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.

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  1. Sabrdance Member
    Sabrdance
    @Sabrdance

    James Of England (View Comment):

    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.

    That the court issued an injunction, that the guy is being punished for violating is not in question.  The question of the OP was whether this is an example of federal overreach.  To state that the government followed its own rules in overreaching is just to say that the government doesn’t consider its own overreach to be overreach.

    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.

    Because that’s the statement made by the defenders in the linked articles.  Again, the point of dispute is not whether the FDA followed its own rules in doing this, but whether the FDA should have this kind of authority over herbal remedies in the first place.

    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.

    I will require more than your sayso on this point.  That courts and the FDA have muddled through and made up the rules as they go I am willing to believe, but any type of rigorous analysis I will want to see.

     

    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.

    The law does not say this -the law says they are drugs if the person selling them says -among other things -that they can be used to cure ailments.  The same compound is, according to the statute you linked, either a drug, or not a drug, depending on the contents of the label, not the contents of the bottle.  As evidence, you may search Amazon for bloodroot being sold, and the only difference is the label and disclaimer text.  This is the problem textbooks examine.

    And as it seems not to be clear -I am not questioning the legal result.  It is probably a good conviction.  A good lawyer might have been able to defend against it, but it doesn’t seem obvious to me that the jury got the wrong result as a matter of what the law is understood to mean in the current era.

    I am not even sure Exjon is complaining about the legal process.

    The complaint is that the FDA should not be doing this, and if the law says otherwise, the law is the problem.

     

    • #91
  2. The Reticulator Member
    The Reticulator
    @TheReticulator

    To give you some idea of how the Amish interact with the government:

    Michigan has been adding rumble strips to state highways in recent years.  In St Joseph and Branch counties the state highway department tried to solicit the opinion of the Amish communities about their plans to install rumble strips, but got no response. The Amish generally try to minimize interactions with governments, so this is not surprising.  So the state went ahead and put rumble strips on the edges and centerlines of highways in those counties.  Then it was noticed that this caused all kinds of problems for Amish buggies, so they sometimes had to drive out further in the road to the point where car traffic couldn’t so easily get around them.  This created safety problems.  So the state went to great expense – far greater than the cost of cutting the rumble strips in the first place – and paved over the rumble strips along the edges.

    (As a bicyclist I was glad in most cases to see the rumble strips go, because in many places they create safety hazards for bicyclists, too. I joined the League of Michigan Bicyclists for a time when it was making this rumble strip issue a cause, but didn’t keep up my membership when they went back to their usual leftish activism.)

    Back to the Amish – they just aren’t very likely to come to public hearings to express their opinions. They don’t interact with the government that way. They aren’t going to lawyer up to dot all the t’s and cross the i’s in dealing with the Federal government on drug issues. They want to be law-abiding citizens to the extent that is consistent with their religious beliefs, but they just don’t interact with the government the way others think is normal, much less the way James of England thinks is normal.

    During World War I a lot of Amish men went to jail because of their pacifism.  The Amish don’t like going to jail any more than anyone else, and most people don’t like to see them going to jail, either.  After the war hysteria died down, and before the next war got too far underway, the government made an accommodation with the Amish (and others) for conscientious objectors. But it wasn’t easy, because there was nobody to represent the Amish in negotiations with the government.  The Amish are very decentralized. Each community develops its own rules of behavior.  The settlements pay attention to what others are doing, and are influenced by each other, but they don’t have a hierarchical command structure to deal with the government. (There was much the same problem in an earlier century when the government was trying to negotiate with Indians.)  The Amish reluctantly formed enough of a central organization with some semblance of authority to deal with the government on this one issue and come to some sort of agreement that helped out in most cases, but aside from that they have mostly stayed decentralized.

    I say mostly, as I think something similar happened in dealing with Social Security issue; however, I’ve read less about how that played out.

