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FDA clarifies when novel nitrosamines trigger supplements or annual reports
Summary
FDA staff explained that novel nitrosamines not listed in the agency tables and proposed above roughly 26.5 ng/day generally require an assessment and prior‑approval supplement, while values below conservative thresholds supported by confirmatory data may be annual‑reportable.
Industry asked about inconsistent decisions when nitrosamines not on FDA's published list are detected. An agency official explained the working framework: 26.5 ng/day is used as a conservative reference; if confirmatory data show the actual value is below conservative thresholds (for example by less than 10%) the instance may be annual‑reportable, but novel nitrosamines above the 26.5 threshold generally need a prior‑approval supplement for FDA review.
"Generally, if you're proposing greater than 26.5...we need to get an assessment of your CPC calculation or other limit that you need," an agency official said, noting that table inclusion and confirmatory data affect whether an event is reportable or requires supplemental review.
