[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2006]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR7]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
SERVICES
PART 7_ENFORCEMENT POLICY
Subpart A_General Provisions
Sec.
7.1 Scope.
7.3 Definitions.
7.12 Guaranty.
7.13 Suggested forms of guaranty.
Subpart B [Reserved]
Subpart C_Recalls (Including Product Corrections)_Guidance on Policy,
Procedures, and Industry Responsibilities
7.40 Recall policy.
7.41 Health hazard evaluation and recall classification.
7.42 Recall strategy.
7.45 Food and Drug Administration-requested recall.
7.46 Firm-initiated recall.
7.49 Recall communications.
7.50 Public notification of recall.
7.53 Recall status reports.
7.55 Termination of a recall.
7.59 General industry guidance.
Subpart D [Reserved]
Subpart E_Criminal Violations
7.84 Opportunity for presentation of views before report of criminal
violation.
7.85 Conduct of a presentation of views before report of criminal
violation.
7.87 Records related to opportunities for presentation of views
conducted before report of criminal violation.
Authority: 21 U.S.C. 321-393; 42 U.S.C. 241, 262, 263b-263n, 264.
Source: 42 FR 15567, Mar. 22, 1977, unless otherwise noted.
Subpart A_General Provisions
Sec. 7.1 Scope.
This part governs the practices and procedures applicable to
regulatory enforcement actions initiated by the Food and Drug
Administration pursuant to the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 301 et seq.) and other laws that it administers. This part also
provides guidance for manufacturers and distributors to follow with
respect to their voluntary removal or correction of marketed violative
products. This part is promulgated to clarify and explain the regulatory
practices and procedures of the Food and Drug Administration, enhance
public understanding, improve consumer protection, and assure uniform
and consistent application of practices and procedures throughout the
agency.
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[43 FR 26218, June 16, 1978, as amended at 65 FR 56476, Sept. 19, 2000]
Sec. 7.3 Definitions.
(a) Agency means the Food and Drug Administration.
(b) Citation or cite means a document and any attachments thereto
that provide notice to a person against whom criminal prosecution is
contemplated of the opportunity to present views to the agency regarding
an alleged violation.
(c) Respondent means a person named in a notice who presents views
concerning an alleged violation either in person, by designated
representative, or in writing.
(d) Responsible individual includes those in positions of power or
authority to detect, prevent, or correct violations of the Federal Food,
Drug, and Cosmetic Act.
(e) [Reserved]
(f) Product means an article subject to the jurisdiction of the Food
and Drug Administration, including any food, drug, and device intended
for human or animal use, any cosmetic and biologic intended for human
use, and any item subject to a quarantine regulation under part 1240 of
this chapter. Product does not include an electronic product that emits
radiation and is subject to parts 1003 and 1004 of this chapter.
(g) Recall means a firm's removal or correction of a marketed
product that the Food and Drug Administration considers to be in
violation of the laws it administers and against which the agency would
initiate legal action, e.g., seizure. Recall does not include a market
withdrawal or a stock recovery.
(h) Correction means repair, modification, adjustment, relabeling,
destruction, or inspection (including patient monitoring) of a product
without its physical removal to some other location.
(i) Recalling firm means the firm that initiates a recall or, in the
case of a Food and Drug Administration-requested recall, the firm that
has primary responsibility for the manufacture and marketing of the
product to be recalled.
(j) Market withdrawal means a firm's removal or correction of a
distributed product which involves a minor violation that would not be
subject to legal action by the Food and Drug Administration or which
involves no violation, e.g., normal stock rotation practices, routine
equipment adjustments and repairs, etc.
(k) Stock recovery means a firm's removal or correction of a product
that has not been marketed or that has not left the direct control of
the firm, i.e., the product is located on premises owned by, or under
the control of, the firm and no portion of the lot has been released for
sale or use.
(l) Recall strategy means a planned specific course of action to be
taken in conducting a specific recall, which addresses the depth of
recall, need for public warnings, and extent of effectiveness checks for
the recall.
