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Federal Overreach: Amish Man Sentenced to 6 Years in Prison for Improper FDA Labeling
Samuel Girod of Bath County, KY, is an Amish farmer who sold homemade herbal remedies. The FDA saw to it he would spend the next six years in federal prison.
The 56-year-old man created a salve made of chickweed, rosemary, beeswax, and olive oil. The label said it was to treat skin disorders such as “dry skin, cuts, burns, draws, and poison ivy.” Girod also handed out pamphlets touting the product’s effectiveness in treating skin cancer, diaper rash, and fungal infections.
When a Missouri resident filed a complaint, the state health department demanded he remove the language. Girod changed the product’s name to “Healing Chickweed,” agents said the word “healing” was verboten, so he renamed it “Original Chickweed.”
Another of Girod’s products, called TO-MOR-GONE, contains bloodroot and was claimed to be “very good at removing tumors.” This old folk remedy has been practiced for centuries, mostly to remove dead skin layers from around skin tumors and wounds. But bloodroot removes this dead skin due to its caustic properties. The FDA decided this was a danger to the public and demanded to inspect his manufacturing process — in other words, his home.
Girod, stating that his products weren’t subject to FDA oversight because they were herbal remedies, barred their entry. As part of the Old Order Amish community, his religious beliefs mandate that he avoid the modern world as much as possible, including modern pharmaceuticals. Nevertheless, the FDA decided that since Girod made vague medical claims, his products were drugs and subject to the full weight of the federal bureaucracy.
In August of last year, Girod missed a status hearing. This led the federal government to label him a fugitive and they arrested him at his family farm. He was held without bail as the trial proceeded.
Bath County Sheriff John Snedegar petitioned the feds, asking why the FDA was “attacking and victimizing such peaceful and law-abiding Americans,” adding he “would not stand by while the rights of peaceful people are violated.”
Local residents agreed with their sheriff. “I can’t even figure out what he has done wrong,” said neighbor Suza Moody. “They live at the foot of the cross and the thought of one of them intentionally doing something wrong is outrageous.” An online petition generated more than 27,000 signatures seeking his immediate release.
Acting as his own counsel, Girod refused to submit to the federal yoke. “I am not a creation of state/government, as such I am not within its jurisdiction,” he wrote. “The proceedings of the ‘United States District Court’ cannot be applied within the jurisdiction of the ‘State of Kentucky.’”
When the judge asked him to make a statement, Girod said, “I do not waive my immunity to this court. I do not consent.”
As a result, the father to 12 and grandfather to 25 has been sentenced to six years in federal prison, three years supervised release following that, $1,300 in fines, and more than $14,000 restitution for his victimless crime. All because beltway bureaucrats didn’t like an Amish farmer’s homemade labels.Published in General
Federal judges (with lifetime appointments) really really really really do not like, at all, criminal defendants who blow off court dates, and so he was picked up and held without bail. Strike One.
Then, federal judges really really really really do not like, at all, criminal defendants who denounce their authority to their face. Strike Two.
Finally, federal judges really really really really do not like, at all, criminal defendants who refuse to accept any responsibility in the face of their conviction. Strike Three.
Probably influenced the judge at sentencing time toward the upper end of the sentencing range.
And that’s how a guy can end up in the slammer for 6 years in a case like this.
What part of this is petty tyranny?
Just because he’s Amish he should be immune from peddling fraudulent miracle cures across state lines? What other crimes should he be immune to because of his religion?
I’ll admit, since you’re pressing, that I don’t know enough about the details of this case to know whether my statement applies here. But I still think it’s a true statement in general, for all the other documented examples of petty tyranny that are easy to find.
Let’s say Mr Girod’s behaviour amounted to the intentional perversion of truth for the purpose of gain at the expense of another person. Surely this is criminal in each of the states in which he operated. Why make a Federal case out of it?
They’ve worked out accommodations with the feds when it comes to military service and social security. Before that happened, a number of them served some jail time, at least in the case of military service.
Maybe the courts could hire some of those consultants who help businesses achieve a less hostile workplace environment. Judges could learn to check their privilege.
Only if you will do a little research on boiled Willow bark as a cure for headache.
