Persius/hicric huggingface dataset:
CPG Sec. 550.270 Currants - Adulteration 
Involving Wormy Fruits 
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*: 
The currants contain an average of 5% or more wormy fruits, by count. 
SPECIMEN CHARGE: 
Article adulterated (when introduced 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 wormy currants. 
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: 10/1/80, 11/1/81 
Revised: 3/95
CPG Sec. 550.450 Jam, Black Currant - 
Adulteration with Mold 
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 jam has an average Howard mold count of 75 percent or more. 
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 decomposed substance by reason of the presence therein of mold. 
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: 10/1/80 
Revised: 11/1/81, 3/95
CPG Sec. 550.590 Cloudberries (Multer 
Berries), Canned - Adulteration by 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 canned berries contain an average of 40 or more thrips per No. 2 can and 20% of the subs 
are materially infested. 
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 thrips. 
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. 
1Winton & Winton "Structure and Composition of Foods," Volume II, 1935. 
*Material between asterisks is new or revised* 
Issued: 10/1/80 
Revised: 11/1/81, 3/95
CPG Sec. 550.680 Pineapple, Canned; Pineapple 
Juice - Adulteration with Mold 
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.  Pineapple, canned -- The average Howard mold count for six or more subsamples is 15% 
or more; or the Howard mold count for any subsample is 40% or more. 
2.  Pineapple Juice -- The average Howard mold count for six or more subsamples is 15% or 
more; or the Howard mold count for any one subsample is 40% or more. 
Article (canned pineapple) (pineapple juice) 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 decomposed substance by reason 
of the presence therein of (moldy/decomposed pineapple) (mold). 
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 specific in existing regulatory procedures issuances. 
Issued: 10/1/80 
Revised: 11/1/81, 3/95
CPG Sec. 555.300 Foods, Except Dairy Products 
- Adulteration with Salmonella 
REGULATORY ACTION GUIDANCE: 
The following represent 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*: 
a.  The lot has been randomly sampled in accordance with the following product categories, 
as defined in Chapter I of the Bacteriological Analytical Manual:  
No. of Sample Minimum No. of 
Product Cat. Units Collected Composite Units Tested 
I 60 4 
II 30 2 
III 15 1 
and 
b.  One or more composite units is positive for Salmonella,  
and 
c.  The sample and analytical controls are negative for Salmonella. 
SPECIMEN CHARGE: 
The article was adulterated (when introduced into and while in interstate commerce) or (is 
adulterated while held for sale after shipment in interstate commerce) within the meaning of 21 
U.S.C. 342(a)(1), in that it contains a pathogenic microorganism, namely Salmonella, which may 
render it injurious to health. 
NOTES: 
1.  Direct reference seizures must be based upon samples conforming to the collection 
criteria established for each specified product category. The criteria of this guide do not 
preclude examination of lots having fewer containers than the number of sample units 
specified. 
2.  Refer to Investigations Operations Manual, Chapter 4, subchapter 400, Sample Schedule 
- Chart 1 for description of sampling procedures.  3.  Test for Salmonella must be in accordance with instructions contained in the 
Bacteriological Analytical Manual. 
4.  A copy of the direct reference seizure should be sent to *HFS-605.* 
5.  Refer to Sec. 527.300 (CPG 7106.08) for compliance guidance on Salmonella in dairy 
products. 
*Material between asterisks is new or revised.* 
Issued: 10/1/80 
Revised: 8/1/86, 11/3/87, 2/1/89, 3/95
CPG Sec. 585.225 Black-Eyed Peas (Cow Peas, 
Field Peas); Dried-Adulteration with Lygus Bug 
Damage 
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 dried black-eyed peas contain an average of 10% or more by count of class 6 damage or 
higher, minimum of 12 subsamples examined. 
NOTE: See FDA Technical Bulletin No. 5 - Macroanalytical Procedures Manual, V-116 for 
classification of black-eyed peas damaged by lygus bug. 
REMARKS: 
If there is reason to believe the lot was graded and certified by the U.S. Department of 
Agriculture, submit the following information via EMS or FAX to *CFSAN/Office of Field 
Programs/Division of Enforcement (HFS-605)* and await reply before proceeding: 
Sample Number Date of Shipment 
Article Involved Dealer 
Amount of Lot Shipper 
Codes Analytical Conclusions 
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 insect damaged peas. 
