FDA Seeking Life In Prison for Amish Salve Maker

My apologies for only just hearing about this. The man is being rail roaded and it’s all very life threatening. Please click through the link and scan the entire article. There is a petition to sign that is linked at the top of the source page. Not sure how much good it will do, but an outcry is the smallest response anyone with a conscience could find acceptable:

KY Amish Farmer Jailed over a Salve Label; the FDA Wants Him Jailed for Life

But then the FDA fixated on him and just would not let go. You’ll see in the indictment. In my line of hobby work (political blogging), I’ve seen this over and over and over again. An alphabet agency gets you in its sights and just will not quit.

And why would they quit? No skin off their teeth and gives them something to do. State agencies are bad enough, but the feds… the feds are especially lawless. There is no accountability in a federal agency, they break their own rules as a matter of course.

I have a little inside info on why this persecution is taking place plus a couple of questions. “Inside info” because I’m involved in food and health freedom, so aware of persecution of other farmers around the country.

The first thing of note is that, when it comes to powerful well-funded federal agencies looking to set precedent, the Amish have a special target on their backs. Why? Because they generally don’t use lawyers which makes them easy prey. They don’t use lawyers because the Amish are self-sufficient, they know their constitutional rights and they are a peaceful community. They don’t fight back (unless lives are at stake).

The FDA is also after an enormously successful Amish farm in PA, Miller’s Organic Farm. Like Sam, the Millers have established a private club whereby only members can purchase products. As a member of Miller’s Organic Farm, I can order anything I want, including raw milk, that can be shipped to me anywhere in the country. (Read up on the Miller’s case here.)

The FDA hates private membership clubs because club sales and products are NOT subject to FDA rules and regulations! Private memberships are protected under the Constitution’s contract clause. I can contract with anyone I want, sell them anything I made or produced, and the state may not interfere. The state, of course, hates this kind of freedom and will do anything it can to pierce that veil. Including bankrupting businesses and jailing a peaceful farmer for the rest of his life.

The FDA also seems to have a special soft spot for bloodroot salves. They’ve been persecuting makers of bloodroot salves for decades, starting with Greg Caton, jailing him twice and driving him from the country. A quick search brought up this company as well.

Two questions:

1. Why was Sam kept handcuffed during the hearing on Friday. Was he a flight risk or a danger to anyone? IMO, the gov was attempting to show Sam who’s the boss. Newsflash: the gov is not Sam’s boss.
2. Why did the FDA wait so long to formally charge Sam? Most of his alleged crimes (Counts 1-11) took place between 9/2013 and 1/2014 with the M.M. situation (Count 12) in 12/2014. If Sam is so dangerous that he needs to be jailed for life… why did they wait for years to charge him?

Here comes the Girod indictment.

This is pretty long but a lot the counts are basically repeats with different dates. The gov likes to pad the bill so the defendant will take a plea.

Remember, folks, we are talking about a Chickweed Salve here along with two other equally benign, non-drug products that are for sale all over the world, that I and my friends have used with no ill-effects (in fact, to good effect). 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 (and, in this case, firearm)?

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)

• 1-16 are BACKGROUND.
• 17-44 are the COUNTS (charges)
• My notes are indented and in italics.
• Total possible prison time is 58 years

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: Ok. I’ve changed my business name more times than Carters got pills. Not a crime yet. Sam’s products are effective and have never hurt anyone. And, if they have hurt anyone, prove it and Sam can make restitution.

Ya know, if one person was harmed in 20+ years of thousands of people using Sam’s products, I’d say that was a pretty good track record. Hey, I know! Let’s compare that to Big Pharma’s drug safety record, ok? Even aspirin kills 11 people a year. Every. Single. Year. And then there’s this: http://bit.ly/deathbydoctor Just sayin’.

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 Sam had an independent lab test all his products. No drugs. THIS IS CRITICAL. No drugs in anything.

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.

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.

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 moot point.

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.

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.

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.

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: 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. Plus, the products were all tested by Sam and the FDA and no actual 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: See previous NOTES.

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 the 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.
c) Allowed the inspection. I’m wondering where the FDA gets its authority to demand a search when the products don’t fall under their jurisdiction?
d) Stopped manufacturing, processing, packaging, labeling, holding, selling, or distributing certain products until a, b and c were met. He’s still not doing any manufacturing or selling which, of course, puts a cramp in the family finances.

Wondering also where the FDA gets its authority to enforce an injunction when products don’t fall under its jurisdiction.

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 FDA the authority to demand this for products outside of their jurisdiction? Yes, I’m asking the same question over and over again.

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.

NOTES: I don’t believe this is true, that Sam defied the injunction, but there are a couple of points to be made here:
1. All together now: these products are not drugs so outside FDA jurisdiction.
2. There were stores all over the country selling Sam’s products. He didn’t know the names of all these stores or even the sellers. Sometimes people would come to Sam and buy lots of bulk product and drive away. That those products were still on the shelves in Podunk, Alaska is simply out of Sam’s control.
3. In the COUNTS below are several claims by the FDA that Sam continued to sell product to the public. I don’t know if that’s true but I doubt it. Sam stopped selling to the public. He did have a private membership club. That is perfectly legal although the FDA hates these clubs. Maybe these sales were through the club and the FDA is neglecting to mention that?
4. Of note is that, at this moment, the FDA is also pursuing Miller’s Organic Farm in PA for selling raw milk and organic home-processed foods all over the country. The Millers do this through their private membership club. The FDA wants to pierce this and end these clubs once and for all.
5. Remember that we are talking about a Chickweed Salve here. Is the purpose of this indictment to protect the public or to punish those citizens who don’t kneel at the pointy end of a bureaucrat’s pen (and, in this case, firearm)?

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.

I don’t know the details on the following 3 points but I can tell you that Sam and his family are always polite and non-threatening. You have to know them… I do.

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.

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.

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: By threats and force? Not Sam. You can bring in character witnesses galore. I’ll bet even the jailers will be testifying on his 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: Didn’t we just cover this? NOT DRUGS, so NOT UNDER FDA jurisdiction.

COUNT 4 21 U.S.C. § 331(a)

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

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

NOTES: They are saying that Sam — with intent to defraud — sold a quantity of Chickweed Salve over state lines. So, again, not a drug therefore not subject to FDA regulations with regard to registering his establishment and labeling.

COUNT 5 21 U.S.C. § 331(a)

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

29. Paragraphs I 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).

NOTES: Not a drug therefore not subject to FDA regulations.

COUNT 6 21 U.S.C. § 33l(a)

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

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

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).

NOTES: Same as above only for TO-MOR-GONE which contains bloodroot. Sam complied with all labeling requirements. Are there specific labeling requirements for bloodroot salve? I don’t know. I am confident Sam would comply with those, too.

COUNT 7 21 U.S.C. § 331(a)

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

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

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).

NOTES: All together now: not a drug, not under the purview of the FDA.

“We trade real labor for fake money to pay fraudulent taxes on stuff we don’t own.” ==Doreen Hannes