Contents

SUBCHAPTER 700 - STATUTORY AUTHORITY

701 - STATUTORY AUTHORITY

Various acts specify the authority conferred on the Secretary of DHHS. This authority is delegated by regulations to the Commissioner of Food and Drugs, and certain authorities are delegated further by him.

701.01 - Federal Food, Drug, and Cosmetic Act

Examinations, Investigations, and Samples - Collecting samples is an important and critical part of FDA's regulatory activities. While inspections and investigations may precede sample collection, a case under the law does not normally begin until a sample has been obtained. Proper sample collection is the keystone of effective enforcement action.

The basic authority for FDA to take samples falls under the statutory provisions of section 702(a) of the FD&C Act [21 USC 372(a)], which authorizes examinations and investigations for the purposes of this Act.

Section 702(b) of the FD&C Act [21 USC 372(b)] requires FDA to furnish, upon request, a portion of an official sample for examination or analysis to any person named on the label of an article, the owner thereof, or his attorney or agent. In a precedent case, "United States v. 75 Cases, More or Less, Each Containing 24 Jars of Peanut Butter, the U.S. Circuit Court of Appeals for the Fourth Circuit held the taking of samples is authorized under section 702(b) of the FD&C Act [21 U.S.C. 372(b)], since this section "clearly contemplates the taking of samples." See Kleinfeld and Dunn 1938-1949 at 126. The FD&C Act also refers to samples in sections 704(c) and 704(d) [21 USC 374(c) and 374(d)].

Authority to Enter and Inspect - Section 704 of the Food, Drug & Cosmetic Act [21 U.S.C. 374] provides the basic authority for establishment inspections. This authorizes you to enter, and to inspect at reasonable times, within reasonable limits, and in a reasonable manner, establishments or vehicles being used to process, hold or transport food, drugs, devices or cosmetics. The statute does not define, in specific terms, the meaning of "reasonable". FDA's establishment inspection procedures maintain this authority extends to what is reasonably necessary to achieve the objective of the inspection.

Food Inspections - Authority to inspect food plants resides in the general inspectional authority of section 704 of the FD&C Act [21 U.S.C. 374].

The Infant Formula Act of 1980 added new authority to the FD&C Act. Section 412 of the FD&C Act [21 U.S.C. 350a] extends the definition of adulteration to include specific nutritional, quality and good manufacturing control requirements. It also mandates a firm make available batch records, quality control records, nutrient test data and methodology, and similar documents for examination and copying. Section 704(a)(3) of the FD&C Act [21 U.S.C. 374(a)(3)] gives investigators the right to examine and copy these records.

Device Inspections - Section 704(a) of the FD&C Act [21 U.S.C. 374(a)] provides the general inspectional authority to inspect medical device manufacturers. The Medical Device Amendments of 1976 provided additional authority to inspect records, files, papers, processes, controls, and facilities to determine whether restricted devices are adulterated or misbranded. The Amendments also provide FDA authority, under section 704(e) [21 U.S.C. 374(e)], to inspect and copy records required under section 519 or 520(g) of the FD&C Act [21 U.S.C. 360i or 360j(g)].

Limitations - Section 704 of the FD&C Act [21 U.S.C. 374] provides authority for FDA to conduct inspections of factories, warehouses, establishments, and vehicles, and all pertinent equipment, finished and unfinished materials, containers, and labeling therein where food, drugs, devices, or cosmetics are manufactured or held. This section does not include a provision to inspect records within those facilities, except for inspections of prescription drugs, nonprescription drugs intended for human use, and restricted devices, as stipulated in 704(a)(1)(B) [21 U.S.C. 374(a)(1)(B)], or inspections of infant formula described in 704(a)(3) of the FD&C Act [21 U.S.C. 374(a)(3)].

Keep in mind that several other sections of the Act or of regulations also include provision for inspection and copying of required records. For example, 505(k) provides authority to access and copy records required for new drug applications and abbreviated new drug applications, 512(k)(2) and 512(m)(5) of the FD&C Act [21 U.S.C. 360b(k)(2) and 360b(m)(5)] provide access and copying of records regarding new animal drug and medicated feed permits, HACCP regulations in 21 CFR 123 for fish and fishery products provide for access and copying of required records.

