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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.
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Every Fourth of July I urge everyone to honor our forefathers by doing something slightly unsafe and illegal. This didn’t happen on the Fourth, and the Amish don’t go for displays of patriotism anyway, but it’s fitting that this is in the news on the week of our nation’s birthday.
If, instead of manufacturing in Kentucky, Girod had manufactured in France, would you see it as an appropriate role for the Federal government to regulate the import of his goods under the Commerce Clause?
Has the FDA proved that it doesn’t? Generally – one is considered innocent of a crime in the US until it is proven in court. Sounds onerous in case sure, but the law is the law. It exists neither for the convenience of the government nor the citizenry. I would point out, however, that ‘fraud’ was not one of the enumerated charges.
I agree with James that there are (among others) two separate issues here:
I grant that the FTC or some other body would likely be a better hammer for this particular nail than the FDA. I also think that it’s silly to have one set of standards for “drugs” and another for “supplements.”
“Intent to defraud or mislead” appears in every one of Counts 3-11.
There’s two different sorts of arguments you could be making here.
One of them is that the claims that he made were accurate. Do you believe this to be the case?
The other is that there has not been a legal process convicting him on the basis that he had an intent to defraud or mislead.
To put it another way, are you making the argument analogous to “OJ did not kill Nicole”, that “It is not reasonable for you to say that OJ killed Nicole given that no jury has determined beyond a reasonable doubt that he did so”, or both?
No – I have not seen any evidence to suggest that is so.
Alternatively, I have not seen any evidence on the part of the government to say they aren’t so.
My status, as of this moment, is that the claims are unproven and un-disproven.
I don’t think the distinction between drugs and supplements is silly. As far as I can tell drugs are substances that have an immediate noticeable affect on body function while supplements do not. One can severely injure, the other not so much (barring allergy concerns which exist for anything).
Nope.
A jury of his peers found OJ not guilty of the crime of murder of Nicole Brown Simpson. – I accept that verdict.
A jury found OJ responsible for the deaths of Nicole Brown Simpson and Ronald Goldman, for which OJ was compelled to pay damages. I accept that verdict as well.
Just like I can say that the Feds failed to prove fraud and that Mr Girod has not been convicted of Fraud.
This, and I’d add a few things:
We could never close the FDA……WHAT ABOUT THE CHILDREN?????
Those aren’t the definitions actually used:
Notice:
Tom, after reading all that I’ll stand by my summarization. If it does something noticeable then it’s a drug, if not then it’s a supplement. If an herb or botanical actually does something in the sense I’m using it then it will be treated as a drug instead of a supplement. If it only purports to “promote wellness” then, well, it’s only a supplement and not a drug – precisely because it doesn’t do anything specifically or immediately noticeable. Of course that is broad and subject to nuance, exception, etc. However, I think it captures good enough the differences described in the paragraphs you quoted.
That would be a pretty good definition but — again — it’s not the one actually used by the FDA. An extremely potent herb that does not make specific medical claims in its marketing is a supplement.
Again, if you market something that purports to do something vague but actually does — or can do — something very specific, then it’s still a supplement according to the FDA. The definition has to do with source and marketing, not potency or effect.
Look at the labels of any dietary supplements you may have or come across. They will often make claims about “supporting bone health,” “balancing hormones,” or “reducing nausea,” but there will then be a disclaimer to the effect that the statements have not been evaluated by the FDA.
A lawyer can carefully word the claims such that they do not actually move into the territory of claiming to do certain things. Perhaps the gentleman would not have run afoul of the law had he said that his salve would “ease skin lesions and swelling associated with tumours*” with the asterisk attached to a statement about the lack of FDA approval for those claims.
Query whether such fine-tuning of language ought to be the difference between freedom and incarceration.
How did they even find this guy?
Did customers complain (are there victims) or does or government feel searching for this type of thing is an effective use of our tax dollars?
What kind of sales does this guy have?
Why not a fine?
Do you feel safer knowing he is behind bars?
Can he request to be sent to prison without electricity?
