
Hook. f. The principal active ingredient is anethole. The quality characteristics
are measured by volatile oil, total and acid insoluble ash.
35. TARRAGON - The dried leaves and flowering tops of Artemisia
dracunculus L. It has a pleasant, anise-like odor and taste.
36. THYME - The dried leave and flowering tops of Thymus vulgaris
L. The dried, brownish-green, curled leaves, when crushed, yield a fragrant,
aromatic odor, and have a warm, aromatic, pungent taste. The principal
active ingredients of the volatile oil are thymol and carvacrol. The quality
characteristics are measured by the volatile oil, total and acid insoluble
ash, and moisture.
37. TURMERIC - The dried root of the perennial herb, Curcumma
longa L. The quality characteristics are measured by the volatile
oil, total and acid insoluble ash, moisture, crude fiber, and color power
(per cent curcumin).
NOTES:
1. Poppy seeds, sesame seeds, dried or dehydrated onions and garlic
are not considered to be spices. When used as an ingredient in foods they
should be declared on the label by common or usual names.
2. Paprika, tumeric and saffron are color as well as spices. When used
as ingredients in foods they shall be designated as "spice and coloring,"
unless each is designated by its specific name, in accordance with 21 CFR
101.22(a)(2).
Issued: 10/1/80
Sec. 525.800 Tomato Sauce or Tomato Hot
Sauce - Labeling (CPG 7109.21)
BACKGROUND:
No standard of identity has been established for tomato sauce or tomato
hot sauce.
However, in the case of U.S. v. 254 cases, et al, *** "Baby Brand
Tomato Sauce," Uddo and Taormina Company, Claimant, the Court recognized
that "There seems to be no question but that dealers in, and consumers
of, tomato products generally throughout the United States consider tomato
sauce to be a spiced product containing not less than 8.37% of salt-free
tomato solids" (63 F. Supp. 916).
In the same case, a finding was made that "Spanish Style"
tomato sauce usually is made with added spice and pepper (sweet peppers
or hot peppers) and that such tomato sauce can be made by adding cayenne
pepper to tomato puree. In TC-309, dated August 20, 1940, we commented
on the proposed labeling of "tomato hot sauce" which we assumed
was "The usual product prepared from tomato puree, peppers, and possibly
spices and other seasonings."
In TC-309 we explained that, since no standard of identity had been
established for "tomato hot sauce" it would be necessary to declare
the presence of all ingredients in accord with section 403(i)(2) of the
Federal Food, Drug, and Cosmetic Act.
We explained further in TC-309 that tomato puree might be declared as
"tomato puree" unless the puree is made in whole or in part from
residual tomato material from canning, and/or residual tomato material
from partial extraction of juice, in which case the label of the tomato
sauce should bear the additional declaration required by the standard for
labeling of tomato puree which includes either or both of these optional
ingredients.
POLICY:
Although no standard of identity has been established for tomato sauce,
it should consist of a spiced tomato product concentrated to contain not
less than 8.37 percent of salt-free tomato solids. It may be made by adding
spices to tomato puree.
"Spanish Style" or "tomato hot sauce" contains added
pepper(s). It, too, should contain a minimum of 8.37 percent of salt-free
tomato solids.
Labels for tomato sauce should bear a listing of ingredients. In accord
with 21 CFRa, these should be listed in descending order of
predominance.
If puree used to make tomato sauce has been made in whole or in part
from either residual material for canning or residual material after partial
extraction of juice, its label declaration as an ingredient in the tomato
sauce should be accompanied by the statements required by 21 CFRb.
a 21 CFR 101.4
b 21 CFR 155.191(a)(3)
Issued: 12/3/73
Reissued: 10/1/80
Sec. 525.825 Vinegar, Definitions - Adulteration
with Vinegar Eels (CPG 7109.22)
I. DEFINITIONS
BACKGROUND:
No standards of identity for vinegar have been established under the
Federal Food, Drug, and Cosmetic Act. Historically, definitions have been
developed for different types or combinations of types of vinegars. These
remain current Agency policy for labeling purposes.
One of the landmark court decisions under the Food and Drugs Act of
1906 was that the Supreme Court in the case of U.S. v. 95 Barrels, More
of Less, Alleged Apple Cider Vinegar, (265 U.S. 438, 1924), in which
the Supreme Court held that vinegar made from dried apples was not the
same as that which would have been produced from the apples without dehydration,
and that the name "Apple Cider Vinegar" did not represent the
article to be what it really was.
