Source: https://healthimpactnews.com/2017/ky-amish-farmer-jailed-over-a-salve-label-the-fda-wants-him-jailed-for-life/
Timestamp: 2019-06-17 17:30:28
Document Index: 380470786

Matched Legal Cases: ['§ 33', '§ 33', '§ 33', '§ 331', '§ 331', '§ 331', '§ 33', '§ 331', '§ 33', '§ 331', '§ 33', '§ 1512', '§ 1512']

Amish farmer Sam Girod of Owingsville makes 3 products: a chickweed salve, a bloodroot salve and an essential oil blend called Sine Eze. A few years ago, the FDA came after Sam for labeling crimes — Sam said his salves could cure certain things and that’s a big FDA no-no. (Source.)
Kentucky Free Press – A Political Watchdog Publication
1. Defendant SAMUEL A. GIROD operated an establishment at 409 Satterfield Lane, Owingsville, KY 40360, which is in Bath County, in the Eastern District of Kentucky. This establishment, which did business under various names, including “Satterfield Naturals,” “S.A.E.G.,” and “A.M.S. Associates,” manufactured and marketed products for the treatment of various ailments, including skin disorders, cancer, and sinus infections.
14. On or about September 17, 2013, the United States District Court for the Western District of Missouri entered an order (hereinafter, “the injunction”) permanently restraining and enjoining GIROD from manufacturing, processing, packaging, labeling, holding, selling, or distributing certain products, until various conditions were met. The products covered by the injunction included Chickweed Healing Salve, TO-MOR-GONE, R.E.P., and any other products similar in composition or effect to Chickweed Healing Salve, TO-MOR-GONE, or R.E.P. The conditions under which the injunction could be lifted included: (a) GIROD’s removal from his products, labels, labeling, and promotional materials, of all claims that caused Chickweed Healing Salve, TO-MOR-GONE, and R.E.P. to be “drugs” within the meaning of the FDCA; (b) GIROD’s removal of all extracts or components of bloodroot plant (Sanguiniaria Canadensis) from his products intended for human use; (c) the FDA’s inspection of GIROD’s establishment; and (d) the FDA’s notification to GIROD of his compliance with the terms of the injunction.
<End of BACKGROUND. Now the COUNTS (charges).>
18. On or about November 21, 2013, in Bath County, in the Eastern District of Kentucky, SAMUEL A. GIROD knowingly and willfully conspired with others to prevent, by force, intimidation, and threat, FDA Compliance Safoty [sic] Officers (“CSOs”) N.L.P. and M.D.S. from discharging the duties of their offices, trust, and places of confidence under the United States; and to induce, by force, intimidation, and threat, FDA CSOs N.L.P. and M.D.S. to leave the place where their duties as officers of the United States were required to be performed.
Not more than 3 years imprisonment, $250,000 fine, and 1 year supervised release.
25. Paragraphs 1 through 22 of this indictment are re-alleged and incorporated by reference as though fully set forth herein.
28. On or about September 27, 2013, in Bath County, in the Eastern District of Kentucky, and elsewhere, SAMUEL A. GIROD, with the intent to defraud or mislead, introduced and delivered for introduction into interstate commerce a quantity of Chickweed Healing Salve, which was misbranded in that it: (a) was manufactured, prepared, propogated, and processed in an establishment that was not registered with the FDA; and (b) failed to bear labeling containing adequate directions for use; all in violation of 21 U.S.C. §§ 33l(a) and 333(a)(2).
29. Paragraphs 1 through 22 of this indictment are re-alleged and incorporated by reference as though fully set forth herein.
