# A labeling violation (US)



## GeezLouise (Mar 9, 2017)

I've read this a couple of times and think I see the errors, but yikes! the penalties seem extreme. http://www.davidgumpert.com/2783-2


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## Obsidian (Mar 9, 2017)

Yes, the penalties do seem extreme and its obvious that there are cultural differences causing some issues. At the same time, this guy was selling a salve to cure cancer, really? That is unethical and wrong on so many levels, I would have reported it too. In fact, I have turned in online soap companies claiming to cure fatal disease, all they are doing is cashing in on peoples fear of dying and possibly making their condition worse.

I really do hope he doesn't end up in jail for the rest of his life, that just isn't fair. Pay a fine and shut down the business if he isn't able to follow the law.


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## The Efficacious Gentleman (Mar 10, 2017)

Let's be honest, they asked him to stop claiming a cancer cure before and the second time he had a product called "to-more-gone"? I don't think that they can expect him to respect a request at this stage.


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## shunt2011 (Mar 10, 2017)

He was also given many opportunities to correct his labeling.  This has been ongoing for almost 3 years or so.  He also refused to let the FDA in to inspect their operation numerous times. It's sad but he wasn't in compliance and was too arrogant to follow the rules and allow the FDA to do what they are supposed to do.  I feel sorry for him somewhat, but he also brought a lot of it upon himself.


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## earlene (Mar 10, 2017)

There are several articles on this topic and with a little delving I found some that are a bit more neutral and less biased toward the defendant.  I find that reading only one source or only sources with a single bias often don't tell the whole story.  And before drawing any conclusion, I'd really like to have a broader understanding of what really happened.  

In this article from a local News station, it is mentioned that in 2013, a Federal Judge in Missouri "banned Girod from distributing these  products until he met certain conditions. Those conditions include  allowing the FDA to inspect where Girod made the goods. According to the  indictment, the FDA says their officers were prevented from conducting  an inspection at the farm. They also say Girod continued to sell the  products without letting his customers know they were the subject of a  court-ordered injunction."  So one has to take the articles where he so innocently claims he believed he had a right to refuse them admittance to his production area, with at least a little doubt.  As much as he may want to claim he did not know what he was doing wrong, he was advised by a Federal Judge even after the FDA told him about it.  He can claim he didn't sell a drug, but the fact of the matter is that by laws defined in our country, that is exactly what he was doing.

According to the Chicago Tribune, "A release from the U.S. attorney's office says Girod continued to sell  the products to customers in Wisconsin, Indiana, and Illinois."

I have no sympathy for him given his arrogant and flagrant disregard for the law of the land and his continued attempts to sell across state lines even after a Federal Judge banned distribution of these products.  If Unilever had done the same thing, I doubt the public would have any sympathy for them if the FDA took them to court.


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## dixiedragon (Mar 10, 2017)

The Efficacious Gentleman said:


> Let's be honest, they asked him to stop claiming a cancer cure before and the second time he had a product called "to-more-gone"? I don't think that they can expect him to respect a request at this stage.


 

ITA. Doing it all is unethical and sketchy. Doing it after being warned? No sympathies here. If he actually got 48 years that would be excessive - nobody (to our knowledge) had been harmed by his products - frankly his business needs to be completely and permanently shut down.

Cultural difference - no dice. "Don't say your products cure cancer." Not hard to understand.


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## dixiedragon (Mar 10, 2017)

And BTW, if they paid attention to Amish puppy milling practices, they wouldn't be so quick to call them "non violent". Drowning unsold puppies by the sackful is NOT non-violent.


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## mx5inpenn (Mar 10, 2017)

dixiedragon said:


> And BTW, if they paid attention to Amish puppy milling practices, they wouldn't be so quick to call them "non violent". Drowning unsold puppies by the sackful is NOT non-violent.



