Diketones in Electronic Cigarette Liquid

Lukas Knight filed this request with the Food and Drug Administration of the United States of America.
Tracking # 1350059-000, DOJ-AP-2016-003421
Status
Completed

Communications

From: Lukas Knight

To Whom It May Concern:

This is a request under the Freedom of Information Act. I hereby request the following records:

All records and reports regarding the safety of diketones - diacetyl, acetylacetone, and hexane-2,5-dione especially - as flavorants as well as any records of reports that specifically mention the use of diketones in juices used to produce inhaled vapours and their possible effects on the respiratory system when ingested in that way.

The requested documents will be made available to the general public, and this request is not being made for commercial purposes.

In the event that fees cannot be waived, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically, by e-mail attachment if available or CD-ROM if not.

Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 20 business days, as the statute requires.

Sincerely,

Lukas Knight

From: Food and Drug Administration

An interim response, stating the request is being processed.

From: Ticker, Douglas

Mr. Knight,

This is in response to your November 23rd, 2015 Freedom of Information Act (FOIA) request for "all records and reports regarding the safety of diketones - diacetyl, acetylacetone, and hexane-2,5-dione especially - as flavorants as well as any records of reports that specifically mention the use of diketones in juices used to produce inhaled vapours and their possible effects on the respiratory system when ingested in that way."

The Center Food Safety and Applied Nutrition (CFSAN) conducted a search and is unable to locate any records responsive to your request. Therefore we are closing our file on this case.

While we believe that an adequate search of appropriate files was conducted for the records you requested, you have a right to appeal the this determination. Your appeal should be mailed within 30 days from the date of receipt of this letter to the address below:

Deputy Chief FOIA Officer
Office of the Assistant Secretary for Public Affairs
U.S. Department of Health and Human Services
Parklawn Building, Room 19-01, 5600 Fishers Lane
Rockville, MD, 20857

Doug Ticker
Government Information Specialist
Office of Regulations, Policy and Social Science
Center for Food Safety and Applied Nutrition (CFSAN)
U.S. Food and Drug Administration
Phone Number: 301-796-5391

From: Ticker, Douglas

Mr. Knight,

I apologize. This email was sent out slightly pre-emptively. There is actually one other office still conducting a search. I will inform you of the results of that search as soon as I hear back from them. Sorry for any confusion this may have caused.

Doug Ticker
Government Information Specialist
Office of Regulations, Policy and Social Science
Center for Food Safety and Applied Nutrition (CFSAN)
U.S. Food and Drug Administration
Phone Number: 301-796-5391

From: Lukas Knight

That's fine, I appreciate your thorough search - thank you!

From: German, Jennifer

This email is related to FOIA request 2015-9732 for all records and reports regarding the safety of diketones - diacetyl, acetylacetone, and hexane-2,5-dione especially - as flavorants as well as any records of reports that specifically mention the use of diketones in juices used to produce inhaled vapours and their possible effects on the respiratory system when ingested in that way. I am processing that request.

FDA Center for Tobacco Products has begun to search for records. However, one of the offices conducting the search has a clarifying question about the requested documents. They would like to know if this request only pertains to adverse event reports or other documents as well as adverse event reports. For instance, would an email discussing a peer reviewed scientific paper on diketones - diacetyl, acetylacetone, and hexane-2,5-dione be responsive to the request? Please let us know what type of documents are responsive to the request. Then we can search for the records expeditiously.

Thanks,
Jennifer J. German
Regulatory Policy Analyst

Office of Health Communications & Education
FDA Center for Tobacco Products
Jennifer.German@FDA.hhs.gov<mailto:Jennifer.German@FDA.hhs.gov> | 301.796.3484

www.FDA.gov/Tobacco<http://www.FDA.gov/Tobacco> |@FDATobacco<https://twitter.com/FDATobacco>

[Description: Center for Tobacco Products Logo]

From: Lukas Knight

Adverse event reports and emails discussing peer reviewed publications regarding diketones would both be equally pertinent to my request and very much appreciated. Thank you for all your help!

From: German, Jennifer

Hello,
We have not begun processing this request yet. We have a huge backlog and this request is one of many in the queue. We have several 2014 requests that have not been processed yet. We will begin processing the request as soon as the request is next in the queue. I can’t give a definitive date when we will complete processing this request given the backlog.

Thanks,
Jennifer J. German
Regulatory Policy Analyst

Office of Health Communications & Education
FDA Center for Tobacco Products
Jennifer.German@FDA.hhs.gov<mailto:Jennifer.German@FDA.hhs.gov> | 301.796.3484

www.FDA.gov/Tobacco<http://www.FDA.gov/Tobacco> |@FDATobacco<https://twitter.com/FDATobacco>

[Description: Center for Tobacco Products Logo]

From: German, Jennifer

Hello,
I need to talk to you via teleconference about the scope of this request. My phone number is 301-796-3484.
This request is on hold until I can talk to you about this request. I can’t proceed with processing the request until I speak to you about it.
Thanks,
Jennifer J. German
Regulatory Policy Analyst

Office of Health Communications & Education
FDA Center for Tobacco Products
Jennifer.German@FDA.hhs.gov<mailto:Jennifer.German@FDA.hhs.gov> | 301.796.3484

www.FDA.gov/Tobacco<http://www.FDA.gov/Tobacco> |@FDATobacco<https://twitter.com/FDATobacco>

[Description: Center for Tobacco Products Logo]

From: German, Jennifer

Hello,

This is a follow up to the email that I sent to you last month. If we do not hear back from you about the scope of this request by COB Tuesday, we will lift the hold on this request. We will close the request and provide you with just the adverse experience reports that are responsive to this request.

In the alternative, if you wish to discuss the scope of the request further, please feel free to call me at 301-796-3484 before COB Tuesday. My calendar is open for the next few days and I will be available to hold a teleconference with you at your earliest convenience to discuss this request. Perhaps later this week or early next? Tuesday? Please let me know what time for the teleconference would be best for you and I will make sure to put it on my calendar.

Thanks,
Jennifer J. German
Regulatory Policy Analyst

Office of Health Communications & Education
FDA Center for Tobacco Products
Jennifer.German@FDA.hhs.gov<mailto:Jennifer.German@FDA.hhs.gov> | 301.796.3484

www.FDA.gov/Tobacco<http://www.FDA.gov/Tobacco> |@FDATobacco<https://twitter.com/FDATobacco>

[Description: Center for Tobacco Products Logo]

From: German, Jennifer

Hello,

Attached is our final response to your request. Please let me know if you have any questions.

Thanks,
Jennifer German
Regulatory Policy Analyst
Center for Tobacco Products
Office of Health Communications & Education
U.S. Food and Drug Administration
Tel: 301-796-3484
Jennifer.German@fda.hhs.gov<mailto:Jennifer.German@fda.hhs.gov>
[cid:image001.png@01D1C57E.DFA022A0]<http://www.fda.gov/>

[cid:image002.jpg@01D1C57E.DFA022A0]<https://www.facebook.com/FDA> [cid:image003.jpg@01D1C57E.DFA022A0] <https://twitter.com/fdatobacco> [cid:image004.jpg@01D1C57E.DFA022A0] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D1C57E.DFA022A0] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D1C57E.DFA022A0] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>

From: German, Jennifer

Attached is our disclaimer regarding e-cigarette safety reports.
Thanks,
Jennifer

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