(m) Recall classification means the numerical designation, i.e., I,
II, or III, assigned by the Food and Drug Administration to a particular
product recall to indicate the relative degree of health hazard
presented by the product being recalled.
(1) Class I is a situation in which there is a reasonable
probability that the use of, or exposure to, a violative product will
cause serious adverse health consequences or death.
(2) Class II is a situation in which use of, or exposure to, a
violative product may cause temporary or medically reversible adverse
health consequences or where the probability of serious adverse health
consequences is remote.
(3) Class III is a situation in which use of, or exposure to, a
violative product is not likely to cause adverse health consequences.
(n) Consignee means anyone who received, purchased, or used the
product being recalled.
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[42 FR 15567, Mar. 22, 1977, as amended at 43 FR 26218, June 16, 1978;
44 FR 12167, Mar. 6, 1979]
Sec. 7.12 Guaranty.
In case of the giving of a guaranty or undertaking referred to in
section 303(c)(2) or (3) of the act, each person signing such guaranty
or undertaking shall be considered to have given it.
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Sec. 7.13 Suggested forms of guaranty.
(a) A guaranty or undertaking referred to in section 303(c)(2) of
the act may be:
(1) Limited to a specific shipment or other delivery of an article,
in which case it may be a part of or attached to the invoice or bill of
sale covering such shipment or delivery, or
(2) General and continuing, in which case, in its application to any
shipment or other delivery of an article, it shall be considered to have
been given at the date such article was shipped or delivered by the
person who gives the guaranty or undertaking.
(b) The following are suggested forms of guaranty or undertaking
under section 303(c)(2) of the act:
(1) Limited form for use on invoice or bill of sale.
(Name of person giving the guaranty or undertaking) hereby
guarantees that no article listed herein is adulterated or misbranded
within the meaning of the Federal Food, Drug, and Cosmetic Act, or is an
article which may not, under the provisions of section 404, 505, or 512
of the act, be introduced into interstate commerce.
(Signature and post-office address of person giving the guaranty or
undertaking.)
(2) General and continuing form.
The article comprising each shipment or other delivery hereafter
made by (name of person giving the guaranty or undertaking) to, or in
the order of (name and post-office address of person to whom the
guaranty or undertaking is given) is hereby guaranteed,
as of the date of such shipment or delivery, to be, on such date, not
adulterated or misbranded within the meaning of the Federal Food, Drug,
and Cosmetic Act, and not an article which may not, under the provisions
of section 404, 505, or 512 of the act, be introduced into interstate
commerce.
(Signature and post-office address of person giving the guaranty of
undertaking.)
(c) The application of a guaranty or undertaking referred to in
section 303(c)(2) of the act to any shipment or other delivery of an
article shall expire when such article, after shipment or delivery by
the person who gave such guaranty or undertaking, becomes adulterated or
misbranded within the meaning of the act, or becomes an article which
may not, under the provisions of section 404, 505, or 512 of the act, be
introduced into interstate commerce.
(d) A guaranty or undertaking referred to in section 303(c)(3) of
the act shall state that the shipment or other delivery of the color
additive covered thereby was manufactured by a signer thereof. It may be
a part of or attached to the invoice or bill of sale covering such
color. If such shipment or delivery is from a foreign manufacturer, such
guaranty or undertaking shall be signed by such manufacturer and by an
agent of such manufacturer who resides in the United States.
(e) The following are suggested forms of guaranty or undertaking
under section 303(c)(3) of the act:
(1) For domestic manufacturers:
(Name of manufacturer) hereby guarantees that all color additives
listed herein were manufactured by him, and (where color additive
regulations require certification) are from batches certified in
accordance with the applicable regulations promulgated under the Federal
Food, Drug, and Cosmetic Act.
(Signature and post-office address of manufacturer.)