30. On or about October 14, 2013, in Bath County, in the Eastern District of Kentucky, and elsewhere, Case: 5:15-cr-00087-DCR-REW Doc #: 1 Filed: 10/01/15 Page: 9 of 15 – Page ID#: 9 SAMUEL A. GIROD, with the intent to defraud or mislead, introduced and delivered for introduction into interstate commerce a quantity of Chickweed Healing Salve, which was misbranded in that it: (a) was manufactured, prepared, propogated, and processed in an establishment that was not registered with the FDA; and (b) failed to bear labeling containing adequate directions for use; all in violation of 21 U.S.C. §§ 33 l(a) and 333(a)(2).
32. On or about October 14, 2013, in Bath County, in the Eastern District of Kentucky, and elsewhere, SAMUEL A. GIROD, with the intent to defraud or mislead, introduced and delivered for introduction into interstate commerce a quantity of TO-MOR-GONE, which was misbranded in that it: (a) was manufactured, prepared, propogated, and processed in an establishment that was not registered with the FDA; (b) failed to bear labeling containing adequate directions for use; (c) failed to bear labeling containing such adequate warnings against use in those pathological conditions where its use may be dangerous to health or against unsafe dosage or methods or duration of administration or application, in such manner and font, [sic] as are necessary for the protection of users; and (d) was dangerous to health when used in the dosage or manner or with the frequency or duration recommended or suggested in the labeling thereof; all in violation of 21 U.S.C. §§ 33l(a) and 333(a)(2).
COUNT 8 21 U.S.C. § 331(a)
35. Paragraphs 1 through 22 of this indictment are re-alleged and incorporated by reference as though fully set forth herein.
36. On or about November 13, 2013, in Bath County, in the Eastern District of Kentucky, and elsewhere, SAMUEL A. GIROD, with the intent to defraud or mislead, introduced and delivered for introduction into interstate commerce a quantity of TO-MOR-GONE, which was misbranded in that it: (a) was manufactured, prepared, propogated, and processed in an establishment that was not registered with the FDA; (b) failed to bear labeling containing adequate directions for use; (c) failed to bear labeling containing such adequate warnings against use in those pathological conditions where its use may be dangerous to health or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users; and (d) was dangerous to health when used in the dosage or manner or with the frequency or duration recommended or suggested in the labeling thereof; all in violation of 21 U.S.C. §§ 331 (a) and 333(a)(2).
NOTES: Sam took all health claims off his products for sale to the public. Not a drug.
COUNT 9 21 U.S.C. § 331(a)
37. Paragraphs 1 through 22 of this indictment are re-alleged and incorporated by reference as though fully set forth herein.
38. On or about November 13, 2013, in Bath County, in the Eastern District of Kentucky, and elsewhere, SAMUEL A. GIROD, with the intent to defraud or mislead, introduced and delivered for introduction into interstate commerce a quantity of R.E.P. [now Sine Eze, essential oils] which was misbranded in that it: (a) was manufactured, prepared, propogated, and processed in an establishment that was not registered with the FDA; and (b) failed to bear labeling that contained a listing of each active ingredient; all in violation of 21 U.S.C. §§ 33l(a) and 333(a)(2).
NOTES: Sam has followed and will continue to follow all labeling requirements for products for sale to the public. Not a drug so not required to register with the FDA.
COUNT 10 21 U.S.C. § 331(a)
39. Paragraphs 1 through 22 of this indictment are re-alleged and incorporated by reference as though fully set forth herein.
40. On or about November 13, 2013, in Bath County, in the Eastern District of Kentucky, and elsewhere, SAMUEL A. GIROD, with the intent to defraud or mislead, introduced and delivered for introduction into interstate commerce a quantity of TO-MOR-GONE, which was misbranded in that it: (a) was manufactured, prepared, propagated, and processed in an establishment that was not registered with the FDA; (b) failed to bear labeling containing adequate directions for use; (c) failed to bear labeling containing such adequate warnings against use in those pathological conditions where its use may be dangerous to health or against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users; and (d) was dangerous to health when used in the dosage or manner or with the frequency or duration recommended or suggested in the labeling thereof; all in violation of 21 U.S.C. §§ 33 l(a) and 333(a)(2).
a) Not a drug so not required to register with the FDA
b, c) Has followed and will continue to follow labeling requirements for products sold to the public
d) Has it been established that bloodroot is dangerous to health when used in the dosage or manner, etc. recommended? Would like to see those studies.
