Food Recalls and the FDA Sean M. Cheney Recall & Emergency

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Food Recalls and the FDA Sean M. Cheney Recall & Emergency

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Title: Food Recalls and the FDA Sean M. Cheney Recall & Emergency


1
Food Recallsand theFDA
  • Sean M. Cheney
  • Recall Emergency Coordinator
  • Dallas District Office/ FDA

2
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3
Agency Organization
4
FDA Regions
5
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6
What are Laws?
  • The basic enabling authority enacted by Congress
  • Food, Drug and Cosmetic Act (FDC)
  • FDA Modernization Act (FDAMA)
  • Orphan Drug Act
  • Prescription Drug User Fee Act (PDUFA)
  • Medical Device User Fee and Modernization Act
    (MDUFMA)

7
What are Regulations?
  • Implement the provisions of the law based on the
    authority provided by the law
  • The development of regulations must follow
    specific procedures that allow public notice and
    comment
  • Legally binding on industry and the agency

8
Federal Register
  • Official daily publication
  • Notices
  • Proposed Rules
  • Final Rules
  • Free online through www.gpo.gov or www.fda.gov
  • GPO subscription

9
Code of Federal Regulations
  • Title 21, Food and Drugs
  • Published yearly
  • Free online through
  • www.gpo.gov
  • www.fda.gov
  • Order through GPO at 1-866-512-1800

10
Guidance Documents...
  • ...Policy Statements and Advisory Opinions
  • Serve to provide the Agencys interpretation of
    the law and applicable regulations
  • The preamble to a regulation has the status of an
    advisory opinion
  • Are not legally binding on the public or the
    agency

11
  • Recallswhat are they (or, at least, what does
    FDA say that they are)?

12
Code of Federal Regulations
  • 21 CFR Part 7, Subpart C Recalls (Including
    Product Corrections) Guidelines on Policy,
    Procedures, and Industry Responsibility
    http//www.access.gpo.gov/nara/cfr/waisidx_04/21cf
    r7_04.html
  • ...provides guidelines for manufacturers and
    distributors to follow with respect to their
    voluntary removal or correction of a marketed
    violative products.
  • Governs FDA policy for handling recalls.

13
Recall Definition (21 CFR 7.3(g))
  • Recall means a firms removal or correction of a
    marketed product(s) 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.

14
Market Withdrawal (21 CFR 7.3(j))
  • Removal or Correction
  • Marketed Product
  • Minor or NO Violation

15
Stock Recovery (21 CFR 7.3(k))
  • Removal or Correction
  • Violation
  • No Marketing 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.

16
21 CFR Part 7
  • Recall is a voluntary action by a firm
  • 7.40 (a), Recall is a voluntary action that takes
    place because manufacturers and distributors
    carry out their responsibility to protect the
    public
  • 7.40(b), Recall may be undertaken voluntarily at
    any time by manufacturers and distributors.

17
Recall Classification
  • 7.41, FDA will perform a health hazard evaluation
    (HHE) to determine the level of hazard the
    recalled product poses.
  • Based on the HHE FDA will assign a recall
    classification, 7.3(m).

18
Recall Classification
  • 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.

19
Class I Examples
  • The direct addition of peanuts to a product that
    is not labeled or promoted to contain peanuts.
  • Other undeclared allergens tree nuts,
    dairy/casein, soy, fish, shellfish, eggs or
    sulfites.

20
Class I Examples (cont.)
  • Pathogens of concern in ready to eat foods
  • Listeria monocytogenes
  • Clostridium botulinum
  • Escherichia Coli 0157H7
  • Salmonella (all serotypes)

21
Classification
  • 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.

22
Class II Examples
  • Undeclared wheat, Yellow 5 and Yellow 6.
  • The product is packed in cans in which the
    soldered seams were found to contain lead (63). 
  • Product may contain glass particles.
  • Product contains Stenotrophomonas maltophila and
    Staphylococcus warneri

23
Classification
  • Class III is a situation in which use of, or
    exposure to, a violative product is not likely to
    cause adverse health consequences.

24
Class III Examples
  • Product is labeled to contain an allergen that
    the product actually does not contain.
  • Products are spoiled due to yeast contamination.
  • Products mislabeled as "fat free". The container
    lids are labeled as "fat free" while the plastic
    pint container cups bear the nutritional facts
    panel with the fat content.

25
7.42, Recall Strategy
  • Assess Hazard and Recall Scope
  • What is the problem? When did the problem begin
    and end?
  • Can additional lots/products be affected other
    than the lot/product analyzed and found
    adulterated
  • Ease of identifying the product. Is the product
    coded with a lot number? How many different sizes
    and different labels?
  • Degree to which the product deficiency is obvious
    to the consumer.
  • Degree to which the product remains unused in the
    market-place. What is the shelf life of the
    product?

