UPDATED: Sam Girod v FDA

Samuel Girod's all-natural herbal products

By Sally Oh on March 30, 2017 | Comments 4 | Affiliate Disclosure

First, please sign and share the petition here: bit.ly/freeamishsam.

Click here for more details and links to all court documents and the indictment.

Feel free to copy and repost on your blog, social media, or print and handout, use as a cover letter for a printed petition (click here to download petition). Since the Amish don’t use the internet, many of them don’t even know about Sam’s situation! Please share the printed petition, get their signatures, then email or mail to me here.

Samuel Girod [G as in Gee: gi-ROD] and his family have been making and selling three all-natural herbal products for nearly 20 years.

No one has ever been harmed by the products; the Girods have pages of testimonials and scores of repeat customers.

Similar products are currently made and sold online worldwide (including on Amazon) by other people using the same or similar basic ingredients. The recipes are online as well, you can make them in your kitchen.

In 2001, an FDA agent informed Sam that his product labels were making medical claims regarding healing certain conditions. At the time, Sam’s label said, ““[g]ood for all skin disorders. Skin cancer, cuts, burns, draws, and poison ivy.”

Sam had to change his label, removing the skin cancer claim specifically, or do very expensive testing proving the claims. Sam changed the label, removing any reference to skin cancer.

Sam did not receive any further communication from the FDA until 2012 when someone called the FDA and reported that a store in MO was selling Sam’s products and that medical claims were being made.

The “medical claims” were in fact customer testimonials contained in a brochure about Sam’s products! These testimonials are no different than Amazon reviews.

Then the FDA claimed to have found a MO customer who had been harmed by Sam’s bloodroot salve.

In early 2013, during the investigation on that claim, FDA agents went to Sam’s home and demanded a warrantless search. Wanting to be cooperative, Sam said OK on one condition: that no photographs were taken (the Amish are religiously opposed to photography). The agents said no problem, no photos.

Then they got on the property, whipped out their cameras and took photos of everything.

Several months later, the Girods went before a federal judge in MO re the medical claims and the person supposedly injured. Turns out, not only has this customer never been identified or produced, the bloodroot salve this customer used was not even Sam’s!!!

Yet that judge put an injunction on Sam’s products with three stipulations:

  1. none could be sold until all medical claims were removed (referring to the brochures);
  2. Sam’s bloodroot salve could never be sold again EVER (1); and
  3. Sam had to allow inspection of his property where the products were made FOR FIVE YEARS.

Sam complied with 1 and 2: he stopped selling the bloodroot salve and stopped using the brochures. He was not so compliant with the searches.

In late 2013, after the injunction, FDA agents came to do a second search. Sam informed them that nothing had changed since the first search 7 months earlier, and that, since they had lied and taken photos during the first search, they were not welcome to do a second.

Sam had a Bath County Sheriff’s deputy there who witnessed the entire event and told the agents to leave the property.

Unfortunately for Sam, he knows his constitutionally-guaranteed rights and he relied on them to make his next decisions.

These three product sales are how Sam’s family made their living. They had been denied this right via an arbitrary regulation made up by a federal agency with no true jurisdiction in the states — and with NO VICTIM.

So the Girods started selling their products again. Then, in 2014, Sam started a legal private membership club and sold his products to members via that framework. Perfectly legal.

Meanwhile, the FDA started criminal proceedings against Sam for disobeying the injunction (selling his products and refusing the search) plus two other very serious charges:

1. The FDA agents claimed that, when they came for the 2nd search, Sam and his family threatened them with physical violence. That is ludicrous enough on the face of it. Plus, the Sheriff’s deputy testified under oath that absolutely no threats were made, that, essentially, the FDA agents lied under oath.

2. The FDA also charged Sam with witness tampering. The witness who was supposedly tampered with? Read the eyewitness account of Mary Miller’s testimony, link below. (2)

The Trial 2.27.17

The Amish do not use lawyers as a rule and Sam did not. This is a decision made by the community, not just the accused. Apparently the Amish don’t trust lawyers. Imagine that.

Because he barely presented a defense against federal prosecutors for whom money and conscience are not problems, Sam was convicted on all counts. (3)

The judge ordered Sam to remain in jail until sentencing on 6/16/17. He’s been in jail since 2/27/17.

