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FDA presenter summarizes three approaches to set nitrosamine acceptable intake limits
Summary
The presenter said FDA recommends three approaches to derive acceptable intake (AI) limits for nitrosamines—carcinogenic potency characterization (CPCA), compound-specific data, or read-across to a structurally relevant surrogate—and outlined CPC scoring tied to numeric AI categories.
An FDA agency official told attendees that the agency typically relies on three approaches to determine AI limits for nitrosamines: carcinogenic potency characterization (CPCA), compound-specific data when available, or read-across from a surrogate with robust carcinogenicity data.
"FDA recommend 3 approaches to determine the AI limit for nitrosamines," the presenter stated, then described the CPC framework that assigns numeric scores for structural features (such as alpha-hydrogen activating or deactivating features) and maps them to potency categories. The presenter said AI limits correspond to categories with values from about 26.5 up to 1,500 nanograms per day depending on potency.
The official noted that the CPC-based approach is intended for nitrosamines lacking compound-specific carcinogenicity data and that applicants should justify any alternate AI limit with the supporting assays and data FDA recommends.
