Amish Father faces life in prison for selling natural skin salves made from herbs

Father of 12 is to be sentenced to 40 year+ prison for selling a product made from common herbs. These same products can be purchased ONLINE at Amazon.There were no injuries, no drugs, no purposeful violation of law.  Sam changed labeling when requested to comply with FDA requirements. However, He refused to submit to five years of searches and inspections. Sam's indictment begs the question, is the purpose of this prosecution to protect the public or to punish those citizens who don’t kneel at the pointy end of a bureaucrat’s pen? Help Sam SIGN THE PETITION TO GET THE INNOCENT OUT OF PRISON! 

The judge will sentence Sam at 10:00 AM on Friday, June 16th 2017. Until then, Sam will presumably be incarcerated in the Fayette County Detention Center.

Sam Girod is a Kentucky farmer who runs a small business selling natural skin salves made from herbs such as chickweed, which seem to help relieve a host of skin conditions, including allergic rashes, psoriasis, poison oak and even skin cancers.

If you look up chickweed on Amazon, you will find pages of chickweed products, dozens and dozens of products, in some cases followed by glowing testimonials from users about how this or that chickweed provided relief from terrible itching, and even cured their skin cancers.

So why has the US Food and Drug Administration picked Girod out from all those producers, and had him indicted by a federal grand jury on a dozen criminal charges that could jail Sam Girod for 48 years? Neither Girod, who is 56 years old and the father of twelve, nor his lawyer, Chuck McFarland, can explain it.

According to McFarland, Girod, who is Amish and has no criminal record, has been selling chickweed for the last 15 years, from his farm in Owingsville, Kentucky and from some convenience stores in Missouri.


Here’s a “one stop” to get links to the entire story:


Background summarized:
For a more detailed version plus links to documents, click here.

Samuel Girod [G as in Gee: gi-ROD] and his family have been making and selling three all-natural herbal products for nearly 20 years.

No one has ever been harmed by the products; the Girods have pages of testimonials and scores of repeat customers.

Similar products are currently made and sold online worldwide (including on Amazon) by other people using the same or similar basic ingredients. The recipes are online as well, you can make them in your kitchen.

In 2001, an FDA agent informed Sam that his product labels were making medical claims regarding healing certain conditions. At the time, Sam’s label said, ““[g]ood for all skin disorders. Skin cancer, cuts, burns, draws, and poison ivy.”

Sam had to change his label, removing the skin cancer claim specifically, or do very expensive testing proving the claims. Sam changed the label, removing any reference to skin cancer.

Sam did not receive any further communication from the FDA until 2012 when someone called the FDA and reported that a store in MO was selling Sam’s products and that medical claims were being made.

The “medical claims” were in fact customer testimonials contained in a brochure about Sam’s products! These testimonials are no different than Amazon reviews.

Then the FDA claimed to have found a MO customer who had been harmed by Sam’s bloodroot salve. *later it was determined that the customer did NOT USE Sam's bloodroot salve.

In early 2013, during the investigation on that claim, FDA agents went to Sam’s home and demanded a warrantless search. Wanting to be cooperative, Sam said OK on one condition: that no photographs were taken (the Amish are religiously opposed to photography). The agents said no problem, no photos.

Then they got on the property, whipped out their cameras and took photos of everything.

Several months later, the Girods went before a federal judge in MO re the medical claims and the person supposedly injured. Turns out, not only has this customer never been identified or produced, the bloodroot salve this customer used was not even Sam’s!!!

Yet that judge put an injunction on Sam’s products with three stipulations:

  1. none could be sold until all medical claims were removed (referring to the brochures);
  2. Sam’s bloodroot salve could never be sold again EVER (1); and
  3. Sam had to allow inspection of his property where the products were made FOR FIVE YEARS.

Sam complied with 1 and 2: he stopped selling the bloodroot salve and stopped using the brochures. He was not so compliant with the searches.


SIGN THE PETITION TO GET THE INNOCENT OUT OF PRISON! 


UPDATE: 


Sam’s indictment is long because the gov likes to pad the bill so the defendant will be terrified into taking a plea. A plea is a win for the gov and that’s what it’s after: a win, not justice.

