Impulsaria LLC investigation
Tracking # |
2022-1735 FDA2281596 |
Submitted | Feb. 25, 2022 |
Due | May 16, 2022 |
Est. Completion | March 31, 2022 |
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Communications
From: Matt Hongoltz-Hetling
To Whom It May Concern:
Pursuant to the Freedom of Information Act, I hereby request the following records:
-- All documents that were generated as part of the investigation of and enforcement against Erb Avore (of Grand Rapids, Michigan) and/or his companies Impulsaria LLC, a Nevada company & Impulsaria LLC, a Michigan company, with regards to a sexual enhancement dietary supplement sometimes marketed as Stiff Nights.
-- All documents that were generated as part of the investigation of and enforcement against NovaCare LLC, of Utah with regards to a sexual enhancement dietary supplement sometimes marketed by the aforementioned Erb Avore as Stiff Nights.
-- Copies of all complaints made by members of the public against Erb Avore, Impulsaria, NovaCare, or the products Stiff Nights, Stiff Days and Aziffa.
This is a resubmission of this request, after addressing the FDA's initial reasons for declining ("indicate the location of these companies and the product area").
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 business days, as the statute requires.
Sincerely,
Matt Hongoltz-Hetling
From: Food and Drug Administration
*** This is an automated message. Please do not reply to this email. ***
Reference: FDA2281596
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
Control number: 2022-1735
Please find the attached acknowledgement regarding your FOIA request. Note: Do NOT reply directly to this E-mail
From: Food and Drug Administration
Hello,
I have received your FOIA Request 2022-1735 for:
All documents that were generated as part of the investigation of and enforcement against Erb Avore (of Grand Rapids, Michigan) and/or his companies Impulsaria LLC, a Nevada company & Impulsaria LLC, a Michigan company, with regards to a sexual enhancement dietary supplement sometimes marketed as Stiff Nights. -
All documents that were generated as part of the investigation of and enforcement against NovaCare LLC, of Utah with regards to a sexual enhancement dietary supplement sometimes marketed by the aforementioned Erb Avore as Stiff Nights. -
Copies of all complaints made by members of the public against Erb Avore, Impulsaria, NovaCare, or the products Stiff Nights, Stiff Days and Aziffa.
I have begun my search for responsive records and have clocked 45 minutes of search time thus far ($37.50-search time, $5.75 admin fee - EST. TOTAL $43.25 so far). Your request stated that you would like to be informed of any incurred charges prior to filling the request.
I anticipate another hour of search unless you would like to provide a timeframe for the documents you are seeking to narrow my search.
In lieu of a continued search, and simple search fee of $11.50, I can provide previously released records for Impulsaria and Novacare (NKA Biovation Labs) to include:
NovaCare, LLC, Murray UT FDA483 issued 4/10/2017
NovaCare, LLC, Murray UT FDA483 issued 3/2/2015
ResReport for Recall 56571
ResReport for Recall 56562
NovaCare, LLC, Salt Lake City UT, FDA483 issued 12/09/2011
NovaCare, LLC Salt Lake City UT, FDA483 issued 3/22/2010
Impulsaria Memo dated 10/23/2009
7 Documents, 46 pages total
If, after review of the previously released records, you feel there is additional information needed you are welcome to submit a new request for the specific documents and/or time frames.
If you would like me to continue the search for an estimated total charge of $89.25, please confirm by March 31st, 2022 if I do not hear from you your request will be closed.
Please do not hesitate to reach out with any questions or concerns.
Jessica Whiting
(she/her)
Government Information Specialist
Partner Disclosure & Special Projects Team
Division of Information Disclosure Policy (DIDP)
Office of Strategic Planning & Operational Policy (OSPOP)
Office of Regulatory Affairs (ORA)
U.S. Food & Drug Administration
From: Food and Drug Administration
Hello,
Just following up on my fee estimate and approval of charges so far in order to proceed with your FOIA request.
Please let me know if you have any questions or concerns.
Jessica Whiting
(she/her)
Government Information Specialist
Partner Disclosure & Special Projects Team
Division of Information Disclosure Policy (DIDP)
Office of Strategic Planning & Operational Policy (OSPOP)
Office of Regulatory Affairs (ORA)
U.S. Food & Drug Administration
From: Matt Hongoltz-Hetling
Hi Jessica;
Thank you very much for responding to my request-- I appreciate the identification of the seven previously released documents, and would like you to complete your search at the estimated charge of $89.25. I wish I had more narrow time parameters to help facilitate, but I don't, so I'm afraid I have to ask you to cast that wide net for me.