Since you issued the challenge, I will accept your research first, along with your opinion as to whether or not the FDA should have a role in preventing boiled Willow bark from coming to market.
I will then conduct independent research via a literature review of Blackroot as a cure for cancer. My only caveat is that I will spend no more than $10 USD to conduct such research.
All these herbs are commonly available in drug stores but can cause birth defects and miscarriage:
The federal government exists to deal with problems that cross state lines, including criminals. I don’t see how even the most fundamentalist, these-words-are-ordained-by-God reading of the Constitution can read otherwise.
Nope. Call me the most fundamentalist, these-words-are-ordained-by-God reader of the Constitution, but I just don’t see it. Was he counterfeiting the Securities and current Coin of the United States? Was he engaging in Piracies and Felonies committed on the high Seas, and Offences against the Law of Nations? Was he in the Navy? Or operating in the District of Columbia? Or evading import restrictions? Or destroying post roads?
Nevertheless, regardless of what the Constitution allows, ought this to be something that requires Federal intervention? No. Thousands, if not millions, of matters are perfectly adequately co-ordinated by sovereign nations with no overarching supra-national body to take charge. Even countries at war manage these things.
I don’t understand why you’re listing the various sections of the Constitution that do not give the Federal Government the power to regulate interstate commerce when there is one that does. In state law matters, the fact that a particular inmate has not molested corpses, violated seatbelt laws, or invaded homes is not a defense against fraudulent sales charges. If your argument is that the Commerce Clause does not give the Feds the ability to regulate interstate commerce, or that this is not an example of that, I’d be keen to know more about your reasoning, ideally with a nod to an authority.
If, instead, cases had been brought by Kentucky, Missouri, Wisconsin, and Illinois, do you believe that this would have presented a lower burden on Girod? Would taxpayers have been less burdened? Would prosecutors have been more likely to arrive at a fair decision if they had four bites at the apple rather than one? It seems to me that there are obvious advantages to having the Federal government be primarily responsible for adjudicating multistate offenses even before one starts to get into the problems with home state bias that motivated so much of the Constitution’s concern with these issues. I’m not familiar with a benefit to having postal retailers traveling to many states to face many different tribunals implementing many different laws.
In this case there is the additional concern that the local sheriff’s department appeared to be keen to resist investigation; if the trials were all held in foreign states, there’s a very good chance that Girod would not have turned up despite their having jurisdiction. Trials of this sort, with bifurcated proceedings for the substance and the enforcement, are less likely to arrive at fair conclusions (it is generally helpful to the interest of justice for the defense to mount a meaningful case) and more expensive to run. Fights between the states aren’t an insurmountable problem, but the political resolution of justice is less likely to lead to a solid rule of law than the judicial resolution of cases.
That’s fair. You’re right in your implied hope that I’m not keen to research willow bark as a cure for headaches.
If you had, you would find that willow bark is the original home remedy and the source for aspirin.
You know, the headache remedy that is now regulated as a drug by the FDA.
By the way, when one of the updates to the law was passed (in recent decades) there was a caveat that exempted home remedies and herbal concoctions, provided it had been known and in use prior to a certain date.
Must have gotten lost in the update.
JoE if you are going to refer to to the “commerce” clause in the US constitution, please tell me where Mr Girod is considered either a State, Foreign Government or an Indian Tribe. Prior to the expansion of the commerce clause in the Wickard case, the power was reserved to the Federal government “To regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes.” – in other words, it was a check on state power, not on individual action.
Not quite right. The Commerce Clause allowed the Federal Government to set the rules under which trade would happen across state lines -blanketly banning state level infringements on trade across borders by elevating those policies to the federal level. It did not prevent the Federal Government from regulating private trades across state borders -see for example Gibbons v. Ogden, 1824. You can also consult the contemporary statements from the founders regarding the trade war between Connecticut, Massachusetts, and Rhode Island, though I don’t have ready links to them.