Remember, folks, we are talking about a Chickweed Salve here along with two other equally benign, non-drug products that thousands of people over the past 20 years  have used to good effect.

That fact alone begs the question: is the purpose of this prosecution to protect the public or to punish those citizens who don’t kneel at the pointy end of a bureaucrat’s pen?

The FDA vs Kentucky Amish Farmer Samuel A. Girod

Case: 5:15-cr-00087 GRAND JURY CHARGES (click here to download a pdf of the indictment)


BACKGROUND

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.

NOTES: The use of the words “treatment” and “cancer” are why Sam’s labels were a problem. WERE. He changed the labels and now they are fine. Why is this even on the indictment?

Sam’s products are effective and have never hurt anyone. And, if they have hurt anyone, prove it — as is required under Common Law — and Sam can make restitution.

Honestly, if one person was harmed* in 20+ years of thousands of people using Sam’s products, that’s an awesome track record. Why don’t we compare that to Big Pharma’s drug safety record? Even aspirin kills 11 people a year. Every. Single. Year. Not only that, a person dies every 19 minutes from an FDA-approved pharmaceutical. And then there’s this: http://bit.ly/deathbydoctor

* The FDA claims to have such a person which is how it got the injunction mentioned below… although that person was never named, not even in the court proceeding getting the injunction! Plus — are you sitting down? — the black salve that supposedly hurt the victim wasn’t even Sam’s salve. Yeah, let that sink in.

2. The Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. (“FDCA”), existed to protect the health and safety of the American public by regulating the manufacture and distribution of all drugs shipped or received in interstate commerce. The Food and Drug Administration (“FDA”) was the federal agency charged with enforcing the FDCA.

NOTES: First of all, NONE of Sam’s products contain any drugs. Zero. The FDA tested all his products and confirmed that there are no drugs in his products!

While the FDA/FDCA can make labeling demands, they can’t accuse Sam of a crime having to do with manufacture or distribution of drugs if there aren’t any drugs in it. Once Sam changed his label to comply and once there were no drugs found in the ANY of the products, the FDA lost whatever jurisdiction it claimed. Yet they persist… why is this allowed?

3. The FDCA required persons who owned or operated an establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a drug to register annually with the FDA. See 21 U.S.C. §§ 360(b)(l), (c)(l). Every establishment in which a drug was manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction was subject to inspection by the FDA. See 21 U.S.C. §§ 360(h)(l) and 374. GIROD did not register his establishment with the FDA.

NOTES: No drugs so no requirement to register the establishment (which, by the way, is the Girod home).

4. GIROD manufactured and distributed a product called “Chickweed Healing Salve.” This product typically bore labeling claiming that the product was “[g]ood for skin disorders. Dry skin, cuts, burns, draws, and poison ivy.” In many cases, GIROD also distributed sales pamphlets touting the product’s effectiveness in treating skin cancer, diaper rash, fungus infections, and various other skin ailments.

NOTES: Per FDA demands, Sam changed his product labels for everything sold to the public. He even took the word “healing” off, so this is a moot point. Why is this mentioned?

5. GIROD manufactured and distributed a product called “TO-MOR-GONE.” This product typically bore labeling identifying the product as a “black salve” and a “natural herbal remedy.” In many cases, GIROD also distributed sales pamphlets touting the product’s effectiveness in removing warts, moles, and other skin growths, and stating: “TO-MOR-GONE is very good at removing tumors.” GIROD used an extract of the bloodroot plant (Sanguiniaria Canadensis) in TO-MOR-GONE. This ingredient was an escharotic agent, meaning that it had a caustic, corrosive effect on human skin.

NOTES: Again, he changed the label when told to do so. Bloodroot is not a drug, either, btw. It’s a PLANT used for thousands of years for HEALING purposes. Like a lot of other plants.

Yes, bloodroot can have a caustic, corrosive effect on human skin, but that’s why we use it, lol. Bloodroot cures skin cancer because it burns off the cells. It’s also a drawing compound so it pulls the cancer cells to the surface, then kills them. People even take the stuff internally.

And it’s legal, sold all over the world. Google it.