(2) For foreign manufacturers:
(Name of manufacturer and agent) hereby severally guarantee that all
color additives listed herein were manufactured by (name of
manufacturer), and (where color additive regulations require
certification) are from batches certified in accordance with the
applicable regulations promulgated under the Federal Food, Drug, and
Cosmetic Act.
(Signature and post-office address of manufacturer.)
(Signature and post-office address of agent.)
(f) For the purpose of a guaranty or undertaking under section
303(c)(3) of the act the manufacturer of a shipment or other delivery of
a color additive is the person who packaged such color.
(g) A guaranty or undertaking, if signed by two or more persons,
shall state that such persons severally guarantee the article to which
it applies.
(h) No representation or suggestion that an article is guaranteed
under the act shall be made in labeling.
Subpart B [Reserved]
Subpart C_Recalls (Including Product Corrections)_Guidance on Policy,
Procedures, and Industry Responsibilities
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Source: 43 FR 26218, June 16, 1978, unless otherwise noted.
Sec. 7.40 Recall policy.
(a) Recall is an effective method of removing or correcting consumer
products that are in violation of laws administered by the Food and Drug
Administration. Recall is a voluntary action that takes place because
manufacturers and distributors carry out their responsibility to protect
the public health and well-being from products that present a risk of
injury or gross deception or are otherwise defective. This section and
Sec. Sec. 7.41 through 7.59 recognize the voluntary nature of recall by
providing guidance so that responsible firms may effectively discharge
their recall responsibilities. These sections also recognize that recall
is an alternative to a Food and Drug Administration-initiated court
action for removing or correcting violative, distributed products by
setting forth specific recall procedures for the Food and Drug
Administration to monitor recalls and assess the adequacy of a firm's
efforts in recall.
(b) Recall may be undertaken voluntarily and at any time by
manufacturers and distributors, or at the request of the Food and Drug
Administration. A request by the Food and Drug Administration that a
firm recall a product is reserved for urgent situations
and is to be directed to the firm that has primary responsibility for
the manufacture and marketing of the product that is to be recalled.
(c) Recall is generally more appropriate and affords better
protection for consumers than seizure, when many lots of product have
been widely distributed. Seizure, multiple seizure, or other court
action is indicated when a firm refuses to undertake a recall requested
by the Food and Drug Administration, or where the agency has reason to
believe that a recall would not be effective, determines that a recall
is ineffective, or discovers that a violation is continuing.
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[43 FR 26218, June 16, 1978, as amended at 65 FR 56476, Sept. 19, 2000]
Sec. 7.41 Health hazard evaluation and recall classification.
(a) An evaluation of the health hazard presented by a product being
recalled or considered for recall will be conducted by an ad hoc
committee of Food and Drug Administration scientists and will take into
account, but need not be limited to, the following factors:
(1) Whether any disease or injuries have already occurred from the
use of the product.
(2) Whether any existing conditions could contribute to a clinical
situation that could expose humans or animals to a health hazard. Any
conclusion shall be supported as completely as possible by scientific
documentation and/or statements that the conclusion is the opinion of
the individual(s) making the health hazard determination.
(3) Assessment of hazard to various segments of the population,
e.g., children, surgical patients, pets, livestock, etc., who are
expected to be exposed to the product being considered, with particular
attention paid to the hazard to those individuals who may be at greatest
risk.
(4) Assessment of the degree of seriousness of the health hazard to
which the populations at risk would be exposed.
(5) Assessment of the likelihood of occurrence of the hazard.
(6) Assessment of the consequences (immediate or long-range) of
occurrence of the hazard.
(b) On the basis of this determination, the Food and Drug
Administration will assign the recall a classification, i.e., Class I,
Class II, or Class III, to indicate the relative degree of health hazard
of the product being recalled or considered for recall.
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Sec. 7.42 Recall strategy.
(a) General. (1) A recall strategy that takes into account the
following factors will be developed by the agency for a Food and Drug
Administration-requested recall and by the recalling firm for a firm-
initiated recall to suit the individual circumstances of the particular
recall:
(i) Results of health hazard evaluation.
(ii) Ease in identifying the product.
