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A credible dietary exposure assessment is a core component of every GRAS notification, food additive petition, and color additive petition submitted to FDA. Getting the methodology right, and the intake estimates defensible, is one of the most consequential parts of the safety case your submission needs to make. QSS prepares exposure assessments that meet CFSAN's current standards and hold up under review.
A dietary exposure assessment estimates how much of a substance consumers are likely to ingest through their diet across all food categories where it is used or proposed for use. FDA's Office of Food Additive Safety (OFAS) uses these estimates to evaluate whether a substance is safe under its intended conditions of use.
OFAS applies established methodologies including the Poundage and Dietary Intake Survey (PADI) and the Maximum Survey-Derived Daily Intake (MSDI), using national food consumption databases.
The right methodology depends on your substance, its proposed use categories, and the type of submission. QSS develops exposure assessments using the methodologies and databases OFAS relies on, so your intake estimates hold up under review.
The right methodology depends on your substance, its use levels, and the food categories involved. QSS assesses your submission type and proposed conditions of use, selects the appropriate OFAS-recognized methodology, and advises on the scope of the exposure assessment before work begins.
QSS conducts the full dietary exposure assessment using FDA-recognized databases and intake methodologies, including PADI, MSDI, and relevant national food consumption data. The assessment covers all proposed food categories and use levels and is documented to meet OFAS’s formatting and transparency expectations.
Where your submission requires exposure estimates for specific population subgroups, including infants, children, or other potentially sensitive groups, QSS develops subgroup-specific intake estimates consistent with OFAS guidance and FDA’s Redbook recommendations.
A dietary exposure assessment is most useful when it is developed alongside the safety narrative it supports. QSS integrates your exposure estimates with the broader toxicological and safety assessment in your GRAS notification, food additive petition, or color additive petition, ensuring the two are consistent and mutually reinforcing.
If OFAS raises questions about your exposure methodology or intake estimates during its review, QSS prepares your responses, provides recalculations where needed, and ensures your exposure assessment remains defensible throughout the review cycle.
Explore articles, blogs, and videos on dietary exposure assessment, FDA CFSAN requirements, and food ingredient safety submissions.
A dietary exposure assessment estimates how much of a substance a consumer is likely to ingest through their diet across all food categories where it is used. FDA’s OFAS uses these estimates to evaluate whether the substance is safe under its intended conditions of use. Without a credible exposure assessment, your GRAS notification or petition cannot demonstrate that consumer intake stays within a range that supports a reasonable certainty of no harm.
A dietary exposure assessment is required for GRAS notifications, direct food additive petitions, and color additive petitions. It is also relevant for New Dietary Ingredient (NDI) notifications for dietary supplements. The scope and methodology of the assessment vary depending on the submission type, the substance’s proposed use levels, and the food categories involved. QSS confirms what is required for your specific submission before work begins.
OFAS applies several recognized methodologies depending on the substance and submission type. The Poundage and Dietary Intake Survey (PADI) estimates intake based on industry use data. The Maximum Survey-Derived Daily Intake (MSDI) uses food consumption survey data to estimate intake at the population level. FDA’s guidance document on estimating dietary intake of substances in food provides detailed direction on how these methodologies are applied. QSS selects and applies the methodology that matches your submission type and OFAS’s current expectations.
In many cases, yes. OFAS may require or expect intake estimates for specific subgroups, including infants, young children, pregnant women, or other potentially sensitive populations, depending on the substance and its proposed uses. QSS develops subgroup-specific estimates where required and ensures they are consistent with FDA’s Redbook guidance and OFAS expectations.
The two are interdependent. The exposure assessment establishes how much of the substance a consumer ingests; the toxicological assessment establishes what level of intake is safe. Together, they form the core of the safety case in your submission. QSS develops both in an integrated way to ensure the exposure estimates and the safety narrative are consistent and support each other in the submission document.
International exposure data can be referenced as supporting context, but OFAS expects intake estimates based on U.S. food consumption data and FDA-recognized methodologies. Exposure estimates developed for EFSA or JECFA submissions use different databases and assumptions and are generally not directly transferable. QSS advises on how international data can be incorporated appropriately and develops the U.S.-specific estimates your submission requires.