Some firms will allow access to files and other materials for which the FD&C Act does not give mandatory access, but retain the right to later refuse. Management may propose the following alternatives:

1. That inspections to obtain data from these files be made without issuing an FDA-482, Notice of Inspection. You cannot agree to this because the act requires the notice be issued before the inspection.
2. That when data is provided, you are advised in writing it is being given voluntarily. In this instance accept the written or oral statement, and include it as part of the EIR.

Management may insist answers to specific questions be provided by the firm's legal department or other administrative officers. In some instances, management may request questions be submitted in writing. In these cases, try to obtain answers necessary to complete the inspection. Do not submit lists of questions unless specifically instructed to do so by your supervisor.

Examinations - The authority for obtaining samples of radiation-emitting electronic products for testing is provided in Section 532(b)(4) of the FD&C Act [21 U.S.C. 360ii(b)(4)].

Electronic Radiation Inspections - The authority to inspect factories, warehouses, and establishments where electronic products are manufactured or held is provided in Section 537(a) of the FD&C Act [21 U.S.C. 360nn(a)]. This authority is limited; FDA must find "good cause" that methods, tests, or programs related to radiation safety (such as noncompliance with a standard) may be inadequate or unreliable. If there is no finding of "good cause," inspections must be voluntary unless another authority, such as Section 704(a) of the FD&C Act [21 U.S.C. 374(a)] for medical devices, exists. The authority to inspect books, papers, records, and documents relevant to determining compliance with radiation standards is provided in Section 537(b) of the FD&C Act [21 U.S.C. 360nn(b)]. The Electronic Product Radiation Control prohibited acts and enforcement authorities are specified in Sections 538 and 539 of the FD&C Act [21 U.S.C. 360oo and 360pp].

701.02 - Selected Amendments to the FD&C; Act

The FDA Modernization Act of 1997 (FDAMA) - A major amendment of the FD&C Act focused on reforming the regulation of food, drugs, medical devices, and cosmetics. A few important provisions of this amendment are to streamline and speed up approval processes, to harmonize regulation of biological and drug products where feasible, to support risk-based regulation of medical devices, and to implement good guidance practices to ensure meaningful public participation in development of agency guidance documents.

Prescription Drug Amendments of 1962 - Amends the FD&C Act to require prescription drug manufacturers to prove to FDA the effectiveness of their products before marketing.

Medical Device Amendments of 1992 - Amends the FD&C Act with respect to Medical Devices.

Nutritional Labeling and Educational Act of 1990 - Amends the FD&C Act to prescribe nutrition labeling for foods.

Prescription Drug Amendments of 1992 - Amends the FD&C Act to coordinate Federal and State regulation of wholesale drug distribution.

Prescription Drug Marketing Act of 1987 - Amends the FD&C Act to ban the re-importation of drugs produced in the United States, to place restrictions on the distribution of drug samples, and to ban certain resale of drugs by hospitals and other health care entities.

Prescription Drug User Fee Act of 1992 - Amends the FD&C Act to authorize human drug application, prescription drug establishment, and prescription drug product fees.

Animal Drug Availability Act (ADAA) of 1996 - Deals with evidence of effectiveness and pre-submission conferences, limitations on residues, import tolerances, feed mill licenses and veterinary feed directives (VFDs).

Animal Medicinal Use Clarification Act (AMDUCA) of 1994 - Allows veterinarians to prescribe extra label uses of certain approved animal drugs and approved human drugs for animal use under certain conditions including existence of a valid veterinary/client/patient relationship (VCPR). The implementing regulations for AMDUCA can be found in 21 CFR Part 530.

Generic Animal Drug and Patent Term Restoration Act (GADPTRA) of 1988 - Addresses submission of abbreviated new animal drug applications (ANADAs) before generic animal drugs can be legally marketed. See IOM 774.03 for additional information.

Safe Medical Device Act of 1990 - Amends and provides additional authority to FDA for regulating devices. The Act provides for such things as: user reporting of deaths and serious injuries; reclassification of certain devices; provisions for mandatory reporting of recalls initiated by manufacturers and additional authority to order the recall of devices; civil penalties; incorporation of the RCHSA into the FD&C Act; and, device design validation requirements. It also contains specific time frames for writing regulations to implement provisions of the Act. The provisions to order the recall of devices, to notify users, to temporarily suspend premarket approval of a device and to impose civil penalties became effective immediately.

