With HACCP Program in Place, Odwalla Declines FDA Extension

A leader in the fresh juice industry in safety, Odwalla has formally declined the Food and Drug Administration's (FDA) extension to comply with its recent rulings concerning fresh juice warning labels in a letter to the agency. Odwalla, which produces all-natural, fresh-squeezed and nutritionally fortified juices and smoothies, says it has met FDA's new regulatory requirements for fresh juice safety for more than a year through its five-point plan for quality assurance, which includes a Hazard Analysis and Critical Control Point (HACCP) program.

Due to the industry's difficulty in meeting FDA's stringent new requirements, the agency gave producers until December 19 to request an extra eight months to comply. In order to preclude the need for warning labels, juice producers must validate a "5-log," or 100,000-fold, reduction of potential contamination in their juice production process. While pasteurization is one way to achieve this degree of safety, FDA has left it open to industry to develop other technologies or processes. In particular, the agency states in the Federal Register that HACCP "is the most effective long-term measure for controlling pathogens and other safety concerns related to the production and distribution of juice products."

HACCP implementation with a validated 5-log reduction has proven to be a difficult task, however, and many fresh juice companies have welcomed the FDA's extension offer. "Odwalla has learned that successful development of fresh juice HACCP takes considerable time, focused commitment and a willingness to make mistakes," said Stephen Williamson, Odwalla's Chairman and CEO.

By implementing a validated HACCP program eight months prior to the deadline, Odwalla may continue to offer its fresh juice without warning labels. "With guidance from FDA and some of the nation's leading food microbiologists, Odwalla has already validated its fresh juice HACCP program to meet the agency's new standards and would like to formally decline the extension to comply," added Williamson.

At the invitation of FDA, Odwalla recently presented its five-point plan for quality assurance to other fresh juice companies at the agency's technical workshop in Irvine, CA, on November 19. This plan includes:

1. Validated HACCP: Odwalla has fully implemented a HACCP program, which has been validated to meet and exceed FDA's safety requirements.
2. Juice Testing: Odwalla tests every batch of fresh juice for an indicator organism that serves as a guideline for purity. Odwalla also had more than 1,000 pathogen tests performed by an outside laboratory over a two-year period. Every one of the tests had negative results. Today, Odwalla uses outside laboratory testing of pathogens on a weekly basis.
3. Environmental Testing: Odwalla performs daily microbiological tests on the production environment during processing and post-sanitation and currently averages 45-50 such site tests per week.
4. Flash Pasteurization: All Odwalla juices in which the skin contacts the juice during production (pressed fruit and vegetables, including apples and carrots) are flash-pasteurized, and all fruit purees are pasteurized.
5. Independent Audits: Odwalla's safety program has been verified by an independent audit. Odwalla will continue to validate the effectiveness of its HACCP program through annual independent audits.

All of Odwalla's juices and fruit purees are pasteurized except for its 100% fresh-squeezed citrus products, which are safety validated through HACCP.

In addition to producing all-natural, fresh-squeezed and nutritionally fortified juices and smoothies, Odwalla also offers all-natural meal replacements, geothermal spring water and food bars.