Aug 2, 2017

How the FDA Made a Felon Out of This Amish Farmer

FDA Made a Felon Out of This Amish Farmer
He is behind bars after selling skin-care products made from natural ingredients without government approval.

JORDAN REIMSCHISEL
Daily Beast
August 1, 2017

In Bath County, Kentucky, a rural area near Lexington, a judge sentenced a 57-year-old Amish farmer and father of 12 to six years in prison for producing a herbal skin cream without the government’s permission.

Samuel Girod formulated homemade skin-care products on his family farm, and sold them for two decades throughout the upper Midwest, largely on word-of-mouth promotion. He claimed that his products could help with poison ivy rashes, psoriasis, headaches, and more. Despite the fact that the products were made from benign, natural ingredients like chickweed, rosemary, olive oil, and peppermint, products intended to treat diseases are considered drugs and must be approved by the Food and Drug Administration and produced in an approved facility.

Amish beliefs teach “cleavage between the church and the larger society,” and a complete separation of the “kingdom of God” from the “kingdom of the world.” The community prefers as such to keep their disputes out of secular courts, turning instead to bishops, the highest ranking members of their church, to solve conflicts. Girod, declining outside counsel, argued at his trial that the FDA’s authority and the federal prosecutor’s charges “do not apply to me” because he is “not a creation of state/government.”

Girod’s fight dates back to 2013, when a federal judge from Missouri ordered him to stop selling his three most popular salves. He continued to sell his products, and later that year two FDA inspectors went to his property to inspect his facility. Again citing his Amish beliefs, he tried to keep the officials out, and the agency then opened a federal criminal investigation.

Girod was eventually charged on 13 counts related to FDA guidelines and procedures, including selling misbranded products, failing to register with the FDA, conspiracy to impede an officer of the United States, and obstruction of proceedings before the FDA.

Notably, not one of Girod’s customers alleged his homemade remedies caused them any harm, though several testified that they would not have purchased them had they known of the FDA’s injunction.

After a two-and-a-half day trial, a jury declared Girod guilty on all counts and Judge Danny Reeves sentenced the farmer to six years in prison followed by three years of supervised release. He’ll also have to pay at least $14,000 in restitution and another $1,300 in assessment fees.

There are precedents for exempting the Amish from laws and regulation. Dr. Donald Kraybill, senior fellow emeritus at Elizabethtown College and an expert on the group, told me that they and Mennonites are exempt from Social Security taxes, and that “other waivers related to septic systems and building codes have also been made on the basis of freedom of religion.” Kraybill added, though, that he was skeptical Girod could win an appeal arguing that the FDA’s rules violated his religious freedom.

Even there, there’s some precedent. In 1972, the Supreme Court ruled that the state could not force the children of Amish parents to attend public schools after the 8th grade, determining that the parents’ religious right to educate their children in Amish schools outweighed the government’s interest in educating children.

In handing down a harsh sentence to the farmer, Judge Reeves told Girod that he “exhibited continuous and blatant disregard for the law.”

Carlton Shier, the acting U.S. Attorney for the Eastern District of Kentucky, said after the verdict that Girod had “brazenly placed the public at risk, openly hampered law enforcement, and intentionally impeded the judicial process.”

Others were skeptical, especially since no one was harmed by his products. T.J. Roberts, a student from Transylvania University, held a sign outside the sentencing: “I don’t need the FDA to protect me from an Amish farmer.”

The sheriff of Bath County, John Snedegar, wrote the court to ask why the FDA is “attacking and victimizing such peaceful and law-abiding Americans.”

Girod’s neighbor, Sally Oh of Morehead, created a petition calling on a pardon for the farmer on Change.org. It now has over 30,000 signatures.

Jordan Reimschisel is a research assistant focusing on medical technology and regulation. He is a Young Voices advocate.

http://www.thedailybeast.com/how-the-fda-made-a-felon-out-of-this-amish-farmer

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