Persius/hicric huggingface dataset:
CPG Sec. 555.550 Foods, Standardized; 
Enriched or Fortified - Adulteration Involving 
Misbranding - Potency 
REGULATORY ACTION GUIDANCE: 
The following represents the criteria for direct reference seizure *requests to the Office of 
Human and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement 
and Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field 
Office within the Human and Animal Food Program*: 
The article is an enriched or fortified food for which a standard of identity has been established, 
and is more than 20% deficient in one or more of the vitamins or minerals required to be present 
by the standard of identity. 
SPECIMEN CHARGES: 
The article is adulterated while held for sale after shipment in interstate commerce, within the 
meaning of 21 U.S.C. 342(b)(1) in that a valuable constituent, namely riboflavin, has been 
wholly or in part omitted, or abstracted therefrom. 
The article is misbranded while held for sale after shipment in interstate commerce, within the 
meaning of 21 U.S.C. 343(g)(1), in that it purports to be and is represented as enriched noodles, a 
food for which a definition and standard of identity has been prescribed by regulations (21 CFR 
139.155) promulgated pursuant to 21 U.S.C. 341, and it fails to conform to such definition and 
standard since paragraph 139.155(a)(1) of such definition and standard prescribes, among other 
things, that enriched noodles contain in each pound not less than 1.7 milligrams of riboflavin; 
whereas the article contains less than 1.7 milligrams of riboflavin in each pound. 
*Material between asterisks is new or revised.* 
Issued: 11/21/79 
Reissued: 10/1/80 
Revised: 2/1/89
CPG Sec. 555.850 Water Damaged Food 
Products in Screw-Top, Crimped-Cap and 
Similar Containers 
BACKGROUND: 
After flooding, whether caused by natural disasters or other problems, FDA Field Offices within 
the Human and Animal Food Program and headquarters components often receive inquiries 
concerning products in screw-top, crimped-cap and similar containers. These concern the status 
of the products which may have been contacted by or submerged in the flood waters.; 
Of prime importance is the question of whether the product should be destroyed, relabeled, 
reprocessed or reconditioned by some other means. 
Information concerning salvage of water distressed bottled liquor has been sent to state and local 
governments in the form of an informational memorandum. This information would also apply to 
other food products in a similar type container. 
POLICY: 
FDA considers any screw capped, crimped-cap or similarly enclosed bottled food that has been 
submerged in flood water, or in any other contaminated water, to be adulterated, because of 
being held under conditions where the bottle may have been contaminated with filth (section 
402(a)(4) of the Federal Food, Drug, and Cosmetic Act). 
Reconditioning may be allowed by reprocessing (e.g., redistillation of liquors) or other means. 
However, this will be decided on a case-by-case basis depending on the product, proposed 
method of reconditioning, extent of damage, etc. 
In those cases where cartons containing bottled foods have not been completely submerged in 
flood or any other contaminated water, the bottles contained therein may be reconditioned only if 
it can be positively demonstrated that none of the contaminated water had reached the closure of 
the bottle. Cleaning, disinfecting and recartoning of these bottles would be a satisfactory 
reconditioning. 
Careful judgement must be exercised in these situations based on the facts of each individual 
situation. If it cannot be clearly demonstrated that the bottle closures have not been in contact 
with flood or contaminated water, FDA would consider such products adulterated. 
Issued: 3/2/77 
Reissued: 11/19/79, 10/1/80, 2/1/89
CPG Sec. 585.150 Asparagus, Canned or Frozen 
- Adulteration with Insect Filth 
REGULATORY ACTION GUIDANCE: 
The following represents criteria for direct reference seizure *requests to the Office of Human 
and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and 
Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office 
within the Human and Animal Food Program*: 
1.  10 Percent or more by count of spears or pieces are infested with six or more attached 
asparagus beetle eggs and/or sacs; 
or 
2.  The asparagus contains an average of 40 or more thrips per 100 grams;  
or 
3.  The asparagus contains an average of 5 or more insects (whole or equivalent) of any size 
per 100 grams, or insects (whole or equivalent) 3mm or longer having an average 
aggregate length of 7 mm or longer per 100 grams of asparagus. 