Missouri is prohibited from enforcing its fraud statutes on Kentucky, therefore Missouri’s only remedy is for the Federal Government to regulate. It has. The point in question is whether the law being applied actually covers the facts of the case. As I’m normally happy to believe juries screw up from time to time, I don’t take the jury’s verdict to be the end of the discussion. As described, this sounds like a regulatory infraction (improper labeling) being enforced via criminal law (fraud) by an agency who’s jurisdiction over the case is questionable to begin with (FDA stepping on the FTC’s territory) and has not actually given a reason that the items in question are within their purview, except ipse dixit. Bloodroot may be dangerous -that is not the FDA’s call. Their jurisdiction does not cover dangerous objects that are not classified as drugs in the statute -bloodroot is not so classified. This is the FTC’s call. They have not made it.
I don’t have strong opinions on the case one way or the other -my current take is that it seems a bad lawyer representing himself tanked his case and pissed off a judge. (Non-)Lawyer who represents himself has a fool for a client and all that. But the FDA’s complaint does not actually prove its jurisdiction, it asserts it, nor does it explain why herbs that have been used from this particular seller for decades, and by Americans since before the founding, are classified as drugs despite the actual language of the statute -again, only asserting them. Nor demonstrated that the products were anything other than what their labels said -again, only asserting the fraud.
Girod’s problems stem entirely from not actually mounting these defenses.
The case for calling this FDA overreach is non-trivial, but not particularly firm.
Count me with those who think this a good case for executive clemency.
Your understanding is that the Commerce Clause allowed Congress to regulate government procurement procedures for the state governments when they called for purchases from other state governments also acting in a commercial capacity? I take it you agree that this has explicitly not been the understanding of US courts from 1824 onwards and that there is no explicit support for this understanding from the courts at any time?
In the 4th Congress, this law was passed regarding trade with the Indian Tribes. You will note that “trade with the tribes” here means trade with members of those tribes. This is not a matter of governmental relations, but of selling things to “with any Indian or Indians whatever”.
Do you have contrary authorities to cite? I’m happy to accept that the Court and early Congress may have been wrong in their understanding of the text, but I feel like there needs to be a little support for the claim.
I’m not clear what you’re claiming here. Is it your understanding that I was claiming that no “natural” remedy has any useful impact? If so, I should be clear that I fully accept that there are many natural products that have all kinds of medicinal properties.
Are you claiming that it is, as a result, impossible to commit fraud by claiming cancer curing abilities? If this case is not fraudulent, what sort of a medical commercial case would seem fraudulent to you?
I’m not sure I follow. How do Girod’s products not fall within 21 U.S. Code § 321 (g)(1)(B)? I understand how they don’t fit into (A) as you describe, but my understanding was that (B) was the reason for the disclaimers placed by law abiding Americans on their quack products.
This is the point in question -whether these are quack products within the jurisdiction of the FDA.
Right. That’s why I cited and linked to the part of the statute that I believe suggests that they are.
Edit: To be more explicit, with the disclaimer it would not be. Without, I believe that it is. Hence the use of the disclaimer. If you can’t pass FDA muster, you want to avoid having that be a question.
I have no opinion on the burden. I do think it would be possible for these various States to take different views as to caveat emptor, for example. If he had killed someone in each of these States, would it be open for different States to come to different conclusions (because of different ideas about self-defence, for example)? (I’m assuming a different fact pattern, obviously.)
Really? Home state bias?
I counter your ‘obvious advantages’ with ‘obvious disadvantages’, where the advantages are technocratic, and the disadvantages implicate the relationship between state and citizen.
Right. According to the linked stories, the disclaimers were added and the medical claims removed, which shifts the product to (if I read the statute correctly) 21 USC section 343(r)(1)(B), which removes it from FDA jurisdiction.
It is true that they could be different. Given that it seems unlikely that Girod would have gone to a lot of effort to research the law in the various states in sensible ways, do you believe that there would have been a practical advantage to this?
It’s hard to see it being so big a deal today, but the vicinage clause in the 6th Amendment and quite a lot of civil procedure is based on this stuff. You still see it occasionally in cases like Loewen, a NAFTA case in which a Canadian funeral company was found against in part because a ridiculous speech about how the capitalist Canadians were trying to force their values on honest Louisianans. When one opens up these cases, a fair number of the trials of foreigners were clearly parts of scams, often involving the judge (Pennoyer v Neff being the most famous).
