Sub Chapter 515
Candy and Sugar
Sec. 515.100 Confectionery - Use of Non-Nutritive
Substances as Ingredients (CPG 7105.01)
BACKGROUND:
Widespread publicity about use in candy of non-nutritive fillers, poisonous
colors, narcotics, and alcoholic liquors helped arouse support for passage
of the Food and Drugs Act of 1906. That act included a provision that a
confectionery was deemed to be adulterated if it contained "terra
alba, barytes, talc, chrome yellow, or other mineral substance or poisonous
color or flavor, or other ingredient deleterious or detrimental to health,
or any vinous, malt or spirituous liquor or compound or narcotic drug."
In 1910, the Circuit Court of Appeals for the Second Circuit ruled that
the prohibition against "mineral" substances applied only if
the "mineral" was used to deceive or was detrimental to health.
(French Silver Dragee Co. v. U.S., 179 Fed. 824).
The Federal Food, Drug, and Cosmetic Act of 1938 included a provision
under which a confectionery was deemed to be adulterated "if it bears
or contains any alcohol or non-nutritive article or substance except authorized
coloring, harmless flavoring, harmless resinous glaze not in excess of
four-tenths of 1 percentum, natural gum, and pectin."
Contrary to the finding in French Silver Dragee Co. v. U.S.,
this section of the act was strictly construed by the FDA to prohibit use
in a confectionery of any non-nutritive substance other than those named,
even when the substance was safe and performed a technological function.
This concept was litigated in the case of U.S. v. 1200 Candy Bars,
More or Less, Labeled in Part "Sta-Trim." The candy bars
were seized on charges of misbranding and adulteration, the latter charge
being based on use of non-nutritive artificial sweeteners. The court condemned
the candy on the misbranding charges but ruled that it was not adulterated
because the non-nutritive sweeteners were not harmful or deceptive. It
cited the case of French Silver Dragee Co., v. U.S. *The government
appealed the decision, but * the Court of Appeals for the Ninth Circuit,
in January 1963, vacated the judgement insofar as it dealt with adulteration
because the candy bars had been destroyed as a result of the misbranding
charge (313 F. 2d 219).
In June 1966, Congress amended section 402(d) to provide that the prohibition
against non-nutritive substances "shall not apply to a safe non-nutritive
substance which is in or on confectionery by reason of its use for some
practical functional purpose in the manufacture, packaging, or storage
of such confectionery if the use of the substance does not promote deception
of the consumer or otherwise result in adulteration or misbranding in violation
of any provision of this Act."
For many years, FDA interpreted this provision as allowing only those
non-nutritive substances that had a technical effect in the production
of a confectionery, i.e., that affected the candy in some way in attaining
or maintaining certain physical characteristics, to be used in candy. This
interpretation led FDA to not permit the use of non-nutritive sweeteners
in a confectionery for the purpose of caloric reduction and sweetening
because neither use was considered to have a technical effect in the confectionery.
FDA reexamined this position in 1992 and concluded that Congress did
not intend to exclude the use of non-nutritive sweeteners in a confectionery.
The purpose of the 1966 amendment was to "place the confectionery
industry on the same basis as other segments of the food industry and permit
that industry to use in the manufacture of candy, food additives cleared
for safety under the Food Additives Amenection 409]." 21 CFR 170.3(o)
defines the terms used to describe the physical or technical functional
effects for which food additives are added to food. "Non-nutritive
sweetener" is listed in 21 CFR 170.3(o) (19) as a technical effect.
POLICY:
Non-nutritive substances may be used in a confectionery if they meet
all of the following criteria:
1. They must be safe. They may be used if listed by FDA as generally
recognized as safe for the proposed use, if subject to a prior-sanction
or interim listed for such use, or if they are food additives or color
additives used in accord with a regulation establishing safe conditions
of use. If there is any question about the safety of a proposed use, this
should be resolved by submitting a petition for a regulation to establish
safe conditions of use.
2. The non-nutritive substances must be used for a practical functional
purpose. 21 CFR 170.3(o) defines those terms that describe a practical
functional purpose. The non-nutritive substance should be used in the minimal
amount needed to achieve its purpose, and its use should otherwise be in
accord with good manufacturing practice.
3. The use of a non-nutritive substance must not promote deception and
must not result in adulteration as defined in section 402(b) of the Act.
