Guidance for Industry
Warning and Notice Statement:
Labeling of Juice Products
Small Entity Compliance Guide ( 1)
There recently have been outbreaks of foodborne illness associated with the consumption of some juice products contaminated with harmful bacteria. Beginning September 8, 1998, for apple juice and apple cider and November 5, 1998, for all other juice products, FDA is requiring labeling with a warning statement those fruit and vegetable juice products (i.e., juices and beverages containing juice) that have not been pasteurized (i.e., heat treated) or treated in another way capable of preventing, reducing, or eliminating harmful bacteria by 100,000 fold. This reduction in bacteria is referred to as "a 5-log reduction."
Products required to bear the statement must be labeled with the following 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.
Manufacturers can apply the warning statement directly on the product or, for a limited time, on signs and placards. Apple juice and apple cider manufacturers may provide the required warning statement on signs or placards in letters at least 1/4 inch in height, rather than on the labels of their products, until September 8, 1999. Manufacturers of all other juice products may provide the warning statement on signs and placards until November 5, 1999. After these dates, the warning statement must appear on the label, i.e., on the container of the products.
QUESTIONS AND ANSWERS
Question: What is the definition of "juice" for the purposes of the warning statement regulation?
Answer: For purposes of this regulation, juice means the aqueous liquid expressed or extracted from one or more fruits or vegetables (e.g., apple juice, apple cider, orange juice, and carrot juice); a puree of the edible portions of the fruit or vegetable that is used as a beverage (e.g., banana puree or peach puree); or any concentrate of such liquids or purees (e.g., grape juice concentrate or grapefruit juice concentrate).
Question: What products are required to bear the warning statement?
Answer: Any juice or beverage containing juice (i.e., any "juice product") that has not been processed in a manner capable of achieving at least a 5-log reduction in the pertinent microorganism (i.e., any "untreated juice product") for the shelf life of the product when stored under normal and moderate abuse conditions must bear the warning statement.
Question: If a juice product is not 100 percent juice but contains a mixture of juice and other ingredients, is the finished product required to have the warning statement?
Answer: Juice that has not been treated must bear the warning statement. If the finished beverage is treated, the individual juice ingredients would not have to be treated. Similarly, if each individual juice ingredient has been treated the finished beverage need not be treated.
Question: Must untreated juice products that are to be used as ingredients bear the warning statement?
Answer: If the juice ingredient is not for distribution to retail consumers and is used solely in the manufacture of other foods, or is to be labeled, or repackaged before sale to retail consumers, it does not have to bear the warning statement provided that the lack of processing to achieve the 5-log reduction is disclosed in documents (e.g. invoices, bills of lading) that accompany the ingredient.
Question: Are untreated juice products that are sold in retail establishments required to bear the warning statement?
Answer: If untreated juice products are sold in package form, they are required to bear the warning statement. However, untreated juice products sold in retail establishments, i.e., restaurants, delis, some grocery stores, and roadside stands, that are intended for immediate consumption and are not pre-packaged do not require warning statements.
Question: What juice products are not required to bear a warning statement?
Answer: Packaged juice products that have been processed in a manner to achieve, at a minimum, a 5-log reduction in the pertinent microorganism. Heat pasteurization is one process that will achieve a 5-log reduction.
Question: If a juice processor has strong GMP's and a strong HACCP system in place, does he have to place a warning statement on his juice products?
Answer: The warning label regulation specifies that the juice product must be processed in a manner to achieve a 5-log reduction. Therefore, only if the system in place achieves a 5-log reduction are the juice products exempted from the warning statement requirement.
Question: Are products other than beverages that contain juice required to bear the warning statement? For example, is a sherbet containing a fruit puree that has not been processed to achieve the 5-log reduction required to bear the statement?
Answer: No. The regulation applies only to juices and beverages containing juice. A fruit puree is included in the definition of juice because it may be used in beverages. However, if sherbet contains the puree, even if the puree is not processed to achieve a 5-log reduction, the sherbet is not required to bear the warning statement because it is not a beverage or a juice.
