Juul FDA communications

Louise Matsakis filed this request with the Food and Drug Administration of the United States of America.
Tracking #

FDA1959879

Status
Rejected

Communications

From: Louise Matsakis

To Whom It May Concern:

Pursuant to the Freedom of Information Act, I hereby request the following records:

1. All communications between Ploom Inc. between January 1, 2009 and December 31, 2014.

2. All communications between Pax Labs Inc. and the Food and Drug Administration between January 1, 2015 and December 31, 2016.

3. All internal communications about Juul from January 1, 2015 and December 31, 2016.

4. All emails between Scott Gottlieb, commissioner of the FDA or Ned Sharpless, acting commissioner of the FDA and representatives of Altria Group Inc. and/or Juul Labs, for the period from September 1st 2018, to October 18, 2019.

5. Any communications between Altria and/or Philip Morris International, and the FDA regarding IQOS between May 5, 2017 and April 30, 2019.

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 there are fees, 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 days.

Sincerely,

Sara Harrison

From: Food and Drug Administration

*** This is an automated message. Please do not reply to this email. ***
Reference: FDA1959879
Dear Requester,
This is to confirm that you submitted a request for record(s) from the Food and Drug Administration
pursuant to the Freedom of Information Act.
FOIA staff will review your request to determine whether it has sufficient information to be processed;
if so, you will receive another email as a formal acknowledgement of your request, with a control number for your request.
If your request is not sufficiently described,
or if there are any other deficiencies with your submission, FOIA staff will contact you via telephone or email.

From: Food and Drug Administration

Note: Do NOT reply directly to this E-mail

Sara Harrison Sara Harrison

Re: Confirmation # FDA1959879
In Reply refer to: 2019-10520

The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:

1. All communications between Ploom Inc. between January 1, 2009 and December 31, 2014. etc

Original Subject: To Whom It May Concern: Pursuant to the Freedom of Information Act, I hereby request the following records: 1. All communications between Ploom Inc. between January 1, 2009 and December 31, 2014. 2. All communications between Pax Labs Inc. and the Food and Drug Administration between January 1, 2015 and December 31, 2016. 3. All internal communications about Juul from January 1, 2015 and December 31, 2016. 4. All emails between Scott Gottlieb, commissioner of the FDA or Ned Sharpless, actin...

We will respond as soon as possible and may charge you a fee for processing your request.
If your informational needs change, and you no longer need the requested records, please contact us to cancel your request,
as charges may be incurred once processing of your request has begun. For more information on processing fees, please see http://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm.
If you have any questions about your request, please call Sarah B. Kotler, Director, Division Of Freedom Of Information at (301) 796-8976 or write to us at: (http://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm)

Division of Freedom of Information, U.S. Food and Drug Administration
5630 Fishers Lane, Room 1035
Rockville, MD 20857
Fax:(301)827-9267

You also have the right to seek dispute resolution services from:

FDA FOIA Public Liaison
Office of the Executive Secretariat
5630 Fishers Lane, Room 1050
Rockville, MD 20857

E-Mail: FDAFOIA@fda.hhs.gov

and/or:

Office of Government Information Services
National Archives and Administration
8601 Adelphi Road ? OGIS
College Park, MD 20740-6001

Telephone: 202-741-5770
Toll-Free: 1-877-684-6448
E-mail: ogis@nara.gov
Fax: 202-741-5769

From: Food and Drug Administration

Dear Requester,

FDA received your request for:

1. All communications between Ploom Inc. between January 1, 2009 and December 31, 2014. 2. All communications between Pax Labs Inc. and the Food and Drug Administration between January 1, 2015 and December 31, 2016. 3. All internal communications about Juul from January 1, 2015 and December 31, 2016. 4. All emails between Scott Gottlieb, commissioner of the FDA or Ned Sharpless, acting commissioner of the FDA and representatives of Altria Group Inc. and/or Juul Labs, for the period from September 1st 2018, to October 18, 2019. 5. Any communications between Altria and/or Philip Morris International, and the FDA regarding IQOS between May 5, 2017 and April 30, 2019.

In order to process your FOIA request, we will need to know what products this involves, and the FDA employees or offices that are reasonably likely to have responsive records. FDA does not conduct agency-wide FOIA searches. If this request is limited to Dr. Gottlieb and Dr. Sharpless, please clarify that in your submitted request.

Please contact me if you have questions about your request. You may also contact the FDA FOIA Public Liaison for assistance at: Office of the Executive Secretariat, US Food & Drug Administration, 5630 Fishers Lane, Room 1050, Rockville, MD 20857, E-mail: FDAFOIA@fda.hhs.gov<mailto:FDAFOIA@fda.hhs.gov>.

Sincerely,

Sarah B. Kotler, J.D.
Director, Division of Freedom of Information
US FDA
301-796-8976

From: Louise Matsakis

Hi,

I am refiling my FOIA request with revised parameters. Please let me know if there is a different way I should be submitting the revised request.