    So it is not surprising that this Amish guy just went ahead and did what he thought was right, and it is not surprising to me that it ended up this way. Government actions in the past have caused scenes (and jailings) that look ugly to the public, and sometimes that results in some kind of accommodation being reached later.  I’m not so sure that will happen this time, given the smash-mouth attitude so prevalent in our government in recent years, but what happens will happen.

    I for one am glad to have the Amish among us to demonstrate that there are other ways of thinking about how interactions with the government should work.

    In thinking back on this, I’m not sure it played out the same in Branch County as in St Joseph County.  What I described definitely took place in St Joseph County, just to the west of Branch County.

    BTW, in northern Indiana, the Amish in the Elkhart area near South Bend tend to be fairly liberal (more color on the homes, more use of technology, women owning their own businesses, etc.) and become more conservative as you go west east across the state.  The same is true in the lower tier of Michigan counties.  Those in St Joseph are more liberal than those in Branch County, and in Hillsdale County, to the east, they are much more conservative.  I find that amusing, given the famous college that also is located in Hillsdale County.  In Indiana, when you get south of Fort Wayne, they are even more conservative than those in Hillsdale County, though another factor is that those south of Fort Wayne are from a different migration to the United States. There are stories of mixed marriages between the extremes of this continuum. It can be very difficult for those marriages to work, especially when a woman from one of the more liberal regions marries a man from a conservative region and goes to live there.

    I don’t know much about the Amish in Kentucky. My only interaction with those was a brief encounter on a bicycle ride further west in the state than where this Girod person ran afoul of the law.

    Late edit: changed west to east.

    • #92
  3. James Of England Inactive
    James Of England
    @JamesOfEngland

    Sabrdance (View Comment):

    James Of England (View Comment):

    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.

    That the court issued an injunction, that the guy is being punished for violating is not in question. The question of the OP was whether this is an example of federal overreach. To state that the government followed its own rules in overreaching is just to say that the government doesn’t consider its own overreach to be overreach.

    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.

    Because that’s the statement made by the defenders in the linked articles. Again, the point of dispute is not whether the FDA followed its own rules in doing this, but whether the FDA should have this kind of authority over herbal remedies in the first place.

    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.

    I will require more than your sayso on this point. That courts and the FDA have muddled through and made up the rules as they go I am willing to believe, but any type of rigorous analysis I will want to see.

    Skyler in #22, Omega Paladin in #23, Tom in #42, and Bridget in #45 were each able to produce the rule with only Tom appearing to have looked it up. It was also my understanding before I looked it up. Both Tom and I found, after looking it up, that the description loooked a lot like the folk understanding. That suggests to me that there’s a fairly high degree of penetration. If you’re wanting a source to say that this stuff is being prosecuted all the time, hopefully this will help (It also responds to your claim about the FTC being the proper agency, suggesting that this case falls partly within FDA exclusive jurisdiction, partly within FDA primary jurisdiction, and partly in FTC primary jurisdiction, with the most important parts being either exclusively or partly in FDA jurisdiction). If you want more than my say so that the common law operates to clarify the meaning of widely litigated statutes over time, any of your textbooks describing the operation of common law should cover this.

    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.

    The law does not say this -the law says they are drugs if the person selling them says -among other things -that they can be used to cure ailments. The same compound is, according to the statute you linked, either a drug, or not a drug, depending on the contents of the label, not the contents of the bottle.

    I don’t see the difference between what you’re saying here and what I’m saying. Given that these drugs were being sold for treatment, according to the labeling, they were drugs.

    As evidence, you may search Amazon for bloodroot being sold, and the only difference is the label and disclaimer text. This is the problem textbooks examine.

    I don’t understand why this is a problem. It is generally the case that it is legal to sell things with honest labeling, but illegal to sell them with dishonest labeling. You can buy plenty of copies of The Moon Is A Harsh Mistress online, but if I sell some claiming that they were the personal copies of Charles Manson and John Lennon without any reason for believing this to be true, I’d be committing a crime. The FDA wanted Girod to stop his fraudulent claims and they wanted to be able to inspect his manufacturing process. He wasn’t down with that and threatened inspectors, so he’s going to jail instead. Pointing out that if you don’t make fraudulent claims and cooperate with inspectors you don’t get into trouble seems like the sort of thing that distinguishes most criminals from most law abiding citizens.