Had Sam had a good attorney, he would certainly have been acquitted on the most egregious counts (threatening federal agents and witness tampering). These charges were clearly manufactured solely to make Sam into a “real” criminal, with the FDA being the only victim.

The only other charges — selling “drugs” across state lines — were manufactured out of whole cloth as well. The FDA’s own tests proved that the products were not drugs, that they were made from all-natural ingredients!!! These charges should have been dismissed from the start.

Sam’s sentencing is 6/16 and he is looking at 68 years in prison. This is essentially a life sentence for charges stemming from an innocent labeling infraction!

Sam should not spend a minute in jail. Please sign and share our petition to President Trump for a presidential pardon: bit.ly/freeamishsam

Burning Questions

  • How does the FDA get away with determining what constitutes a “medical claim” anyway?
  • How are they able to define “drug” so broadly that a topical salve made from all edible ingredients becomes a “drug?”
  • Why are Amazon reviews ok but Sam’s customers’ testimonials a basis for criminal charges?
  • How is the FDA able to create criminal penalties for violation of arbitrary rules?
  • How does this kind of action against an Amish grandfather making salves from all-natural ingredients protect the public, particularly considering that every 19 minutes, someone dies from an FDA-approved pharmaceutical, an actual drug that has been tested and “proven safe”?
  • How will Sam’s incarceration for life make the American public any safer?
  • Considering that no one was harmed by his products, how has spending millions of dollars on Sam’s prosecution and 16 years of harassment made the world a better place?

A SOLUTION

There is a better way to handle this. Let us Americans make healing claims on our products with the disclaimer, “These claims have not been scientifically proven. Please use your internet and library to verify claims to your own satisfaction prior to use.”

Sam’s prosecution is a prime example of bureaucracy run amok, enforcement for enforcement’s sake to justify an agency’s existence. There are literally thousands of people in jail (4) for breaking agency regulations fabricated by the agencies! Their rules and regulations are as arbitrary and illegal as they can be, with the result of making us all criminals in our own homes.

Who exactly is being protected here?


Resources:


(1) In the indictment, bloodroot is repeatedly referred to as “dangerous” with no documentation whatsoever. Bloodroot is from a plant grown in North America, it’s perfectly legal and used by millions of people for centuries for healing purposes. Bloodroot products are sold all over the internet, including on Amazon.


(2) Mary Miller is the 2nd witness called: http://www.kyfreepress.com/2017/03/trial-fda-v-samuel-girod-day-2/


(3) Trial Day 1, Trial Day 2, Trial Day 3


(4) http://thefreedomcoalition.com

Sally Oh

Sally Oh

Sally Oh is a native Kentuckian, wife, mother, blogger, homesteader, chickenista, recovering REALTOR® and Functional Medicine Practitioner. A liberty activist and registered voter, that’s her falling down a rabbit hole.

CONTINUE READING…

This is the story of the FDA’s persecution of Samuel Girod.

 

By Sally Oh on March 1, 2017 | Comments 2 | Affiliate Disclosure

Here’s a video explaining the entire thing, transcript with links below.

Let’s be clear about a couple of pertinent facts:

1. The FDA made up arbitrary rules, then accused Sam of breaking those rules.

2. There are no victims. Samuel Girod has hurt no one.

3. FDA-approved pharmaceutical drugs kill 1 person every 19 minutes. Merck’s FDA-approved Vioxx killed over 68,000 people. Nobody in Big Pharma goes to jail. They pay out billions in fines (after making billions in profits.) No companies close, nobody goes to jail. Nobody. Even after killing and harming 100s of thousands of people.

4. Sam Girod and his products have hurt no one.

The Story of the FDA v Samuel Girod

Samuel Girod and his family have been making and selling 3 all-natural herbal products for nearly 20 years. In all those years, one woman had a bad reaction to a salve (which Sam made right and the woman was fine).

No one has ever been harmed by the products, the Girods have pages of testimonials and scores of repeat customers.

The 3 products are: Original Chickweed, a beeswax, essential oils and olive oil salve; Sine-Eze, a blend of essential oils; and To-Mor-Gone, an herbal bloodroot product in a base of beeswax and olive oil aka “black salve”.