(iii) Degree to which the product's deficiency is obvious to the
consumer or user.
(iv) Degree to which the product remains unused in the market-place.
(v) Continued availability of essential products.
(2) The Food and Drug Administration will review the adequacy of a
proposed recall strategy developed by a recalling firm and recommend
changes as appropriate. A recalling firm should conduct the recall in
accordance with an approved recall strategy but need not delay
initiation of a recall pending review of its recall strategy.
(b) Elements of a recall strategy. A recall strategy will address
the following elements regarding the conduct of the recall:
(1) Depth of recall. Depending on the product's degree of hazard and
extent of distribution, the recall strategy will specify the level in
the distribution chain to which the recall is to extend, as follows:
(i) Consumer or user level, which may vary with product, including
any intermediate wholesale or retail level; or
(ii) Retail level, including any intermediate wholesale level; or
(iii) Wholesale level.
(2) Public warning. The purpose of a public warning is to alert the
public that a product being recalled presents a serious hazard to
health. It is reserved for urgent situations where other means for
preventing use of the
recalled product appear inadequate. The Food and Drug Administration in
consultation with the recalling firm will ordinarily issue such
publicity. The recalling firm that decides to issue its own public
warning is requested to submit its proposed public warning and plan for
distribution of the warning for review and comment by the Food and Drug
Administration. The recall strategy will specify whether a public
warning is needed and whether it will issue as:
(i) General public warning through the general news media, either
national or local as appropriate, or
(ii) Public warning through specialized news media, e.g.,
professional or trade press, or to specific segments of the population
such as physicians, hospitals, etc.
(3) Effectiveness checks. The purpose of effectiveness checks is to
verify that all consignees at the recall depth specified by the strategy
have received notification about the recall and have taken appropriate
action. The method for contacting consignees may be accomplished by
personal visits, telephone calls, letters, or a combination thereof. A
guide entitled ``Methods for Conducting Recall Effectiveness Checks''
that describes the use of these different methods is available upon
request from the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The
recalling firm will ordinarily be responsible for conducting
effectiveness checks, but the Food and Drug Administration will assist
in this task where necessary and appropriate. The recall strategy will
specify the method(s) to be used for and the level of effectiveness
checks that will be conducted, as follows:
(i) Level A--100 percent of the total number of consignees to be
contacted;
(ii) Level B--Some percentage of the total number of consignees to
be contacted, which percentage is to be determined on a case-by-case
basis, but is greater that 10 percent and less than 100 percent of the
total number of consignees;
(iii) Level C--10 percent of the total number of consignees to be
contacted;
(iv) Level D--2 percent of the total number of consignees to be
contacted; or
(v) Level E--No effectiveness checks.
[43 FR 26218, June 16, 1978, as amended at 46 FR 8455, Jan. 27, 1981; 59
FR 14363, Mar. 28, 1994; 68 FR 24879, May 9, 2003]
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Sec. 7.45 Food and Drug Administration-requested recall.
(a) The Commissioner of Food and Drugs or designee may request a
firm to initiate a recall when the following determinations have been
made:
(1) That a product that has been distributed presents a risk of
illness or injury or gross consumer deception.
(2) That the firm has not initiated a recall of the product.
(3) That an agency action is necessary to protect the public health
and welfare.
(b) The Commissioner or his designee will notify the firm of this
determination and of the need to begin immediately a recall of the
product. Such notification will be by letter or telegram to a
responsible official of the firm, but may be preceded by oral
communication or by a visit from an authorized representative of the
local Food and Drug Administration district office, with formal, written
confirmation from the Commissioner or his designee afterward. The
notification will specify the violation, the health hazard
classification of the violative product, the recall strategy, and other
appropriate instructions for conducting the recall.
(c) Upon receipt of a request to recall, the firm may be asked to
provide the Food and Drug Administration any or all of the information
listed in Sec. 7.46(a). The firm, upon agreeing to the recall request,
may also provide other information relevant to the agency's
determination of the need for the recall or how the recall should be
conducted.