I and many of my friends have used bloodroot for years for small skin cancers, moles, small growths. Works like a charm and doesn’t leave a scar. Amazing stuff. I got mine (before I knew Sam) from altcancer.com formulated by Greg Caton, the first guy the FDA put in jail for bloodroot products (scroll down the altcancer.com page for that info).

6. GIROD manufactured and distributed a product called “R.E.P.” This product typically bore labeling that instructed the consumer as follows: “For sinus infection, put on forehead and cheeks. For breath freshener put drop on tongue.” In many cases, GIROD also distributed sales pamphlets touting the product’s effectiveness in treating sinus infections, cold symptoms, and sore throats.

NOTES: Again, Sam took all the healing claims out of his literature for all products sold to the public.

Sine Eze (the new name for R.E.P.) is amazing, by the way, a blend of essential oils. Love the stuff. Seriously. This has been sold for over 20 years, no drugs in it, Sam took all the healing claims out of the literature… where’s the beef?

7. The FDCA defined a “drug” as an article that was: (a) intended for use in the diagnosis. cure, mitigation, treatment, or prevention of disease in man; and/or (b) intended to affect the structure or any function of the body of man. See 21 U.S.C. § 321(g)(l)(B) and (C). Chickweed Healing Salve, TO-MOR-GONE, and R.E.P., were “drugs,” as defined within the FDCA.

NOTES: When Sam removed the offending language, those products were no longer able to be classified as drugs by the FDCA. Again, the products were all tested by the FDA and no drugs were found.

8. The FDCA prohibited the introduction or delivery for introduction into interstate commerce (or the causing thereof) of any drug that was misbranded. See 21 U.S.C. § 33 l(a).

NOTES: Not drugs, branding corrected, no longer subject to FDCA/FDA regulations.

9. A drug was misbranded if it was manufactured, prepared, propagated, compounded, or processed in an establishment that was not registered with the FDA. See 21 U.S.C. § 352(0). Chickweed Healing Salve, TO-MOR-GONE, and R.E.P. were each manufactured, prepared, propagated, and processed in GIROD’s unregistered establishment and, thus, were each misbranded.

NOTES: Not drugs so establishment not required to be registered.

10. A drug was also misbranded unless its labeling contained “adequate directions for use.” 21 U.S.C. § 352(f)(l). Adequate directions for use were directions under which a layman “can use a drug safely and for the purposes for which it is intended.” 21 C.F.R. § 201.5. Chickweed Healing Salve and TO-MOR-GONE did not bear labeling containing adequate directions for use and, thus, were each misbranded.

NOTES: Not drugs so this requirement does not apply.

11. A drug was also misbranded unless its labeling contained a listing of each active ingredient. See 21 U.S.C. § 352(e)(l)(A)(ii). R.E.P. did not bear labeling that contained a listing of each active ingredient and, thus, was misbranded.

NOTES: Not drugs so labeling requirements do not apply.

12. A drug was also misbranded unless its labeling contained “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.” 21 U.S.C. § 352(f)(2). TO-MOR-GONE did not bear labeling warning of its caustic, corrosive effect on human skin and the scarring that could result. TO-MOR-GONE also did not bear labeling warning against its exclusive use to treat skin cancer. As such, TO-MOR-GONE was misbranded.

NOTES: Not a drug so labeling requirements do not apply. If bloodroot has its own requirements for labeling, I can’t find those requirements. That said, Sam has always complied with every labeling requirement for all products sold to the public and remains committed to doing so.

13. A drug was also misbranded if it was “dangerous to health when used in the dosage or manner, or with the frequency or duration prescribed, recommended, or suggested in the labeling thereof.” 21 U.S.C. § 352(j). TO-MOR-GONE was dangerous to health when used in the dosage, manner, frequency, and duration that was recommended and suggested in the labeling and, thus, was misbranded.

NOTES: Not a drug, not even bloodroot salve is a drug. If it’s dangerous, the FDA must PROVE it. They haven’t. They just like saying it.

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.