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: 11/7/79 
Reissued: 10/1/80 
Revised: 12/8/88, 3/95
CPG Sec. 250.500- Plasma Brokers - Registration and Compliance with Good Manufacturing Practices 
Issued: 2/1/84
Revised: 3/95
Withdrawn: 7/16/2018
CPG Sec. 300.400 Contamination of Devices Labeled as Sterile 
BACKGROUND: 
Certain devices labeled as sterile are frequently used on debilitated patients whose resistance to 
microorganisms is lower than that of a normal healthy person. 
Recent experience has demonstrated that devices labeled as sterile and intended for use under sterile 
conditions may be nonsterile. 
POLICY: 
*A device labeled as sterile which fails to pass USP tests for sterility is adulterated under Section 50l(c) in 
that its purity and quality falls below that which it is represented to possess and is misbranded under 
502(a) in that the label statement "sterile" is false or misleading as applied to a product which is not 
sterile, but is contaminated with viable organisms.* 
Device nonsterility should be treated as top priority, because of the seriousness of the health hazard 
posed by the microbial contamination of sterile products. The responsible firm should be notified of our 
finding to afford it the opportunity to voluntarily recall its device. 
Appropriate legal action and/or recall should be recommended when the examination of a sterile device 
reveals defective packaging (separated seams, torn or punctured outer wrap) and there is no other 
protection of package contents. Confirmation of nonsterility by sterility testing is unnecessary in these 
cases. Inspection reports, exhibits and the results of analysis for defective packaging should be included 
in the recommendation of the division within the Office of Medical Device and Radiological Health 
Operations (OMDRHO) to CDRH when appropriate. The results of analysis should include the number of 
units examined, the number of units found defective, the types of defects identified and the range in 
size and numbers of holes or broken seams found per unit. 
In situations where there is more than one wrap or there are questions regarding whether the nature of 
the packaging defect meets the conditions outlined in this guideline, the appropriate division within 
OMDRHO should consult with CDRH when appropriate. 
*Material between asterisks is new or revised* 
Issued: 8/23/74 
Reissued: 6/11/76 
Revised: 10/1/80, 9/24/87, 3/95
CPG Sec. 355.200 Electrical Muscle Stimulators  
BACKGROUND 
Certain importers, manufacturers, and individuals are promoting and selling Electrical Muscle 
Stimulators (EMS) directly to salons and the general public for a variety of uses including body slimming 
and trimming, body shaping and contouring, weight loss, bust development, and wrinkle and cellulite 
removal. FDA has seen no valid scientific data to support the use of EMS devices for these conditions 
and purposes. 
The health care community recognizes EMS devices as effective for muscle reeducation, relief of muscle 
spasm, increasing range of motion, disuse atrophy therapy, increased local blood circulation, and 
immediate postsurgical stimulation of calf muscles to prevent venous thrombosis. Adequate directions 
for safe and effective use by the laity for these devices cannot be written. FDA, therefore, regards EMS 
devices to be subject to 21 CFR 801.109 as prescription devices. 
POLICY: 
EMS devices may only be lawfully sold by or on the order of practitioners licensed by state law to use or 
order the use of such devices. Such devices may only be sold to, or used by, laymen on the prescription 
or other order of a licensed practitioner in the course of his or her professional practice. 
An EMS device labeled for conditions or purposes other than those recognized by the consensus of 
medical opinion as referenced above, are considered misbranded under Section 502(a) of the Federal 
Food, Drug, and Cosmetic Act (the Act) in that the labeling is false *or* misleading. In addition, an EMS 
device which does not comply with 21 CFR 801.109 is misbranded pursuant to subsection 502(f)(1) of 
the Act in that the labeling fails to bear adequate directions for use. Prior to submitting a 
recommendation for legal action, the appropriate division within the Office of Medical Device and 
Radiological Health Operations program should assure that the situation meets the conditions for 
considering regulatory action in CPG 7150.10 (See Sec. 120.500), Health Fraud - Factors in Considering 
Regulatory Action. *(Please Note: The Health Fraud definition includes the "... promotion, 
advertisement, distribution or sale of articles, intended for human or animal use ...")*. Where possible, 
action should be taken against the devices in the possession of the manufacturer or primary distributor, 
rather than at a salon. Salon activities generally should be turned over to local and state licensing 
agencies since salon activities fall within their jurisdiction. 