As long as the confectionery is properly labeled, the use of non-nutritive
sweeteners in a confectionery is not considered to promote deception. However,
the use of any *non-nutritive* substance, including cheap fillers, such
as talc, which would promote deception, is still prohibited.
The agency advises that this CPG represents its current position regarding
the interpretation of Section 402(d) of the Federal Food, Drug, and Cosmetic
Act as it applies to the use of non-nutritive sweeteners and other non-nutritive
substances in a confectionery. This CPG may be useful to FDA district officers
when interpreting the agency's policy on the use of non-nutritive sweeteners
in a confectionery. Furthermore, this CPG does not bind the agency, and
it does not create or confer any rights, privileges, or benefits for or
on any person.
*Material between asterisks is new or revised*.
Issued: 10/1/80
Revised: 9/2/92, 3/95
Sec. 515.200 Malt Extract; Malt Syrup;
Malted Cereal Syrup; Liquid Malt; Dried Malt (CPG 7105.02)
BACKGROUND:
Trade Correspondence (TC-225) issued April 11, 1940, included this statement,
"This Administration has been holding that 'malt syrup' without qualification,
means barley malt syrup. If this name is used to designate any other product,
in our opinion, it would be misleading under Section 403(a) of the Act.
A product of this type made from barley and other cereal or cereals would
be more appropriately named 'malted cereal syrup'."
Malt extract was the subject of a monograph in National Formulary
XI. It was defined as: "Malt Extract is the product obtained by
extracting malt, the partially and artificially germinated grain of one
or more varieties of Hoedeum vulgare Line (Fam. Gramineae).
The malt is infused with water at 60o, the expressed liquid
concentrated at a temperature not exceeding 60o, preferably
under reduced pressure. The extract may be mixed with 10 percent, by weight,
of glycerin. It contains dextrin, maltose, a small amount of glucose, and
amylolytic enzymes.
Malt extract is capable of converting not less than 5 times its weight
of starch into water-soluble sugars."
Although NF XIII does not contain a monograph, Malt Extract is described
on page 921.
Jacobs in "Food and Food Products," 2nd Edition (page 2026)
describes the preparation of malt syrup or extract as follows:
"The manufacture of malt sirups, concentrated malt extracts, etc.
involves:
1. The solution and extraction of soluble and colloidal substances from
the crushed barley malt by means of water of proper hardness and reaction
held at suitable temperatures for sufficient time intervals to enable the
various enzyme systems in the malt to hydrolyze the desired grain components,
principally carbohydrates, and proteins.
2. Filtering the solution. The filtrate, or wort, in some instances
is boiled to sterilize it and to precipitate unstable and undesirable substances.
3. Further concentration of the wort by means of vacuum evaporators,
the process depending upon the final product manufactured."
We have consistently advised inquirers that an article labeled "malt
syrup" or "liquid malt" should consist of malt in a liquid
vehicle. The terms "malt syrup" and "malt extract"
have sometimes been used interchangeably.
In July 1966 we initiated seizure action against an article labeled
in part "Sweetened and Preserved Liquid Malt." The article was
alleged to be misbranded within the meaning of Section 403(a) of the Act
in that the statements "Sweetened and Preserved Liquid Malt"
and "Liquid Malt" were false and misleading as applied to a product
consisting of malt wort, corn syrup, malt syrup, malt flour, and potassium
sorbate. This seizure was contested, and the case tried to a jury of six
on August 22, 1967. The jury returned a verdict for the Government. They
found that the label was false and misleading. Experts who were interviewed
during preparation for this trial agreed that "malt extract"
and "malt syrup" were water infusions of pure powdered malt which
are boiled down to various degrees of viscosity with a preservative sometimes
added, and that an article labeled "liquid malt" should not contain
other ingredients.
POLICY:
The designations "malt extract" and "malt syrup"
should be used only for concentrated water infusions of malt, with or without
added safe preservative.
The terms "malt extract" or "malt syrup" unqualified
should be applied only to products prepared from barley. If any other malted
grain is used, the extract or syrup may be designated by a specific name
such as "extract of malted barley and corn."
The designation "liquid malt" is considered false and misleading
as applied to mixtures of malt extract or malt syrup with corn syrup or
other substances which are not normal constituents of malt extract.