I live in an area with a fairly high Amish population. They have had many many years of doing as they liked, without interference, because of their beliefs. I have no problem with their practice of their beliefs as they see fit. Unfortunately, it sometimes creates "run-off" to the rest of the population. That is where I take issue. Exception is made here for them regarding hunting. They can hunt outside the legal season on their own property, which no one else can do, regardless if it is for food rather than sport. It doesnt stop them from hunting everyone else's properties during the regular season,  in huge lines running anything they don't get away, prohibiting others chances. In my opinion, it has created a feeling among their communities that they can do as they please and that hurts the rest of us. I had to compete with them when I was baking and they didn't have inspected kitchens with required equipment (that they can't have due to religious beliefs) and I was regularly priced higher than them because of my costs to remain legal. I'm glad he is finally being held to the law that everyone else has to follow and hope this sets a standard that shows other communities they need to follow these laws.


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## Seawolfe (Mar 10, 2017)

He is claiming that his product cures cancer, and using testimonials as proof - which is really frightening. Did anyone check on the testimonials to verify that these people actually had cancer? Did anyone check months or years later to verify that they were cancer free? Were they using other treatments as well? Every time I have seen actual research into these - they have all fallen apart. The people either did not have cancer, also had medical treatment, or, most horrific of all, had died of the cancer after the testimonial. This is how some of the worst types of snake-oil salesmen get their hooks into vulnerable people.

And would you want to put a product on your skin from a place that REFUSED inspection? Ew. 

Sorry, no sympathy.


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## randycoxclemson (Mar 10, 2017)

I only blame him for not being more circumspect in his labeling.  I am a firm believer in herbal remedies (as much as I believe in pharmaceuticals), so labeling with some verbiage along the lines of "traditionally used by medical practitioners to treat cancer" and of course including a disclaimer of "none of these claims have been verified by governmental oversight regulators" would have been prudent.  He could have made it work, I believe.


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## Arimara (Mar 10, 2017)

Forty-eight years is excessive for jail time. If all is true, the guy deserves it. Just because you are part of a subculture doesn't mean you are exempt from federal laws. If my former tribe and other indigenous people were not allowed to excommunicate blacks who have been tribal members for scores and decades just for being black (pure racial discrimination at it's underhanded best) why should it be any different for any other subculture? Let me not be "antisemitic" and mention the outrage that was brought upon one of the Jewish communities with allegations of a rabbi having sexual contact with an underaged girl in Brooklyn, NY. *sigh* Entitlement...


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## Zany_in_CO (Mar 10, 2017)

Oh my. I'll say my piece and then run and hide. 

Okay. This is the way I see it. He's been selling the salve  successfully for 15 years. If the buyer likes it, they buy some more; if  not, they can pitch it and not buy any more. The market regulates  itself. No harm; no foul. No one died; no one got sick, no need to call in the troops, as far as I  could tell. 

If I read it correctly, the thing about curing cancer was in  a testimonial written by a happy customer. I know what Judge Judy would  say about that... _" 'hearsay' evidence, not admissible in court!"_ LOL Gosh, where is the ACLU when you need them? Overworked and underpaid, no doubt.

As far as the FDA is concerned, they may be within their rights, but I see it as an 'abuse of power' by a large arm of the federal government picking on the little guy... a small entrepreneur. My guess is, it's personal... he put somebody's nose of joint and they sicced the Feds on him. Shame on them.

What we need is a law to protect those of us who make and sell homemade herbal remedies from the Feds. Don't get me started on how the Big Pharmaceuticals are running the medical profession these days and thus are the culprits behind many of the unfair laws governing the industry. 

T'ain't fair, McGee. 'Nuff said.


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## The Efficacious Gentleman (Mar 10, 2017)

The market is not unregulated though. He's selling a drug and drugs ARE regulated!

Using a testimonial is putting your stamp of approval on that statement. 

This is basic stuff


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## Rusti (Mar 10, 2017)

Drugs are *very* regulated. Even doTerra got smacked on the wrist for making drug-related/medical claims about their essential oil and oil blends. You don't get to do that without the the required research and collaboration with the FDA. There's a good reason it's so heavily regulated.