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[43 FR 26218, June 16, 1978, as amended at 69 FR 17290, Apr. 2, 2004]
Sec. 7.46 Firm-initiated recall.
(a) A firm may decide of its own volition and under any
circumstances to
remove or correct a distributed product. A firm that does so because it
believes the product to be violative is requested to notify immediately
the appropriate Food and Drug Administration district office listed in
Sec. 5.115 of this chapter. Such removal or correction will be
considered a recall only if the Food and Drug Administration regards the
product as involving a violation that is subject to legal action, e.g.,
seizure. In such cases, the firm will be asked to provide the Food and
Drug Administration the following information:
(1) Identity of the product involved.
(2) Reason for the removal or correction and the date and
circumstances under which the product deficiency or possible deficiency
was discovered.
(3) Evaluation of the risk associated with the deficiency or
possible deficiency.
(4) Total amount of such products produced and/or the timespan of
the production.
(5) Total amount of such products estimated to be in distribution
channels.
(6) Distribution information, including the number of direct
accounts and, where necessary, the identity of the direct accounts.
(7) A copy of the firm's recall communication if any has issued, or
a proposed communication if none has issued.
(8) Proposed strategy for conducting the recall.
(9) Name and telephone number of the firm official who should be
contacted concerning the recall.
(b) The Food and Drug Administration will review the information
submitted, advise the firm of the assigned recall classification,
recommend any appropriate changes in the firm's strategy for the recall,
and advise the firm that its recall will be placed in the weekly FDA
Enforcement Report. Pending this review, the firm need not delay
initiation of its product removal or correction.
(c) A firm may decide to recall a product when informed by the Food
and Drug Administration that the agency has determined that the product
in question violates the law, but the agency has not specifically
requested a recall. The firm's action also is considered a firm-
initiated recall and is subject to paragraphs (a) and (b) of this
section.
(d) A firm that initiates a removal or correction of its product
which the firm believes is a market withdrawal should consult with the
appropriate Food and Drug Administration district office when the reason
for the removal or correction is not obvious or clearly understood but
where it is apparent, e.g., because of complaints or adverse reactions
regarding the product, that the product is deficient in some respect. In
such cases, the Food and Drug Administration will assist the firm in
determining the exact nature of the problem.
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Sec. 7.49 Recall communications.
(a) General. A recalling firm is responsible for promptly notifying
each of its affected direct accounts about the recall. The format,
content, and extent of a recall communication should be commensurate
with the hazard of the product being recalled and the strategy developed
for that recall. In general terms, the purpose of a recall communication
is to convey:
(1) That the product in question is subject to a recall.
(2) That further distribution or use of any remaining product should
cease immediately.
(3) Where appropriate, that the direct account should in turn notify
its customers who received the product about the recall.
(4) Instructions regarding what to do with the product.
(b) Implementation. A recall communication can be accomplished by
telegrams, mailgrams, or first class letters conspicuously marked,
preferably in bold red type, on the letter and the envelope: ``drug [or
food, biologic, etc.] recall [or correction]''. The letter and the
envelope should be also marked: ``urgent'' for class I and class II
recalls and, when appropriate, for class III recalls. Telephone calls or
other personal contacts should ordinarily be confirmed by one of the
above methods and/or documented in an appropriate manner.
(c) Contents. (1) A recall communication should be written in
accordance with the following guidelines:
(i) Be brief and to the point;
(ii) Identify clearly the product, size, lot number(s), code(s) or
serial number(s) and any other pertinent descriptive information to
enable accurate and immediate identification of the product;
(iii) Explain concisely the reason for the recall and the hazard
involved, if any;
(iv) Provide specific instructions on what should be done with
respect to the recalled products; and
(v) Provide a ready means for the recipient of the communication to
report to the recalling firm whether it has any of the product, e.g., by
sending a postage-paid, self-addressed postcard or by allowing the
recipient to place a collect call to the recalling firm.
