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Presenter Lynn lists common deficiencies: weak controls, improper justifications, and filing errors
Summary
Lynn told reviewers often find control strategies that rely solely on release testing, inadequate justification for exceeding AI limits (FDA rejects lifetime-average or foreign-regulator reliance), and incorrect filing categories for interim-limit releases.
Lynn said reviewers frequently see control strategies that “solely based on the release testing result without addressing the formation mechanism” and lacking justification for effectiveness and sustainability across product lifetimes. She emphasized FDA’s expectation is to prevent nitrosamine formation, not just to detect it in finished product.
She listed justifications FDA does not accept for exceeding recommended AI limits: a lifetime-average exposure approach (transcript: "lisonbee lifetime approach"), sole reliance on other agencies’ recommended limits such as EMA or Health Canada, and using an interim limit to justify a permanent product specification. Lynn also flagged frequent incorrect filing categories, and reiterated that progress updates with supporting data are required when interim limits are used.
