Miracle Mineral Supplement and the Genesis II Church of Health and Healing (Food and Drug Administration)

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Reference: FDA2067375
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.
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if so, you will receive another email as a formal acknowledgement of your request, with a control number for your request.
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or if there are any other deficiencies with your submission, FOIA staff will contact you via telephone or email.

Jennifer J. Halpert Jennifer J. Halpert
Re: Confirmation # FDA2067375
Requester Ctrl #:
In Reply refer to: 2020-5849
The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding:
Any documents related to investigations into the pseudo-medical use of the toxic substance "Chlorine Dioxide", also called "Miracle Mineral Supplement", "Miracle Mineral Solution", "MMS", "CDS" and sold in a different form as "Sodium Chlorite". In particular, any documents relating to: * "Genesis II Church of Health and Healing", the organization which is its most active proponent * Mark Grennon, founder of Genesis II * Shane Hawkins, high-level member of Genesis II * Jim Humble, the founder of the MMS movement * Duane Hanes, known collaborator of Jim Humble * Kerri Rivera, another notable purveyor and proponent of MMS treatment * Charlotte Lackney, credited with designing "treatment protocols" for MMS * Bruce Tanner, original operator of online discussion board "mmsforum" and active proponent of MMS treatments 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, Jennifer J. Halpert Upload documents directly: https://https://www.muckrock.comhttps://accounts.muckrock.com/accounts/login/?url_auth_token=AAAj8qsyCFVBiER0gQ87e_PE26s%3A1k5MO7%3AR0-BgpmNcz5nk1e3o19CtEn66Qc&next=https%3A%2F%2Fwww.muckrock.com%2Faccounts%2Flogin%2F%3Fnext%3D%252Faccounts%252Fagency_login%252Ffood-and-drug-administration-116%252Fmiracle-mineral-supplement-and-the-genesis-ii-church-of-health-and-healing-food-and-drug-administration-100726%252F%253Femail%253DFDAFOIA%252540fda.hhs.gov
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Attn: Jennifer J. Halpert

This is in response to your August 11, 2020, Freedom of Information Act (FOIA) request to the Food and Drug Administration (FDA), Center for Food Safety and Applied Nutrition (CFSAN) seeking, Any documents related to investigations into the pseudo-medical use of the toxic substance "Chlorine Dioxide", also called "Miracle Mineral Supplement", "Miracle Mineral Solution", "MMS", "CDS" and sold in a different form as "Sodium Chlorite". In particular, any documents relating to: * "Genesis II Church of Health and Healing", the organization which is its most active proponent * Mark Grennon, founder of Genesis II * Shane Hawkins, high-level member of Genesis II * Jim Humble, the founder of the MMS movement * Duane Hanes, known collaborator of Jim Humble * Kerri Rivera, another notable purveyor and proponent of MMS treatment * Charlotte Lackney, credited with designing "treatment protocols" for MMS * Bruce Tanner, original operator of online discussion board "mms forum" and active proponent of MMS treatments 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, Jennifer J. Halpert Upload documents directly: https://https://www.muckrock.comhttps://accounts.muckrock.com/accounts/login/url_auth_token=AAAj8qsyCFVBiER0gQ87e_PE26s%3A1k5MO7%3AR0-BgpmNcz5nk1e3o19CtEn66Qc&next=https%3A%2F%2Fwww.muckrock.com%2Faccounts%2Flogin%2F%3Fnext%3D%252Faccounts%252Fagency_login%252Ffood-and-drug-administration-116%252Fmiracle-mineral-supplement-and-the-genesis-ii-church-of-health-and-healing-food-and-drug-administration-100726%252F%253Femail%253DFDAFOIA%252540fda.hhs.gov<https://https:/www.muckrock.comhttps:/accounts.muckrock.com/accounts/login/url_auth_token=AAAj8qsyCFVBiER0gQ87e_PE26s%3A1k5MO7%3AR0-BgpmNcz5nk1e3o19CtEn66Qc&next=https%3A%2F%2Fwww.muckrock.com%2Faccounts%2Flogin%2F%3Fnext%3D%252Faccounts%252Fagency_login%252Ffood-and-drug-administration-116%252Fmiracle-mineral-supplement-and-the-genesis-ii-church-of-health-and-healing-food-and-drug-administration-100726%252F%253Femail%253DFDAFOIA%252540fda.hhs.gov>.

Attached are documents responsive to your request. They are being released in part. After a thorough review of the responsive records, we have determined that portions of the documents are exempt from disclosure under exemption (b)(4), (b)(5) and (b)(6) of the FOIA 5 U.S.C. § 552, as delineated below.

* Exemption (b)(4) protects from disclosure "trade secrets" (TS) and "commercial confidential information" (CCI) or financial information that was obtained from a person outside the government and that is privileged or confidential.

* Exemption (b)(5) protects "inter-agency or intra-agency emails, memorandums or letters which would not be available by law to a party in litigation with the agency." This exemption covers multiple privileges, including those that protect an attorney's work product, a work product that is in draft format, attorney-client communications, and the deliberative process. 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 privacy information, the release of which would constitute a clearly unwarranted invasion of personal privacy.
CFSAN considers this request closed. You have the 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: Director, 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>. Please clearly mark both the envelope and your letter "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 Kimberly.Jones@fda.hhs.gov<mailto:Kimberly.Jones@fda.hhs.gov> or by phone 240-402-1825. 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 as follows: Office of Government Information Services, National Archives and Records Administration, 8601 Adelphi Road-OGIS, College Park, MD 20740-6001; telephone at 202-741-5770; toll free at 1-877-684-6448; or facsimile at 202-741-5769; e-mail at ogis@nara.gov<mailto:ogis@nara.gov>.
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

r/v

Sheila Wright
FOIA Officer
Center for Food Safety & Applied Nutrition
Office of Regulations and Policy
Tel: 240-402-2812
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