POLICY:
FDA considers the following to be satisfactory guidelines for the labeling
of vinegars:
Natural vinegars as they come from the generators normally contain in
excess of 4 grams of acetic acid per 100 mL. When vinegar is diluted with
water, the label must bear a statement such as "diluted with water
to _______ percent acid strength", with the blank filled with the
actual percent of acetic acid - in no case should it be less than 4 percent.
Each of the varieties of vinegar listed below should contain 4 grams of
acetic acid per 100 mL.(20oC).
VINEGARS:
1. VINEGAR, CIDER VINEGAR, APPLE VINEGAR. The product made by the alcoholic
and subsequent acetous fermentations of the juice of apples.
2. WINE VINEGAR, GRAPE VINEGAR. The product made by the alcoholic and
subsequent acetous fermentations of the juice of grapes.
3. MALT VINEGAR. The product made by the alcoholic and subsequent acetous
fermentations, without distillation, of an infusion of barley malt or cereals
whose starch has been converted by malt.
4. SUGAR VINEGAR. The product made by the alcoholic and subsequent acetous
fermentations of sugar sirup, molasses, or refiner's sirup.
5. GLUCOSE VINEGAR. The product made by the alcoholic and subsequent
acetous fermentations of a solution of glucose. It is dextrorotatory.
6. SPIRIT VINEGAR, DISTILLED VINEGAR, GRAIN VINEGAR. The product made
by the acetous fermentation of dilute distilled alcohol.
7. VINEGAR, MADE FROM A MIXTURE OF SPIRIT VINEGAR AND CIDER VINEGAR.
The product should be labeled as a blend of the products with the product
names in order of predominance. This labeling is applicable to a similar
product made by acetous fermentation of a mixture of alcohol and cider
stock.
8. VINEGAR MADE FROM DRIED APPLES, APPLE CORES OR APPLE PEELS. Vinegar
made from dried apples, apple cores or apple peels should be labeled as
"vinegar made from ______," where the blank is filled in with
the name of the apple product(s) used as the source of fermented material.
II. ADULTERATION WITH VINEGAR EELS
BACKGROUND:
Because some information which indicates that vinegar eels aid in vinegar
production, we do not believe the finding of vinegar eels in a firm's bulk
storage tanks or generators should be considered as an objectionable condition
unless the firm's filtration system is not functioning or unless the eels
are present in the finished product.
POLICY:
The finding of vinegar eels in finished product would be considered
objectionable and would render the finished product adulterated within
the meaning of 402(a)(3).
REGULATORY ACTION GUIDANCE:
The following represents criteria for direct reference seizure to the
*Division of Compliance Management and Operations (HFC-210),* and for direct
citation by District Offices:
Actionable if finished vinegar in consumer-sized bottles contains any
vinegar eels.
SPECIMEN CHARGE:
Article adulterated (when introduced into and while in interstate commerce)
(while held for sale after introduction into interstate commerce), within
the meaning of 21 U.S.C. 342(a)(3), in that it consists in part of a filthy
substance by reason of the presence therein of vinegar eels.
NOTE: Only use direct reference citation authority when prosecution
is anticipated and evidence to support a prosecution is included with the
adulteration charge. Evidence
necessary to support a prosecution is specified in existing regulatory
procedures issuances.
*Material between asterisks is new or revised.*
Issued: 4/25/77
Reissued: 10/1/80
Revised: 11/1/81, 4/1/83, 3/95
Sec. 525.850 Whole Plant (Unprocessed)
Oregano, Crushed Oregano and Ground Oregano - Adulteration by Insect and
Rodent Filth; Mold; Mammalian Excreta (CPG 7109.23)
REGULATORY ACTION GUIDANCE:
1. The following represents criteria for direct reference seizure to
Division of Compliance Management and Operations (HFC-210) and for direct
citation by District Offices:
Whole Plant (Unprocessed) Oregano:
a. Insect Filth and Mold:
The spice contains an average of 5% or more insect infested and/or moldy
pieces by weight.
or
b. Mammalian Excreta:
The spice contains an average of 1 milligram oor more of mammalian excreta
per pound (mammalian excreta should be identified as to source when possible).
