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FDA: antioxidant use to mitigate nitrosamine formation is "fit for purpose"; test per product
Summary
FDA staff said antioxidant mitigation (examples included vitamin C and vitamin E) must be evaluated product‑by‑product during method development because some antioxidants work in particular products or lifecycles while others do not.
An industry attendee identified antioxidant addition—vitamin C and vitamin E among those mentioned on slides—as a mitigation strategy and asked whether FDA recommends specific antioxidants.
An agency representative said antioxidant choice is 'fit for purpose' and must be demonstrated in method development: "We tried, vitamin c. We tried, the other antioxidant. Some of them works. Some of them doesn't work. So you need to do your method development initially...you need to test them and see because sometime, they may work initially, but over life cycle, they may not." The speaker noted FDA has published a number of antioxidants that can be used as references.