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## TeresaT (Mar 10, 2017)

earlene said:


> There are several articles on this topic and with a little delving I found some that are a bit more neutral and less biased toward the defendant.  I find that reading only one source or only sources with a single bias often don't tell the whole story.  And before drawing any conclusion, I'd really like to have a broader understanding of what really happened.
> 
> In this article from a local News station, it is mentioned that in 2013, a Federal Judge in Missouri "banned Girod from distributing these  products until he met certain conditions. Those conditions include  allowing the FDA to inspect where Girod made the goods. According to the  indictment, the FDA says their officers were prevented from conducting  an inspection at the farm. They also say Girod continued to sell the  products without letting his customers know they were the subject of a  court-ordered injunction."  So one has to take the articles where he so innocently claims he believed he had a right to refuse them admittance to his production area, with at least a little doubt.  As much as he may want to claim he did not know what he was doing wrong, he was advised by a Federal Judge even after the FDA told him about it.  He can claim he didn't sell a drug, but the fact of the matter is that by laws defined in our country, that is exactly what he was doing.
> 
> ...




Earlene,  the article from WKYT directly quoted the indictment.  I read throughout the majority of it.  The defense attorney and the defendant are trying to garner sympathy and re-direct attention from the facts.  The FDA does not have to have a search warrant to inspect a drug-manufacturing facility.  That is part of the function of the FDA and the reason facilities are supposed to register with them.   Facilities register so they can be inspected to ensure compliance with federal regulations.  Inspections are not optional, they are mandatory.  Especially when they are court issued because you failed to comply with the regulations in the first place.  That's the government's way of giving you a second chance.  That's the government's way of saying, "We're not big mean guys.  We know everybody makes mistakes.  We just want you to fix them.  We'll help you.  We've pointed them out.  You fix them.  We'll give you six months then come back and see how you're doing."  This guy just flipped off the judge and told Uncle Sam to pound sand.  Uncle Sam does not like to be told to pound sand.   He was given every opportunity to cease and desist, yet he chose to continue to use bloodroot in his formulation and he continued to engage in interstate commerce.  He thumbed his nose at the government and they had no choice but to bring it to a grand jury.    BTW:  I'm almost positive his argument regarding photography being against his religion will not hold up in court.  The FDA inspectors were not taking photographs of humans.  They were taking photos of the facility and the equipment: no "graven images" to be had there. There would be no religious violations or conflicts by photographing the facility.


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## earlene (Mar 10, 2017)

Exactly my observations, as well, Teresa.

Thanks for bringing up the blood root.  I didn't want to read it all again to find that particular ingredient, but remembered that was a very serious issue left unmentioned by his supporters.


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## dibbles (Mar 10, 2017)

CeeMoor said:


> Oh my. I'll say my piece and then run and hide.
> 
> Okay. This is the way I see it. He's been selling the salve  successfully for 15 years. If the buyer likes it, they buy some more; if  not, they can pitch it and not buy any more. The market regulates  itself. No harm; no foul. No one died; no one got sick, no need to call in the troops, as far as I  could tell.
> 
> ...



Oh, CeeMoor, don't run and hide. People all have differences of opinions, and you are entitled to yours. If you make herbal remedies, you look at this from a different view than those of us who don't.

But, regulations are in place for a reason. When someone is claiming a cure, they are putting themselves in the realm of the FDA and all that comes with it. Unfortunately, there are a lot of people out there that do not do their own research and will believe anything. 

And here is the view I look at this from. When my dad was diagnosed with an aggressive cancer and told he had 4 months, needless to say, we were all shocked. He would not have tried an herbal remedy he found at a little store somewhere, but had he fit the criteria, he would have participated in a pharmaceutical study. Receiving a diagnosis of terminal, inoperable cancer could lead many people to grasp onto this hope.

I worked for a medical device company for many years. While not specifically pharmaceuticals, this industry is also heavily regulated. For good reason. All the regulations were followed to a T, without exception. It is what we expect as the end users of these types of devices and medications.