26
7.42, Recall Strategy
  • Recall Depth
  • Class I generally to consumer/user depth via
    press release
  • Class II generally to retail depth some to
    consumer/user via press release
  • Class III generally to wholesale depth when
    problem is obvious to consumer

27
7.42, Recall Strategy
  • Public Warning/ Press Releases
  • Usually only necessary for Class I recalls.
    However, can be useful in some Class II recalls.
  • Follow FDA models as closely as possible fill
    in the blanks
  • Do not change hazard statement dont take out
    life threatening
  • Issue press release to Associated Press
  • Provide FDA with confirmation that press release
    was sent to AP
  • FDA will issue if firm will not or if firms
    press is inadequate
  • Press Releases posted on FDA website
  • NEW FDA asks that a photograph/scan of the
    recalled products label be submitted along with
    the draft of the press release for inclusion on
    the FDA website.

28
7.49, Recall Communications/ Recall Letters
  • Clearly identify the name of the product
  • Concisely explain the reason for the recall and
    the hazard involved
  • Explain that further distribution or use of any
    remaining product should cease immediately
  • Include instructions regarding what to do with
    the product.
  • When appropriate, requests that the direct
    account should conduct a sub-recall
  • Provide a means for the recipient to report back
    to the recalling firm.

29
7.42, Recall Strategy
  • Recall Effectiveness Checks
  • Conducted by the recalling firm. Performed to
    verify that all consignees have received
    notification of the recall and have taken
    appropriate action
  • If not done, the firm is not meeting its
    obligation and responsibility to the consumer.
  • Guidance Document, Methods for Conducting Recall
    Effectiveness Checks
  • Levels A (100), B (lt100 to gt10), C (10), D
    (2), E (None, 0)

30
Reporting a Recall
  • 7.46, A firm that recalls should immediately
    notify the appropriate FDA office.
  • 21 CFR Part 107, Subpart E Infant Formula
    Recalls, recalls of adulterated or misbranded
    infant formula that presents a risk to human
    health, must be reported to the FDA and the
    recall must be conducted in the manner specified
    in this part.

31
Where Do I Report?
  • District Recall Coordinator see link
    http//www.fda.gov/ora/inspect_ref/iom/iomoradir_m
    onitors.htmlrecall
  • Recall Coordinators are a wealth of knowledge.
    Recalls are their daily business. Its their job
    to ensure you do an effective recall. Use them!!

32
How/What do I Report?
  • Guidance for Industry Product Recalls,
    Including Removals and Corrections 11/03
    http//www.fda.gov/ora/compliance_ref/recalls/ggp_
    recall.htm
  • Info needed by FDA includes
  • Product (identity, size and type of containers,
    brand names, lot numbers, whether refrigerated/
    frozen/ shelf stable)
  • Lot codes
  • Amount and dates manufactured and distributed,
  • Number of and types of consignees, area of
    distribution
  • Reason for recall
  • Consignee list
  • Actual labels or clear photos of labels

33
Open Communication with FDA
  • Discuss recall strategy with FDA early in the
    process.
  • Let FDA review text of phone notifications,
    written recall notifications, press releases
    (follow models provided in FDA guidance)
  • Discuss your plan for disposition of recalled
    product with your recall coordinator.

34
FDA Responsibilities
  • Discuss and approve recall strategy including
    press releases (district/center - Office of
    Public Affairs for press)
  • Classify the recall (center)
  • Monitor the recall by reviewing firms status
    reports and conducting audit checks (district)
  • Terminate the recall (district for class II and
    III center approval needed for class I)

35
Preparation Before A Recall
  • Review available recall guidance
  • Develop a recall plan
  • Maintain manufacturing and distribution records
    in a manner to facilitate a timely and effective
    recall
  • Identify finished products with a lot number/code
  • Mock Recalls

36
Recall Info on FDAs Website
  • Click link to Recalls, Product Safety on the
    www.fda.gov home page
  • Expanded industry guidance, model press releases,
    model recall communications

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Recall Info on FDAs Website
  • Regulatory Procedures Manual, Chapter 7
    http//www.fda.gov/ora/compliance_ref/rpm/pdf/ch7.
    pdf
  • Includes model recall letters, envelopes,
    response cards, etc

41
Recall Info on FDAs Website
  • Investigations Operations Manual, Chapter 8
    http//www.fda.gov/ora/inspect_ref/iom/contents/ch
    8_toc.html
  • Methods for Conducting Recall Effectiveness
    Checks http//www.fda.gov/OHRMS/DOCKETS/DOCKETS/76
    s0006/76s-0006-rec0001-01.pdf
  • Investigations Operations Manual, Chapter 8
    http//www.fda.gov/ora/inspect_ref/iom/contents/ch
    8_toc.html
  • Methods for Conducting Recall Effectiveness
    Checks http//www.fda.gov/OHRMS/DOCKETS/DOCKETS/76
    s0006/76s-0006-rec0001-01.pdf

42
Recall Info on FDAs Website
  • 21 CFR Part 7 - Enforcement Policy for Recalls
    http//www.access.gpo.gov/nara/cfr/waisidx_00/21cf
    r7_00.html

43
Food Recall Statistics by Class5 Year
44
Contact Info
  • Sean M. Cheney
  • Recall and Emergency Coordinator
  • FDA Dallas District Office
  • 4040 N. Central Expressway, Ste. 300
  • Dallas, TX 75204
  • 214-253-5222
  • 214-253-5314 (fax)
  • sean.cheney_at_fda.hhs.gov

45
  • ANY QUESTIONS?