(2) The recall communication should not contain irrelevant
qualifications, promotional materials, or any other statement that may
detract from the message. Where necessary, followup communications
should be sent to those who fail to respond to the initial recall
communication.
(d) Responsibility of recipient. Consignees that receive a recall
communication should immediately carry out the instructions set forth by
the recalling firm and, where necessary, extend the recall to its
consignees in accordance with paragraphs (b) and (c) of this section.
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Sec. 7.50 Public notification of recall.
The Food and Drug Administration will promptly make available to the
public in the weekly FDA Enforcement Report a descriptive listing of
each new recall according to its classification, whether it was Food and
Drug Administration-requested or firm-initiated, and the specific action
being taken by the recalling firm. The Food and Drug Administration will
intentionally delay public notification of recalls of certain drugs and
devices where the agency determines that public notification may cause
unnecessary and harmful anxiety in patients and that initial
consultation between patients and their physicians is essential. The
report will not include a firm's product removals or corrections which
the agency determines to be market withdrawals or stock recoveries. The
report, which also includes other Food and Drug Administration
regulatory actions, e.g., seizures that were effected and injunctions
and prosecutions that were filed, is available upon request from the
Office of Public Affairs (HFI-1), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857.
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Sec. 7.53 Recall status reports.
(a) The recalling firm is requested to submit periodic recall status
reports to the appropriate Food and Drug Administration district office
so that the agency may assess the progress of the recall. The frequency
of such reports will be determined by the relative urgency of the recall
and will be specified by the Food and Drug Administration in each recall
case; generally the reporting interval will be between 2 and 4 weeks.
(b) Unless otherwise specified or inappropriate in a given recall
case, the recall status report should contain the following information:
(1) Number of consignees notified of the recall, and date and method
of notification.
(2) Number of consignees responding to the recall communication and
quatity of products on hand at the time it was received.
(3) Number of consignees that did not respond (if needed, the
identity of nonresponding consignees may be requested by the Food and
Drug Administration).
(4) Number of products returned or corrected by each consignee
contacted and the quantity of products accounted for.
(5) Number and results of effectiveness checks that were made.
(6) Estimated time frames for completion of the recall.
(c) Recall status reports are to be discontinued when the recall is
terminated by the Food and Drug Administration.
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Sec. 7.55 Termination of a recall.
(a) A recall will be terminated when the Food and Drug
Administration determines that all reasonable efforts have been made to
remove or correct the product in accordance with the recall strategy,
and when it is reasonable
to assume that the product subject to the recall has been removed and
proper disposition or correction has been made commensurate with the
degree of hazard of the recalled product. Written notification that a
recall is terminated will be issued by the appropriate Food and Drug
Administration district office to the recalling firm.
(b) A recalling firm may request termination of its recall by
submitting a written request to the appropriate Food and Drug
Adminstration district office stating that the recall is effective in
accordance with the criteria set forth in paragraph (a) of this section,
and by accompanying the request with the most current recall status
report and a description of the disposition of the recalled product.
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Sec. 7.59 General industry guidance.
A recall can be disruptive of a firm's operation and business, but
there are several steps a prudent firm can take in advance to minimize
this disruptive effect. Notwithstanding similar specific requirements
for certain products in other parts of this chapter, the following is
provided by the Food and Drug Administration as guidance for a firm's
consideration:
(a) Prepare and maintain a current written contingency plan for use
in initiating and effecting a recall in accordance with Sec. Sec. 7.40
through 7.49, 7.53, and 7.55.
(b) Use sufficient coding of regulated products to make possible
positive lot identification and to facilitate effective recall of all
violative lots.
(c) Maintain such product distribution records as are necessary to
facilitate location of products that are being recalled. Such records
should be maintained for a period of time that exceeds the shelf life
and expected use of the product and is at least the length of time
specified in other applicable regulations concerning records retention.
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Subpart D [Reserved]
Subpart E_Criminal Violations
Sec. 7.84 Opportunity for presentation of views before report of
criminal violation.