2. The following represents the criteria for recommending legal action
to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605).*
a. Ground Oregano
The ground oregano contains an average of 1250 or more insect fragments
and/or an average of 5 or more rodent hairs per 10 gram subsample.
b. Crushed Oregano
The crushed oregano contains an average of 300 or more insect fragments
and/or an average of 2 or more rodent hairs per 10 gram subsample.
NOTE: Determinations for all defects are made on a minimum of six (6)
ten (10) gram subsamples for ground and crushed oregano. See Macroanalytical
Procedures Manual for number of grams of subsamples used in analyses of
whole spices.
REMARKS:
Since the majority of spices are imported, determine that the lot in
question has not been previously examined and released by FDA as an import.
If the lot has been examined and released previously, submit all available
facts to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*
for seizure consideration in the usual manner.
SPECIMEN CHARGES (for all including leafy spices):
Article (whole plant unprocessed/crushed/ground oregano) adulterated
(when introduced into and while in interstate commerce) (while held for
sale after shipment in interstate commerce) within meaning of 21 U.S.C.
342(a)(3), in that it consists wholly or in part of a filthy substance
by reason of presence therein of (insects), (insect fragments), (insect
webbing), (insect excreta), (insect damaged oregano), (mammalian excreta)
and (rodent hairs); and that it consists in part of a decomposed substance
by reason of the presence therein of (moldy, decomposed oregano) (mold).
NOTE: Only use direct citation authority when prosecution is anticipated
and evidence to support a prosecution is included with the adulteration
charge. Evidence necessary to support a prosecution is specified in existing
regulatory procedures issuances.
*Material between asterisks is new or revised.*
Issued: 2/01/86
Revised: 3/95
Sec. 525.900 Whole Plant (Unprocessed)
Marjoram, Unground (Processed) Marjoram and Ground Marjoram - Adulteration
by Insect and Rodent Filth; Mold; Mammalian Excreta (CPG 7109.24)
REGULATORY ACTION GUIDANCE:
1. The following represents criteria for direct reference seizure to
the Division of Compliance Management and Operations (HFC-210) and for
direct citation by District Offices:
Whole Plant (Unprocessed) Marjoram
a. Insect Filth and Mold
The spice contains an average of 5% or more insect infested and/or moldy
pieces by weight.
or
b. Mammalian Excreta
The spice contains an average of 1 milligram or more of mammalian excreta
per pound (mammalian excreta should be identified as to source when possible).
2. The following represents the criteria for recommending legal action
to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*:
a. Ground Marjoram
The ground marjoram contains an average of 1175 or more insect fragments
and/or an average of 8 or more rodent hairs per 10-gram subsample.
b. Unground (Processed) Marjoram
The unground processed marjoram contains an average of 250 or more insect
fragments and/or an average of 2 or more rodent hairs per 10-gram subsample.
NOTE: Determination for all defects are made on a minimum of six (6)
ten (10) gram subsamples for ground and unground processed marjoram.
See Macroanalytical Procedures Manual for number of grams of subsamples
used in analyses of whole spices.
REMARKS:
Since the majority of spices are imported, determine that the lot in
question has not been previously examined and released by FDA as an import.
If the lot has been examined and released previously, submit all available
facts to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*
for seizure consideration in the usual manner.
SPECIMEN CHARGES (for all including leafy spices):
Article (whole plant unprocessed/unground processed/ground marjoram)
adulterated (when introduced into and while in interstate commerce) (while
held for sale after shipment in interstate commerce) within meaning of
21 U.S.C. 342(a)(3), in that it consists wholly or in part of a filthy
substance by reason of presence therein of (insects), (insect webbing),
(insect fragments), (mammalian excreta), and (insect damage, marjoram),
(rodent hairs); and that it consists in part of a decomposed substance
by reason of the presence therein of (moldy, decomposed marjoram) (mold).
NOTE: Only use direct citation authority when prosecution is anticipated
and evidence to support a prosecution is included with the adulteration
charge. Evidence necessary to support a prosecution is specified in existing
regulatory procedures issuances.