All of these products are currently ALSO made and sold online worldwide (including on Amazon) by other people using these same basic ingredients. The recipes are online as well, you can make them in your kitchen.

HOW IT STARTED

Sixteen years ago, in 2001, an FDA agent visited Sam at his home in IN and informed Sam that he could not claim his products could help skin cancer. At that time, the chickweed salve label said: “[g]ood for all skin disorders. Skin cancer, cuts, burns, draws, and poison ivy.”

According to the FDA, when you make a medical claim about a product, that means the product is a “drug. Therefore you have to do years of testing, costing millions of dollars to prove the claim.

Sam had to change his label or do the testing.

So Sam changed the label, removing the reference to skin cancer.

He asked the agent to get back to him on what label would be acceptable to the FDA. The agent said she would within three weeks but she never did.

The label now said, “[g]ood for skin disorders. Dry skin, cuts, burns, draws, and poison ivy.” No skin cancer reference.

Between 2001 and 2004, Sam was visited several times by FDA agents. When he asked the agents what was acceptable on the label, none would give
an answer.

Sam did not receive any further communication from the FDA until 2012.

In Jan 2012, someone called the FDA and reported that a store in MO was selling Chickweed Healing Salve and that medical claims were being made.

The FDA confiscated the products from the store and opened #Case 4:12-cv-00362-GAF on Sam. You will find a link to the complaint and a link to Sam’s answer in the transcript below.

This is the complaint: http://bit.ly/27-on-120928-Girod-Amended-Complaint

This is Sam’s answer to the complaint: http://bit.ly/37-on-121228-Girod-Answer-Defenses


In fact, here are all the court documents on Sam’s entire case. There are two folders: the 1st is for the labeling, the 2nd is for the criminal indictment.


PLEASE FOLLOW THIS LINK TO THE FULL STORY!

CONTINUE READING AND TO VIDEO HERE!

A KENTUCKY RESOLUTION to encourage the United States Food and Drug Administration to study the use of medical marijuana

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On Thursday, February 25, 2016,  HR 173(BR-1583)  was  introduced in House.  This is a Kentucky RESOLUTION to encourage the United States Food and Drug Administration to study the use of medical marijuana.

The Sponsors are David Osborne, Lynn Bechler, and Brad Montell.

This is to encourage the United States Congress to authorize and direct the United States Food and Drug Administration to study the benefits, side effects, drug interactions, and other aspects of medical marijuana.

On Monday, February 29, 2016 it was sent to Health & Welfare (H).

16RS/HR173 (PDF LINK)

UK gets $6 million grant to research cocaine addiction

Saturday, November 21, 2015 

 

Posted: Saturday, November 21, 2015 12:22 AM

By Linda B. Blackford Lexington Herald-Leader

LEXINGTON – A group of University of Kentucky researchers has won a $6 million grant to further develop a potential treatment for cocaine abuse.

UK College of Pharmacy professor Chang-Guo Zhan, along with UK professors Fang Zheng and Sharon Walsh, and Wake Forest University professor Mei-Chuan Ko, are researching new therapies for overdose and addiction.

“Dr. Zhan’s groundbreaking work in this field cannot be overstated,” interim dean Kelly M. Smith said. “There currently is no FDA approved treatment for cocaine overdose or cocaine addiction, and Dr. Zhan and his research team are trying to change that. Developing such therapies would be a major breakthrough for health care.”

Previously, Zhan’s team designed and tested CocH1, an enzyme that breaks down cocaine in the bloodstream without producing harmful byproducts in the body.

CONTINUE READING…

Kentucky: CBD-Only Marijuana Oil Bill Won’t Help Patients For Years, If Ever

Submitted by steveelliott on Thu, 05/15/2014 – 17:53

CBDCannabidiol

By Steve Elliott
Hemp News

In the past few months, a wave of “CBD-only” marijuana oil bills has passed, particularly in more conservative states where an actual medical marijuana bill might have found it difficult going. But unfortunately, many of these hastily passed pieces of legislation were so poorly crafted as to help no patients at all for months, years, or maybe ever, and Kentucky’s new law is one of those.