Thanks very much for your help, and will look forward to hearing what you might come up with ...
Matt
From: Food and Drug Administration
Thank you, Matt
I'll continue my search for additional documents for another estimated hour and keep the search wide.
Once I come up with a list of responsive documents I will reach out and let you know what the anticipated review time will be.
At that time you can review the list and narrow if you feel you can, or approve the additional charges for review and we'll go from there.
Please let me know if you have any questions or concerns.
v/r
Jessica Whiting
(she/her)
Government Information Specialist
Partner Disclosure & Special Projects Team
Division of Information Disclosure Policy (DIDP)
Office of Strategic Planning & Operational Policy (OSPOP)
Office of Regulatory Affairs (ORA)
U.S. Food & Drug Administration
From: Food and Drug Administration
Hi Matt,
My apologies. I referenced the wrong FOIA request when I replied, there are no Review charges for your category of requester, just the search charges.
I'll see what I can find and get back to you if I have any questions.
Have a great weekend,
Jessica Whiting
(she/her)
Government Information Specialist
Partner Disclosure & Special Projects Team
Division of Information Disclosure Policy (DIDP)
Office of Strategic Planning & Operational Policy (OSPOP)
Office of Regulatory Affairs (ORA)
U.S. Food & Drug Administration
From: Matt Hongoltz-Hetling
Hey, that's great news-- thank you Jessica!
I appreciate your efforts, and can't wait to see what they yield ...
From: Muckrock Staff
To Whom It May Concern:
I'm following up on the following Freedom of Information Act request, copied below, and originally submitted on Feb. 28, 2022. You had previously indicated that it would be completed on March 31, 2022. I wanted to check on the status of my request, and to see if there was a new estimated completion date. You had assigned it reference number #2022-1735.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Hello,
Thank you for your patience.
Your request is at the top of the Complex Queue.
I anticipate completion this week.
Please let me know if you have any additional questions, and thank you again for your patience.
Jessica Whiting
(she/her)
Government Information Specialist
Partner Disclosure & Special Projects Team
Division of Information Disclosure Policy (DIDP)
Office of Strategic Planning & Operational Policy (OSPOP)
Office of Regulatory Affairs (ORA)
U.S. Food & Drug Administration
From: Food and Drug Administration
Dear Requestor,
The attached record(s) are being provided by the Office of Regulatory Affairs (ORA) Division of Information Disclosure Policy (DIDP) - [Freedom of Information Act (FOIA) Branch 2 in response to your request 2022-1735 for record(s) from the Food and Drug Administration pursuant to the Freedom of Information Act regarding:
All documents that were generated as part of the investigation of and enforcement against Erb Avore (of Grand Rapids, Michigan) and/or his companies Impulsaria LLC, a Nevada company & Impulsaria LLC, a Michigan company, with regards to a sexual enhancement dietary supplement sometimes marketed as Stiff Nights. Etc
Your request is granted in part.
After a thorough review of the responsive records, we have determined that portions of the documents are exempt from disclosure under FOIA exemptions (b)(4), (b)(5), (b)(6), and b(7) of the FOIA 5 U.S.C. § 552, as amended and delineated below:
* Exemption (b)(4) permits the withholding of trade secrets and commercial or financial information obtained from a person that is privileged or confidential. We have determined that portions of the enclosed records satisfy these criteria.
* Exemption (b)(5) permits the withholding of inter-agency or intra-agency communications records which are part of the deliberative process and pre-decisional. Disclosure of such material could inhibit the open and candid expression of opinions and diminish the quality of the decision-making process.
* Exemption (b)(6) permits the withholding of information which, if released, would constitute a clearly unwarranted invasion of personal privacy. In this case, it was determined that there is no countervailing public interest qualifying under the standard set forth, under exemption (b)(6), to release the personal identifying information of certain third parties.
* Exemption (b)(7) protects from disclosure "records or information compiled for law enforcement purposes, but only to the extent that the production of such law enforcement records or information (A) could reasonably be expected to interfere with enforcement proceedings, (B) would deprive a person of a right to a fair trial or an impartial adjudication, (C) could reasonably be expected to constitute an unwarranted invasion of personal privacy, (D) could reasonably be expected to disclose the identity of a confidential source, including a State, local, or foreign agency or authority or any private institution which furnished information on
a confidential basis, and, in the case of a record or information compiled by a criminal law enforcement authority in the course of a criminal investigation, or by an agency conducting a lawful national security intelligence investigation, information furnished by a confidential source, (E) would disclose techniques and procedures for law enforcement investigations or prosecutions, or would disclose guidelines for law enforcement investigations or prosecutions if such disclosure could reasonably be expected to risk circumvention of the law, or (F) could reasonably be expected to endanger the life or physical safety of any individual.