I’m not sure that it’s helpful for the relationship between state and citizen for Girod to be hauled to be tried in dozens of states; that sounds like the sort of burden that would exclude people from interstate commerce until they availed themselves of an Amazon or other larger partner. It’s helpful from a state-citizen perspective to have the law being accessible and understandable to all. This is particularly the case when the law is expensive or otherwise difficult to comply with.
The Home State Bias problem wasn’t a hypothetical, and the courts were dealing with it well into the late 19th century, if not later. The above mentioned Ogdon case dealt with New York government and courts favoring New Yorkers against residents from out of state, and this in turn drew reprisals from New Jersey. I don’t know if it would be a problem today, but if it is not a problem today, part of the reason is probably that the federal courts spent decades stamping it out.
As I understand it, the name of the “chickweed healing salve” was twice changed, but I see no claims that disclaimers were added. The government says explicitly that they were not, and that the marketing was the same. The jury came to the same conclusion as the government. More importantly, he does not even pretend to have complied with the injunction to stop producing and selling his goods. With the FDA having jurisdiction over the first case, it would be normal for them to have continuing jurisdiction to enforce the holding.
Apparently he came to view the FDA as evil at some point along the process, and complains that they would not help him design compliant labeling. Since it was not legal for him to produce or sell the stuff by that stage no matter what the labeling, I can understand why the FDA would not be keen to help him do so.
It’s the difference between whether or not the lawyers and bureaucrats will make a living out of this stuff.
Whether the injunction was proper is the point being debated. To state that the FDA followed its own rules and that a jury agreed the FDA followed its own rules is begging the question of whether those rules are proper ones for the FDA to follow in the first place given that we are talking about plants, not what are commonly considered drugs. Also, this section of the law is actually a textbook (as in, I have textbooks where this is the example used) of a badly written definition that seems really narrow, but is actually defined more by its exceptions (not food) than its actual definition. But that the FDA is not a well thought out organization isn’t much of a shock to people here.
As I have said, representing himself in the process seems to be the root of his problem. But I’m not willing to give the FDA that much deference -they make demands and then refuse to explain them. Since their entire claim on the case is not that they are drugs, but that they are mislabled as such, this seems wrong.
“The first thing we do, let’s kill all the lawyers.”
My understanding was that we debating the second, case, the one with jail time. I don’t think I’ve seen a single comment focus on the first case.
I have no idea what the “plants” thing is about. Contrary to the beliefs of certain hippies, something being natural does not make it not a drug. So long as it is a substance intended to treat the ills listed, it’s there. That doesn’t make it illegal to sell, you just can’t sell it as a treatment for [x] unless it has some [x] treating properties. People on this thread were able to spell out the rule (it’s fine to sell quackery so long as you don’t claim that it heals stuff), so it doesn’t appear to me that the rule is particularly obscure or difficult to follow.
I’m happy to believe that there’s been argument about it, but even if in 1906 there was real debate over this, by this point the virtues of the common law have taken hold. We should thus have a clearer sense of what is and is not allowed. Again, empirical evidence suggests that this is working.
This has been a process that has taken years. If he’s able to sell his stuff in a bunch of states, he probably knows some alternative medicine enthusiasts, many of whom I’m sure had more useful advice than the Ron Paul stuff. If he wanted to understand this stuff, he’s twice had court appointed lawyers who I’m sure would have been super happy to have explained it to him (indeed, who I’m sure tried to do so). The degree of stubbonness suggests to me that he was deliberately steered into violation by some of the people making money off of the outrage, but I could be wrong.
I don’t believe that it is their entire claim that these were wrongly claimed to be drugs. I think they were drugs; the mislabeling is the claim that they do stuff, but whether or not they do stuff, if they’re sold for the purpose of treatment, they’re drugs. If you tell me you have AIDS and I sell you a carrot with instructions to stuff your sinuses with it as a way of preventing death, the carrot is a drug. There are more arguable points, the sort of thing that courts ponder over, when instead I sell you a labeled “non-medicinal carrot” while waggling my eyebrows and glancing at a website that touts the AIDS curing properties of carrots.
I agree that if he put up disclaimers, that would be a point in his favor that should have been considered at his sentencing. Heck, it might even have cleared him of some of the charges.