Rita Wooton of Louisville’s story of her son Eli, who has frequent seizures, and the promise of CBD (cannabidiol) oil to treat it, helped convince the Kentucky General Assembly to pass the bill, reports Gregory A. Hall of the Louisville Courier-Journal. But now doctors and researchers are telling Wooton and other parents that it could take years to even begin trials treating children such as Eli with the oil.

“We’re really, really heartbroken,” Wooton said. “It’s just really sad that everyone put that much time and effort and energy into it and now it’s going absolutely nowhere.”

“For people like us and Eli, who have intractable epilepsy, seizures that are nearly impossible to even control or get a handle on, our hope is gone,” Wooton said.

Some of the many issues surrounding implementation of the bill include the availability of CBD oil, the possible need for FDA approval, and the expense of studies, which preliminary estimates indicate could be $10,000 per patient.

But some doctors hoping to conduct the trials are still hopeful.

“I am extremely excited about it,” said pediatric epilepsy specialist Dr. Karen Skjei of the University of Louisville, citing anecdotal reports of the oil reducing seizures when traditional pharmaceuticals can’t.

According to supporters, the oil can provide relief to children who have severe epilepsy. It contains low levels of THC, the main psychoactive component of cannabis. CBD isn’t psychoactive and therefore doesn’t get the kids high.

Senate Bill 124, sponsored by Sen. Julie Denton (R-Louisville), allows “trials” of the CBD oil at the University of Louisville and the University of Kentucky’s medical schools or through FDA trials. But passing the bill is “just the initial part of the puzzle,” according to Dr. Christopher Shafer, who specializes in adult epilepsy at the University of Louisville.

“Dr. Skjei and I want this for our patients, probably, almost as badly as the patients want it themselves,” Dr. Shafer said. “And it’s really discouraging for us to not be able to tell them that we have it available. It’s going to take some time.”

“While there is certainly an interest in this initiative, there are significant issues that remain to be addressed,” said spokesman Jay Blanton of the University of Kentucky. “Additional research, the securing of funding and support, as well as support from the appropriate regulatory body, all would be required before a trial could be conducted.

“That process could likely take months, if not years,” Blanton said.

Currently, the oil isn’t being legally manufactured in Kentucky, and shipping it across state lines violates federal law. Discussions are ongoing with one “West Coast businessman” about setting up a Kentucky dispensary, Skjei said.

“As of right now, there’s really nowhere to get it,” she said.

“I feel their desperation,” Shafer said of the patients, adding he wishes he could start prescribing it tomorrow. “Everybody who asks me about it, I’m keeping a list and I have a long list already.”

“I still have patients that are talking about moving to Colorado, because they understand it’s going to be awhile before this is up and running,” Skjei said.

What’s Up With CBD?

Cannabidiol, or CBD as it’s more popularly known, is the new darling of lawmakers in conservative states who sense the rising tide of popular support for medical marijuana — and would love to appear to be “doing something” — but lack the political courage or will to advocate for an actual medical marijuana law.

CBD is politically safe because, as a non-psychoactive component of cannabis, it doesn’t get anyone high, and better yet, it helps to quell seizures of the kind often found in pediatric epilepsy. So the combination of “helping kids” and “it doesn’t get you high” has proven an “in” for medical marijuana in what would otherwise have been quite forbidding places, such as the halls of power in Georgia, Alabama, Mississippi, Florida and now Kentucky.

The disquieting fact about these no-political-risk types of laws (Alabama’s passed unanimously in both chambers, amidst much self-congratulation) is that (a) they are written so narrowly as to help only a handful of children, or perhaps none at all, according to some critics; and (b) all of the dozens of cannabinoids found in marijuana work most effective in a synergistic fashion, potentiating each others’ medical benefits in what Dr. Sanjay Gupta has called the “Entourage Effect.”

Additional important information of which the legislators seem to be unaware is that, as first reported on Toke Signals, it doesn’t even have to be a high-CBD strain to treat pediatric seizures without getting kids high. THC which hasn’t been decarboxylated — that is, THC acid (THCA) which hasn’t been exposed to heat — is also effective against seizures, and it isn’t psychoactive, either.

That’s important information for struggling parents who may not be able to afford the sky-high prices of CBD oil which are unfortunately occurring due to the media frenzy over cannabidiol; THC-rich strains of marijuana are much more affordable.

