When is food not considered food by Maryland regulators?
When it has marijuana in it.
Now that state lawmakers have approved medical cannabis “edibles” such as cookies and brownies, state regulators are beginning this month to write the complicated rules for making sure the baked medications deliver consistent doses to patients in child-resistant packaging.
But the edible cannabis law signed by Gov. Larry Hogan was careful not to classify such treats as “food” for a reason: Doing so would have required redundant oversight from the Maryland Medical Cannabis Commission and the Department of Health’s food safety division. Instead, as in 30 other states, edible cannabis products are now a class of their own in Maryland overseen by the commission.
“Edibles are actually an accepted way in which to get the medical cannabis in more than 30 states,” said Del. Cheryl Glenn, the Baltimore Democrat who sponsored the legislation, during a hearing on her bill. “We want Maryland to be able to offer this option to patients and caregivers.”
Opponents say a candy-and-treats category undermines a program that regulates cannabis as a medicine, not as a snack. There is no purpose, they say, of adding baked goods and gummy bears to the 18-month-old market when patients who better handle cannabis by ingesting it — rather than smoking or vaping it — already have the option to take pills.
“There’s absolutely no reason for any medicine to be in a brownie, a cookie or a lollipop,” said Ryan Vandrey, a Johns Hopkins University School of Medicine professor who has studied the effects of edibles for five years at the school’s Behavioral Pharmacology Research Unit. “From a public health perspective, it makes no sense at all.”
Regulations should require manufacturers to make products that deliver uniform doses throughout an entire batch of brownies or risk some portions delivering more THC — the ingredient that delivers the high — than other parts, Vandrey said. That can be dangerous to individuals who are not used to the effects of cannabis, he said.
“Dosing is critically important,” he said.
Regulators in Maryland should consider that the sampling, testing and manufacturing of cannabis used in edibles will have to be different for each distinct baked, liquid or gummy product to assure equal distribution of the drug, he said.
The cannabis commission understands the difficulty of regulating edibles and expects the rules-writing process to last for the rest of this year, said William Tilburg, the commission’s policy director.
Regulators are scheduled to begin a series of meetings and public hearings with industry, food safety and public health experts to devise the standards for the “packaging, labeling, marketing, and appearance of edible cannabis products to ensure the safety of minors,” the agency announced recently.
“The hope is that there would be regulations by the end of the calendar year,” Tilburg said.
The administrative costs for starting an edibles program are estimated to be $297,000 for hiring three people “trained in food safety or sanitation,” according to an analysis by the Department of Legislative Services.
The legislation allowing for edibles passed easily in the General Assembly, which required the commission to devise the new regulations.
Sen. Robert Cassilly, a Harford County Republican, said he voted against edibles because he believes “it was a step too far” that would make it easy for teens to use without detection at school and while driving.
“I don’t want to deprive anyone of their medication, but let’s treat this like medicine, not make little gummy bears out of it,” Cassilly said. “You’re just flirting with legalization.”
The new regulations are likely to require edible packaging to be small to prevent patients from eating too much. The effects of cannabis often take longer to kick in when it’s eaten, which can lead patients to eat more. That can result in adverse reactions that land users in emergency rooms, which has happened in other states that allowed packaging in large portions without dosing instructions, experts said.
“Dosing has to be consistent and reliable,” said Mackie Barch, owner of the Culta dispensary in Baltimore’s Federal Hill and chairman of the Maryland Wholesale Medical Cannabis Trade Association. “Safety is paramount. We don’t want people having bad experiences on edibles.”
Vandrey’s research with edibles at Hopkins has shown that doses of 25 and 50 milligrams caused vomiting, dizziness, memory problems and paranoid responses in some healthy, adult patients who were not routine cannabis users. Dose-packaging of edibles should deliver no more than 10 milligrams of THC, he said.
That’s the limit set by several other states that have legalized cannabis and the dose that Canada has proposed for edibles when they are legalized. In Vandrey’s lab studies, 10mg doses were associated with either no or only mild impairment of cognitive function.
A Colorado study published in April in the Annals of Internal Medicine examined emergency room visits and found that patients who arrived after eating edible marijuana presented “more acute psychiatric” issues than those who smoked or vaped the drug.
A 2016 study by the National Institute on Drug Abuse stated that “further research into cannabinoids, and edibles in particular, is needed so that policy makers can be well informed when establishing regulations regarding the manufacture, labeling, and sale of edibles.”
The industry’s chief concern, Barch said, is keeping edibles “out of the hands of kids” to avoid accidental ingestion.
Mike Gimbel, who led Baltimore County's Office of Substance Abuse for more than a decade, said he hopes the commission will limit the amount of edibles.
“If you go into a dispensary in California, it’s like going into a supermarket with cannabis infused into everything,” Gimbel said.