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) authorized, in part, user fees for device premarket submissions, inspections of device manufacturers by accredited persons, the identification of the manufacturer on the actual device or attachment, electronic registration and device labeling, and premarket and labeling requirements for reprocessed single use devices.

701.03 - Other Acts

See IOM 708 and IOM 311.03 for special authorities involving detentions under the Federal Meat Inspection, Poultry Products Inspection, and Egg Products Inspection, Acts.

Anabolic Steroids Control Act of 1990 - Amends the Controlled Substances Act by adding Anabolic Steroids to Schedule III of section 202(c).

Fair Packaging and Labeling Act (FPLA) - An Act to prevent the use of unfair or deceptive methods of packaging or labeling of certain consumer commodities.

Federal Anti-Tampering Act - Prohibits certain tampering with consumer products (18 USC 1365). See IOM 970 for guidance on tampering investigations.

Federal Import Milk Act - Regulates the importation of raw and pasteurized bovine milk and cream from foreign producers.

Federal Caustic Poison Act - Primarily a labeling Act specifying warnings and precautionary statements on labeling of certain household caustic preparations.

Poison Prevention Packaging Act - Provides for special packaging to protect children from serious personal injury or serious illness resulting from handling, using, or ingesting household substances.

Public Health Service Act (PHS) - Sampling: For biological products, which are also drugs under the FD&C Act, the sampling authority of both Acts exists.

Section 351(c) of Part F, Title III of the Public Health Service (PHS) Act [42 USC 262(c)] authorizes inspections of biological establishments (vaccines, serum, and blood). Authority to collect samples and records is found in 21 CFR 600.22. Section 361(a) of Part G of the PHS Act [42 USC 264] authorizes inspection and other activities for the enforcement of 21 CFR 1270, Human Tissue Intended for Transplantation, and 21 CFR 1240, Interstate Quarantine Regulations. Part 1240 covers the mandatory pasteurization for all milk in final package form intended for direct human consumption; the safety of molluscan shellfish; the sanitation of food service; and food, water, and sanitary facilities for interstate travelers on common carriers.

Mammography Quality Standards Act of 1992 - Amends the Public Health Service Act to establish the authority for the regulation of mammography services and radiological equipment.

701.04 - Code of Federal Regulations (CFR)

The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government.  The Code is divided into 50 titles which represent broad areas subject to Federal regulation.  Each title is divided into chapters which usually bear the name of the issuing agency.  Each chapter is further subdivided into parts  covering specific regulatory areas.  For example, the specific regulation covering drug GMPs appears as "21 CFR 211", that is, Title 21, Part 211.   Regulations enforced by FDA are found in volumes 1-8 of Title 21, parts 1-1299.   They are updated as of April 1 of each year.   The Federal Register and the CFR must be used together to determine the latest version of a given rule.   

702 - DEFINITIONS

The following terms are used in assignments, correspondence, and various procedures described in this manual and used throughout FDA.

Civil Number - A docket number used by US district courts to identify civil cases (seizure and injunction).

Citation (Cite) - The section 305 Notice is a statutory requirement of the FD&C Act. It provides a respondent with an opportunity to show cause why he should not be prosecuted for an alleged violation. Response to the notice may be by letter, personal appearance, or an attorney(s).

Criminal Number - A docket number used by the US district courts to identify criminal cases (prosecutions).

FDC and INJ Numbers - The number used by the Chief Counsel's office to identify FDA cases.

Complaint For Forfeiture - A document furnished to the U.S. attorney for filing with the clerk of the court to initiate a seizure.

Home District - The district in whose territory the alleged violation of the Act occurs, or in whose territory the firm or individual responsible for the alleged violation is physically located. The original point from which the article was shipped, or offered for shipment, as shown by the interstate records, is usually considered the point where the violation occurred; and the shipper of such article, as shown by such records, may be considered to be the alleged violator.

Where actions against a firm are based on goods which became violative after interstate shipment was made, or after reaching its destination (such as 301(k) violations), the dealer in whose possession the goods are sampled may be considered the violator, and the location of this dealer determines the "Home District".

