Regulatory Compliance
Food Law
FSC-421
1
What are we talking about?
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Judicial Enforcement
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Remedies available to the consumer
Products Liability
 Private Actions against the Government
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Regulatory Enforcement
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Remedies available to Government
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Recalls, Seizures, Injunctions
2
Judicial Remedies
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Products Liability
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Breach of Warranty
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Negligence
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Implied or express warranties of merchanability
Breach of duty of care to consumer
Strict Liability
Liability without fault
 2nd Restatement of Torts
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3
Defenses to Products
Liability Actions
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HACCP
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GMPs
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Written Plans
Compliance with all applicable
Mitigation of Damages
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Initiate immediate recall
Cure the defect
Public Notice
4
Private Actions Against US
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Persons damaged by administrative act of the
government
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Federal Torts Claim Act
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Approval of DES
Abrogates common law sovereign immunity
US can be sued for acts and omissions by its
investigative and enforcement officers based
on assault, battery, false imprisonment, false
arrest, etc.
5
Examples of Private Actions
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Diethyl stilbesterol approval
Xylocaine approval
Approval of polio vaccine
Death due to approval of live polio
vaccine
Illegal seizure
Reliance on FDA certification of
marketability
6
Regulatory Remedies
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Movement of adulterated or misbranded
food products are primary basis for
enforcement activities by regulatory
authorities
Adulteration includes poisonous and
deleterious substances in food
Misbranding includes false and misleading
statements
7
Prohibited Acts
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FDCA Sec 301 lists “prohibited acts”
301(a) sets broad prohibition
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“introduction into interstate
commerce of any food ….. that is
adulterated or misbranded
Actual crossing of state line not
required, contract for sale is violation
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US v. Seven Barrels..Spray dried whole
eggs
8
Example
St. Louis FDA inspector goes to Illinois defendant seller
and poses as purchaser from Memphis, Tennessee,
indicating he wants product for use in Tennessee.
Defendant sold inspector misbranded drug product.
Inspector returned to St. Louis and initiated enforcement
action based on interstate shipment of misbranded product.
Court said “not guilty” b/c “intent of the buyer and seller
must match. Fact that drug traveled across state line was
immaterial.
9
Prohibited Acts
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Section 301(a) 
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Section 301(b) 
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introduction or delivery of any
adulterated or misbranded food into
interstate commerce (I/C)
adulteration or misbranding of any food
in I/C
covers common carriers
Sec 301(c) 
receipt of any…………. (rarely used)
10
Prohibited Acts
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What if food adulterated after crosses state
line (tampering)?
Sec 301(k) 
Alteration, mutilation, destruction, obliteration or
removal in whole or part of any label…..if done
while held for sale and after shipment in I/C
11
Other Prohibited Acts
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301(d) 
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301(e) 
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shipment w/o a permit if required
refusal to permit copying of shipping
record
301(h)
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Guarantee from supplier that goods not
adulterated is defense to prosecution
unless guarantee is false
12
Concurrent Jurisdiction
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Cooperation between agencies to
ensure compliance with adulteration and
misbranding provisions of FDCA and
other Acts
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Includes Federal, State, and Foreign
agencies
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agencies of foreign governments
FDA, USDA, OHSA, EPA, DOJ
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Memorandums of Understanding
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MOU's issued as compliance policy
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“Deals between agencies”
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Defines relationships between:
guides
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two or more federal agencies
U.S. agency and foreign government
U.S. agency and state agency
14
Examples of MOU's
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CPG 7155a01 is MOU between FDA and
USDA/AMS for inspection of fruit and
vegetable products
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CPG 7155a16 is MOU between FDA and
USDA/FSIS for inspection of facilities
regulated by both agencies
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Monster Rancher villian
15
Food, Drug, and Cosmetic Act
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Primary act enforced by FDA
FDA promulgates regulations for
interpretation and enforcement
FDA implement compliance programs
and enforcement procedures
16
Inspections
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Primary FDA compliance tool for keeping
adulterated products out of I/C
Inspection authority comes from Sec. 704 of
FDCA
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"…FDA may inspect a factory, warehouse,
establishment or vehicle in which food is
manufactured, processed, packed… to examine all
pertinent equipment, finished and unfinished
materials and labeling."