(a)(1) Except as provided in paragraph (a) (2) and (3) of this
section, a person against whom criminal prosecution under the Federal
Food, Drug, and Cosmetic Act is contemplated by the Commissioner of Food
and Drugs shall be given appropriate notice and an opportunity to
present information and views to show cause why criminal prosecution
should not be recommended to a United States attorney.
(2) Notice and opportunity need not be provided if the Commissioner
has reason to believe that they may result in the alteration or
destruction of evidence or in the prospective defendant's fleeing to
avoid prosecution.
(3) Notice and opportunity need not be provided if the Commissioner
contemplates recommending further investigation by the Department of
Justice.
(b) If a statute enforced by the Commissioner does not contain a
provision for an opportunity to present views, the Commissioner need
not, but may in the Commissioner's discretion, provide notice and an
opportunity to present views.
(c) If an apparent violation of the Federal Food, Drug, and Cosmetic
Act also constitutes a violation of any other Federal statute(s), and
the Commissioner contemplates recommending prosecution under such other
statute(s) as well, the notice of opportunity to present views will
include all violations.
(d) Notice of an opportunity to present views may be by letter,
standard form, or other document(s) identifying the products and/or
conduct alleged to violate the law. The notice shall--
(1) Be sent by registered or certified mail, telegram, telex,
personal delivery, or any other appropriate mode of written
communication;
(2) Specify the time and place where those named may present their
views;
(3) Summarize the violations that constitute the basis of the
contemplated prosecution;
(4) Describe the purpose and procedure of the presentation; and
(5) Furnish a form on which the legal status of any person named in
the notice may be designated.
(e) If more than one person is named in a notice, a separate
opportunity for presentation of views shall be scheduled on request.
Otherwise, the time and place specified in a notice may be changed only
upon a showing of reasonable grounds. A request for any change shall be
addressed to the Food and Drug Administration office that issued the
notice and shall be received in that office at least 3 working days
before the date set in the notice.
(f) A person who has received a notice is under no legal obligation
to appear or answer in any manner. A person choosing to respond may
appear personally, with or without a representative, or may designate a
representative to appear for him or her. Alternatively, a person may
respond in writing. If a person elects not to respond on or before the
time scheduled, the Commissioner will, without further notice, decide
whether to recommend criminal prosecution to a United States attorney on
the basis of the information available.
(g) If a respondent chooses to appear solely by designated
representative, that representative shall present a signed statement of
authorization. If a representative appears for more than one respondent,
the representative shall submit independent documentation of authority
to act for each respondent. If a representative appears without written
authorization, the opportunity to present views with respect to that
respondent may be provided at that time only if the authenticity of the
representative's authority is first verified by telephone or other
appropriate means.
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[44 FR 12167, Mar. 6, 1979]
Sec. 7.85 Conduct of a presentation of views before report of criminal
violation.
(a) The presentation of views shall be heard by a designated Food
and Drug Administration employee. Other Food and Drug Administration
employees may be present.
(b) A presentation of views shall not be open to the public. The
agency employee designated to receive views will permit participation of
other persons only if they appear with the respondent or the
respondent's designated representative, and at the request of, and on
behalf of, the respondent.
(c) A respondent may present any information of any kind bearing on
the Commissioner's determination to recommend prosecution. Information
may include statements of persons appearing on the respondent's behalf,
letters, documents, laboratory analyses, if applicable, or other
relevant information or arguments. The opportunity to present views
shall be informal. The rules of evidence shall not apply. Any
information given by a respondent, including statements by the
respondent, shall become part of the agency's records concerning the
matter and may be used for any official purpose. The Food and Drug
Administration is under no obligation to present evidence or witnesses.
(d) If the respondent holds a ``guaranty or undertaking'' as
described in section 303(c) of the act (21 U.S.C. 333(c)) that is
applicable to the notice, that document, or a verified copy of it, may
be presented by the respondent.