Your request is still pending with our office. If you have any questions about this response, you may contact Jessica Whiting at 312-596-4182 or Jessica.Whiting@fda.hhs.gov<mailto:Jessica.Whiting@fda.hhs.gov>. This is not the agency final response, and you will receive additional appeal rights with the final response, so you do not have to act at this time.
Please do not submit payment until you receive an invoice. The following charges for this request to date may be included in a monthly invoice:
Reproduction=$0.00 Search=$0.00 Review $0.00 Other $0.00 Total=$0.00
Sincerely
Jessica Whiting
(she/her)
Government Information Specialist
Partner Disclosure & Special Projects Team
Division of Information Disclosure Policy (DIDP)
Office of Strategic Planning & Operational Policy (OSPOP)
Office of Regulatory Affairs (ORA)
U.S. Food & Drug Administration
Attachments:
NovaCare LLC, Murray UT, 1000220648, FDA483 dtd 4/10/17
NovaCare LLC, Murray UT, 1000220648, FDA483 dtd 3/2/15
RESReport Recall 56571
RESReport Recall 56562
NovaCare LLC, Salt Lake City UT, 1000220648, FDA483 dtd 12/9/11
NovaCare LLC, Salt Lake City UT, FDA483 dtd 3/22/10
Impulsaria, Grand Rapids MI, 3007881794, Inv Memo dated 10/23/09
From: Matt Hongoltz-Hetling
Hi Jessica!
Thank you very much for sending me this information, and I have no issue with any of the exception-driven redactions.
However, I'm confused by how few documents were determined to be responsive to my request. Other reporting that I've done on Erb Avore (aka the Jamie Greene referenced in the documents you sent) shows that the FDA tracked emails and payments between Erb and a NovaCare employee from 2007-2010, and in 2009 issued a public warning that Impulsaria's Stiff Nights brand was tainted by sulfoaildenafil. Other events/documentation that I am aware of:
-- Oct./Nov. 2009 correspondence between FDA and Erb/Impulsaria
-- March and June 2010 correspondence between FDA and Erb/Impulsaria (which may have included a sit-down meeting)
-- A June 2010 FDA raid of various Grand Rapids, Mich. properties associated with Erb/Impulsaria during which FDA agents seized product
-- A Dec. 2010 FDA determination that Stiff Nights was fraudulently labeled
-- Various documents related to Erb's status as an unindicted co-conspirator in the case against Kelley Harvey, of NovaCare.
The memorandum you sent also references an email alert about Stiff Nights, generated when three consumers became sick after taking it, and so I assume there are narratives describing the experiences of those three consumers. I am also aware that one man, David McElwee, died after taking Stiff Nights, and so I wonder if that triggered any sort of investigation on the part of the FDA.
I may not have worded my request very well, but my intent was that my request for "all documents that were generated as part of the investigation of and enforcement against" Erb Avore/Impulsaria would cover all of the paperwork (or at least summaries) that all of these events must have generated.
I'm sorry to be a pest, and I do hate to tax the resources of an agency dedicated to the public good, but I really was expecting hundreds of pages of documents, so this surprised me!
Please let me know if this explanation helps to define my request better.
Thank you;
Matt
From: Food and Drug Administration
Hi Matt,
Thank you for reviewing the first production of records. Your request is still open and pending with our office. The records I was able to provide initially were previously released, and therefore did not require review.
I am still researching available records and will use the information you provided to help in my search. I’m also thinking that additional offices may have information. I will continue to research/review and provide another production shortly.
Thank you for your patience,
Jessica Whiting
(she/her)
Government Information Specialist
Partner Disclosure & Special Projects Team
Division of Information Disclosure Policy (DIDP)
Office of Strategic Planning & Operational Policy (OSPOP)
Office of Regulatory Affairs (ORA)
U.S. Food & Drug Administration
-
~WRD0000
From: Matt Hongoltz-Hetling
Oh! I see-- chalk that up to my unfamiliarity with the process. Thanks so much, Jessica-- I will look forward to seeing what else you manage to lay hands on!