And lastly, when I used to sell M&P soaps at craft shows, I was within earshot of a woman who sold bee pollen and royal jelly products. I overheard her, more than once, talking to people about all the things her products could - not help with - cure. Including cancer. To me, this is inexcusable. I saw her a couple of years ago at a farmer's market. I assume she is still at it.

All that said, I do appreciate herbal remedies, and a homeopathic approach. And I do think 48 years is excessive.


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## TeresaT (Mar 11, 2017)

earlene said:


> Exactly my observations, as well, Teresa.
> 
> Thanks for bringing up the blood root.  I didn't want to read it all again to find that particular ingredient, but remembered that was a very serious issue left unmentioned by his supporters.





GeezLouise said:


> I've read this a couple of times and think I see the errors, but yikes! the penalties seem extreme. http://www.davidgumpert.com/2783-2



This is going to sound really odd, but I love reading indictments.  I've gotten so used to reading them because of work, that whenever there is an article that actually has a link to the indictment, I prefer to read the indictment and then go back to see what the article has to say. 

The penalties cited are the maximum penalties allowed under the law.  If he were found guilty of every count in the indictment and given the maximum sentence to run consecutively, then that is what he would get.  However, there are federal sentencing guidelines that judges follow that include "downward departures" and "upward departures."  That means, with recommendations from pre-trial services and other federal agencies, the judge can give much lower sentences or some what higher.  The US Attorney will want to attempt to reach a plea agreement and avoid a trial.  It will be in his best interest to do so.  A plea agreement ensures a specific sentence: probation, fines, minimal jail sentence, etc.  A trial, although it is your right, is a crap-shoot.  If you are found not-guilty, you are only out lawyer's fees.  If you are found guilty, you go through the sentencing.  And this is where it gets a bit touchy.  If you were a total jerk during trial and "wasted the court's time" (translated: pi$$ed off the judge) you are going to get the higher end of the sentencing guidelines.  If you were a nice defendant and didn't try to blame everyone but yourself, then you're going to get the downward departure.  Very few prosecutors actually want to go to trial on cases that can be taken care of with plea agreements.


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## GeezLouise (Mar 12, 2017)

TeresaT said:


> This is going to sound really odd, but I love reading indictments.  I've gotten so used to reading them because of work, that whenever there is an article that actually has a link to the indictment, I prefer to read the indictment and then go back to see what the article has to say.



I do engineering policies & procedures and read the indictment too. I don't think that is odd at all.
 

After reading it, I think the farmer was deliberately obtuse and a few other descriptors that aren't coming to mind in my cold-addled brain. Earlier comments in this thread about differing rules or expectations based on religion may also illustrate part of the problem the farmer is having. I wasn't aware of that being an issue in some areas.

What first interested me in the story is that I'm a customer of a raw milk dairy that is running into problems w/state Ag dept and have been following their progress. 

The second reason for my interest is I like to plan in advance and maybe in a few years I want to sell soap without running afoul of FDA or even interacting with them... 
For instance, sell a salt bar containing activated charcoal because some people believe it helps their acne. Seems to me like it would be easy to slide into the realm of "drug" and fall under purview of FDA. "What would one say to a potential customer who wants to know what AC is for?" is a thought I've had. Probably ought to buy Ms. Gale's book.


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## GeezLouise (Mar 12, 2017)

randycoxclemson said:


> I only blame him for not being more circumspect in his labeling.  I am a firm believer in herbal remedies (as much as I believe in pharmaceuticals), so labeling with some verbiage along the lines of "traditionally used by medical practitioners to treat cancer" and of course including a disclaimer of "none of these claims have been verified by governmental oversight regulators" would have been prudent.  He could have made it work, I believe.



While I'm willing to experiment on myself and do make and use occasional herbal remedies, I wouldn't feel comfortable buying from another person or providing remedies to anyone other than myself. There's the whole "untested" thing and "anecdotes aren't the same as facts (data)" because feelings and perceptions are involved.