If he was indeed in violation of the law I would agree with this for the most part. It doesn’t look like he actually broke the law but I will say that he should have simply changed up the wording more and avoided the whole thing. He was being belligerent in that regard and this is what happens when bureaucrats think a citizen is getting “uppity.” In this case I think it would be an excellent PR move for Trump to pardon this man but maybe do it near Christmas. The man has to do a little time and maybe that will inspire him to be more careful with his wording of herbal remedies and at the same time Trump will be giving a Christmas present to an average man who got roughly handled by the system.
“If I’m being punished, why did you send me to this fancy hotel?”
Is there an example of a highly potent substance which is treated as a supplement instead of a drug? Are there examples of substances which are not potent at all which are still treated as drugs?
All I’m saying is that the distinction between drug and supplement isn’t silly as you said, even if the actionable distinction is merely surrounding the claims being made by the seller (if it’s some known yet undisclosed physical effects which are giving rise to an action then I’d imagine the FDA would have some jurisdiction there too and the tort lawyers would handle the rest). Can the definitions be tweaked and tightened? Probably. But why do we need to get into those weeds for our discussion of this case? 1) I think the FDA is correctly involved based either on your language or my summarization, 2) semantically I agree with you that herbs can be highly potent – but then I’d refer to those as drugs and I think most people would do likewise (e.g. mushrooms, canabis, peyote).
Bridget, is such fine tuning of language really the difference between freedom and incarceration? Weren’t there a few more intervening steps you’re leaving out? No notices of non-compliance? No decisions to ignore the notices? No fines and decisions to ignore those fines?
Yes. From Consumer Reports:
Tom, this is from Consumer Reports, not the FDA. If each of these things actually purports what Consumer Reports says they purport, then it seems each would be within the FDA jurisdiction as you quoted it. In fact, for many of these the FDA has acted on them in some way (at least according to the notes in the table). If the substances fall short of claiming specific benefits, then it seems like limited government restraint for the FDA to merely issue warnings about the dangers.
Quite the opposite.
Let’s not lose sight of the fact that the FDA didn’t put a single person in jail. Ever.
A jury put him in jail.
His peers, who unlike us, heard all the pertinent evidence, decided that he needed to be punished. I’ll support their unbiased conviction.
No.
Those “notices of non-compliance” would not have been issued if the language were slightly different, nor would other notices and fines. You seem to be (rather in a statist way) implying that if a slight change to behaviour triggers a whole slew of criminal and civil processes, which in turn trigger more processes, that the starting action is the slight change in behaviour. That’s just bizarre reasoning.
Okee dokee. Bizarre and statist it is then.
For the record, I disagree that we’re talking about simple and meaningless semantic differences.
In addition, I think partly underlying the disconnect here is that old discussion about not having laws unless you’re willing to kill over them. Jaywalking doesn’t deserve a death penalty, but if the offender makes a series of followup decisions of escalating import then we’re no longer talking about simple jaywalking and the person making those choices has agency and responsibility. Those intervening choices make all the difference in the world. Don’t like the law? Ok, then take it to the ballot box. Not guilty? Then have your day in court. Otherwise, we don’t get to simply disregard the law at our whim and expect no repercussions.
A jury of Mr. Girod’s peers found that he was guilty on a number of counts that claimed fraud, as I noted above. How do you think Mr. Girod ended up where he did?
I encourage you to do a little independent research into blackroot as a cure for cancer. I imagine it will help you to sympathize with the jurors. It’s straight up alchemy, and not the thoughtful kind.
This doesn’t seem like a sound strategy for dealing with the petty tyranny of unaccountable regulatory agency overreach.
I don’t think that this is quite right. To get to where he did, Girod needed to both make false claims about his products and ignore and violate the judgment of the court in his previous case, along with a variety of administrative warnings. You don’t have to start the process with the former to make the latter necessary for the result.
If you’re going to have laws that prohibit fraud, no matter how limited those laws are, you have to have a fine line between fraudulent and non-fraudulent claims. That doesn’t make the law arbitrary; all laws make important differences between conduct that slightly crosses the line and conduct that slightly avoids doing so. The penalty for providing someone with fractionally less than a lethal dose of poison is considerably less than the penalty for providing someone with fractionally more.
Claiming that a product with no cancer curing properties whatsoever cures cancer isn’t close to the line, but a law abiding citizen will generally not come close to the line, which is not exactly super hard to avoid.