*Material between asterisks is new or revised.*
Issued: 2/1/86
Revised: 3/95
Sec. 525.925 Whole Plant (Unprocessed)
Thyme, Unground Processed Thyme and Ground Thyme - Adulteration by Insect
and Rodent Filth; Mold; Mammalian Excreta (CPG 7109.25)
REGULATORY ACTION GUIDANCE:
1. The following represents criteria for direct reference seizure to
the Division of Compliance Management and Operations (Hdirect citation
by District Offices:
Whole Plant (Unprocessed) Thyme
a. Insect Filth and Mold
The spice contains an average of 5% or more insect infested and/or moldy
pieces by weight.
b. Mammalian Excreta
The spice contains an average of 1 milligram or more of mammalian excreta
per pound (mammalian excreta should be identified as to source when possible).
2. The following represents the criteria for recommending legal action
to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*:
a. Ground Thyme
The ground thyme contains an average of 925 or more insect fragments
and/or an average of 2 or more rodent hairs per 10-gram subsample.
b. Unground (Processed) Thyme
The unground processed thyme contains an average of 325 or more insect
fragments and/or an average of 2 or more rodent hairs per 25-gram subsample.
NOTE: Determinations for all defects are made on a minimum of six (6)
ten-gram subsamples for ground and six (6) twenty-five-gram subsamples
for unground thyme.
See Macroanalytical Procedures Manual for number of grams of subsamples
used in analyses of whole spices.
REMARKS:
Since the majority of spices are imported, determine that the lot in
question has not been previously examined and released by FDA as an import.
If the lot has been examined and released previously, submit all available
facts to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*
for seizure consideration in the usual manner.
SPECIMEN CHARGES (for all including leafy spices):
Article (whole plant unprocessed/unground processed/ground thyme) adulterated
(when introduced into and while in interstate commerce) (while held for
sale after shipment in interstate commerce) within meaning of 21 U.S.C.
342(a)(3), in that it consists wholly or in part of a filthy substance
by reason of presence therein of (insects), (insect fragments), (insect
webbing), (insect excreta), (insect damaged thyme), (mammalian excreta),
and (rodent hairs); and that it consists in part of a decomposed substance
by reason of the presence therein of (moldy, decomposed thyme) (mold).
NOTE: Only use direct citation authority when prosecution is anticipated
and evidence to support a prosecution is included with the adulteration
charge. Evidence necessary to support a prosecution is specified in existing
regulatory procedures issuances.
*Material between asterisks is new or revised.*
Issued: 2/1/86
Revised: 6/1/86, 3/95
Sec. 525.950 Whole Plant (Unprocessed),
Sage, and Ground Sage Adulteration by Insect and Rodent Filth; Mold; Mammalian
Excreta (CPG 7109.26)
REGULATORY ACTION GUIDANCE:
1. The following represents criteria for direct references seizure to
the Division of Compliance Management and Operations (HFC-210) and for
direct citation by District Offices:
Whole Plant (Unprocessed) Sage
a. Insect Filth and Mold
The spice contains an average of 5% or more insect infested and/or mold
pieces by weight.
or
b. Mammalian Excreta
The spice contains an average of 1 milligram or more of mammalian excreta
per pound (mammalian excreta should be identified as to source when possible).
2. The following represents the criteria for recommending legal action
to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*:
Ground Sage
The ground sage contains an average of 200 or more insect fragments
and/or an average of 9 or more rodent hairs per 10 gram subsample.
NOTE: Determinations for all defects are made on a minimum of six (6)
ten(10) gram subsamples for ground sage. See Macroanalytical Procedures
Manual for number of grams of subsamples used in analysis of whole spices.
REMARKS:
Since the majority of spices are imported, determine that the lot in
question has not been previously examined and released by FDA as an import.
If the lot has been examined and released previously, submit all available
facts to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)*
for seizure consideration in the usual manner.
SPECIMEN CHARGES (for all including leafy spices):
Article (whole plant unprocessed/ground sage) adulterated (when introduced
into and while in interstate commerce) (while held for sale after shipment
in interstate commerce) within the meaning of 21 U.S.C 342(a)(3) in that
it consists wholly or in part of a filthy substance by reason of presence
therein of (insects), (insect fragments), (insect webbing), (insect excreta),
(insect damaged sage), (mammalian excreta), and (rodent hairs); and that
it consists in part of a decomposed substance by reason of the presence
therein of (moldy, decomposed sage) (mold).
NOTE: Only use direct citation authority when prosecution is anticipated
and evidence to support a prosecution is included with the adulteration
charge. Evidence necessary to support a prosecution is specified in existing
regulatory procedures issuances.
*Material between asterisks is new or revised.*
Issued: 2/1/86
Revised: 3/95
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