*Material between asterisks is new or revised* 
Issued: 7/1/82 
Revised: 11/21/88, 3/95
CPG Sec. 398.350 Regulatory Actions Against Assemblers of X-ray Equipment that Fail to File Reports 
of Assembly  
BACKGROUND: 
21 CFR 1020.30(d) requires that assemblers of diagnostic x-ray systems file reports of assembly (FD 
2579). Completed reports must be submitted to the Director, Center for Devices and Radiological Health 
(CDRH) as well as to the purchaser, and, where applicable, to the State, within 15 days following 
completion of the assembly. The reports are date stamped at CDRH and sent to the field for review and 
filing. 
POLICY: 
When an assembler of diagnostic x-ray equipment fails to submit a report(s) of assembly, the 
appropriate Division within the Office of Medical Devices and Radiological Health Operations 
(OMDRHO)* may initiate and issue a Notice of Noncompliance Letter or a Warning Letter. If the 
assembler does not correct the violation(s) in a timely manner and continues to fail to comply, the 
*appropriate Division within OMDRHO *should submit a request for civil penalties and/or injunction to 
the CDRH. 
Thirty (30) days is sufficient time for completing a report, mail time, and completion of other 
administrative activities. Reports of assembly received more than 30 days after assembly is completed 
will be considered late. 
REGULATORY ACTION GUIDANCE: 
The following represents criteria for direct reference issuance of Warning Letters to the assembler by 
*the appropriate Division within OMDRHO *: 
1.  The *appropriate Division within OMDRHO *must establish clear proof that the form FD-2579 
was either never filed or was filed late. This can be obtained by records inspection at the firm, 
review of records at the FDA **Office, review of CDRH computer files, interview of purchaser, 
and review of State records. 
  
and  
  
2.  The *appropriate Division within OMDRHO *shall have sent at least one Notice of 
*Noncompliance Letter* addressing late filing or failure to file. This must be confirmed by a 
return receipt or other evidence of receipt. 
Criteria for requesting civil penalties and/or injunction:  The *appropriate Division within OMDRHO *should establish a clear record of continuing violation and 
of warning; e.g., the assembler has failed to report or has reported late at least twice and the assembler 
has been warned in writing at least twice within a twelve month period. The assembler has received a 
Warning Letter and failed to respond, correct or comply with provisions of the Warning Letter. Civil 
penalty will ordinarily be the action of choice. 
*Material between asterisks is new or revised* 
Issued: 2/1/85 
Revised: 3/95
CPG Sec. 400.100 Drugs, Human - Failure to Register  
BACKGROUND: 
Sections 510(b)&(c) of the Act requires the registration of all producers of drugs and devices. When the 
legislation amending the Act was passed, Congress found and declared that in order to make the 
regulation of interstate commerce in drugs effective, it was necessary to provide for the registration and 
inspection of all establishments in which drugs were manufactured, prepared, propagated, 
compounded, or processed; as the products of such establishments were likely to enter interstate 
commerce; and that the regulation of interstate commerce in drugs without provision for registration 
and inspection of establishments engaged only intrastate commerce of drugs would discriminate against 
and depress interstate commerce of such drugs, and adversely burden, obstruct, and affect such 
interstate commerce. Section 510(h) requires that each registrant be inspected for compliance every 
two years. 
REGULATORY ACTION GUIDANCE: 
If an establishment is required to register and has failed to do so, then every reasonable effort should be 
made to convince management to register the establishment on a voluntary basis during the initial 
inspection. If this effort is unsuccessful then an informal discussion between the  appropriate Division 
Director within the Office of Pharmaceutical Quality Operations and the establishment's management 
should be held. If registration is not accomplished after these initial steps then the issuance of a 
*warning* letter will be considered by the *CDER*. 
*Material between asterisks is new or revised* 
Issued: 10/1/80 
Revised: 3/95
This guidance was written prior to the February 27, 1997 implementation of FDA's 
Good Guidance Practices, GGP's. It does not create or confer rights for or on any person 
and does not operate to bind FDA or the public. An alternative approach may be used if 
such approach satisfies the requirements of the applicable statute, regulations, or both. 
This guidance will be up dated in the next revision to include the standard elemnt s of GGP 's .  DEPARTMENT OF HEALTH & HUMAN SERVICES  Pubtic Health Service 
8 
Food and Drug Administration 
Center for Devices and 
Radiilogicai Heab 
2098 Gaither Road 
Rockville MD 20860 
FEB  2 3 1994 
qO: Manufacturers, Distributors and Importers of Condom Products 
On February 13, 1989, the Food and Drug Administration (FDA) issued a 
statement of policy regarding the marketing of condom-like products (a.k.a. 
