When Janel Ralph, founder and CEO of Palmetto Harmony, was told by physicians at the Medical University of South Carolina that she could not obtain cannabidiol (CBD) for her daughter’s condition because it was a controlled substance, she decided to take matters into her own hands.
Ralph, whose daughter Harmony was diagnosed at birth with a rare form of epilepsy, entered the CBD space in 2014.
“Everything I researched when it came to severe cases of epilepsy at the time kept leading me back to CBD,” she said. “What I kept hearing was that CBD was a constituent of marijuana […] which is not the case. CBD is actually a constituent of hemp. It’s what makes hemp, hemp.”
Harmony has lissencephaly, or “smooth brain,” a rare genetic condition in which the outer layer of the brain cannot form due to a genetic deletion of the 16th chromosome. There are approximately 800 cases worldwide at any given time.
“With that particular condition, and what possibly makes it so rare worldwide is the [fact that] it comes with intractable epilepsy,” Ralph explained.
This means that 95% of the time or more, children with lissencephaly cannot gain control of their seizures with modern day medicine.
In 2014, when Harmony was 4 years old, she was on six different antiepileptic drugs.
“The doctors told us that there was nothing more they could do for her because at that point, she had spent [9 days] in the hospital in status epileptic, or one steady state of epileptic seizure,” Ralph said.
That’s when Ralph went to the internet to seek information on alternative medicine options for her daughter’s condition. Just a few weeks after she started her research on the benefits of CBD, a bill was passed in South Carolina, her home state, which allowed patients with conditions similar to Harmony to obtain CBD as a form of alternative medicine.
Yet, despite receiving a letter of recommendation from her physician, Ralph had to begin the difficult process of obtaining CBD.
“What I quickly learned was that there was a lot of people in the [CBD] space to steal a lot of money from you, and will give you bad product or mislabeled product,” she said.
After months of searching for CBD, Ralph acquired nearly a month’s worth supply from a friend. By day 12 of the alternative medicine, Harmony’s seizures completely stopped without changing her pharmaceuticals; however, Ralph only had a limited supply and she had to find a more permanent solution.
Hoping that she could share her experience with others, she started a Facebook group entitled, “CBD for Children with Epilepsy.” There, she included parents of children with lissencephaly that she knew of and a few members from the CBD industry. Trial and error ensued, but she insists that she learned from her experience.
“At the end of the day, if it’s going to help our children, it has to be accessible to them,” she said. “And that’s what it came down to for me: how do we get this, and how to we make it accessible for the people who need it?”
By chance, Ralph met an individual who had a child with epilepsy and who was growing high CBD varieties in Kentucky through their PILOT program. Almost immediately, Ralph purchased a crop of CBD and began preparations to build a manufacturing facility in Kentucky.
Ralph then set up the packaging, shipping and customer service department in South Carolina. Today, Palmetto Harmony has become a completely vertically integrated company as one of the first legal licensed facilities in South Carolina.
“And, because of what I went through, we were one of the first companies that continuedly drove the narrative on third party lab testing,” Ralph said.
The company triple checks their product: the grow, after it is extracted, and the final product. Although their products are grown in compliance with the Federal Farm Bill of 2014, they also provide the third party lab results to any customer who sends their batch and lot number.
All the while, Ralph has learned to wear many hats, both as CEO of Palmetto Harmony and its manufacturing arm Palmetto Synergistic Research, as well as the founder of a government lobbying firm that worked on the 2018 Farm Bill to legalize hemp.
Now, her goal is FDA regulation.
“Once the FDA starts regulating it just like every other front-of-the-counter drug, like an herbal product, there will be certain high standards that they will require from the manufacturing products that will remove some of these bad products off the market. I’m really looking for to the FDA regulation,” she said.
All the while, Ralph has tackled each issue from the eyes of a mother.
“At the end of the day, Harmony, this is what she relies on. Flash forward 4 years, she has a 90% reduction in seizures and an 95% reduction in pharmaceutical intake. There’s no catalyst there beside the CBD, it’s the only difference,” she said.
- Ralph, Janel. American Society of Consultant Pharmacists. Interview, April 2019.