17
Inspectors
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Must present appropriate credentials,
warrant and written notice of inspection
Must conduct at reasonable times, within
reasonable limits and in a reasonable
manner
FDA also authorized to collect samples
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Must give receipts
Copies of any analysis
Authorized to make copies of interstate
shipping records
18
Inspections
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FDA may not conduct an inspection without
either consent or a warrant.
Warrantless inspections violate 4th
amendment unless:
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Have consent
Emergency conditions exists
Pervasively regulated industry
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Mining, auto junkyards, Drug manufacturing industry
Is Food Industry a prevasively regulated industry
so that warrantless inspections should be legal?
19
Inspections
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Two types of warrants:
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Criminal search warrant
Broad authority to looks for evidence of a crime
 Need only show "probable cause"
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Administrative inspection warrant
Need specific evidence of an existing violation
 Results may not be admissable at trial
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20
Inspections
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Two types:
1. Comprehensive
Wall to wall inspection
 Covers everything under FDA jurisdiction
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2. Directed inspections
Covers specific areas to certain depth
(limits)
 Usually in response to consumer complaint
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21
Inspections
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Inspection begins with "Opening Conference"
Details purpose and scope of inspection
Company decision to consent or require warrant
Company has right to time to inspect warrant
Can allow inspection and file "written protest"
Inspection conducted in accordance with
"Investigations Operations Manual"
Ends with "Closing Conference"
Inspector prepares "Establishment Inspection
Report"
22
Penalties
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Imprisonment up to one year and fine
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Increased for subsequent convictions
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Imprisonment up to 3 years and/or
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Per day/per violation
up to $1,000 or both
fine up to $10,000
23
Enforcement Options
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FDA cannot file criminal charges
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FDA options
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can recommend this be done by DOJ
Seizures, injunctions, recalls, warning
letters
USDA options
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Mandatory inspections, refusal of
inspection
24
FDA’s Regulatory Philosophy
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Objective is to insure voluntary
compliance
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cannot ensure safety of food by policing
Empowered to use full force of legal
system if necessary ("big stick")
advising a company of violations is
often sufficient
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has led to increase use of warning letters
25
Warning Letter
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Written communication from FDA
notifying ……that the agency considers
one or more products, practices or
procedures to be in violation of the
FDCA or other acts and that failure to
take prompt and appropriate action
to correct the violation may be
expected to result in enforcement
action without further notice.
26
Warning Letters
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Criteria for issuance
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there is reason to believe prompt
corrective action will be taken
violation is clear and not ambiguous
other enforcement action taken, if
necessary
considered appropriate by District Office
Issued by District Office without review
by headquarters
27
Warning Letters
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intended to encourage voluntary
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if response is not timely or adequate:
compliance
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further action can be taken (Seizure)
without contact with company (ex-parte)
letters are public documents
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available to press (neg-pub)
28
Warning Letters
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Written response required
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Responses become public
documents
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should be carefully drafted
agreeing to corrective action is
acknowledgment of problem
FDA not required to reply to
response
29
Seizure
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Section 304 FDCA authorizes seizure of
any food that is adulterated or
misbranded when introduced into
interstate commerce or while held for
shipment in interstate commerce
Action is against the product itself, not
against company or employees
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Subject matter jurisdiction
Seized product destroyed after finding of
adulteration or misbranding by court if not
corrected
30
Seizure Process
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Magistrate issues "Arrest Warrant" for
goods
US Marshalls takes actual possessions or
places good "under seal" wherever he/she
finds them
Company must file "claim of ownership"
w/n 10 days
Matter handled as "civil action" with or w/o
jury
Notice of seizure must be published
31
Seizure
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Response to seizure action
 litigation is expensive
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could result in adverse publicity
three basic options for response
no response - product destroyed or
diverted
 file a claim and litigate the order to seize
 consent to seizure and negotiate to
recondition product
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32
Injunctive Relief
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requires that cause of problem be
corrected before product is
shipped
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issued against company or
individual
prevents violative product from
entering marketplace
requires corrective action
33
Injunctions
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Temporary Restraining Order
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Issued ex-parte for 10 days to stop
violation while government applies for
injunction
Preliminary Injunction (Gov must
show)
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Substantial likelihood of success at
trial
Threat of irrepairable harm
Harm outweighs result of injunction
34
Injunction
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Used in situations which require
immediate action to safeguard
welfare of consumers
FDA may request preliminary injunction
or temporary restraining order
temporary restraining order is fastest
way to remove product from the market
 preliminary injunction requires a hearing
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35
Injunction
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Irrepairable harm shown by:
storage under insanitary conditions
 noncompliance with labeling
requirements
 failure to follow GMPs
 product requires, but does not have
FDA approval
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36
Injunction (cont.)
