Florida regulators faced a packed room of profit-seeking hopefuls and desperate parents Monday as they launched their first hearing on draft rules authorizing marijuana in the state for limited medical use.
The standing-room-only crowd came to offer feedback to a proposed rule drafted by the Florida Department of Health as it decides how to implement the law that legalizes marijuana that is low in THC (tetrahydrocannabinol) and high in CBD (cannabidiol) for patients with seizures, severe and persistent muscle spasms and cancer. The rules must be in effect by Jan. 1, and only patients who are placed on a state-run “compassionate use registry” will be eligible for the drug.
After almost seven hours of testimony and almost 50 speakers, one thing became clear: Regulations will be key to determining whether the state’s experiment with medical cannabis will go smoothly or become a series of lessons learned.
The law the Legislature passed last spring authorizes five nurseries in each region of the state to cultivate and distribute marijuana for medical purposes. The draft rule proposed by the Department of Health envisions a lottery in each region whose eligible participants would include at least 41 nurseries that have been in operation 30 years.
Those ideas were roundly rejected by several commentators who warned that they fail to recognize the quality of technology, expertise and experience offered by various growers.
“If it’s a lottery, the most qualified companies may not even apply,” said Kerry Herndon, owner of Kerry’s Nursery in Apopka, who hopes to apply to run the nursery located in Central Florida. “I’ve put an enormous amount of energy into this already and, if it’s a lottery, I wasted my time.”
Other commentators warned that the law would create near monopolies for a handful of companies that could suppress price competition and be bad for consumers.
“Essentially you’re creating not an oligopoly but a monopoly in that region,” said Bill Pfeiffer, a former state administrative law judge now working for a group of marijuana investors. He also suggested that each company should be able to offer its product at multiple locations within a region and within the state.
“I think the Legislature has made it very clear they can offer it statewide or regionally as determined by the department.”
Jennifer Tschetter, the Department of Health’s general counsel, said there would be one winner in each region, and each would be restricted to offering its products to customers exclusively in its region. (The Southeast region would include Palm Beach, Broward, Miami-Dade and Monroe counties.)
Families who worked to persuade a reluctant Legislature to pass the bill urged regulators to move quickly and carefully.
“We’re really grateful we’ve gotten to this point,” said Seth Hyman of Weston, whose 8-year-old daughter Becca suffers from intractable epilepsy. “We watch our daughter suffer every day — yesterday she turned blue. We hope the state sets fair and realistic guidelines and, if they rush it, it’s got to be done right.”
The proposed criteria are strict: The plants must adhere to the formula of no more than 0.8 percent THC or less than 10 percent CBD — or all of the product would be destroyed; growers must inventory their plants, cuttings and seeds daily or be subject to penalty; chemical additives must be screened and carefully controlled; and the entire operation must be under lock and key.
Florida became the 22nd state to legalize a form of marijuana for medical purposes and the 11th to authorize low-THC exclusively. The law is considered just the first step in bringing the plant legally to Florida because an amendment pending on the November ballot would allow for the medical use of the plant for a much broader array of ailments.
Regulators hope that the process they put in place this summer for the limited strain could be the blueprint for the wider law if voters approve it. It sets the price of a license at $150,000, and the grower must post a bond of $5 million. The investment also involves immense security and technology, and a requirement that growers fingerprint and screen their employees.
The law envisions growers becoming store owners, creating a series of dispensaries in each region of the state. The proposed rules suggest their stores be open at least 30 hours a week, and no later than 10 p.m. The products they sell would be limited — no edible cannabis products, such as cookies or candy, and no cigarettes.
The potential industry has already spawned a rush of businesses waiting to strike it rich on Florida’s new crop. Some of the state’s most prominent lobbyists filled the room, as well as growers from Israel, Colorado and California, and farmers from throughout the state.
Representatives of doctors, investors and biotech specialists who also want to get on the cannabis train attended, as did the mother of Charlotte Figi, the Colorado girl whose parents worked to first develop the low-THC strain of marijuana for children with severe epilepsy.
Joel Stanley, the marijuana grower who developed the “Charlotte’s Web” strain urged regulators to be aware that the genetic composition of the plants is important to quality control.
“What makes Charlotte’s Web particularly special is it does have that track record,” he said. “We have eight different phenotypic expressions of the Charlotte’s Web product . . . We choose to use the same one over and over again because we have found that others don’t have the same level of efficacy.”
He noted that not all applicants will be equal, and urged regulators to focus on those that are able to produce the strain more quickly and safely than others.
“They are still going to have extremely different levels of teams that they’ve assembled to prove that they can put this product out in bulk but also safely,” he said.
Stanley, whose company manufactures the low-THC extract through a nonprofit group called Realm of Caring, is one of a handful of companies hoping to partner with growers in Florida to bring the product to Florida.
Tschetter said regulators chose the lottery approach because “what we’re trying to do is get this out to patients as quickly as we can.”
The department has estimated that about 125,000 children with intractable epilepsy could be eligible for the drug and, if the constitutional amendment passes, 420,000 patients and 1,800 treatment centers would be needed.
Several people testified that the growers must be allowed to obtain the marijuana plants without being subject to federal crimes for possession of the illegal drug.
Kim Russell, the Orlando woman who started the petition drive five years ago to get access to marijuana to help her father with Parkinson’s disease, agreed that a random lottery to select the five chosen companies was not the best approach. She urged regulators to focus on getting the product to patients first.
“This is the compassion act, not the green rush act,” she said.
Tschetter said at the end of the meeting that the department would consider changes to its rule and conduct a second workshop later this month to finish its work on the proposed rule.