SPECIMEN CHARGE: 
*The article was adulterated when introduced into and while in interstate commerce, and is 
adulterated while held for sale after shipment in interstate commerce within the meaning of said 
Act 21 U.S.C. 342(a)(3) in that it consists in part of a filthy substance by reason of the presence 
therein of: asparagus beetle eggs or sacs or thrips or insects or insect fragments*. 
NOTE: Use direct reference citation authority only 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: 11/7/79 
Reissued: 10/1/80 
Revised: 11/1/81, 12/8/88
CPG Sec. 585.260 Broccoli, Frozen - 
Adulteration with Insects 
REGULATORY ACTION GUIDANCE: 
The following represents criteria for direct reference seizure *requests to the Office of Human 
and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and 
Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office 
within the Human and Animal Food Program*: 
The broccoli contains an average of 60 or more aphids, thrips or mites (or any combination of 
these) per 100 grams. 
SPECIMEN CHARGE: 
The article was adulterated when introduced into and while in interstate commerce, and is 
adulterated while held for sale after shipment in interstate commerce within the meaning of said 
Act 21 U.S.C. 342(a)(3) in that it consists in part of a filthy substance by reason of the presence 
therein of insects. 
NOTE: Use direct reference citation authority only 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: 11/1/81, 12/8/88
CPG Sec. 585.350 Corn Husks (for Tamales) - 
Adulteration with Filth 
REGULATORY ACTION GUIDANCE: 
The following represents the criteria for direct reference seizure *requests to the Office of 
Human and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement 
and Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field 
Office within the Human and Animal Food Program*: 
The corn husks contain an average of 5% or more by weight of insect-infested (including insect 
damaged) or moldy husks. 
SPECIMEN CHARGE: 
*The article was adulterated when introduced into and while in interstate commerce, and is 
adulterated while held for sale after shipment in interstate commerce within the meaning of said 
Act 21 U.S.C. 342(a)(3) in that it consists in part of a filthy substance by reason of the presence 
therein of insects, insect damage; and of a decomposed substance by reason of the presence 
therein of moldy corn husks.* 
*Material between asterisks is new or revised.* 
Issued: 11/21/79 
Reissued: 10/1/80 
Revised: 12/8/88
CPG Sec. 585.450 Greens, Canned - 
Adulteration by Mildew 
REGULATORY ACTION GUIDANCE: 
The following represents criteria for direct reference seizure *requests to the Office of Human 
and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and 
Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office 
within the Human and Animal Food Program*: 
The greens contain on average of 10 percent or more of leaves by count or weight showing 
mildew over 1/2" in diameter. 
SPECIMEN CHARGE: 
*The article was adulterated when introduced into and while in interstate commerce, and is 
adulterated while held for sale after shipment in interstate commerce within the meaning of said 
Act 21 U.S.C. 342(a)(3) in that it consists in part of a decomposed substance by reason of the 
presence therein of mildewed greens. 
NOTE: Use direct reference citation authority only 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: 11/1/81, 12/8/88
CPG Sec. 585.700 Potato Chips - Adulteration 
with Rot 
REGULATORY ACTION GUIDANCE: 
The following represents the criteria for direct reference seizure *requests to the Office of 
Human and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement 
and Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field 
Office within the Human and Animal Food Program*: 
The potato chips contain an average of six percent or more rot by weight. 
SPECIMEN CHARGE: 
*The article was adulterated when introduced into and while in interstate commerce, and is 
adulterated while held for sale after shipment in interstate commerce within the meaning of said 
Act 21 U.S.C. 342(a)(3) in that it consists in part of a decomposed substance by reason of the 
presence therein of decomposed potato chips. 
NOTE: Use direct reference citation authority only when prosecution is anticipated and evidence 
to support a prosecution is included with the adulteration charge. Evidence to support a 
prosecution is specified in existing regulatory procedure issuances.* 
*Material between asterisks is new or revised.* 
Issued: 11/ 7/79 
Reissued: 10/1/80 
Revised: 12/8/88
CPG Sec. 578.200 Corn Meal - Adulteration by 
Insect and Rodent Filth 
REGULATORY ACTION GUIDANCE: 
The following represents criteria for direct reference seizure *requests to the Office of Human 
and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and 
Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office  
within the Human and Animal Food Program*: 
1.  Insects - The corn meal contains an average of 1 or more whole insects or equivalent/50 
gms. (0.5 or more whole insects or equivalent/25 gms.); 
or 
2.  Insect fragments - The corn meal contains an average of 25 or more insect fragments/25 
gms.; 
or 
3.  Rodent hair - The corn meal contains an average of 1 or more rodent hairs/25 gms.; 
or 
4.  Rodent excreta - The corn meal contains an average of 1 or more rodent excreta 
fragments/50 gms. 