NOTES: Sam obeyed a and b of injunction as follows:
a) Changed the labeling on all products sold to the public as ordered.
b) Stopped making the salve. I’m not sure how the FDA can require this since there are bloodroot salves for sale online… even on Amazon. 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 which establish this fact.
c) He had allowed an inspection in early 2013, about 3 or 4 months prior to the injunction. At that first inspection, Sam requested no cameras. The FDA agents said no problem. Then they got on the property and whipped out their cameras, taking pictures of everything. When the agents came back AFTER the injunction for that 2nd inspection, Sam refused them entry because they lied the first time. Sam said that nothing had changed in the few months since the the previous search.

That’s when the trouble began in earnest for Sam.

15. The injunction pennitted [FDA typo] the FDA to inspect GIROD’s establishment, without prior notice and when reasonably deemed necessary, for five years from the date of entry of the order. Among other things, the injunction provided that these inspections would include reasonable and immediate access to buildings, equipment, raw ingredients, in-process materials, finished products, containers, packing material, labeling, and other material therein.

NOTES: Really? What gives the judge the authority to allow searches for products outside of FDA jurisdiction? And for FIVE YEARS?

16. Following the injunction, GIROD continued to manufacture, market, and distribute, in interstate commerce, Chickweed Healing Salve, TO-MOR-GONE, R.E.P., and other products similar in composition and effect. GIROD did not inform the purchasers of these products that he was under a court ordered injunction and was prohibited from distributing these products.

Yes, he did continue to sell his products. However — all together now — these products are not drugs so outside FDA jurisdiction. Unfortunately for Sam, he knows his constitutional rights. IMO, he didn’t realize how vicious are the thugs he is dealing with. Nobody knows until you get into the weeds with them.

<End of BACKGROUND. Now the COUNTS (charges).>

COUNT 1 18 u.s.c. § 372

Not more than 6 years imprisonment, $250,000 fine, and 3 years supervised release

17. Paragraphs 1 through 16 of this Indictment are re-alleged and incorporated by reference as though fully set forth herein. [This phrase is repeated throughout, I guess a bureaucratic requirement.]

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 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.

MANNER AND MEANS OF THE CONSPIRACY
The manner and means used to accomplish the objectives of the conspiracy included, among others, the following:

19. Members of the conspiracy, including GIROD, physically surrounded N.L.P. and M.D.S. when they arrived to inspect GIROD’s establishment pursuant to the injunction.

NOTES: The Amish surround everyone who visits. They like to hear the conversation, they like to participate and to ask questions. They are not shy, nor are they armed or threatening in any way shape or form. This claim is positively ludicrous. Go visit an Amish family or church and start a lively conversation. You’ll be surrounded shortly.

Oh, and one of the “members of the conspiracy” was a Bath County KY Sheriff’s deputy who was there to protect Sam from federal harassment.

20. Members of the conspiracy, including GIROD, obstructed N.L.P.’s and M.D.S.’s attempts to gather information about GIROD’s establishment.

21. Members of the conspiracy, including GIROD, prevented N.L.P. and M.D.S. from inspecting GIROD’s establishment.

Re. 20 and 21: This was the SECOND INSPECTION. At the first inspection 3-4 months earlier, FDA agents demanded a warrant-less inspection. Sam said ok with one condition: that the agents not take photos because the Amish don’t allow photos. The agents agreed to the no photos stipulation. Sam let them on the property and the agents whipped out their cameras and took photos of everything! So at this SECOND INSPECTION, Sam told the feds, “No, you can’t inspect. You lied last time.”

22. Members of the conspiracy, including GIROD, demanded that N.L.P. and M.D.S. leave GIROD’s establishment. All in violation of 18 U.S.C. § 372.

Actually, it was a Bath County Sheriff’s deputy who told the feds to leave the property. I believe his exact word were, “There’s the road.” Why hasn’t the deputy been indicted as part of the conspiracy?

COUNT 2 18 u.s.c. § 1505

Not more than 5 years imprisonment, $250,000 fine, and 3 years supervised release.

23. Paragraphs 1 through 22 of this Indictment are re-alleged and incorporated by reference as though fully set forth herein.

24. On or about November 21, 2013, in Bath County, in the Eastern District of Kentucky, SAMUEL A. GIROD corruptly, by threats and force, and by threatening communication, influenced, obstructed and impeded, and endeavored to influence, obstruct, and impede the due and proper administration of the law under which a pending proceeding was being had before the FDA, all in violation of 18 U.S.C. § 1505.