Question: Are citrus oils required to bear the warning statement?
Answer: No. Citrus oils do not fit the definition of juice because they are not aqueous liquids.
THE 5-LOG REDUCTION
Question: What is a 5-log reduction?
Answer: A 5-log reduction means a reduction in the number of microorganisms by 100,000-fold. For example, if a juice product contained 100,000 pertinent microorganisms, a 5-log reduction would reduce the number of pertinent microorganisms to 1.
Question: How does a juice manufacturer achieve a 5-log reduction without pasteurizing the product?
Answer: A manufacturer can achieve a 5-log reduction by using control measures that have been shown to be effective in reducing the number of microorganisms. A processor can use one control measure that has been shown to reduce the pertinent microorganism by at least 100,000-fold (e.g., pasteurization), or a combination of control measures that have a cumulative effect of a 100,000-fold reduction.
Question: What steps in the processing of juice may a manufacturer consider in determining control measures to achieve a 5-log reduction?
Answer: The control measures used to achieve a 5-log reduction may include any measure at the farming, harvesting, or processing phases over which the processor has control and which are effective in reducing the number of pertinent microorganisms.
Question: How can a manufacturer determine whether a process achieves a 5-log reduction?
Answer: A processor can conduct its own studies to validate the effectiveness of its process or rely upon scientific studies conducted by others (e.g., researchers, states, etc.). Validation studies may include (1) tests of the control measure with a known level of the pertinent microorganism in a controlled experimental setting which is similar to a production setting, or (2) tests with a surrogate microorganism in an experimental or process setting. Manufacturers of equipment or sanitizers that can be used to control harmful microorganisms may test the control measure they are recommending and supply the validation information to the processor.
Question: If I have information from validation studies done by others (e.g., researchers, states, etc.), do I have to do anything else to show that my process is validated?
Answer: Yes. A processor must show that the validated control measure is being used in the same manner as it was used in the validation study. For example, any machinery should be used in the same manner or any sanitizer at the same concentration as used in the validation study.
Question: What does "pertinent microorganism" mean?
Answer: The pertinent microorganism is the most resistant (i.e., most resistant to being killed by the specific treatment under consideration) foodborne pathogenic (i.e., illness-causing) microorganism that is reasonably likely to occur in a particular juice. Pathogenic microorganisms can be introduced into juice both within and outside the processing plant environment, including before, during, and after harvesting. A pathogenic microorganism that is likely to occur in a juice is one that, based on the evidence provided by experience, illness data, scientific reports, and other information, has a reasonable possibility of occurring in the particular juice if appropriate controls to protect against its occurrence are not put in place.
Question: What does "surrogate microorganism" mean?
Answer: A surrogate microorganism is any non-pathogenic microorganism that has acid-tolerance, heat resistance, or other relevant characteristics similar to pertinent microorganisms. Food-grade lactic acid bacteria that have GRAS (generally recognized as safe) status are a possible option if their characteristics are similar to the pertinent microorganisms.
Question: What are some examples of pertinent microorganisms?
Answer: For many juice manufacturers, the most pertinent microorganism will be E. coli O157:H7 or Listeria monocytogenes. E. coli O157:H7 is known to be unusually acid resistant and L. monocytogenes is relatively heat resistant. Other microorganisms may be pertinent if they are known to be reasonably likely to occur in a particular juice product or process.
Question: What is the required warning statement for packaged juice products that have not been pasteurized or otherwise processed to prevent, reduce, or eliminate pathogenic microorganisms that may be present?
Answer: 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.
Question: Where must the warning statement be placed on the label?
Answer: The statement must appear either on the information panel (the label panel immediately to the right of the principal display panel) or on the principal display panel (that part of the label most likely to be seen by the consumer at the time of purchase, generally the front of the package).
Question: How should the warning statement appear on a label?