 Here is an anecdote: I used to believe I was a great judge of time while working. I also forget to stop working, even with reminders. One week I actually tracked time on different projects (differently billed) and learned that my perception is wholly unreliable. Even though I really believed it and am an honest, trustworthy person.

As to ways to create more circumspect labeling, I'm no expert and plan to read Ms. Gale's well-regarded book to learn more.


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## randycoxclemson (Mar 12, 2017)

GeezLouise said:


> While I'm willing to experiment on myself and do make and use occasional herbal remedies, I wouldn't feel comfortable buying from another person or providing remedies to anyone other than myself. There's the whole "untested" thing and "anecdotes aren't the same as facts (data)" because feelings and perceptions are involved.
> 
> As to ways to create more circumspect labeling, I'm no expert and plan to read Ms. Gale's well-regarded book to learn more.


I have no problem providing my neighbors and friends (and even coworkers) with tinctures and salves made with herbs.  I just tell them "I am not a doctor" and explain what the purported qualities are and that they go back in time a good ways and that in most cases, they were found to work well enough to get by (before we had the strict, but no better, sampling methods of the FDA).

I have read Ms. Gale's book and that's where I came up with all the a$$-covering rhetoric I'd include.


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## The Efficacious Gentleman (Mar 13, 2017)

GeezLouise said:


> I do engineering policies & procedures and read the indictment too. I don't think that is odd at all.
> 
> 
> 
> ...





If you keep your claims to "appearances" then it is only a cosmetic. "Reduces the appearance of acne and blemishes" is not claiming to heal or cure. Which is why most cosmetic adverts use that word. Appearance of fine lines, younger looking skin, and so on


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## TeresaT (Mar 13, 2017)

Yes, if he had bothered to follow ANY of the label or labeling rules (Ms. Gale's book really would have helped him!) he may not have had the problems to start with.  But even after being told about the misbranding of (mislabeled) his products, he continued to do it.  He was under a federal court injunction and ignored that.  He brazenly disregarded the laws of the land and decided they did not apply to him.  He was creating an unsafe product in an unsafe manner in an unsafe environment in an unregistered facility and refused access to authorities.  He deserves everything he gets.


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## GeezLouise (Mar 13, 2017)

The Efficacious Gentleman said:


> If you keep your claims to "appearances" then it is only a cosmetic. "Reduces the appearance of acne and blemishes" is not claiming to heal or cure. Which is why most cosmetic adverts use that word. Appearance of fine lines, younger looking skin, and so on



 I'm leaning toward making no claims other than "It's soap"


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## mobe_45 (Mar 17, 2017)

*why did this thread get hijacked with puppy mills and hunting?*

:headbanging:
But... what did puppy mills have to do with soaping at all?

:headbanging:


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## TeresaT (Mar 17, 2017)

mobe_45 said:


> :headbanging:
> But... what did puppy mills have to do with soaping at all?
> 
> :headbanging:



This thread didn't get "hijacked" with puppy mills and hunting.  Two people made comments regarding their personal opinions of the general perception of Amish culture as being (1) non-violent and (2) obedient to the law.  The non-violent (i.e. pacifist) mythology was dispelled (in that person's view) by the violent destruction of life in dog breeding (puppy mills).  

 It doesn't have anything to do with soaping, but then again, neither does this thread, which is why it is in the  "LABELS & PACKAGING" section of the forum.  The Soap Making Forum isn't just about soap.   We like talking about all kinds of stuff.  Stinky armpits is a good topic to talk about; everybody's got a pair.  :mrgreen:


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## TeresaT (Mar 17, 2017)

GeezLouise said:


> I'm leaning toward making no claims other than *"It's soap"*



GeezLouise, don't forget to add: "it'll get you clean."


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## Arimara (Mar 17, 2017)

TeresaT said:


> GeezLouise, don't forget to add: "it'll get you clean."



You must have frogs in business suits on the packaging.


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## GeezLouise (Mar 18, 2017)

TeresaT said:


> GeezLouise, don't forget to add: "it'll get you clean."



LOL; that one is yours, isn't it?


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