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might be avoided by:
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correcting conditions that led to Warning
Letter
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correcting problems that caused seizure
action
making deliberate effort to comply with law
being alert and responsive to actions that
indicate inadvertent and unintentional
violation
37
Injunction con't
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Issued by Federal District Court
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In response to recommendations by
FDA
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FDA District Office
FDA Headquarter’s Center
FDA Office of General Counsel
U.S. Justice Department
Assistant U.S. Attorney in District Court
38
Injunctions
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Consent Decree
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Opportunity to avoid injunction trial
deficiencies must be corrected
 violative products destroyed
 FDA paid for filing cost
 FDA may impose other requirements
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Violation of injunction or consent decree
punished by contempt of court finding
39
Recall
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Firm's removal or correction of a
marketed product that FDA
considers to be in violation of the
FDCA and against which the Agency
would otherwise initiate legal action
Includes removal of product from:
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Warehouses, distribution centers, retail sales
outlets,
even homes
40
Recalls
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Recalls are voluntary. FDA has no
statutory authority to compel and recall.
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FDA may strongly encourage recall
as alternative to stronger agency
action such as seizure.
Most rapid and effective method of
removing widely distributed violative
products which are beyond control of the
recalling company from market
41
Recalls
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FDA can mandate recall of adulterated
infant formulas (1986)
FDA has published guidelines regarding
how, when and why to initiate a recall
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21CFR 7.42
42
Recalls
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3 types of product removals
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“stock recovery” - product is still under
control of manufacturer
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“market withdrawal” - product is of
lower quality than desired or "technical
violation"
“recall” - product represents potential
hazard
first step is to determine type of
removal
43
Recalls
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Consumers may need to be alerted to
potential danger
Recall should reach down to the
consumer level
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Market withdrawal will not go below
retail outlet level
44
Classes of recalls
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Class I - product will cause serious
health consequences or death
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Class II - product may cause
temporary or medically reversible
health consequences
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Class III - product not likely to cause
adverse health consequences; may be
aesthetically displeasing
45
FDA Recall strategy
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FDA will consider:
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evaluation of health hazard
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ability to identify product in marketplace
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consumer’s identification of defective product
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amount of product still in marketplace
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Recall Information
What FDA will want to know:
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identity of product
reason and date discovered
evaluation of risk
total amount of suspect product
distribution information
company’s recall communication
proposed recall procedure
name, address, phone number of
company
47
Termination of a Recall
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When all reasonable efforts have
been made to remove or correct the
product in accordance with the
recall strategy
If FDA not involve = company's decision
If FDA involved = company makes initial
determination to terminate recall and
seek FDA concurrence by submitting
documentation of effectiveness and
disposal
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Recalls
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Industry guidance:
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have a written plan and rehearse it
have a product code system that will
facilitate product removal
maintain records of product distribution
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USDA Remedies
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Most prohibitions in FDCA are also
prohibited by Federal Meat
Inspection Act (FMIA)
Standard for criminal liability is same
US v. Cattle King (1986)
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Shipment in I/C of adulterated meat
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Employees "directly involved" held liable
50
USDA Remedies
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Can seize and condemn violative meat
products
Rarely used b/c USDA has authority to
"detain" violative product for 21 days
w/o hearing
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Any uninspected meat
Adulterated but capable of being used as
food
51
USDA Remedies
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FMIA also authorizes injunctive relief
Like FDA, USDA has authority to
conduct mandatory inspections.