– See more at: http://hemp.org/news/content/kentucky-cbd-only-marijuana-oil-bill-wont-help-patients-years-if-ever#sthash.ihqsdrBt.dpuf

Kentucky’s first industrial hemp crop in decades will start going into the ground next month

Comer: First hemp crop in decades set for planting

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LOUISVILLE, Ky. (AP) — Kentucky’s first industrial hemp crop in decades will start going into the ground next month now that the pipeline for shipping seeds into the state is opening up to allow the experimental plantings, state Agriculture Commissioner James Comer said Tuesday.

Comer said he expects the first batches of hemp seeds to arrive in coming days at the state Agriculture Department at Frankfort.

“We’re rapidly approaching a crucial time for the seeds to be put in the ground,” he said by phone.

So far, eight pilot projects are planned statewide as part of a small-scale reintroduction to gauge the versatile crop’s potential in the marketplace and as a money maker for farmers. The first planting is scheduled for May 16 in Rockcastle County, said Comer’s chief of staff, Holly Harris VonLuehrte.

“Hopefully we can get enough seeds to have credible research data gathered by this fall,” Comer said. “And next year, hopefully we’ll have enough seeds to have several processors in the state and several farmers under contract growing it.”

Hemp production was banned decades ago when the federal government classified the crop as a controlled substance related to marijuana. Hemp and marijuana are the same species, Cannabis sativa. Hemp has a negligible amount of THC, the psychoactive compound that gives marijuana users a high.

The crop’s comeback gained a foothold with passage of the new federal farm bill. It allows state agriculture departments to designate hemp pilot projects for research in states that already allow the growing of hemp.

Kentucky lawmakers passed legislation last year that allowed hemp to be reintroduced, if the federal government allows its production.

Once the farm bill allowed the experimental plantings, the next challenge was getting hemp seed into the state.

Comer said Tuesday his staff has “gone through every level of federal bureaucracy you can go through to get those seeds in.”

U.S. Border Patrol officials have been cooperative as Comer’s office worked to develop a supply route to bring in hemp seeds, VonLuehrte said. The initial seeds are coming from Canada and Italy, Comer said.

State agriculture officials have helped match farmers with researchers for the pilot hemp projects. Some hemp grown will be sold for commercial uses after the fall harvest to help determine the crop’s marketability, VonLuehrte said. Some hemp will be grown purely for research, she said.

One pilot project in Fayette County will focus on hemp’s potential in medicine, she said. Gov. Steve Beshear recently signed into law a bill that allows doctors at two Kentucky research hospitals to prescribe cannabidiol to treat patients.

Several universities are participating in the hemp projects, also aimed at answering basic production questions for a crop that once thrived in Kentucky.

“It’s going to answer every question that a prospective farmer … would want to know,” Comer said. “What’s the optimum date to plant? Which variety of seeds grows best on which soil? What type of farm equipment does it take to harvest this hemp?”

Comer sees hemp as a way to boost Kentucky’s economy, especially in rural areas, through crop production, processing and manufacturing. Hemp was historically used for rope but has many other uses: clothing and mulch from the fiber; hemp milk and cooking oil from the seeds, and soap and lotions.

The next goal will be to win congressional approval to deregulate hemp, he said.

“We’re hopeful that after a year or two, that it can be deregulated and treated like any other agricultural crop,” Comer said.

CONTINUE READING…

Open Seeds: Biopiracy and the Patenting of Life by grtv

 

Open Seeds: Biopiracy and the Patenting of Life

by grtv

As the world begins to digest the implications of intellectual property for online censorship, another IP issue threatens an even more fundamental part of our daily lives: our food supply. Backed by legal precedent and armed with seemingly inexhaustible lobbying funds, a handful of multinationals are attempting to use patents on life itself to monopolize the biosphere.

Find out more about the process of patenting life and what it means for the food supply on this week’s GRTV Backgrounder.

Transcript and sources:

The oft-neglected legal minefield of intellectual property rights has seen a surge in public interest in recent months due to the storm of protest over proposed legislation and treaties related to online censorship.[1] One of the effects of such legislation as SOPA and PIPA and such international treaties as ACTA is to have drawn attention to the grave implications that intellectual property arguments can have on the everyday lives of the average citizen.