SPECIMEN CHARGE: 
*The article was adulterated (when introduced into) (while in) (while held for sale after shipment 
in) interstate commerce within 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 insects, insect fragments, rodent hairs, and 
rodent excreta fragments, as applicable. 
NOTES: 
1.  If the evidence establishes that the article became adulterated after receipt in interstate 
commerce, then charge only that the article "is adulterated while held for sale after 
shipment in interstate commerce" 
2.  If the evidence does not establish where the article became adulterated and the violation 
is such that it could have occurred anywhere, i.e. it is not a manufacturing defect, then 
charge only that the article "is adulterated while held for sale after shipment in interstate 
commerce."*  *Material between asterisks is new or revised.* 
Issued: 10/11/79 
Revised: 10/1/80, 6/6/88
CPG Sec. 578.300 Wheat - Adulteration by 
Insect and Rodent filth 
REGULATORY ACTION GUIDANCE: 
The following represents criteria for direct reference seizure *request to the Office of Human and 
Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and Import 
Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office within the 
Human and Animal Food Program*: 
1.  Insect filth - The wheat contains an average of 32 or more insect damaged kernels per 
100 gms; 
or 
2.  Rodent excreta - The wheat contains an average of 9 mg or more rodent excreta pellets 
and/or fragments of rodent excreta pellets per kg; 
or 
3.  Plugging - There is clear-cut evidence of uneven loading or plugging, and wheat from 
any identifiable portion of the load meets the above criteria for insect damaged kernels or 
rodent excreta pellets. 
SPECIMEN CHARGE: 
*The article was adulterated (when introduced into) (while in) (while held for sale after shipment 
in) 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 damaged wheat kernels, insects, 
insect fragments, rodent hairs, and rodent excreta fragments, as applicable. 
NOTES: 
1.  If the evidence establishes that the article became adulterated after receipt in interstate 
commerce, then charge only that the article "is adulterated while held for sale after 
shipment in interstate commerce" 
2.  If the evidence does not establish where the article became adulterated and the violation 
is such that it could have occurred anywhere, i.e. it is not a manufacturing defect, then 
charge only that the article "is adulterated while held for sale after shipment in interstate 
commerce"* 
*Material between asterisks is new or revised.*  Issued: 10/11/79 
Revised: 10/1/80, 6/6/88
CPG Sec. 578.450 Wheat Flour-Adulteration 
with Insect Fragments and Rodent Hairs 
REGULATORY ACTION GUIDANCE: 
The following represents criteria for direct reference seizure *requests to the Office of Human 
and Animal Food Operations (OHAFO) in consultation with the Office of Enforcement and 
Import Operations (OEIO) and CFSAN, and for direct citation by the appropriate Field Office 
within the Human and Animal Food Program*: 
Examination of six 50 gram subsamples shows: 
* 
1.  Insect fragments - an average of 75 or more insect fragments per 50 grams;* 
or 
2.  Rodent Hairs - an average of 1.0 or more rodent hair per 50 grams. 
*NOTE: These criteria do not apply to flour prepared from durum and/or red durum wheats.* 
SPECIMEN CHARGE: 
*The article was adulterated when introduced into, while in, and is adulterated while held for 
sale after shipment in interstate commerce within the meaning of said Act 21 U.S.C. 342(a)(3) 
because it consists in part of a filthy substance by reason of the presence therein of insect 
fragments and rodent hairs. 
NOTES: 
1. If the evidence establishes that the article became adulterated after receipt in interstate 
commerce, then charge only that the article "is adulterated while held for sale after shipment in 
interstate commerce." 