Unlike FDA, USDA has additional
authority to withdraw mandatory
inspection
No inspection, no distribution
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b/c shipment of uninspected meat in
I/C is?)
52
Criminal Actions
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Extensive review prior to initiation
Defendant gets Sec. 305 hearing
(notice and opportunity to be
heard prior to formal charge)
Referral to DOJ (prosecutorial
discretion)
Grand Jury
Plea Bargaining
53
Strict Criminal liability
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US v. Dotterwich 20 U.S. 277 (1943)
Standard for proving criminal
violations
Gov need not prove "knew or
intended to violate law"
Buffalo Pharmacal Company shipped
adulterated drugs in I/C
President Dotterwich alleged "knew
nothing" (not even about shipment)
54
Dotterwich (con't)
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Supreme Court (Justice Franfurter)
Offense is committed by all those
responsible for putting the product
into I/C
Mere proof of shipment is enough to
prove violation.
Any corporate officer who "stands in
responsible relation to the violative
act"
55
Responsible Relationship
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US v. Park 421 U.S. 658 (1975)
President of Acme Supermarkets
headquarters in Philadelphia
FDA found violations at Baltimore
wharehouse (insanitary conditions)
FDA send letter of notice of
conditions addressed to Park who
told Vice-President to fix
56
U.S. v Park (con't)
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Park testified VP told him problem fixed
so no wrongful act on his part
Supreme court (Justice Burger) said:
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FDCA imposes positive duty to seek out
and remedy violations and to implement
measures to insure violations do not occur.
Public has right to expect this of those who
voluntarily assume positions of
authority in business enterprises
57
Summary
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Regulatory vs. Judicial enforcement
FDA has authority to enforce prohibitions
listed in FDCA
Movement in interstate commerce
of adulterated or misbranded food
product is general jurisdictional
prerequisite
Actual movement across border not
necessary
58
Summary
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Regulatory enforcement mechanisms
include: recalls (voluntary), seizures and
injunctions
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Warning Letters and Consent decrees
being used more frequently
Penalty for violation of administrative
order is contempt of court
Justice Department has the "Big Stick" and
can file criminal actions against
responsible parties.
59
Concurrent Jurisdiction
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State enforcement agencies
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Scope of state inspector's authority differs
according to enabling legislation of each
state
State inspecting officials can exercise
their authority to seize product
Can exercise state power to assist feds
Most state laws modeled after fed
60
Conflicts of Laws
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Choice of applicable law when lawsuit
instituted against company?
Marketing product in multi-state or
national distribution chain
Traditionally: Law of the location
where the injury took place
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So far, no states have conflicting laws
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Laws can be complied with simultaneously
61
Example:
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Company organized in Delaware
Manufacturing plant in Pennsylvania
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Buys flour from Kansas
Leavenings from Minnesota
Packaging from Ohio
Product sold to New York distributor
Plaintiff purchases in Connecticut
Consumes and becomes ill on flight home
to California
62
State Enforcement
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All 50 states have food laws: "little Acts"
Traditionally, states could only enforce their
own laws against food products located in
that state
Today, NLEA gave States authority to sue
in Federal court for violations of FDCA in
their own name if:
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30 days notice to FDA
FDA has not instituted an action
FDA has not been "diligent" in pursing
63