Nolle Prosequi (Nol-Pros) - The prosecutor or plaintiff in a legal matter will proceed no further in prosecuting the whole suit or specified counts.

Nolo Contendere (Nolo) - A plea by a defendant in a criminal prosecution meaning "I will not contest it".

Seizing District - The district where seizure is actually accomplished. The seizing district is not necessarily the collecting district, as in the case of intransit samples.

Subpoena Duces Tecum - A writ commanding a person to appear in court bringing with him certain designated documents or things pertinent to the issues of a pending controversy.

Supervising District - The district which exercises supervision over reconditioning lots in connection with seizure actions.

704 - SEIZURE

Seizure is a judicial civil action directed against specific offending goods, in which goods are "arrested."  Originally designed to remove violative goods from consumer channels, it was intended primarily as a remedial step; however, the sanction often has a punitive and deterrent effect.

District Recommendation - The district considers all evidence, including any establishment inspection, sample collection, and analytical results. If indicated, seizure is recommended to headquarters.

Headquarters - Except for certain direct seizure authority, district seizure recommendations are referred to the appropriate center for approval. If approved, the case is referred to the Office of Enforcement (HFC-200) which then requests the Chief Counsel to initiate seizure action.

Department of Justice - The Food and Drug Division of the Department's Office of Chief Counsel reviews and forwards the seizure action to the U.S. attorney in whose judicial district the violative goods are located, through the seizing district. The U.S. attorney files a Complaint For Forfeiture addressed to the U.S. district court, setting forth the facts of the case and calling for the "arrest" of the goods. This Complaint is filed with the appropriate district court.

U.S. District Court - The court orders the arrest of the goods by issuing a motion and warrant to the U.S. marshal, directing seizure of the goods.

The marshal seizes the goods, which then become the property of the court. You may be asked to assist the marshal in the seizure. If so, submit a memorandum to your district office covering this activity.

Claimant & Options - Any person who has an interest in the goods may appear as claimant or to intervene, and claim the goods.

Abandonment - If no claimant appears within a specified time, (return date), then the U.S. attorney requests a Default Decree of Condemnation and Forfeiture, in which the court condemns the goods and directs the U.S. marshal to destroy or otherwise dispose of the goods. Usually, the District assists the marshal in determining the method of disposal, and you may be asked to help in the actual disposition. Any disposition must be in accordance with the National Environmental Policy Act of 1969 (NEPA); 42 U.S.C. 4321-4347.

Reconditioning for Compliance - A claimant may appear and propose the goods be reconditioned to bring them into compliance. After the FDA agrees to the method of reconditioning, the court issues a Decree of Condemnation permitting reconditioning under the supervision of the FDA, after a bond is posted. Salvage operations may include:

1. cleaning, reworking, or other processing,
2. relabeling, or
3. denaturing.

Contested Seizure - A claimant may file an answer to the complaint and deny the allegations. The issues then go to trial.

District Follow-up - The district monitors the progress of the seizure and forwards appropriate reports to the headquarters.

For more information on seizure actions consult Chapter 6 of the Regulatory Procedures Manual

705 - PROSECUTION

Prosecution is a criminal sanction directed against a firm and/or responsible individuals. They can be pursued at two levels: misdemeanor or felony. A prosecution is punitive, with the view of punishing past behavior and obtaining future compliance.

Section 305 Notice - The section 305 Notice is a statutory requirement of the Act. It provides a respondent with an opportunity to explain why he should not be prosecuted for the alleged violation. Response to the notice may be by letter, personal appearance or attorney.

Under certain circumstances, the Agency will refer prosecution (or for further investigation) without first providing the opportunity for presentation of views in accordance with section 305 [See 21 CFR 7.84(a)(2) and (3)].

The facts developed at the hearing are reviewed, along with other evidence, and the district prepares a recommendation the case be:

1. placed in permanent abeyance, with no further action, or
2. placed in temporary abeyance, in which case the decision is delayed pending additional evidence, or for other reasons, or
3. requests, with RFDD concurrence, ad hoc meeting when there is an indication of potential felony charges or the case is especially unusual, or
4. forwarded to the Justice Department for prosecution.

