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Monday, November 2, 2015

Juice Processor Ordered to Cease Operations for Lack of Compliance

An Idaho juice processor was ordered to cease production after not complying  with FDA regulations.  The juice processor was not heat pasteurizing, and according to juice regulations, there must be validated reduction steps in place.  Normally, juice processors use heat pasteurization to accomplish this.  It is unclear what, if anything, this processor was doing.

FDA News Release
http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm470328.htm
FDA orders juice manufacturer to cease operations
For Immediate Release
October 30, 2015
Release

The U.S. Food and Drug Administration (FDA) has ordered Sun Valley Juice Company of Ketchum, Idaho, to stop receiving, processing, preparing, packing, holding, and distributing juice until the agency determines that the company is in compliance with laws and regulations applicable to producing food that is safe.

Sun Valley Juice Company has received a letter ordering it to cease all operations, and confirm within five days that it has complied with the letter. The company complied with those demands of the letter.

The FDA has made several attempts to help the company comply with the applicable regulations before seeking the shutdown. In 2006, a federal judge signed a court-ordered agreement, called a consent decree, between the FDA and Sun Valley Juice Company, in which the company agreed, among other things, to establish and implement a hazard prevention plan. However, FDA investigators have repeatedly found the company out of compliance with the Federal Food, Drug and Cosmetic Act and the terms of the consent decree.

“When a company repeatedly disobeys food safety laws and regulations, and does not stick to a court-ordered agreement designed to protect public health, the FDA must use the full power of the courts to protect consumers,” said Melinda K. Plaisier, the FDA’s associate commissioner for regulatory affairs.

Because Sun Valley Juice Company does not pasteurize its juice, a process known to kill bacteria that could cause illness such as E. coli, the company must take other steps to prevent potentially harmful bacteria from contaminating its juice. The consent decree and subsequent inspections were intended to ensure that the company was taking these necessary steps designed to protect human health.

The company can resume operations only once the FDA is confident it can abide by the appropriate laws and regulations.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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