2. If the evidence does not establish where the article became adulterated and the violation is 
such that it could have occurred anywhere, i.e. it is not a manufacturing defect, then also charge 
only that the article "is adulterated while held for sale after shipment in interstate commerce."* 
*Material between asterisks is new or revised.* 
Issued: 10/1/80 
Revised: 12/31/87
..- 
DEPARTMENT OF HEALTH & HUMAN SERVICES  Pubhc Health Serv~ce 
Food and Drug Adrnrnrstration 
SEP  2  8 7 5 7 Georg~aA venue 
Sllver Spr~ngM D 209 10 
TO: ALL MANUFACTURERS, IMPORTERS AND POTENTIAL MANUFACTURERS OF SUNLAMPS 
SUBJECT: POLICY ON LAMP COMPATIBILITY 
BACKGROUND: 
The amended performance standard for sunlamp products (21 CFR  1040.20)  was 
published in the September 6, 1985, issue of the Federal Register and will 
become effective September 8, 1986.  Any ultraviolet lamp (intended to be 
used in sunlamp products) and sunlamp products manufacturedeon or after 
that date must comply with the amended standard. 
. .- 
The amended standard requires the user instructions of an ultraviolet 
lamp not accompanying a sunlamp product to contain a clear identification 
by brand name and model designation of all lamp models for which 
replacement lamps are promoted, if applicable [21 CFR  1040.20(f)(2)(iii)1. 
As stated in the preamble of the amendments to-the standard (Federal 
Register issue of September 6, 1985) the promotion of incompatible lamps 
wlll be considered as marketing a falsely certified product. 
The Center for Devices and Radiological Health (CDRH) has been asked what 
criteria will be used to evaluate lamp compatibility. 
POLICY :  < 
A replacement lamp will be considered compatible with (or equivalent to) 
another (original) lamp if: 
1) The replacement lamp will not cause any sunlamp product intended to use 
the original lamp to fail to comply with the standard or to become 
defective as defined by 21 CFR 1003.2,  and; 
2) the lamp is as effective, within plus or minus ten percent, as the 
original lamp, in causing erythema and melanogenesis. 
It should be noted that the above criteria apply to the sunlamp product 
exposure schedule and maximum timer interval which must appear on the 
product's labeling.  The manufacturer should use the following procedure to 
establish conformance with criterion number 2 above:  Page 2 - POLICY ON LAMP COMPATIBILITY 
1)  Calculate the recommended maximum exposure time for a single original 
lamp (Y) using the CDRH August 21, 1986, guidance (POLICY ON MAXIMUM 
TIMER INTERVAL AND EXPOSURE SCHEDULE FOR SUNLAMP PRODUCTS). 
2) Calculate the recommended maximum exposure time for a single replacement 
lamp (X) using the same method. 
3) Compare the values, If  the value for the replacement lamp (X) is within 
plus or minus 10% of the value of the original lamp (Y), the lamp would 
be considered compatible [Y= X  +/-  LOX]. 
The distance(s)  used for this comparison should represent the typical use 
distance range in products using the original (Y) lamp, 
The CDRH welcomes comments on this policy. 
I 
did 
Walter E.  Gundaker. Director 
Office of ~om~lianiie 
Center for Devices and 
Radiological Health .
Public Health Service 
- - 
Food and Drug Adm~n~stration 
8757 Georgia Avenue 
Silver Spring MD 2091 0 
TO:  ALL  MANUFACTURERS,  IMPORTERS AND POTESJTIAL MANUFACTURERS 
OF  SUNLAMP  PRODUCTS. 
SUBJECT:  POLICY  ON  WARNING  LABEL  REQUIRED ON  SUNLAMP  PRODUCTS. 
BACKGROUND: 
The Center for Devices and Radiological Health has fobd numerous  inported 
and dcmestic sunlamp products labeled in such a way  as to render the label 
illegible and/or  inaccessible to view by  the consumer  under  normal 
conditions of purchase and use. 
Sunlamp products are electronic products as defined by  Section 355(2) 
[42 U.S,C  263c(2)1 of  the Radiation Control for Health and Safety Act 
of  1968 (RCHSA)  and medical devices as defined by  Section 201(h)(3) of  the 
Federal Food, Drug,  and Cosmetic Act  (FD&C) [21 U.S.C.321(h)(3)1.  The 
performance  standard for sunlamp products  (21 CFR  1040.20)  promulgated 
under  authority of  Section 358 of  the RCHSA,  requires that labels 
containing specific information be permanently affixed or inscribed on an 
exterior surface of  the product so as to be legible and readily accessible 
to view when  the product  is fully assembled for use.  The general labeling 
provisions for medical devices under  21 CFR  801.5  require adequate 
directions for use be provided  to the user and  21 CFR  801.15  defines the 
praninence  of  the required label statements for devices. 