Matt
From: Muckrock Staff
To Whom It May Concern:
I'm following up on the following Freedom of Information Act request, copied below, and originally submitted on Feb. 28, 2022. You had previously indicated that it would be completed on March 31, 2022. I wanted to check on the status of my request, and to see if there was a new estimated completion date. You had assigned it reference number #2022-1735.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Thank you for your patience,
I am working on getting the correct Centers involved for your request. Due to the complexity of your request and the age of the records it has taken some time, again I appreciate your patience.
v/r
Jessica Whiting
(she/her)
Government Information Specialist
Partner Disclosure & Special Projects Team
Division of Information Disclosure Policy (DIDP)
Office of Strategic Planning & Operational Policy (OSPOP)
Office of Regulatory Affairs (ORA)
U.S. Food & Drug Administration
From: Food and Drug Administration
Good Morning,
I just wanted to touch base with you and thank you for your patience while I worked on your request.
After some digging and back and forth emails I’ve been informed that your request should be open to additional offices and centers within FDA (FDA/OFVM/CFSAN/ORP/RDS/;FDA/OC/ORA/OCI/).
The records provided by them should be responsive to your questions and provide all the documents you are seeking.
If you have any additional questions please do not hesitate to reach out to me. This has been such an interesting request to research and I want to make sure you get what you are looking for!
Again, thank you for your patience. The additional action offices will be responding to your request.
v/r
Jessica Whiting
(she/her)
Government Information Specialist
Partner Disclosure & Special Projects Team
Division of Information Disclosure Policy (DIDP)
Office of Strategic Planning & Operational Policy (OSPOP)
Office of Regulatory Affairs (ORA)
U.S. Food & Drug Administration
From: Matt Hongoltz-Hetling
Hi Jessica;
Thank you so much for this update -- I really appreciate your responsiveness, and glad you found the subject matter to be as colorful as I have!
Can you please clarify? When you say my request should be open to the additional offices listed, does that mean that I need to do something proactively to have it fulfilled? Or will those offices respond to my initial request without further action?
Thanks again!
Matt
From: Food and Drug Administration
Good Morning,
You do NOT need to do anything.
I have opened your request to the additional offices, OCI and CFSAN. They have the assignment and will provide you documents directly.
I will be closing out my portion, but again if you have any questions please do not hesitate to reach out to me.
Jessica Whiting
(she/her)
Government Information Specialist
Partner Disclosure & Special Projects Team
Division of Information Disclosure Policy (DIDP)
Office of Strategic Planning & Operational Policy (OSPOP)
Office of Regulatory Affairs (ORA)
U.S. Food & Drug Administration
From: Food and Drug Administration
Dear Requestor,
This email is in response to your FOIA Request for "All documents that were generated as part of the investigation of and enforcement against Erb Avore (of Grand Rapids, Michigan) and/or his companies Impulsaria LLC, a Nevada company & Impulsaria LLC, a Michigan company, with regards to a sexual enhancement dietary supplement sometimes marketed as Stiff Nights. Etc."
Because the search terms are so broad in scope and dates, the search has resulted in several hundred documents and will take some time to review and redact. If you would like a timely response, please consider narrowing the scope of your request. Please respond to this email with your decision or you may call the number below if you have any questions. I look forward to hearing from you.
v/r
[cid:image001.jpg@01D88CD2.84972B70]
Jennifer Cliette, MJ, RHIA
Government Information Specialist
Office of Criminal Investigations (OCI)
Office of Regulatory Affairs (ORA)
U.S. Food and Drug Administration
737-837-0005
jennifer.cliette@fda.hhs.gov<mailto:jennifer.cliette@fda.hhs.gov>
-
image001
From: Matt Hongoltz-Hetling
Hi Jennifer;
Thanks so much for responding with this information, and I am considering narrowing the scope -- can you give me a sense of what categories of documents exist, and what sort of a narrowing would be helpful? I felt like I had to word it so broadly because I didn't know what was out there. Or, if you can provide an index of responsive documents, I could use that to be a bit more focused.
Thanks;
Matt
From: Food and Drug Administration
Good Morning,
I just put in the search terms you requested so I wouldn’t know until I opened every single document. If had an idea of what you were looking for I could help you narrow the search. I would also suggest adding a specific date range vs. “any and all” to narrow the search.