*Novelty Condoms*),  Thie letter revioes and supersede8 that policy. 
Condoms are medical devices which many conapmers rely upon for 
contraception and prevention of eexually trbnemitted diseasee (STD's), 
especially AIDS.  Therefore, condoms or products that can'be used as 
condoms, must comply with specific condom leak testing requirements as well 
as other regulatory requirements for medical devices.  Some marketers have 
misinterpreted the 1989 policy and believe kt permits the marketing of 
condoms as novelty item even though they dp not comply with these 
requiremente.  Theee novelty products frequbntly consist of a condom 
packaged or labeled for adult humor.  They are traditionally sold in adult 
entertainment shops.  This eituation has ca sed confusFon and may result in 
the use of these noncompliant products by ctnsumers with the expectation 
that they are effective in preventing pregnbncy and STDs. 
Products that can cover the penis with a closely fitting membrane and 
otherwise have the appearance of a condom are regarded as condoms 
regardless of packaging or labeling.  These:producte, by form and function, 
meet the definition of a condom as defined in 21 CFR 884.5300 and must 
therefore comply with all requirements for condoms including leak testing, 
compliance with Good Manufacturing Practicep regulations, manufacturer 
registration, product listing, and pre-market notification and clearance. 
In order to market a condom-like product which is not subject to the above 
requiremente, the product cannot be usable as a condom in any way.  For 
example, a condom could be rendered unusable by removing the cloeed end; 
shredding the aides; eealing the roll in ouch a way that' it cannot be 
unrolled, or.by some other method rendering.it equally unusable.  Labeling 
a functional condom as a novelty is not sufficient. 
Questions concerning this policy can be directed to Mr.  Byron L. Tart by 
writing to the letterhead address or phoning (301) 594-4639. 
Director 
Office of Compliance 
Center for Devices and 
FtadiolodJical Health
CPG Sec. 335.800 Clinical Thermometer - Adulteration; Misbranding Defects  
BACKGROUND: 
The FDA has stated that NBS Commercial Standard CS 1-52, which became a Voluntary Product Standard 
PS 39-70, would be used as the basis for regulatory action against clinical thermometers (mercury-in-
glass, reusable). The voluntary standard has now developed into an ASTM Standard E 667-81. The 
following criteria reflect this updated material. 
POLICY: 
If clinical thermometers are found to be outside the specifications for accuracy as found in the ASTM E 
667-81 Standard they will be considered to be violative. 
REGULATORY ACTION GUIDANCE: 
The following represents criteria for direct reference seizure to *the Office of Medical Device and 
Radiological Health Operations (OMDRHO) with consult to* the Division of Enforcement, Office of 
Enforcement and Import Operations,  Office of Regulatory Affairs, Food and Drug Administration. 
Sample Size Defects 
15 2 or more 
24 3 or more 
A clinical thermometer is considered defective for accuracy if the following accuracy cannot be met. 
(Round to one decimal place) 
Celsius Scale Fahrenheit Scale 
Less than 35.80C 0.30C Less than 96.40F 0.40F 
35.80C to 37.00C 0.20C 96.40F to 98.00F 0.30F 
37.00C to 39.00C 0.10C 98.00F to 102.00F 0.20F 
39.00C to 41.00C 0.20C 102.00F to 10600F 0.30F 
Greater than 41.00C 0.30C Greater than 106.00F 0.40F 
SPECIMEN CHARGES: 
That the article of device is adulterated when introduced into and while in interstate commerce within 
the meaning of 21 U.S.C. 351(c) in that its quality falls below that which it purports or is represented to 
possess. 
That the article of device is misbranded when introduced into and while in interstate commerce (or after 
receipt in interstate commerce if applicable) within the meaning of 21 U.S.C. 352(a) in that the label 
statements "Accurate", "Dependable", "Easy Reading", and "*** this thermometer conforms to all of the 
requirements established in ASTM Standard E 667-81" are false *or* misleading or are otherwise 
contrary to fact.  *Material between asterisks is new or revised* 
Issued: 1/1/73 
Reissued: 10/1/80 7/18/94 
Revised: 9/24/87, 3/95