POLICY: 
The  intended purpose of  the warning  label required on sunlanp products  is 
to provide  that information necessary for the consumer  to make  an informed 
decision regarding the risks of  using sunlamp products and to provide 
adequate directions for skin tanning.  Therefore,  the label must be legible 
and conspicuously placed on the product so as to render  it likely to be 
read by  the user under  nonnal  conditions of  purchase and use.  The Agency 
w i l l  consider sunlarnp products to be nonccanpliant with the performance 
standard under  Section 358(a)(1) of  the RCHSA  and misbranded under Section 
502(c) of  the FD&C Act if the required product  label is not  legible and 
accessible to view  for the following reasons:  Page  2 
1.  The  label required under  21 CFR  1040.20(d)(l) does not appear on a 
praminent  part or panel which  is presented or displayed under  normal 
conditions of  purchase and/or  use. 
2.  Adequate  space is not provided  for the required  label or the 
label is not prminently displayed on the device. 
3.  The  normal  individual can not read the label from a distance 
of  one meter because of  inadequate  lettering size and background 
contrast.  Lettering of  ten  (10) millimeters  (height) for the word 
"I;\ANGERW and five (5) millimeters for the rest of  the label information 
is recamended to meet  the visibility requirements. 
rc&l& 
Wa  ter  Gundaker.  Director 
Off ice of  compliance 
Center for &vices 
and Radiological  Health
Plasma Derived from Therapeutic Plasma Exchange (12/14/84)
Date:     December 14, 1984
From:     Acting Director,
          Office of Biologics Research and Review
          Center for Drugs and Biologics              
Subject:  Plasma Derived from Therapeutic Plasma Exchange
To:       All Establishments Collecting Blood for Transfusion
          All Source Plasma (Human) Establishments
          
In an April 1, 1983, Notice published in the Federal Register
(Vol. 48, No. 64, page 14048), the Food and Drug Administration
(FDA) advised that plasma derived from therapeutic exchange
procedures is a biological product subject to the licensing
provisions of the Public Health Service Act [42 USC 262 (a)] then
collected and shipped for further manufacture into in vitro
diagnostic products.
Since the publication of that Notice, several establishments have
applied and been considered for licensure. However, inspectional
and investigational information gathered over the last six
months-has shown that some blood establishments may not be aware
of this requirement. Of particular concern was a situation where
Therapeutic Exchange Plasma (TEP) was being sold through a broker
(middleman). The broker represented the TEP as Recovered Human
Plasma (RHP) [Footnote: Recovered Human Plasma is derived from
single units of Whole Blood, or Single Donor Plasma, or as a
by-product in the preparation of blood components from whole
blood collection].  The establishments supplying the TEP were
advised that the intended use was for research.  Since RHP is, in
some situations, used in the manufacture of injectable products,
FDA instituted regulatory action to control the violative TEP
product.
The purpose of this memorandum is to provide an additional
notification to all those establishments which may have an
organizational component (blood bank, dialysis unit,
or apheresis center) actively engaged in therapeutic plasma
exchange procedures.
Important points are as follows:
-- TEP, when intended for further manufacture, is a biological
product subject to licensure under the Public Health
Service Act [42 USC 262 (a)]
-- Because the TEP is often derived from patients with a
disorder that may be transmissible or of unknown etiologic
origin, the product represents a potential health hazard. -- TEP has been limited in its intended use to further
manufacture into specific in vitro diagnostic products for
which there are no alternate source materials.
-- If the applicable regulatory requirements are not met, FDA
may invoke appropriate regulatory action.
-- FDA is not regulating a physician's choice of therapeutic
plasma exchange as a medical procedure.
-- TEP is not Recovered Human Plasma and must not be labeled
or represented as such. 
If this Memorandum was not directed to the office of the most
responsible individual (e.g., Hospital Administrator) at the
establishment, we request that a copy be forwarded to that
office.  This will assure that all appropriate components, within
an establishment, are notified.
                        Elaine C. Esber, M.D.