I can try just searching the companies alone without all of the verbiage and see if that decreases the number of documents.
v/r
[cid:image001.jpg@01D891EB.50BFF890]
Jennifer Cliette, MJ, RHIA
Government Information Specialist
Office of Criminal Investigations (OCI)
Office of Regulatory Affairs (ORA)
U.S. Food and Drug Administration
737-837-0005
jennifer.cliette@fda.hhs.gov<mailto:jennifer.cliette@fda.hhs.gov>
-
image001
From: Food and Drug Administration
Attn: Matt Hongoltz-Hetling
This is in response to your March 2, 2022 Freedom of Information Act (FOIA) request for records pertaining to:
* All documents that were generated as part of the investigation of and enforcement against Erb Avore (of Grand Rapids, Michigan) and/or his companies Impulsaria LLC, a Nevada company & Impulsaria LLC, a Michigan company, with regards to a sexual enhancement dietary supplement sometimes marketed as Stiff Nights. etc
The Center for Food Safety and Applied Nutrition (CFSAN) conducted a search and is unable to locate any records responsive to your request. CFSAN considers this request closed.
Please be advised that your request has been submitted to one or more component offices within FDA. These offices will reply to you directly.
While we believe that an adequate search of appropriate files was conducted for the records you requested, you have a right to appeal this determination. By filing an appeal, you preserve your rights under FOIA and give the agency a chance to review and reconsider your request and the agency's decision.
Your appeal must be mailed within 90 days from the date of this response, to Agency Chief FOIA Officer, U.S. Department of Health and Human Services, Office of the Assistant Secretary for Public Affairs, Room 729H, 200 Independence Avenue, S.W. Washington, DC 20201, E-mail FOIARequest@PSC.hhs.gov<mailto:FOIARequest@PSC.hhs.gov>
Please clearly mark both the envelope and your letter or e-mail "FDA Freedom of Information Act Appeal."
If you would like to discuss our response before filing an appeal to attempt to resolve your dispute without going through the appeals process, please contact samantha.wilde@fda.hhs.gov <mailto:samantha.wilde@fda.hhs.gov%20%20> or call 240-402-0003.
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>
If you are unable to resolve your FOIA dispute through our FOIA Public Liaison, the Office of Government Information Services (OGIS), the Federal FOIA Ombudsman's office, offers mediation services to help resolve disputes between FOIA requesters and Federal agencies. The contact information for OGIS is Office of Government Information Services, National Archives and Records 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<mailto:ogis@nara.gov>, Fax: 202-741-5769.
Sincerely,
Samantha Wilde
Samantha Wilde
Government Information Specialist
Center for Food Safety and Applied Nutrition (CFSAN)
Office of Regulations and Policy
U.S. Food and Drug Administration (FDA)
Tel: 240-402-0003
samantha.wilde@fda.hhs.gov<mailto:samantha.wilde@fda.hhs.gov>
[cid:image001.png@01D89527.84377600]<http://www.fda.gov/>
[cid:image002.jpg@01D89527.84377600]<https://www.facebook.com/FDA> [cid:image003.jpg@01D89527.84377600] <https://twitter.com/US_FDA> [cid:image004.jpg@01D89527.84377600] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image005.jpg@01D89527.84377600] <http://www.flickr.com/photos/fdaphotos/> [cid:image006.jpg@01D89527.84377600] <http://www.fda.gov/AboutFDA/ContactFDA/StayInformed/RSSFeeds/default.htm>
From: Food and Drug Administration
Dear requester,
Attached is your FOIA invoice. Please follow instructions on invoice on how to make payment. If you would like to pay online, please visit https://userfees.fda.gov/pay.
Any questions, please feel free to contact me directly.
Thank you
Kenisha Armstrong
Program Support Specialist
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-9276
Kenisha.Armstrong-Dock@fda.hhs.gov<mailto:Kenisha.Armstrong-Dock@fda.hhs.gov>
Have a great day!
[cid:image001.png@01D65B59.BFC89960]<http://www.fda.gov/>
[cid:image003.jpg@01D65B59.BFC89960]<https://www.facebook.com/FDA> [cid:image005.jpg@01D65B59.BFC89960] <https://twitter.com/US_FDA> [cid:image007.jpg@01D65B59.BFC89960] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image009.jpg@01D65B59.BFC89960] <http://www.flickr.com/photos/fdaphotos/>
Kenisha Armstrong
Program Support Specialist
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-9276
Kenisha.Armstrong-Dock@fda.hhs.gov<mailto:Kenisha.Armstrong-Dock@fda.hhs.gov>
Have a great day!