Issued: 10/1/80
Revised: 3/95, 8/96
Sec. 515.300 Honey - Source Declaration
(CPG 7105.03)
POLICY:
A honey may be labeled with the name of the plant or blossom provided
that the particular plant or blossom is the chief floral source of the
honey, such as "Orange Blossom Honey" or "Clover Honey,"
and provided that the honey producer is in a position to demonstrate that
the plant or blossom designated on the label constitutes the chief floral
source of the honey.
Issued: 10/1/80
Sec. 515.350 Candy - Mixed with Trinkets
and Sold in Vending Machines (CPG 7105.04)
BACKGROUND:
For many years confectionery and nuts have been intermingled with various
types of trinkets and dispensed from vending machines. The FDA has consistently
viewed this practice with apprehension because of possible injury to children
if they bite down on or swallow such trinkets.
A seizure was instituted against a lot of gum and candy intermingled
with trinkets. It was alleged that the mingling of trinkets with candy
resulted in adulteration in violation of Section 403(a)(1) of the Federal
Food, Drug, and Cosmetic Act which provides that food shall be deemed adulterated
"if it bears or contains any poisonous or deleterious substance which
may render it injurious to health". The seizure was contested. The
U.S. District Court upheld the seizure, but on July 24, 1951 the 4th Circuit
Court of Appeals reversed this decision, holding that the trinkets were
not contained within the gum or candy. (Cavalier Vending Corporation
v. United States, 190 F. 2nd 386 Reversing 95 F. Supp. 490).
In 1964, HEW and FDA initiated legislation intended to clearly outlaw
the practice of vending confectionery mingled with trinkets through an
amendment to Section 402(d) of the Act. Section 402(d)(1) was amended to
provide that confectionery shall be deemed to be adulterated if it has
partially or completely imbedded therein any non-nutritive object.
Considering the amendment, both the House and Senate Reports mentioned
the Cavalier case, and both mentioned that FDA had asked for legislation
to put a stop to the intermingling of trinkets with candy unless the trinkets
were wrapped in cellophane or otherwise separated from the candy. Both
the House and Senate said that such legislation should not be allowed,
because the vending machine operators had one of the lowest liability insurance
rates in the food industry, indicating a low incidence of injuries.
POLICY:
The FDA is still apprehensive about possible injuries resulting from
vending trinkets intermingled with confectionery. FDA recommends that the
trinkets be physically separated from candy or gum by some form of wrapping
as a safety precaution.
However, because of the decision of appellate court in Cavalier Vending
Corp. v. U.S., and the legislative history of P.L. 89-477, amending
Section 402(d)(1), the Administration is not in a position to take regulatory
action because of the intermingling of trinkets with confectionery, so
long as the trinkets are not completely or partially imbedded in candy
or gum.
Issued: 10/1/80
Sec. 515.400 Raw Sugar (CPG 7105.05)
BACKGROUND:
"Raw sugar" is the term generally applied to the intermediate
food product as it leaves the sugar factory mill for further refinement
in sugar refineries before use as food. In general, raw sugar is unsuitable
for human food use because it contains extraneous impurities which are
removed in the refining process. On occasion the agency has taken action
against raw sugar intended for human food use without further refinement
which was found to contain impurities rendering it unsuitable for food
use. The only practical process for freeing raw sugar of such impurities
such as filth, dirt, and decomposition is the usual refining process of
sugar refiners.
POLICY:
The Federal Food, Drug, and Cosmetic Act does not prohibit the shipment
of raw sugar for further refinement in sugar refineries or for non-human
food use. However, the agency will take legal action against raw sugar
intended for human food use without further refinement which contains impurities
making it unsuitable for *human* food use.
*Material between asterisks is new or revised.*
Issued: 10/1/80
Revised: 3/95
Sec. 515.425 Sugar - Water Damaged - Reconditioning
(CPG 7105.14)
BACKGROUND:
The Center for Food Safety and Applied Nutrition has agreed to the following
refining process for reconditioning water damaged sugar.
1. Introduce sugar into refining process at site of high raw sugar melter
or "high remelt" melter.
2. Determine if sugar condition warrants lime, P205,
etc. treatment.
3. Mix with water or process juices to a 65-70 percent concentration.
4. Maintain temperature at 95oC (203oF) or greater.
5. Add filter aid or diatomaceous earth and pass process sirup through
clarifiers or pressure filters and continue through char, *carbon, and/or
ion exchange resin* filters to improve color.
6. Introduce filtered liquors into vacuum pans and boil to point of
supersaturation.