To Whom It May Concern:

Pursuant to the Freedom of Information Act, I hereby request the following records:

1. All communications between Ploom Inc. and the Food and Drug Administration Center for Tobacco Products between January 1, 2009 and December 31, 2014.

2. All communications between Pax Labs Inc. and the Food and Drug Administration Center for Tobacco Products between January 1, 2015 and December 31, 2016.

3. All internal communications within the Food and Drug Administration Center for Tobacco Products about Juul from January 1, 2015 and December 31, 2016.

4. All emails between Scott Gottlieb, commissioner of the FDA or Ned Sharpless, acting commissioner of the FDA and representatives of Altria Group Inc. and/or Juul Labs, for the period from September 1st 2018, to October 18, 2019.

5. Any communications between Altria and/or Philip Morris International, and the FDA Center for Tobacco Products regarding IQOS between May 5, 2017 and April 30, 2019.

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 there are fees, 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 days.

Sincerely,

Sara Harrison

From: Food and Drug Administration

An interim response, stating the request is being processed.

From: Food and Drug Administration

Good Afternoon Ms. Harrison,

I am the FOIA Specialist that's been reassigned to process your Freedom of Information Act (FOIA) request to the U.S. Food and Drug Administration (FDA), Center for Tobacco Products (CTP).

I'd also like to apologize for the delay in processing your request, you request is important to us. Your request will be placed in the que based on the date of your request.

After reviewing your request, can you clarify some parts of your request? In addition to the clarification of the request, can you provide the maximum amount you would be willing to pay for the request please?

For numbers 1-3 below, can you clarify which office(s), or person(s) you are seeking communications from and anything specific within these communications you are seeking?

For number 5, can you specify what communications you are seeking, (i.e.: applications submissions, meeting requests).

1. All communications between Ploom Inc. and the Food and Drug Administration
Center for Tobacco Products between January 1, 2009 and December 31, 2014.

2. All communications between Pax Labs Inc. and the Food and Drug Administration
Center for Tobacco Products between January 1, 2015 and December 31, 2016.

3. All internal communications within the Food and Drug Administration Center for
Tobacco Products about Juul from January 1, 2015 and December 31, 2016.

4. All emails between Scott Gottlieb, commissioner of the FDA or Ned Sharpless,
acting commissioner of the FDA and representatives of Altria Group Inc. and/or Juul
Labs, for the period from September 1st 2018, to October 18, 2019.

5. Any communications between Altria and/or Philip Morris International, and the
FDA Center for Tobacco Products regarding IQOS between May 5, 2017 and April 30,
2019.

Should you have any questions in the interim please do not hesitate to contact me directly.

Thank you,

Tewodros "Ted" Makonnen
Government Information Specialist

Center for Tobacco Products
Office of Health Communications & Education
FDA Center for Tobacco Products
240-402-8245
Tewodros.Makonnen@FDA.hhs.gov<mailto:Tewodros.Makonnen@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: Food and Drug Administration

Hello Ms. Harrison,

I'm following back on a previous email I sent regarding your case.

Can you assist me with performing a better search for records by responding to my questions below please.

Thanks in advance,

Tewodros "Ted" Makonnen
Government Information Specialist

Center for Tobacco Products
Office of Health Communications & Education
FDA Center for Tobacco Products
240-402-8245
Tewodros.Makonnen@FDA.hhs.gov<mailto:Tewodros.Makonnen@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>

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From: Food and Drug Administration

Ms. Harrison,

I'm reaching out to see if you can provide any update to the questions I sent to you below.

Regards,

Tewodros "Ted" Makonnen
Government Information Specialist

Center for Tobacco Products
Office of Health Communications & Education
FDA Center for Tobacco Products
240-402-8245
Tewodros.Makonnen@FDA.hhs.gov<mailto:Tewodros.Makonnen@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>

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From: Food and Drug Administration

Hi Ms. Harrison.

Please see the attached letter regarding your case.

Regards,

Tewodros "Ted" Makonnen
Government Information Specialist

Center for Tobacco Products
Office of Health Communications & Education
FDA Center for Tobacco Products
240-402-8245
Tewodros.Makonnen@FDA.hhs.gov<mailto:Tewodros.Makonnen@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>

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From: Food and Drug Administration

Hello Ms. Harrison,

This email is to inform you that your FOIA request has been closed due to no response received from our Still Interested Letter dated, 4/17/2020.

If you have any questions, please contact me via email or telephone.

Regards,

Tewodros "Ted" Makonnen
Government Information Specialist

Center for Tobacco Products
Office of Health Communications & Education
FDA Center for Tobacco Products
240-402-8245
Tewodros.Makonnen@FDA.hhs.gov<mailto:Tewodros.Makonnen@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>

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