Answer: The statement must appear on the label prominently, conspicuously, and must appear in a minimum type size of one-sixteenth inch. The statement must appear in a box set off by hairlines. The word "warning" must appear in bold capital letters. For example:
WARNING: This product has not been pasteurized and, therefore, may contain harmful bacteria that may cause serious illness in children, the elderly, and persons with weakened immune systems.
Question: Can manufacturers use signs or placards instead of changing their labels?
Answer: Yes temporarily. Manufacturers may provide the warning statement on signs or placards, until September 8, 1999, for apple juice and apple cider and until November 5, 1999, for all other juices.
Question: How should the warning statement appear on signs or placards?
Answer: The statement should appear prominently and conspicuously in letters that are legible in a minimum type size of one-fourth inch.
Question: Where must signs or placard be placed?
Answer: The sign or placard must be placed at the point of purchase of the juice product. Point of purchase means at the place where the product is displayed, e.g, on the outside of the refrigerated case or on a shelf inside the case.
Question: Must the warning statement on signs be printed in professionally set type?
Answer: The regulation does not address how the sign must be printed. Therefore, the sign can be done by any means, including written by hand, as long as the statement is legible and the letters are at least one-fourth inch in height.
Question: When must warning statements appear on covered products?
Answer: The warning statement must be available to consumers at point of purchase by September 8, 1998, for apple juice and apple cider, and by November 5, 1998, for other juice products. The warning statement may appear either on the labels of covered products or on signs and placards displayed with the products until September 8, 1999 for apple juice and apple cider, and until November 5, 1999, for other juice products. After these dates, the warning statement must appear on the labels of the packaged products.
Question: Is it the manufacturer or retailer who is responsible for providing the signs or placards?
Answer: Both share responsibility. The firm identified as the manufacturer or distributor of the product is responsible for producing the label. A firm may decide to provide signs instead of changing their labels to add the warning statement. If a firm decides not to use the label but to provide a sign, the retailer must display the sign with the product because failing to do so would constitute misbranding of the product, which is a violation of the Federal Food, Drug, and Cosmetic Act.
Question: How will FDA determine whether juice that is sold after the effective dates of the rule is properly labeled?
Answer: FDA may conduct inspections at juice firms that do not provide warning labels or signs and that do not pasteurize. FDA would identify the control measures that are used to reduce pathogens and review any scientific data that the firms provide to show that their process provides a 5-log reduction and, therefore, does not require the warning statement.
Question: Can a juice product that has been heat treated to pasteurize the product be labeled "fresh?"
Answer: No. The term "fresh" implies that a food is raw and unprocessed. Juice products that have been pasteurized are processed and, therefore, can not be labeled "fresh."
Question: If juice products, themselves, have been treated to achieve the 5-log reduction in ways other than heat pasteurization (e.g., high pressure treatment, sodium benzoate etc.), can they be labeled "fresh?"
Answer: No. Juice products that have been preserved or otherwise processed are not unprocessed and, therefore, cannot be labeled "fresh."
Question: FDA encouraged voluntary warning label statement in a Federal Register notice in 1997. Must a manufacturer who uses a warning statement on a juice product that has different wording than the statement in the regulation have to change the labels?
Answer: A manufacturer may continue to label their products using the advice provided in FDA's August 28, 1997 notice until the label inventory is depleted. Any applicable labels printed after July 7, 1998 must use the exact warning statement as noted above in #20.
- The Food and Drug Administration (FDA) has prepared this guide in accordance with section 212 of the Small Business Regulatory Fairness Act (P.L. 104-121). This guidance document restates in plain language the legal requirements set forth in the current regulation for the labeling of juice products that have not been processed to prevent, reduce, or eliminate harmful bacteria. Any statement in this guidance document that goes beyond merely restating the applicable legal requirements represents the agency's current thinking on this subject. The regulation is binding and has the force and effect of law; however, this guidance document does not, itself, create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both.
Additional copies are available from:
Office of Food Labeling (HFS-150)
Food and Drug Administration
200 C Street SW
Washington, DC 20204