[cid:image001.png@01D65B59.BFC89960]<http://www.fda.gov/>
[cid:image003.jpg@01D65B59.BFC89960]<https://www.facebook.com/FDA> [cid:image005.jpg@01D65B59.BFC89960] <https://twitter.com/US_FDA> [cid:image007.jpg@01D65B59.BFC89960] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image009.jpg@01D65B59.BFC89960] <http://www.flickr.com/photos/fdaphotos/>
From: Matt Hongoltz-Hetling
Hi Kenisha;
Thank you for the help with my request. However, in my initial request, I asked that I be notified of fee estimates before moving forward with searches. The only figure that was mentioned to me was $89, so this invoice is quite a shock. It exceeds what I was prepared to pay by tenfold.
Can you please review my case and tell me how to proceed? I would have never authorized this sort of expense.
Matt
From: Matt Hongoltz-Hetling
Hi there;
I sent the following to Kenisha Armstrong, Program Support Specialist, about a week ago, and wanted to also share it as an appeal:
******
Thank you for the help with my request. However, in my initial request, I asked that I be notified of fee estimates before moving forward with searches. The only figure that was mentioned to me was $89, so this invoice is quite a shock. It exceeds what I was prepared to pay by tenfold.
Can you please review my case and tell me how to proceed? I would have never authorized this sort of expense.
*******
I also should reiterate that, if other FDA departments are undertaking searches related to this request, I would like to have a pricing estimate before they proceed.
Thank you;
Matt
From: Food and Drug Administration
"Good morning Matt,
After reviewing your request we found a email chain between you and Jessica Whiting excepting the charges. Please see below:
From: requests@muckrock.com requests@muckrock.com
Sent: Friday, March 25, 2022 4:42 PM
To: Kotler, Sarah Sarah.Kotler@fda.hhs.gov
Subject: [EXTERNAL] RE: Freedom of Information Act Request #2022-1735
CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the
sender and know the content is safe.
Food and Drug Administration
FOIA Office
12420 Parklawn Drive
Rockville, MD 20850
March 25, 2022
This is a follow up to request number 2022-1735:
Hi Jessica;
Thank you very much for responding to my request-- I appreciate the identification of the seven previously released documents, and would like you to complete your search at the estimated charge of $89.25. I wish I had more narrow time parameters to help facilitate, but I don't, so I'm afraid I have to ask you to cast that wide net for me.
Thanks very much for your help, and will look forward to hearing what you might come up with ...
Matt
From: requests@muckrock.com <requests@muckrock.com>
Sent: Friday, July 15, 2022 2:42 PM
To: FOIA Billing <FOIABilling@fda.hhs.gov>
Subject: [EXTERNAL] RE: Freedom of Information Act Request #2022-1735
CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the sender and know the content is safe.
Food and Drug Administration
FOIA Office
12420 Parklawn Drive
Rockville, MD 20850
July 15, 2022
This is a follow up to request number 2022-1735:
Hi Kenisha;
Thank you for the help with my request. However, in my initial request, I asked that I be notified of fee estimates before moving forward with searches. The only figure that was mentioned to me was $89, so this invoice is quite a shock. It exceeds what I was prepared to pay by tenfold.
Can you please review my case and tell me how to proceed? I would have never authorized this sort of expense.
Matt
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PLEASE NOTE: This request is not filed by a MuckRock staff member, but is being sent through MuckRock by the above in order to better track, share, and manage public records requests. Also note that improperly addressed (i.e., with the requester's name rather than "MuckRock News" and the department number) requests might be returned as undeliverable.
---
On July 15, 2022:
Subject: FOIA Invoice
Dear requester,
Attached is your FOIA invoice. Please follow instructions on invoice on how to make payment. If you would like to pay online, please visit https://userfees.fda.gov/pay.
Any questions, please feel free to contact me directly.
Thank you
Kenisha Armstrong
Program Support Specialist
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-9276
Kenisha.Armstrong-Dock@fda.hhs.gov<mailto:Kenisha.Armstrong-Dock@fda.hhs.gov>
Have a great day!