(e) A respondent may have an oral presentation recorded and
transcribed at his or her expense, in which case a copy of the
transcription shall be furnished to the Food and Drug Administration
office from which the notice issued. The employee designated to receive
views may order a presentation of views recorded and transcribed at
agency expense, in which case a copy of such transcription shall be
provided to each respondent.
(f) If an oral presentation is not recorded and transcribed, the
agency employee designated to receive views shall dictate a written
summary of the presentation. A copy of the summary shall be provided to
each respondent.
(g) A respondent may comment on the summary or may supplement any
response by additional written or documentary evidence. Any comment or
addition shall be furnished to the Food and Drug Administration office
where the respondent's views were presented. If materials are submitted
within 10 calendar days after receipt of the copy of the summary or
transcription of the presentation, as applicable, they will be considered
before a final decision as to whether or not to recommend
prosecution. Any materials received after the supplemental response
period generally will be considered only if the final agency decision
has not yet been made.
(h)(1) When consideration of a criminal prosecution recommendation
involving the same violations is closed by the Commissioner with respect
to all persons named in the notice, the Commissioner will so notify each
person in writing.
(2) When it is determined that a person named in a notice will not
be included in the Commissioner's recommendation for criminal
prosecution, the Commissioner will so notify that person, if and when
the Commissioner concludes that notification will not prejudice the
prosecution of any other person.
(3) When a United States attorney informs the agency that no persons
recommended will be prosecuted, the Commissioner will so notify each
person in writing, unless the United States attorney has already done
so.
(4) When a United States attorney informs the agency of intent to
prosecute some, but not all, persons who had been provided an
opportunity to present views and were subsequently named in the
Commissioner's recommendation for criminal prosecution, the
Commissioner, after being advised by the United States attorney that the
notification will not prejudice the prosecution of any other person,
will so notify those persons eliminated from further consideration,
unless the United States attorney has already done so.
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[44 FR 12168, Mar. 6, 1979]
Sec. 7.87 Records related to opportunities for presentation of views
conducted before report of criminal violation.
(a) Records related to a section 305 opportunity for presentation of
views constitute investigatory records for law enforcement purposes and
may include inter- and intra-agency memorandums.
(1) Notwithstanding the rule established in Sec. 20.21 of this
chapter, no record related to a section 305 presentation is available
for public disclosure until consideration of criminal prosecution has
been closed in accordance with paragraph (b) of this section, except as
provided in Sec. 20.82 of this chapter. Only very rarely and only under
circumstances that demonstrate a compelling public interest will the
Commissioner exercise, in accordance with Sec. 20.82 of this chapter,
the authorized discretion to disclose records related to a section 305
presentation before the consideration of criminal prosecution is closed.
(2) After consideration of criminal prosecution is closed, the
records are available for public disclosure in response to a request
under the Freedom of Information Act, except to the extent that the
exemptions from disclosure in subpart D of part 20 of this chapter are
applicable. No statements obtained through promises of confidentiality
shall be available for public disclosure.
(b) Consideration of criminal prosecution based on a particular
section 305 notice of opportunity for presentation of views shall be
deemed to be closed within the meaning of this section and Sec. 7.85
when a final decision has been made not to recommend criminal
prosecution to a United States attorney based on charges set forth in
the notice and considered at the presentation, or when such a
recommendation has been finally refused by the United States attorney,
or when criminal prosecution has been instituted and the matter and all
related appeals have been concluded, or when the statute of limitations
has run.
(c) Before disclosure of any record specifically reflecting
consideration of a possible recommendation for criminal prosecution of
any individual, all names and other information that would identify an
individual whose prosecution was considered but not recommended, or who
was not prosecuted, shall be deleted, unless the Commissioner concludes
that there is a compelling public interest in the disclosure of the
names.
(d) Names and other information that would identify a Food and Drug
Administration employee shall be deleted from records related to a
section 305 presentation of views before public disclosure only under
Sec. 20.32 of this chapter.
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[44 FR 12168, Mar. 6, 1979]