The district recommendation is reviewed by Headquarters units in the light of current policy and procedure. If prosecution is indicated, the case is forwarded to the Office of Chief Counsel (OCC) for review. If the Chief Counsel agrees, the matter is forwarded to the Department of Justice (DOJ) where it is reviewed again. If DOJ concurs, the case is forwarded to the appropriate U. S. Attorney. Non-concurrence results in return of the case to FDA.

Information - An Information is a legal document filed in misdemeanor actions identifying the defendants and setting forth the charges. The Information is forwarded to the appropriate U.S. Attorney, who then files the legal instruments. A trial date is set by the court. Ideally, trial preparation is a collaboration between representatives of the U. S. Attorney's office, OCC, the District and the involved Center.

Grand Jury Proceedings - The Justice Department must proceed by indictment in all felony cases. Evidence in possession of the government is presented to the grand jury which decides if it is sufficient to warrant prosecution. If the grand jury returns a "True Bill", and the defendant pleads not guilty at the arraignment, preparation for trial begins.

The deliberations of a federal grand jury are secret, and only those whom the court has placed under Rule 6(e) of the Federal Rules of Criminal Procedure may be privy to the grand juries activities. Consequently, if you have been designated under the Rule, you may not divulge your knowledge of grand jury affairs to anyone, including colleagues or supervisors, unless they, too, have been placed under the Rule. Strict adherence to the rule of grand jury secrecy protects not only the integrity of the government's investigation, and the validity of any indictment the grand jury might return, but the rights of the person accused. See IOM 511.09 Working with a Grand Jury.

When you are assigned to work with, or for, a grand jury and are instructed as part of that assignment to conduct an inspection or an investigation, do not issue a Notice of Inspection (FDA-482) (See IOM 511.04 Conducting Regulatory Inspections When the Agency is Contemplating Taking, or is Taking, Criminal Action). Check with district management and the Assistant U.S. Attorney or Chief Counsel attorney involved, prior to initiating this type of assignment. Also, refer to IOM 511.04, 511.05, 511.06, 511.07, 511.08 and 511.09.

District Follow-up - Appropriate reports are made to the Administration when the case terminates. Follow-up may involve inspections either of a routine nature or as directed by the court.

706 - INJUNCTION

An injunction is a civil restraint issued by the court to prohibit violations of the Act. Injunction is designed to stem the flow of violative products in interstate commerce, and to correct the conditions in the establishment.

Injunction actions must be processed in strict time frames. Therefore, you may be requested to conduct an inspection to determine the current condition of a firm and to obtain specific information required for the injunction.

Temporary Restraining Order (TRO) - Upon presentation of evidence, the U.S. district court may issue an order restraining defendant from certain acts, for a specific length of time. This period may be extended by order of the court.

Hearing for Injunction - Prior to the expiration of the TRO, if one is involved, the U.S. Attorney, assisted by the district, presents evidence to support an injunction.

Consent Decree of Injunction - The defendants may, following conferences with the U.S. Attorney, consent to a decree of preliminary or permanent injunction. If not, the issue goes to trial.

Trial for Injunction - A preponderance of evidence is required to support an injunction. This differs from a prosecution, which requires evidence establishing guilt "beyond a reasonable doubt". Trial is before the district court. There is no trial by jury, unless demanded by the defendant. In violations of injunction (contempt), the action is brought under the Rules of Criminal Procedure.

Preliminary or Permanent Injunction - A preliminary or permanent injunction enjoins a firm or individuals from continuing a specific violation(s). The terms of the injunction specify the steps to be taken to correct the violations at issue.

District Follow-up - Generally, the district will police an injunction to assure the terms of the decree are met. This may include routine inspections or actual supervision of compliance activities dictated by the terms of the injunction.

707 - EMERGENCY PERMIT CONTROL

708 - DETENTION POWERS

Sections 402 and 409(b) of the Federal Meat Inspection Act, sections 19 and 24(b) of the Poultry Products Inspection Act, sections 5(d), 19, and 23(d) of the Egg Products Inspection Act, and section 304(g) of the FD&C Act [21 U.S.C. 334 (g)] provides certain detention powers.