NOTES: This is like a repeat of Count 1… By threats and force? Not Sam and not his family. You can bring in character witnesses galore to prove that. Heck, I’ll bet even the jailers will be testifying on Sam’s behalf after his vacay at the prison on Old Frankfort Pike.

COUNT 3 21 u.s.c. § 33l(p)

Not more than 3 years imprisonment, $250,000 fine, and I year supervised release.

25. Paragraphs I through 22 of this Indictment are re-alleged and incorporated by reference as though fully set forth herein.

26. In or about September 2013, and continuing through in or about July 2015, in Bath County, in the Eastern District of Kentucky, SAMUEL A. GIROD, with the intent to defraud or mislead, operated an establishment at 409 Satterfield Lane, Owingsville, KY 40360, at which location GIROD manufactured, prepared, propagated, and processed Chickweed Healing Salve, TO-MOR-GONE, R.E.P., and products similar in composition and effect, and which GIROD had failed to register with the United States Food and Drug Administration in accordance with 21 U.S.C. § 360, all in violation of 21 U.S.C. §§ 33 l(p) and 333(a)(2).

NOTES: In Counts 3-11, the feds are saying that Sam, with intent to defraud, sold a quantity of the 3 products over state lines; that he failed to register his establishment; that the labeling did not meet FDA guidelines.

Again, long before this indictment, Sam took all health claims off his products for sale to the public. Sam has followed and will continue to follow labeling requirements for products sold to the public.

Again, the FDA tested all the products and determined that there are no drugs in the products, they are all natural ingredients. Since Sam’s products are not drugs, they are not subject to FDA regulations. This includes not having to register his establishment — that is only a requirement for drug manufacturing.

[Counts 4-11 are basically repeats of Count 3 for various products on various dates. To save space, they are included in full at the bottom of this post.]

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 denies he tampered with any witness and does not know who M.M. is. The Amish don’t threaten. {Mary Miller is revealed on Day 2 of the trial here: http://www.kyfreepress.com/2017/03/trial-fda-v-samuel-girod-day-2/. She did not want to testify, obviously a friend to Sam, did not feel threatened or corrupted by him.}

</end of Indictment>

PENALTIES
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 I year supervised release.
COUNT 12: Not more than 20 years imprisonment, $250,000 fine, and 3 years supervised release.
PLUS: Mandatory special assessment of $100 per count.
PLUS: Restitution, if applicable.

Counts 4-11 are below, basically repeats of Count 3 for various products on various dates. The penalty for all these counts is the same: not more than 3 years imprisonment, $250,000 fine, and I year supervised release.

COUNT 4 21 U.S.C. § 331(a)

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 of21 U.S.C. §§ 33l(a) and 333(a)(2).

COUNT 5 21 U.S.C. § 331(a)

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).

COUNT 6 21 U.S.C. § 33l(a)

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 fonn, 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 of21 U.S.C. §§ 33l(a) and 333(a)(2).

COUNT 7 21 U.S.C. § 331(a)

34. 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 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).

COUNT 8 21 U.S.C. § 331(a)

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).

COUNT 9 21 U.S.C. § 331(a)

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).

COUNT 10 21 U.S.C. § 331(a)

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).

COUNT 11 21 U.S.C. § 331(a)

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, 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).


SAM’S DEFENSE

We’ve been waiting the entire trial for Sam to defend himself. Because Sam represented himself, it would look silly for him to ask himself questions, so Sam wrote the questions for himself in advance, the public defender posed the questions to Sam, and Sam answered each question in his own words. There were approximately four or five questions. Sam described himself and his family, a wife, 12 children including five boys still at home, and 27 grandchildren. He described the start of his business. In 1999 he watched his mother cooking chickweed and became intrigued by the herbal properties as this subject has always interested him. He made approximately a gallon of chickweed salve and gave most of it away to friends and family members. He initially had no intention to sell any products, but he was urged to do so by people who were pleased with the salve.

Sam described the FDA coming to his home in Indiana and objecting to the skin cancer claim so he removed that from the label. Sam asked if they had any other concerns and was told they would like to think about it for a week. They never responded. After a few weeks, Sam contacted them and they didn’t reply.

