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September 1998

FDA requires warning labels on unpasteurized cider

WEST LAFAYETTE, Ind. -- They're not just found on cigarettes and alcoholic beverages anymore. Now, apple cider has to carry a warning label, too.

"It's official," said Peter Hirst, assistant professor of horticulture at Purdue University. "Cider made this year must have warning labels, unless the cider is pasteurized."

The Food and Drug Administration is requiring warning labels on all apple cider sold to the public, unless the cider has been processed to achieve a 100,000 fold reduction in the number of harmful microbes that may be present. "Ninety-eight percent of all fruit juice sold in this country is already pasteurized," Hirst said.

Cider produced at the Purdue Horticulture Farm and sold in the Lafayette area is not pasteurized, so it will have to carry the warning.

The FDA decided to require warning labels on unpasteurized juice after a number of outbreaks of illnesses caused by the bacterium E. Coli in fruit juice. In 1996, an outbreak in the western United States and Canada caused by unpasteurized apple cider killed one child and sickened 66 people. The FDA estimates that unpasteurized fruit juice sickens 16,000 to 48,000 people each year.

Hirst has compiled a list of highlights of the FDA's 54-page ruling on warning labels:

  • Anyone who sells apple cider to the public must use the new labels.

"The rule on warning labels applies to everyone who sells cider, regardless of the amount they produce," Hirst said.

According to Hirst, if the apple cider being produced is sold to a manufacturer to be used in the production of another product, warning labels are not required. However, the fact that the cider is not pasteurized must be stated in documents accompanying the cider.

Unpackaged cider sold for immediate consumption on the premises -- for example, at a cider bar or at a festival -- does not require a warning label.

  • The warning label must contain specific language.

First, the word "warning" is to be set in bold type, and the warning should read: "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."

Pasteurized cider does not have to carry a warning label. Hirst cautioned, though, that if the cider is pasteurized, describing it as "fresh" is a violation of FDA regulations.

According to Hirst, the FDA decided to use the word "pasteurized" in the label even though other technologies may be used in the future, such as irradiation, to remove microbes. "The word was chosen because the FDA felt that it was something that the public could understand," he said.

  • The warning label does not have to be on the container of cider itself.

For this year only, the warning may be placed on a sign on the cider display or case where the cider is sold. If a sign is used instead of a label, the type size can not be less than one-fourth inch tall.

  • Warning labels should be placed on the main label on the container.

If warning labels are placed on cider jugs, they must appear on the principal display panel or the information panel on the cider container, Hirst said, and they must be large enough to, in the FDA's words, "be read and understood by the ordinary individual under customary conditions of use." The warning should be set off from the rest of the label by placing a border around it.

  • It is the responsibility of the producer, the wholesaler, and the retail outlet -- all of them -- to make sure that the cider is properly labeled.

According to the FDA statement, it is the "principal responsibility" of the producer to make sure that the cider is properly labeled. However, the FDA statement goes on to say "... retailers and wholesalers also have legal responsibility to ensure that products they sell are properly labeled."

  • This is not the end of the apple cider rules.

The FDA soon will enforce a new rule requiring what the FDA terms Hazard Analysis and Critical Control Point, or HACCP. "This is basically a food safety procedure that seeks to identify any point in a process where a hazard can occur," Hirst said. "Then the producer is to put measures into place to address the potential hazard."

The FDA's rules regarding HACCP are not yet final and will not be in place for the coming cider season. Once the HACCP rule is in place, large apple cider producers will have a year to implement a plan, small businesses will have two years, and very small businesses will have three years. "The way it looks now is that cider makers who produce fewer than 40,000 gallons per year will be exempt from the HACCP rule," Hirst said. "We expect the final rule from the FDA in the next few months, but this won't impact producers for this season."

Source: Peter Hirst, (765) 494-1323; hirst@hort.purdue.edu

Writer: Steve Tally, (765) 494-9809; tally@aes.purdue.edu;
https://www.agcom.purdue.edu/AgCom/homepages/tally/

Purdue News Service: (765) 494-2096; e-mail, purduenews@purdue.edu


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