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U.S. Department of Health and Human Services

About FDA

New Technologies to Assess Food and Cosmetic Safety

Description: CFSAN scientists are developing/using medium throughput biomarker assays and integrated alternative model systems to assess the safety of food and cosmetic components. It is our hope that the identification of medium throughput screening methods and alternative models will improve toxicity characterization, increase efficiency, reduce cost as well as refine, reduce or replace animal use.

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

A. Foods:

9/30/2015

On Track

i. Evaluate liquid chromatography quadripole mass spectrometer (LC/MS/MS)-based global metabolomics in cultured human hepatocyte cell lines and cultured primary human hepatocytes as a method for discovery of biomarkers of liver toxicity

9/30/2012

(9/30/2013)

Completed 9/30/2013

ii. Evaluate the effects of gender on hepatotoxicity using male- and female-derived liver cells in vitro. This includes evaluating the effect of gender specific hormones, their precursors and metabolites on potential liver toxicants on human liver cells

3/31/2013

Completed 1/26/2013

iii Evaluate the interaction of inflammation including inflammatory cytokines (large molecules that signal changes in the animal's internal environment which creates a hostile environment for an invading organism) and liver toxicants using liver cells in vitro

9/30/2013

Completed 9/30/2013

iv. Present data collected from these studies at scientific meetings and in scientific publications

9/30/2015

On Track

B. Cosmetics

9/30/2015

On Hold

i. Initiate percutaneous absorption (skin absorption) studies of nanomaterials (dendrimers) with surface modifications with and without radiolabel using diffusion cell techniques. Studies will be conducted using pig and human skin. The ability of the nanomaterial to penetrate the skin will be determined visually using laser confocal microscopy and quantitatively using liquid scintillation counting (a method used to determine how much of the material has penetrated into the skin).

5/28/2011

(5/28/2013)

(5/31/2014)

(5/31/2015)

On Hold

ii. Continue percutaneous absorption studies and analysis of dendrimers including repeat dose studies and enhanced absorption studies of model compounds

10/31/2011

(10/31/2013)

Completed 9/30/2013

iii. Continue analysis of diffusion cell studies of dendrimers, repeat dose studies and model compounds

4/30/2012

(4/30/2014)

(12/30/2014)

On Hold

iv. Complete analysis of diffusion cell studies of dendrimers, repeat dose studies and model compounds

6/30/2013

(6/30/2014)

(5/30/2015)

Not Yet Started

v. Present data collected from these studies at scientific meetings and in scientific publications

9/30/2015

Not Yet Started

Key Projects Legend

Milestone StatusDefinition
Not Yet StartedWork for specific milestone has not yet been started.
CompletedMilestone and/or overall project is completed.
On TrackMilestone - On track for completion by milestone deadline. Quarter status - Project is on track for completion based on overall milestone status.
On HoldMilestone - On hold, but deadline for completion has not passed. Quarter status - Project is on hold, based on overall milestone status.
DelayedMilestone - Delayed as it has not been completed and deadline has passed. Quarter status - Project is delayed based on overall milestone status.

Glossary

Note: The data provided on this website is produced on an ongoing basis for performance management purposes and is subject to change due to updates of preliminary estimates, corrections, or other reasons. In addition, FDA may change the type or amount of data provided on this website at any time. Information marked as "Completed" may include measures and/or key projects for which activities are ongoing but no longer tracked as part of FDA-TRACK.