Sam refuted the claim that the Amish were physically intimidating. He explained that they would never intimidate or threaten anyone. Anybody with even a passing familiarity with the Amish would know that to be the truth. He also stressed that nobody cursed at the FDA agents, as that is something they do not do.

Sam stated that he never harmed anybody and never acted to deceive anybody.

Sam explained that he never threatened or intimidated Mary Miller to prevent her from providing evidence to a grand jury. They had discussed the matter because she had no prior dealings with the FDA and in fact that was the last thing this Amish woman wanted, and Sam felt bad that his actions had inadvertently drawn the FDA’s attention to Mary. Sam followed up with a letter to several customers and business associates in a letter addressed to “Friends”. He stated in the letter that everyone was free to do whatever they wanted to do. From the federal government’s perspective it was inappropriate for Sam to contact them, but he was reaching out to confused and very worried friends with whom he had a close personal business relationship. He was trying to explain what was happening to the best of his understanding. A subpoena from the federal government is a terrifying thing to an Amish person. It was obvious from the testimony of all of the FDA’s subpoenaed witnesses that they did feel threatened and intimidated… by the FDA. They were clearly on Sam’s side, even though they were being compelled to testify against him.

Sam admitted to receiving the letter announcing his status hearing, but he didn’t understand that he was required to attend the status hearing. Previous letters specifically instructed Sam to appear but this one did not. Sam believed this status letter to be informational, so he could attend if he chose to do so. To him, it seemed like the announcement of a procedural meeting pertaining to his case that constituted internal court business. Sam became convinced that he was not going to get a fair trial in this court and filed a motion to have his case moved to the 6th Court of Appeals. He had a manager at the 6th Court of Appeals sign when he filed his motion. After that, Sam considered his case to be in the appeals court. When he received a letter from the US District Court, Sam marked RETURN TO SENDER on the envelope and returned it unopened, believing that the district court had not yet been notified of the change of venue by the appeals court.

When the problems first surfaced with the FDA, some time around 2003, Sam hired a lawyer and his lawyer hired an FDA approved lab to test Sam’s products. The FDA also tested Sam’s products in their own lab using liquid chromatography and mass spectroscopy. Both labs reached the same conclusions. The ingredients matched the label’s ingredients list, the samples did not contain any drugs as commonly defined or any alkaloids or poisons, and the samples from different containers of the same product were consistent. In 2003 and 2004, the FDA requested more label changes and Sam made the changes, removing all health claims and only listing the ingredients on the label.

Sam’s testimony made a few points that needed to be made to indicate what he was thinking and why he did what he did in good faith and with malice toward nobody, but the information was presented in a seemingly random order and was not very compelling, particularly after the prosecutor had spent two days, unopposed, maligning Sam as a greedy lawless profiteer whose unregulated products were dangerous.

SAM’S CLOSING ARGUMENTS

Sam made simple declaratory statements of truth.

“There was never an injured party in this case.”

“I’m not dealing with drugs. Their testing will show that.”

“I did not purposefully or knowingly violate one law. That’s not what I do.”

“I changed the labels on different times but I kept getting harassed.”

“Most of all, it’s taken some of our freedom away.”

THE VERDICT

The officers of the court appeared nervous when the 32 court watchers filed into the court to hear the verdict, with a small overflow crowd in the hallway outside the small courtroom. We were repeatedly warned to maintain order, no matter what they verdict may be. They are apparently not too accustomed to having the public take any interest in these federal court cases, and they seemed to be anticipating a guilty verdict and an angry mob, even though most of the court watchers were Amish and none of the court watchers had demonstrated the slightest evidence of prior misconduct.

The jury returned guilty verdicts on all 13 charges. Not only that, but they found Sam guilty of each separate part of each count, even when only one part would be needed to make Sam guilty of that count against him.

The jury was polled and asked if the verdict as read represents their verdict in this case, and each answered, “Yes.”

The judge will sentence Sam at 10:00 AM on Friday, June 16th 2017. Until then, Sam will presumably be incarcerated in the Fayette County Detention Center.


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