Food%20and%20Drug%20Administration

1
Food and Drug Administration

• Juice Warning Statement

2
Juice Warning Statement

• Final Rule -
• Published July 8, 1998 - 63 FR 37030
• Effective Date
• September 8, 1998 for Apple juice/cider
• November 5, 1998 for all other juices

3
Juice Warning Statement

• Final Rule -
• Requires that fruit and vegetable juice products
  that have not been pasteurized or otherwise
  processed to achieve a 5-log reduction bear a
  warning statement.

4
Juice Warning Statement

• Juice means -
• The aqueous liquid expressed or extracted from
  one or more fruits or vegetables
• A puree of the edible portions of the fruit or
  vegetable that is used as a beverage
• Any concentrate of such liquids or purees
  

5
Juice Warning Statement

• What products must bear the warning statement?
• Any juice or beverage containing juice that has
  not been processed to achieve at least a 5-log
  reduction in the pertinent microorganism for the
  shelf life of the product when stored under
  normal and moderate abuse conditions.

6
Juice Warning Statement

• 5-log Reduction -
• Reduces the number of microorganisms by
  100,000-fold
• Can be accomplished by a single control measure
  such as pasteurization
• Can be accomplished by a combination of control
  measures that have a cumulative effect of
  100,000-fold reduction

7
Juice Warning Statement

• Control Measures
• Discarding blemished, bruised or broken
  fruit/vegetable
• Culling and washing fruit/vegetable
• Pasteurization
• UV light
• Ultra High Pressure
• Electromagnetic Pulse

8
Juice Warning Statement

• Pertinent Microorganism
• Most resistant foodborne illness-causing bacteria
  that is reasonably likely to occur in the
  particular juice
• Examples
• E. coli 0157H7
• L. monocytogenes

9
Juice Warning Statement

• What products are exempt from the warning
  statement?
• Untreated juice products sold in retail stores,
  intended for immediate consumption, and that are
  not pre-packaged -
• e.g., products sold by the glass in
  restaurants

10
Juice Warning Statement

• Juice ingredients that are to be used solely in
  the manufacturer of other foods, relabeled, or
  repackaged before sale to retail consumers need
  not bear the warning statement on the product
  label provided the information is disclosed in
  documents accompanying the product, e.g.,
  invoices, bills of lading.

11
Juice Warning Statement

• Label Statement -
• WARNING This product has not been
  pasteurized and, therefore, may contain harmful
  bacteria that can cause serious illness in
  children, the elderly, and persons with weakened
  immune systems.

12
Juice Warning Statement

• Placement and Prominence of Warning Statement on
  the Label -
• Information panel or
• Principal display panel
• Set of in a box with the use of hairlines
• In type size no less than one-sixteenth inch
• WARNING in bold capital letters

13
Juice Warning Statement

• Placement and Prominence of Warning Statement in
  Labeling -
• On sign, placard, counter card, etc. at point
  where juice product is displayed
• In type size no less than one-fourth inch

14
Juice Warning Statement

• The Warning Statement may appear in labeling
  until -
• September 8, 1999 for Apple juice/cider
• November 5, 1999 for all other juices

15
Juice Warning Statement

• Who is responsible for providing the signs,
  placards, or counter cards?
• The manufacturer or distributor is responsible
  for producing the label
• The retailer is responsible for displaying the
  label