In essence, articles subject to the Federal Meat Inspection Act or the Poultry Products Inspection Act that are believed to be adulterated or misbranded under the FD&C Act may be detained. FDA representatives may detain articles subject to the Egg Products Inspection Act, which are suspected to be in violation of that statute.

Devices may be detained under the FD&C Act for a maximum of thirty days when there is reason to believe they are adulterated or misbranded under the FD&C Act.

See IOM 750 for inspectional procedures, which must be followed, in exercising the detention authority.

709 - COURTROOM TESTIMONY

Effective testimony, whether it be in court before a judge or jury, grand jury or opposing counsel at a deposition, is a result of quality investigative skills; the ability to prepare factual and informative investigative reports; and thorough preparation for being a fact witness.

As a witness, you are required to testify from memory, but you are allowed to refer to diary notes, reports and memoranda, when necessary to refresh your recollection. For this reason, and the fact they are available to opposing counsel, the Agency insists your notes, reports and the like always be accurate, organized and complete.

There is little difference in giving testimony in court, in a deposition or before a grand jury. In a deposition, testimony is given upon interrogation by opposing counsel, under oath, before a court reporter. Be guided by your (the Government's) attorney in preparing for a deposition. Once completed, the deposition is available to all persons interested in the case, and is available for use at trial.

In a grand jury, testimony is given under oath to a group of jurors who determine whether sufficient evidence exists to charge someone with a felony (See IOM 705).

709.01 - Testimony Preparation

The following suggestions may be helpful in preparing to provide testimony in court, before a grand jury or at a deposition:

1. Carefully and thoroughly reviewing your diary notes, inspection reports and all samples collected.
2. Be neat in your personal appearance; dress conservatively in business attire, and be well groomed.
3. When you take the witness stand, get comfortable, sit erectly and carefully look around to familiarize yourself with the court surroundings.
4. Tell the truth. If asked, do not hesitate to admit you have discussed your testimony in advance with the U.S. Attorney's office.
5. Be sure you understand the question before you answer. If you don't understand the question, request clarification. Take your time. Give each question such thought as required to understand and formulate your answer. Do not answer questions too quickly. Give your attorney time to raise an objection in case it is a question you should not answer. Answer questions clearly and loudly enough so everyone can hear you. Look at the jury and address your remarks to it so all jury members will be able to hear and understand you. Speak directly and authoritatively, and do not use ambiguous phrases such as, "I guess so", "I believe," etc. Do not be afraid to say, "I don't know".
6. Be polite and serious at all times. Give an audible answer to all questions. Do not nod your head yes or no.
7. Do not lose your temper, even if baited by an attorney. Do not spar with examining attorneys; answer questions frankly, factually and confidently, then stop. Do not answer questions, which have been objected to until the court rules on the objection. Do not volunteer information.
8. If you make a mistake answering a question, correct it immediately. If a question can't be truthfully answered with a yes or no, you have the right to explain your answer. If you are asked questions about distances, time or speed, and your answer is only an estimate, be sure you make that clear.
9. If a recess is declared while you are on the stand, keep to yourself. Do not discuss your testimony with anyone except on special instructions from the U.S. Attorney or his/her assistant.
10. Be natural, be yourself. Do not be intimidated by personalities.

709.02 - Interviewing Persons Under Arrest

Miranda Warning - In the Agency's normal course of operation, it is not necessary to read a person their rights, (i.e.: Miranda warnings) because the Agency does not routinely interview individuals who are in custody (under arrest). Miranda warnings are not necessary, during discussions with management when conducting inspections, during investigational interviews, or during a section 305 of the FD&C Act [21 U.S.C. 335] meeting because the individuals being interviewed are not in custody, and are free to leave at any time.

In certain situations, however, FDA personnel may interview someone who is already in custody. In this case, the individual must be given their Miranda rights.

When this situation is encountered, copy page 1 of IOM Exhibit 700-A. If the subject cannot speak/read English, you must arrange for a form in the appropriate language. Read this material to the individual, preferably in the presence of another person, and then have them sign and date the waiver statement. Submit the signed statement with your report. If the individual refuses to sign the statement, indicate this on the unsigned statement, and identify the witness on the document. Submit the unsigned statement with your report.