7. Introduce seed crystals and continue crystal growth to optimum size.
8. Centrifuge, wash with hot water, and dry in granulator.
9. Place in bulk refined storage or screen to desired commercial product
size.
10. The supernate and centrifugal washings are returned to normal process
stream.
POLICY:
The above method is suitable for reconditioning sugar damaged by non-potable
fresh or salt water.
NOTE: The method is not suitable for reconditioning sugar if there is
evidence that the sugar was damaged by chemicals or sewage (floods, flooded
ship's toilet, etc.).
*Material between asterisks is new or revised.*
Issued: 10/1/80
Revised: 3/95
Sec. 515.500 Barley Sugar - Definition,
and Barley Sugar Candy (CPG 7105.07)
BACKGROUND:
Available information indicates that when sugar is heated to 160oC.
(320oF.) it melts without loss in weight, and congeals on cooling,
to a transparent amorphous yellowish mass which becomes gradually opaque
on the surface from the formation of minute crystals, and that the resulting
product is sometimes referred to as barley sugar. A second source of information
states that when rock candy is heated to 185oC. (365oF.),
it melts into a viscid, liquid, which on being suddenly cooled from a transparent
mass called barley sugar.
It is apparent that the term barley sugar is being loosely applied to
a product which is not now prepared even in part from barley. We doubt
that the term has a derived meaning which would make it understandable
to the purchaser, although it may be understood by sugar technologists.
POLICY:
We are therefore inclined to discourage the use of the terms barley
sugar and barley sugar candy as it is proposed to use them, since they
appear to be ambiguous. However, we have made no investigation of consumer
understanding of these terms and can advise interested persons only that
the responsibility for their use rests upon the manufacturer of the products.
Issued: 10/1/80
Sec. 515.600 Candied Citron - Labeling
(CPG 7105.09)
POLICY:
The term "Candied citron" is generally recognized in the trade,
and by the consumer, to be applicable only to the candied peel of fruit
of the citron tree, Citrus medica L., variety genuina Engl.,
a citrus fruit similar to the lemon but larger and possessing a thick rind
of characteristic flavor.
The rind of the citrus melon, Citrullus vulgaris Schrad., is
often used in a similar manner to candied citron. The candied rind of this
variety of watermelon, may not be designated as "Candied citron."
It should be labeled "candied citron melon," "Candied watermelon,"
or some similar designation that is not false or misleading.
It is also considered that such terms as "American citron,"
"Candied domestic citron," or the like, are not correct designations
for the candied citron melon and when used will be deemed misbranding,
except when applied to the American product of the citrus fruit "citron,"
described above.
Issued: 10/1/80
Revised: 3/95
Sec. 515.700 Chocolate & Chocolate
Liquor - Adulteration with Insect and Rodent Filth (CPG 7105.11)
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:
1. Insec Filth
a. The chocolate in six (6) 100 gram subsamples contains an average
of 60 or more insect fragments per 100 grams.
or
b. Any one subsample contains 90 or more insect fragments, even if the
overall average of all the subsamples is less than 60.
2. Rodent Filth
a. The chocolate in six (6) 100 gram subsamples contains an average
of more than 1.0 rodent hair per 100 grams, regardless of the size of the
hairs or hair fragments.
or
b. Any one subsample contains more than 3 rodent hairs even if the overall
average is less than 1.0 rodent hair.
*NOTE: Insect and rodent filth analyses are conducted using method 965.38,
Official Methods of Analysis, (1990) 15th Edition, AOAC, Arlington,
VA.*
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 (insect fragments) (rodent
hairs).
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: 5/1/85
Revised: 3/95, 8/96
Sec. 515.750 Cocoa Beans - Adulteration
by Mold, Insect Infestation, and Mammalian Excreta (CPG 7105.12)
REGULATORY ACTION GUIDANCE:
The following represents criteria for direct reference seizure to *Chief
Counsel* through Division of Compliance Management and Operations (HFC-210)
and for direct citation by District Offices:
Examination shows:
1. The cocoa beans contain an average of more than 4 percent moldy beans
by count;
2. The cocoa beans contain an average of more than 4 percent insect
infested or insect damaged beans, by count; or
3. The cocoa beans contain an average of more than 6 percent reject
beans (moldy plus insect infested or insect damaged beans) by count.
REMARKS:
If live external infestation is present use the CPG "Food Storage
and Warehousing - Adulteration - Filth" (See Sec. 580.100 for CPG
7103.01).