[cid:image001.png@01D65B59.BFC89960]<http://www.fda.gov/>
[cid:image003.jpg@01D65B59.BFC89960]<https://www.facebook.com/FDA> [cid:image005.jpg@01D65B59.BFC89960] <https://twitter.com/US_FDA> [cid:image007.jpg@01D65B59.BFC89960] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image009.jpg@01D65B59.BFC89960] <http://www.flickr.com/photos/fdaphotos/>
Kenisha Armstrong
Program Support Specialist
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-9276
Kenisha.Armstrong-Dock@fda.hhs.gov<mailto:Kenisha.Armstrong-Dock@fda.hhs.gov>
Have a great day!
[cid:image001.png@01D65B59.BFC89960]<http://www.fda.gov/>
[cid:image003.jpg@01D65B59.BFC89960]<https://www.facebook.com/FDA> [cid:image005.jpg@01D65B59.BFC89960] <https://twitter.com/US_FDA> [cid:image007.jpg@01D65B59.BFC89960] <http://www.youtube.com/user/USFoodandDrugAdmin> [cid:image009.jpg@01D65B59.BFC89960] <http://www.flickr.com/photos/fdaphotos/>
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On July 11, 2022:
Subject: Your FOIA request ref: 2022-1735
Attn: Matt Hongoltz-Hetling
This is in response to your March 2, 2022 Freedom of Information Act (FOIA) request for records pertaining to:
* All documents that were generated as part of the investigation of and enforcement against Erb Avore (of Grand Rapids, Michigan) and/or his companies Impulsaria LLC, a Nevada company & Impulsaria LLC, a Michigan company, with regards to a sexual enhancement dietary supplement sometimes marketed as Stiff Nights. etc
The Center for Food Safety and Applied Nutrition (CFSAN) conducted a search and is unable to locate any records responsive to your request. CFSAN considers this request closed.
Please be advised that your request has been submitted to one or more component offices within FDA. These offices will reply to you directly.
While we believe that an adequate search of appropriate files was conducted for the records you requested, you have a right to appeal this determination. By filing an appeal, you preserve your rights under FOIA and give the agency a chance to review and reconsider your request and the agency's decision.
Your appeal must be mailed within 90 days from the date of this response, to Agency Chief FOIA Officer, U.S. Department of Health and Human Services, Office of the Assistant Secretary for Public Affairs, Room 729H, 200 Independence Avenue, S.W. Washington, DC 20201, E-mail FOIARequest@PSC.hhs.gov<mailto:FOIARequest@PSC.hhs.gov>
Please clearly mark both the envelope and your letter or e-mail "FDA Freedom of Information Act Appeal."
If you would like to discuss our response before filing an appeal to attempt to resolve your dispute without going through the appeals process, please contact samantha.wilde@fda.hhs.gov <mailto:samantha.wilde@fda.hhs.gov%20%20> or call 240-402-0003.
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>
If you are unable to resolve your FOIA dispute through our FOIA Public Liaison, the Office of Government Information Services (OGIS), the Federal FOIA Ombudsman's office, offers mediation services to help resolve disputes between FOIA requesters and Federal agencies. The contact information for OGIS is Office of Government Information Services, National Archives and Records 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<mailto:ogis@nara.gov>, Fax: 202-741-5769.
Sincerely,
Samantha Wilde
Samantha Wilde
Government Information Specialist
Center for Food Safety and Applied Nutrition (CFSAN)
Office of Regulations and Policy
U.S. Food and Drug Administration (FDA)
Tel: 240-402-0003
samantha.wilde@fda.hhs.gov<mailto:samantha.wilde@fda.hhs.gov>
[cid:image001.png@01D89527.84377600]<http://www.fda.gov/>
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On July 7, 2022:
Subject: RE: [EXTERNAL] RE: Freedom of Information Act Request #2022-1735
Good Morning,
I just put in the search terms you requested so I wouldn’t know until I opened every single document. If had an idea of what you were looking for I could help you narrow the search. I would also suggest adding a specific date range vs. “any and all” to narrow the search.
I can try just searching the companies alone without all of the verbiage and see if that decreases the number of documents.
v/r
[cid:image001.jpg@01D891EB.50BFF890]
Jennifer Cliette, MJ, RHIA
Government Information Specialist
Office of Criminal Investigations (OCI)
Office of Regulatory Affairs (ORA)
U.S. Food and Drug Administration
737-837-0005
jennifer.cliette@fda.hhs.gov<mailto:jennifer.cliette@fda.hhs.gov>
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On July 3, 2022:
Subject: RE: Freedom of Information Act Request #2022-1735
Hi Jennifer;
Thanks so much for responding with this information, and I am considering narrowing the scope -- can you give me a sense of what categories of documents exist, and what sort of a narrowing would be helpful? I felt like I had to word it so broadly because I didn't know what was out there. Or, if you can provide an index of responsive documents, I could use that to be a bit more focused.