COUNT 11 21 U.S.C. § 331(a)
41. Paragraphs 1 through 22 of this indictment are re-alleged and incorporated by reference as though fully set forth herein.
42. On or about January 10, 2014, in Bath County, in the Eastern District of Kentucky, and elsewhere, SAMUEL A. GIROD, with the intent to defraud or mislead, introduced and delivered for introduction into interstate commerce a quantity of Chickweed Healing Salve, which was misbranded in that it: (a) was manufactured, prepared, propagated, and processed in an establishment that was not registered with the FDA; and (b) failed to bear labeling containing adequate directions for use; all in violation of 21 U.S.C. §§ 33 l(a) and 333(a)(2).
NOTES: Not a drug so not required to register with the FDA. Sam has followed and will continue to follow all labeling requirements for products for sale to the public.
COUNT 12 18 U.S.C. § 1512(b)(2)(A)
Not more than 20 years imprisonment, $250,000 fine, and 3 years supervised release.
43. Paragraphs 1 through 22 of this indictment are re-alleged and incorporated by reference as though fully set forth herein.
44. On or about December 15, 2014, in Bath County, in the Eastern District of Kentucky, and elsewhere, SAMUEL A. GIROD knowingly threatened, attempted to threaten, and attempted to corruptly persuade M.M., and engaged in misleading conduct toward M.M., with the intent to cause and induce M.M. to withhold records and documents from an official proceeding, to wit, the investigation of a federal grand jury in the Eastern District of Kentucky, all in violation of 18 U.S.C. § 1512(b)(2)(A).
NOTES: M.M. is not identified in the 28,000 pages of discovery docs as is required by law, so not possible to investigate. Sam absolutely denies he did this. And he does not threaten. Character witnesses galore.
</end of indictment>
COUNT 1: Not more than 6 years imprisonment, $250,000 fine, and 3 years supervised release
COUNT 2: Not more than 5 years imprisonment, $250,000 fine, and 3 years supervised release.
COUNTS 3-11: Not more than 3 years imprisonment, $250,000 fine, and 1 year supervised release.
COUNT 12: Not more than 20 years imprisonment, $250,000 fine, and 3 years supervised release.
The FDA has been going after small farmers for decades and if they haven’t been doing so in your state, they will soon. What’s to stop them?
For evidence of FDA and USDA abuses, watch Farmageddon on Amazon or Netflix. This has been going on for far too long and it’s time to stop it. Only YOU and I can do that!
Just lately these agencies have been particularly venomous toward the Amish. Reining in federal agencies is a huge promise made by almost every politician of late. Let’s hold them to it!!!
We beg President Trump to issue an immediate pardon for Sam. Please sign this petition today!
An email to Trump could only help.
We sincerely hope that Atty General Sessions will step in and stop this gov’t abuse. A quick email to him will help.
Call or email your legislators, all of them. Your U.S. Senators and House Reps as well as your state legislators, even if you don’t live in KY. Just do a search on your legislator’s name and you’ll find a phone number or email address.
Find your KY legislators here.
Contact Matt Bevin by phone at (502) 564-2611. Matt Bevin’s Facebook page can be found here.
Call Sheriff John Snedeger of Bath County KY at (606) 674-2931
Donate to Sam’s legal fees.
Attend Sam’s trial on 2/27/17 at 9am at the Federal Courthouse, 101 Barr Street, Lexington, KY. It’s slated to go for four days. Even if you can’t stay very long, a presence at any time will be helpful. Probably earlier is better, but any time.
Find the Justice4SamGirod Facebook page here.
Read the full article at KYFreePress.com. Republished with permission.