SPECIMEN CHARGE:
Article (cocoa beans) 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 there in of (insects)
(insect fragments) (insect damaged cocoa beans); and that it consists in
part of a decomposed substance by reason of the presence therein of (moldy,
decomposed cocoa beans).
CRITERIA FOR RECOMMENDING LEGAL ACTION:
The following represents criteria for recommending legal action to CFSAN/Office
of Field Programs/Division of Enforcement (HFS-605):
The cocoa beans contain an average of 10 mgs or more mammalian excreta
per pound.
NOTE: Analyses for mold, insect damage, and mamalian excreta are conducted
using the method specified in FDA Technical Bulletin 5,
Macroanalytical Procedures Manual, Chapter V.4.A - Method for
Cocoa Beans.
*Material between asterisks is new or revised.*
Issued: 8/1/83
Revised: 3/95, 8/96
Sec. 515.775 Cocoa Powder, Press Cake
- Adulteration with Insect and Rodent Filth (CPG 7105.13)
REGULATORY ACTION GUIDANCE:
The following represents criteria for recommending legal action to CFSAN/Office
of Field Programs/Division of Enforcement (HFS-605):
1. Insect Filth
a. The cocoa powder or press cake in six or more subsamples contains
an average of 75 or more insect fragments per 50 grams.
or
b. Any one subsample contains 125 or more insect fragments, even if
the overall average for all subsamples is less than 75.
2. Rodent Filth
a. The cocoa powder or press cake in six or more subsamples contains
more than 2.0 rodent hairs per 50 grams.
or
b. Any one subsample contains more than four rodent hairs, even if the
overall average is less than 2.0 hairs.
*NOTE: Insect and rodent filth analyses are conducted using method 965.38,
Official Methods of Analysis, (1990) 15th Edition, AOAC, Arlington,
VA.*
*Material between asterisks is new or revised.*
Issued: 5/1/85
Revised: 3/95, 8/96
Sec. 515.800 Labeling of Products Purporting
to be "Chocolate" or "Chocolate Flavored" (CPG 7105.15)
BACKGROUND:
In response to an inquiry submitted on behalf of the Chocolate Manufacturers
Association concerning the proper labeling of food products that purport
to be or are represented as containing "chocolate" or to have
a "chocolate flavor", the Associate Commissioner for Regulatory
Affairs issued an advisory opinion (Docket Number 86A-0513/AP). The relevant
policy expressed in the advisory opinion is quoted under the POLICY heading
of this guide.
POLICY:
The label of a nonstandardized food which bears no artificial chocolate
flavor or natural flavor derived from a source other than cacao beans may
bear the term "chocolate" (in contrast to "chocolate flavor")
provided the product meets one of the following conditions:
1. The product bears as its only source of chocolate flavoring an ingredient
that complies with one of the standards of identity for cacao products
found in 21 CFR 163.111; 163.123; 163.130; 163.135; 163.140; or 163.145.
In addition, products which comply with 21 CFR 163.153 or 163.155 may bear
the term "chocolate" followed by the specific name of the vegetable
oil used.
2. The product is flavored with cocoa and the food is one that consumers
have long recognized as containing cocoa as the characterizing chocolate
flavoring ingredient and is one that consumers do not expect to contain
a chocolate ingredient. This condition is based on a statement the agency
made in the preamble to the final rule on the label declaration of spices,
flavoring, colorings, and chemical preservatives (Federal Register
dated December 3, 1973 (38 FR 33287 comment #30)). This comment reads:
A question was raised about the proper labeling of products containing
cocoa, which have in the past been labeled as "chocolate."
The Commissioner advises that such products as chocolate pudding, made
from cocoa rather than chocolate, may continue to be labeled as "chocolate
pudding" because the consumer has long recognized that this product
may be made from cocoa and does not expect it to contain chocolate. A chocolate
bar, on the other hand, is expected to contain chocolate and may not be
made from cocoa without being labeled as a "natural chocolate flavored"
or "chocolate flavored" candy.
In light of condition (2), the use of the term "chocolate"
need not be limited to chocolate cake, chocolate cookies, chocolate pudding,
and chocolate milk. We believe that any other nonstandardized food product
that contains cocoa as the chocolate flavoring ingredient may bear the
term "chocolate" so long as it can be demonstrated that consumers
have long recognized that the food product may be made from cocoa and do
not expect it to contain some other chocolate ingredient.
