November 24, 2019 at 5:00 pm | By Samantha J. Gross of the Miami Herald
MIAMI — The hemp plant — marijuana’s non-euphoric cousin — has been touted as a “miracle crop” that can revitalize nutrient-deficient soil, grow all year and bring economic freedom to farmers burdened with timber loss or citrus greening.
It can be turned into thousands of products, ranging from animal bedding to body lotions to textiles like towels and clothing.
But what about painkillers? One leading hemp research company is looking at creating an FDA-approved capsule that could replace ibuprofen to treat acute pain.
Fort Lauderdale, Fla.-based Green Point Research, which funded the existing hemp pilot program at the University of Florida, has announced a new partnership with Florida State University to conduct a study analyzing Green Point’s Satividol CBD softgel capsule and its benefits.
The CBD compound, unlike its psychoactive sister THC (tetrahydrocannabinol), won’t get you high but has been anecdotally reported to have calming and anti-inflammatory effects.
Green Point worked with UF as a university partner as allowed under the 2014 federal Farm Bill. The 2018 Farm Bill removed prohibitions on industrial hemp in place since 1937 and authorized states to create hemp programs beyond the university research setting. During the 2019 legislative session, the Legislature passed a bill allowing hemp pilot programs to exist at any school with a college of pharmacy, engineering or agriculture, not just UF or Florida A&M University.
The company’s founders — three FSU College of Law graduates — were excited to jump on the opportunity to work with their alma mater.
“It was a natural fit. We already love the university, and they have strong expertise in exactly where we needed it,” said David Hasenauer, CEO of Green Point. “It came together organically after the new law passed.”
The research efforts will be led by FSU’s vice president for research, Gary Ostrander. The actual clinical research will be done in Australia through an FDA “fast track” program, Hasenauer said, and will take around two years to complete. Green Point provides the material and funding, FSU conducts the research and publishes the data.
“It’s a true independent review,” Hasenauer said.
The product being tested will be a stronger, higher dose than what Green Point already sells, and will be aimed at patients who have conditions like arthritis or sleep issues.
“We’re doing this research to really find out what’s causing these effects in everybody,” Hasenauer said. “We don’t want a runaway cycle with CBD where everyone gets disenchanted because people are pumping out pseudoscience.”
He added that because drugs like ibuprofen have long-term effects on liver function, he hopes CBD products can provide a safer alternative. Hasenauer hopes FDA certification would allow drugs like Green Point’s to show up in medical school curricula or critical care plans in hospitals.
As of now, the only FDA-approved CBD drug on the market is Epidiolex, a prescription medication used to treat seizures. It was approved by the FDA in June 2018.
Agriculture Commissioner Nicole “Nikki” Fried, a former marijuana lobbyist who also oversees Florida’s consumer services division, says studies and testing are key to making steps toward safe, quality CBD products. The state’s nascent industrial hemp program was a campaign promise of Fried’s.
She has, however, warned Floridians to use caution when buying CBD products, as there’s no regulation in place ensuring the safety of its contents.
“We know that CBD products can improve quality of life, so it’s crucial for public safety that we get this right,” she said Wednesday. “I’m glad to hear that the FDA is working with a Florida business. Our state has some of the nation’s leading research institutions — Florida is ready to help lead the way on safe, quality CBD.”
Before the clinical trial can begin in February, however, Green Point Research must grow the hemp to process for the softgel capsules. Right now, the company grows the hemp at a farm in Crawford, Colo., then ships it to California for processing and to Fort Lauderdale for storage and sale.
However for this study, the hemp will be grown at farms in north, central and south Florida as part of a separate study on commercial hemp farming. Hasenauer said that any day now, they will receive the permit to get seeds in the ground.
The hemp pilot will span 450 acres at three different farms statewide, and will hopefully help produce a guide for best management practices for farmers who are interested in getting a license to grow industrial hemp themselves, Hasenauer said. The final results will show how many workers are needed to run a successful grow, what types of watering styles work best and what kind of unique pests might be present in Florida farms.
“We know it’s a nascent industry and we have decades of catching up to do,” said Hasenauer. “We’re just excited about the potential.”
Despite the hype around the concept, industrial hemp hasn’t been the easiest nor the simplest crop to grow in Florida.
While hemp farmers that are part of the pilot project can draw analogies to similar regions and climates, Florida is different from any other climate in the country. Jerry Fankhauser, assistant director of UF’s program, spoke in front of a Senate panel last week to highlight difficulties their program has faced, like excessive rainfall, high temperatures and pollen drift.
He noted that Florida is unique, and said “it’s a process of learning together.”
The state of Florida has already started creating its own manual specific to growing hemp, Florida Cannabis Director Holly Bell said, and she welcomes all outside efforts to add to the conversation. The Legislature’s hemp bill creates a permitting process for potential hemp farmers to apply, and Bell has said permits will be issued in early 2020.
“We want to arm growers with the best knowledge and information to make Florida’s hemp program a model for the nation,” she said. “As we work to modernize and update our (best management practice) standards, we’re also working to create a new (best management practice) manual specifically for hemp to help Florida farmers by empowering them with the latest science and innovative growing practices.”
Glenn Whitworth Jr. helps run his family farm, Whitworth Farms, west of Boynton Beach. His family is leasing land to Green Point for the pilot project.
As a third-generation produce farmer who has seen the ups and downs of the industry, Whitworth says hemp may be a “good shot in the arm” for the industry.
“This is an untested race track with untested horses,” he said. “There’s going to be a lot of trials and tribulations and failures. It’s something new, and once things get going, the possibilities are endless.”