For acidified foods (pH of 4.6 or below, and a water activity greater than 0.85), Expert teams include assistance in filing required FDA forms, process consultation, Process Authority Letters, and scientific studies to verify process performance.
According to the FDA, an acidified food is defined as “a low acid food with added acid or acid food(s) to obtain a pH of 4.6 or below, and a water activity greater than 0.85.” While acidified products have an outstanding safety record, recent outbreaks have shown that a number of pathogens can survive for extended periods. The Food and Drug Administration (FDA) now requires manufacturers of these products to register their facility and file scheduled processes for their products with the agency in accordance with 21 CFR 108 and 114. Last month, the FDA issued a draft guidance outlining proposed changes to procedures utilized by acidified food manufacturers for submitting process information. Support services provided by ConnectFood review teams include assistance in filing required FDA forms, process consultation, Process Authority Letters, and scientific studies to verify process performance. Personal consultation on filing the required processing forms is offered upon request. Process consultation can be conducted via telephone or during an on-site visit. ConnectFood Review Teams are qualified to issue a Process Authority Letter, which assesses submitted production process and formulation details, supplemented in some cases with literature review and other scientific substantiation. For the acidified foods requiring a scientific study, such as a challenge or preservative efficacy study, to verify log reduction or organism inactivation, the ConnectFood Review Teams have the needed expertise and tools at their fingertips.
Click here to view an example of a process authority letter.
Here is the FDA Guide to Inspections of Low Acid Canned Food