Thanks;
Matt
---
On June 30, 2022:
Subject: FOIA Request 2022-1735
Dear Requestor,
This email is in response to your FOIA Request for "All documents that were generated as part of the investigation of and enforcement against Erb Avore (of Grand Rapids, Michigan) and/or his companies Impulsaria LLC, a Nevada company & Impulsaria LLC, a Michigan company, with regards to a sexual enhancement dietary supplement sometimes marketed as Stiff Nights. Etc."
Because the search terms are so broad in scope and dates, the search has resulted in several hundred documents and will take some time to review and redact. If you would like a timely response, please consider narrowing the scope of your request. Please respond to this email with your decision or you may call the number below if you have any questions. I look forward to hearing from you.
v/r
[cid:image001.jpg@01D88CD2.84972B70]
Jennifer Cliette, MJ, RHIA
Government Information Specialist
Office of Criminal Investigations (OCI)
Office of Regulatory Affairs (ORA)
U.S. Food and Drug Administration
737-837-0005
jennifer.cliette@fda.hhs.gov<mailto:jennifer.cliette@fda.hhs.gov>
---
On Feb. 25, 2022:
Subject: Freedom of Information Act Request: Impulsaria LLC investigation
To Whom It May Concern:
Pursuant to the Freedom of Information Act, I hereby request the following records:
-- All documents that were generated as part of the investigation of and enforcement against Erb Avore (of Grand Rapids, Michigan) and/or his companies Impulsaria LLC, a Nevada company & Impulsaria LLC, a Michigan company, with regards to a sexual enhancement dietary supplement sometimes marketed as Stiff Nights.
-- All documents that were generated as part of the investigation of and enforcement against NovaCare LLC, of Utah with regards to a sexual enhancement dietary supplement sometimes marketed by the aforementioned Erb Avore as Stiff Nights.
-- Copies of all complaints made by members of the public against Erb Avore, Impulsaria, NovaCare, or the products Stiff Nights, Stiff Days and Aziffa.
This is a resubmission of this request, after addressing the FDA's initial reasons for declining ("indicate the location of these companies and the product area").
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 business days, as the statute requires.
Sincerely,
Matt Hongoltz-Hetling
View request history, upload responsive documents, and report problems here:
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PLEASE NOTE: This request is not filed by a MuckRock staff member, but is being sent through MuckRock by the above in order to better track, share, and manage public records requests. Also note that improperly addressed (i.e., with the requester's name rather than "MuckRock News" and the department number) requests might be returned as undeliverable."
From: Matt Hongoltz-Hetling
Thank you for this response, but can you please clarify?
I'm not sure if you are referencing the email in which Jessica notified me that I would be excepted from charges related to my request, or whether you meant to say "accepted," and are referencing the $89 charge that I agreed to (before Jessica told me I was exempt).
From: Food and Drug Administration
Good morning,
Yes, you accepted the charges in the email chain that was provided in the email that was sent to you. Sorry for the confusion.
Thank you,
Wilson M. Russ
Government Information Specialist
Office of the Executive Secretariat
Division of Freedom of Information
U.S. Food and Drug Administration
Tel: 301-796-8981
wilson.russ@fda.hhs.gov<mailto:wilson.russ@fda.hhs.gov>
[cid:image001.png@01D8A8A9.4A9A8690]<http://www.fda.gov/>
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[cid:image007.gif@01D8A8A9.4A9A8690]
From: Matt Hongoltz-Hetling
Hi William;
Thanks for the speedy response. Can you point out where specifically in the email chain you believe I accepted charges? The way I read it, I only accepted $89 in charges. And the email chain you sent me omits the email in which Jessica told me I wouldn't even have to pay that $89, because of the category of my request.
But even in the emails you sent me, I specifically requested an estimate of charges before they were incurred, and nothing I received suggested to me that there was a $1,300 charge coming. I do not have the resources to pay this, and I'm really hoping someone can engage with my correspondence, understand my objection to the invoice, and let me know why those objections don't apply.
Matt
Matt
From: Food and Drug Administration
Good morning,
Please disregard the invoice. That amount on the invoice is incorrect and because you were listed as other, and it was under 2 hours, you will not be charged.
Thanks so much,
Kenisha
From: Matt Hongoltz-Hetling
Thank you Kenisha!
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