December 30, 2015

TO: JPA Members

FROM: Patricia Faison

JPA Regulatory Update: FDA Withdraws Draft Acidified Foods Guidance

In September 2010, JPA notified members that the Food and Drug Administration (FDA) had published a draft guidance, " Draft Guidance for Industry: Acidified Foods," detailing the Agency's current thinking regarding the acidified foods regulation defined in 21 Code of Federal Regulations (CFR) Part 114. The draft guidance defined a number of terms (e.g., "pH that does not significantly differ" and "acid food containing small amounts of low-acid food") mentioned in the acidified foods regulations but not previously defined by the FDA. The draft guidance also contained a number of "Decision Tables" to help processors determine whether a product is covered under the acidified foods regulation or excluded. JPA submitted extensive comments to the Agency expressing concern with the provision that would subject "water-based liquids" (e.g., juice beverages containing less than 100% juice) to the acidified foods regulations.

Today, the FDA issued a Federal Register notice (80 FR 81550), available here, announcing the Agency is withdrawing the draft guidance, in part, for the following reasons:

(1) “The procedures for voluntary submission of process filings by processors of non-acidified foods are addressed by our recently issued guidance entitled ‘Submitting Form FDA 2541 (Food Canning Establishment Registration) and Forms FDA 2541d, FDA 2541e, FDA 2541f, and FDA 2541g (Food Process Filing Forms) to FDA in Electronic or Paper Format’ (80 FR 60909, October 8, 2015).” JPA members were earlier notified of FDA’s publication of these new process filing forms for acidified and low-acid canned foods. Members were also advised that the forms included categories for vegetable juice/drink.

(2) The final rule “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” published in September 2015 (as part of the FDA’s implementation of the FDA Food Safety Modernization Act (FSMA)) and companion guidance documents being developed by the FDA “should help processors in ensuring safe manufacturing, processing, and packing processes and in employing appropriate quality control procedures.”

The withdrawal is effective today.

As always, please contact me with questions or comments.

Patricia Faison

(404) 252 - 3663

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