As important as the protection of online freedoms is, however, an even more fundamental part of our lives has come under the purview of the multinational corporations that are seeking to patent the world around us for their own gain. Unknown to a large section of the public, a single US Supreme Court ruling in 1980 made it possible for the first time to patent life itself for the profit of the patent holder.

The decision, known as Diamond v. Chakrabarty, centered on a genetic engineer working for General Electric who created a bacterium that could break down crude oil, which could be used in the clean-up of oil spills.[2] In its decision, Supreme Court Chief Justice Warren Burger ruled that:

“A live, human-made micro-organism is patentable subject matter under 35 U.S.C. § 101”

With this ruling, the ability to patent living organisms, so long as they had been genetically altered in some novel way, was established in legal precedent.

The implications of such a monumental ruling are understandably wide-reaching, touching on all sorts of issues that have the potential to change the world around us. But it did not take long at all for this decision’s effects to make itself felt in one of the most basic parts of the biosphere: our food supply.

In the years following the Diamond v. Chakrabarty decision, an entire industry rose up around the idea that these new patent protections could foster the economic incentive for major corporations to develop a new class of genetically engineered foods to help increase crop yields and reduce world hunger.

The first commercially available genetically modified food, Calgene’s “Flavr Savr” tomato, was approved for human consumption by the Food and Drug Administration in the US in 1992 and was on the market in 1994.[3] Since then, adoption of GM foods has proceeded swiftly, especially in the US where the vast majority of soybeans, corn and cotton have been genetically altered.

By 1997, the problems inherent in the patenting of these GM crops had already begun to surface in Saskatchewan, Canada. It was in the sleepy town of Bruno that a canola farmer, Percy Schmeiser, found that a variety of GM canola known as “Roundup Ready” had infected his fields, mixing with his non-GM crop.[4] Amazingly, Monsanto, the agrichemical company that owned the Roundup Ready patent, sued Schmeiser for infringing their patent. After a years-long legal battle against the multinational that threatened to bankrupt his small farming operation, Schmeiser finally won an out-of-court settlement with Monsanto that saw the company agree to pay for the clean-up costs associated with the contamination of his field.

In India, tens of thousands of farmers per year commited suicide[5] in an epidemic labeled the GM genocide.[6] Sold a story of “magic seeds” that would produce immense yields, farmers around the country were driven into ruinous debt by a combination of high-priced seeds, high-priced pesticides, and crop failure. Worst of all, the GM seeds had been engineered with so-called “terminator technology,” meaning that seeds from one harvest could not be re-planted the following year. Instead, farmers were forced to buy seeds at the same exorbitant prices from the biotech giants every year, insuring a debt spiral that was impossible to escape. As a result, hundreds of thousands of farmers have committed suicide in the Indian countryside since the introduction of GM crops in 1997.

As philosopher, quantum physicist and activist Vandana Shiva has detailed at great length, the effect of the invocation of intellectual property in enabling the monopolization of the world’s most fundamental resources was not accidental or contingent.[7] On the contrary, this is something that has been self-consciously designed by the heads of the very corporations who now seek to reap the benefit of this monopolization, and the monumental nature of their achievement has been obscured behind bureaucratic institutions like the WTO and innocuous sounding agreements like the Agreement on Trade-Related Aspects of Intellectual Property Rights.

Although the deck appears to be stacked in favour of the giant multinationals and their practically inexhaustible access to lobbying and legal funds, the people are by no means incapable of fighting back against this patenting of the biosphere.

In India itself, where so much devestation has been wrought by the introduction of genetically engineered crops, the people are fighting back against the world’s most well-known purveyor of GMO foods, Monsanto. The country’s National Biodiversity Diversity Authority has enabled the government to proceed with legal action against the company for so-called biopiracy, or attempting to develop a GM crop derived from local varieties of eggplant, without the appropriate licences.[8]

Although resistance to the patenting of the world’s food supply should be applauded in all its forms, what is needed is a fundamental transformation in our understanding of life itself from a patentable organism to the common property of all of the peoples who have developed the seeds from which these novel GM crops are derived.

This concept, known as open seeds, is being promoted by organizations around the globe, including Dr. Vandana Shiva’s Navdanya organization.[9]

PLEASE CONTINUE READING HERE…