    And as it seems not to be clear -I am not questioning the legal result. It is probably a good conviction. A good lawyer might have been able to defend against it, but it doesn’t seem obvious to me that the jury got the wrong result as a matter of what the law is understood to mean in the current era.

    Fine.

    I am not even sure Exjon is complaining about the legal process.

    I think Exjon is suggesting that this is Federal overreach, with what appears to be an inaccurate claim that this was being handled by beltway bureaucrats. My understanding is that you join with me and Amy in believing that the fraudulent interstate sale of goods is properly federal in jurisdiction. It really seemed to me that you were saying that the law as it is currently understood puts the jurisdiction for this stuff under the FTC rather than the FDA and that it suggested that these salves were not drugs despite being labeled as drugs. Those claims suggested to me that your problem was with the legal process, thus disagreeing with me and Exjon.

    The complaint is that the FDA should not be doing this, and if the law says otherwise, the law is the problem.

    To be clear, this is because you believe that the proper people to handle this stuff are the FTC? Do you have something to cite for this?
    If that is the problem, why should the law put this under the FTC? If that is not the problem, could you describe what the problem is?

    • #93
  4. Sabrdance Member
    Sabrdance
    @Sabrdance

    James Of England (View Comment):

    Sabrdance (View Comment):

    James Of England (View Comment):

    I don’t care.  We are now into sub-arguments of sub-arguments of what are probably at least 2 separate, though related arguments.  And I barely cared in the first place.  Whatever.  I find your certainty and stridency on this case baffling, and I find your justification to be much weaker than you apparently do.  But we’ve now been around the loop twice with neither of us shifting positions at all, and I’m bored.

    This may be a limitation of the medium, and it might be a better conversation to have in person when we’re not responding to quotes of quotes of quotes, that were actually responding to something different.

    By the way -I realize you think you’re being thorough, but every time you do one of these massive quote/counterpoint comments, my desire to continue talking to you declines rapidly -because I can’t do it back (having only 500 words to work with) and also because it means that the single comment may have a dozen different arguments in it.  I’m sure its a great debate tactic -it’s a horrible conversation.

    Good day.

    • #94
  5. James Of England Inactive
    James Of England
    @JamesOfEngland

    Sabrdance (View Comment):

    James Of England (View Comment):

    Sabrdance (View Comment):

    James Of England (View Comment):

    I don’t care. We are now into sub-arguments of sub-arguments of what are probably at least 2 separate, though related arguments. And I barely cared in the first place. Whatever. I find your certainty and stridency on this case baffling, and I find your justification to be much weaker than you apparently do. But we’ve now been around the loop twice with neither of us shifting positions at all, and I’m bored.

    This may be a limitation of the medium, and it might be a better conversation to have in person when we’re not responding to quotes of quotes of quotes, that were actually responding to something different.

    By the way -I realize you think you’re being thorough, but every time you do one of these massive quote/counterpoint comments, my desire to continue talking to you declines rapidly -because I can’t do it back (having only 500 words to work with) and also because it means that the single comment may have a dozen different arguments in it. I’m sure its a great debate tactic -it’s a horrible conversation.

    Good day.

    I will try to engage in more cutting in conversations with you; I’d appreciate it if you could remind me to do so. It’s not a word limit power play; if you look back to my earliest days on the site, long before greater word limits were a thing, you’ll find lots of multiple comment responses doing the same thing, back and forward.

    I don’t really understand the sub-arguments claim. I thought until #91 that you were disagreeing about the legal process and the outcome. I now have less idea what the complaint is; I think it has something to do with the FTC not taking action, and provided a link explaining why that was, but I got the impression that we’d zoomed out rather than in. While I didn’t shift my position much, I did learn a fair amount about FDA and FTC regulations. That said, if you’re bored, you’re bored, and there’s no sense in continuing if you’re not having fun.

    • #95
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