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U.S. Department of Health and Human Services

About FDA

Toxic/Carcinogenic Effects of Dietary Supplements and Food Container Materials

Description: Evaluate potential toxic/carcinogenic effects resulting from exposure to dietary supplements and nanoscale-sized particles associated with food containers, food preparation surfaces, and food wraps. These studies are supported by an interagency agreement between NIEHS/NTP and FDA to support studies of mutual benefit to FDA and NIEHS/NIH.

Definition: By conducting nanomaterials research, FDA will have a better understanding of the consequences of human exposure to nanoscale materials in food preparation materials. These studies will help determine early predictors of toxicity-risk to food preparation materials.

Public Health Outcome: This research will help the FDA determine the health effects from exposure to dietary supplements and from nanoparticles associated with food preparation materials.

1. Aloe Vera Water Studies

Accomplishment:The nomination to study Aloe vera came from the National Cancer Institute, because of Aloe’s widespread use and concern that some components may cause cancer. The two-year study of a non-decolorized whole leaf extract of Aloe vera given in an animal’s drinking water found clear evidence of carcinogenic activity in male and female rodents, based on tumors of the large intestine. There was no evidence of carcinogenic activity in the rodents. These rodent studies give cause for serious concern. Some questions that need to be answered before their importance can be fully appreciated include: 1) what products are actually in the market place, 2) what are the aloin levels across a broad spectrum of products, and 3) what are the patterns of human exposure? There is not enough information currently available to know how much Aloe vera people are consuming or for how long. Consequently, further research is needed. For further information on this study and what it means to public health, please reference the NTP Report on Aloe Vera .

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

a. Complete the NCTR technical report on Aloe vera dosed water studies and submit report to NCTR Quality Assurance Unit

4/30/2010

Completed 4/30/2010

b. Submit revised NCTR technical report on Aloe vera dosed water studies to NCTR Office of Scientific Coordination for NTP report formatting

8/1/2010

Completed 8/1/2010

c. Present technical report on Aloe vera dosed water studies to NTP Technical Report Review Committee

1/1/2011

(4/5/2011)

Completed 4/5/2011

2. Aloe Vera Leaf Extract Studies

Briefing Status: ON TRACK

Prior Briefing Status: ON TRACK

Milestone DescriptionMilestone DateMilestone StatusMilestone Completion Date

a. Submit concept paper to CFSAN to evaluate the carcinogenic potential of Aloe charcoal-filtered whole leaf extract and senna

11/1/2010

Completed 6/20/2010

b. Outline preliminary protocol to TSSRC on the carcinogenic potential of Aloe charcoal-filtered whole leaf extract and senna

11/1/2010

Completed 11/16/2010

c. Obtain final approval for protocol on the carcinogenic potential of Aloe charcoal-filtered whole leaf extract and senna

1/3/2011

(4/15/2011)

Completed 5/26/2011

d. Conduct research

TBD

Not Yet Started

e. Complete the assessment of research findings

TBD

Not Yet Started

f. Complete the draft manuscript

TBD

Not Yet Started

g. Complete the peer review (NCTR and other FDA researchers) of draft manuscript

TBD

Not Yet Started

h. Obtain NCTR Center Director approval of the draft manuscript via the document tracking system

TBD

Not Yet Started

i. Submit manuscript to a scientific journal

TBD

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

NIEHS

National Institute of Environmental Health Sciences

NTP

National Toxicology Program

NIH

National Institutes of Health

CFSAN

Center for Food Safety and Applied Nutrition

TSSRC

Toxicology Study Selection and Review Committee

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.