Source: https://newspunch.com/amish-man-jailed-herbal-remedy/
Timestamp: 2019-04-19 04:19:47+00:00

Document:
Amish farmer and grandfather Sam Girod has been thrown in jail and is being prosecuted by the FDA for making herbal remedies in his home.
Mr. Girod of Owingsville, Kentucky lives on a farm with his wife, 12 children and 25 grandchildren. They practice a traditional Amish way of life and that includes the production of many healing herbal salves and remedies.
The herbs that have been healing members of the Girod family for over a century cannot be put in bottles with the word “healing” on them, according to the FDA.
The FDA hates the Amish and 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.
My notes are indented and in italics.
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. 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.
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.
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.
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)?

References: § 301
 § 321
 § 33
 § 352
 § 352
 § 201
 § 352
 § 352
 § 352