The terms "chocolate flavored" or "natural chocolate
flavored" must be used on the labeling of any nonstandardized food
in which the consumer could reasonably expect a chocolate ingredient but
which contains cocoa as the sole source of chocolate flavoring.
Issued: 5/13/88
Sub Chapter 517
Canned Foods
Sec. 520.100 Canned Foods, Use of the
Term "Solid Pack" (CPG 7120.05)
BACKGROUND:
Until l967, when the standard of identity for canned tomatoes was amended
to provide for a product designated as "solid pack," none of
the standards for canned fruits contained provisions for a "solid
pack" product. However, there have been instances where the term "solid
pack" was used in describing and labeling certain canned fruits that
were otherwise the subject of standards of identity. Trade Correspondence
236 acknowledged use of the term in conjunction with peaches and State
Cooperation Information Letter No. l4 stated "packing of apples without
additional water seems to be impossible ***" and "worthy of investigation,
whenever a pack *** is encountered with a label statement 'Solid Pack'."
POLICY:
Solid pack tomatoes must conform to the definition in the canned tomato
standard of identity.
A product consisting of peaches canned without a liquid packing medium
may be sold under its common or usual name "Solid Pack Peaches."
The food should otherwise bear labeling in accordance with the section
403(i) provisions of the act.
Canned fruits designated in labeling as "solid pack" *should*
not contain any added liquid packing medium. The terms "in water"
and "solid pack" on the same label constitute a contradiction.
If any water at all is added in packing the food, the term "solid
pack" should not appear at any place on the label.
Issued: 8/20/73
Reissued: 10/1/80
Revised: 2/1/89, 3/95
Sec. 520.200 Canned Foods - Seam Defects
(CPG 7120.16)
BACKGROUND:
The primary intent of 21 CFR Part 113 regarding the control and testing
of can seams is to prevent product adulteration due to leakage during cooling
and handling after retorting. Seam defects are much like can dents in that,
although the defect may be substantial, the product in the can may not
be adulterated. Many variables occurring during processing and subsequent
handling determine whether the defects will lead to product adulteration.
A can with a seam defect (droops, false seams, loose seams, etc.) will
have a better chance of leaking but if the cooling water is chlorinated
properly and the cans are handled properly after cooling, leakage and contamination
still may not
occur. Conversely, a can with apparently adequate seams if handled improperly,
may leak and, regardless of the cooling water quality, may become adulterated.
By adulteration we mean the food consists of the filthy, putrid, or
decomposed substance. It may also be adulterated if the can is swollen
(even if no decomposition is noted) or leaking, since we generally consider
these types of defects as rendering the food unfit for human consumption.
POLICY:
Because seam defects do not always lead to product adulA cannot support
legal action against products based on seam defects only. It must be demonstrated
that the product is adulterated (swollen, leaking, contains viable microorganisms
or is decomposed) or other deviations from 21 CFR 113 must be documented
as well as the seam defects.
Therefore, the analysis of canned foods should be complete, as outlined
in LIB No. 1704 and BAM, to determine if the product is adulterated. The
can seam examination and microleak test serve only to document an apparent
reason for the adulteration.
NOTE: No reduction in can seam evaluation during inspections or warehouse
examination should be made as a result of this policy.
Continue to follow instructions in the IOM and compliance programs.
Issued: 10/1/80
Sec. 520.300 Acidified Low-Acid Canned
Foods - Adulteration Due to High pH (CPG 7120.25)
REGULATORY ACTION GUIDANCE:
The following represents the criteria for recommending legal action
to *CFSAN/Office of Field Programs/Division of Enforcement (HFS-605)* or
for detaining imports.
Recommend legal action to *CFSAN/Office of Field Programs/Division of
Enforcement (HFS-605)* for domestic samples (detain imports) if: one or
more containers, analyzed by procedure outlined in LIB 1789, pages 1 through
6, is found to have a measured pH value of 4.75 or above by both the original
and check analysis.
NOTE: Notify *CFSAN/Office of Field Programs/Division of Enforcement
(HFS-605)* immediately of all detentions.
REMARKS:
Districts should also notify DOE if analysis of a domestic or imported
sample shows: (1) one or more containers to have measured pH value of less
than 4.75 but greater than or equal to 4.65; or (2) if the mean pH of the
sample plus 2 standard deviations is 4.65 or above.
*Material between asterisks is new or revised.*
Issued: 10/1/80
Revised: 3/95
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