Rx Test

It’s been two years since Nicole Schmidt last put on medical scrubs and drove to her dream job as a registered nurse at Presbyterian Hospital Radiology Clinic. When her autoimmune system went awry in the summer of 2012, she lost the ability to work, as constant joint inflammation rendered her unable to write on patients’ charts.

Seeking relief from painful neuropathy, Schmidt registered as a cannabis patient with the state of New Mexico and was approved to both grow her own plants and purchase the medicine from state-licensed producers.

Between her personal harvests, Schmidt has also purchased brownies, chocolates and tinctures infused with THC and cannabidiol (CBD) from several dispensaries, but stopped when those edible products didn't seem to alleviate her symptoms.

Schmidt may be down, but she isn't out. Two weeks ago, with her fingers inflamed and aching, "Nurse Nicole," as she likes to be called, agreed to be a secret shopper for an SFR investigation.

After publishing a news story last month on the increasing popularity of cannabis-derived products, SFR learned that not all the labels on these goods accurately portray how much medicine they contain.

With the help of the only private scientific laboratory in New Mexico approved to conduct tests for the medical cannabis program, we sought to determine whether the state's nearly 11,000 patients are getting a good value for their money and purchasing consistently dosed packages.

Accompanied by SFR, Schmidt set off on her shopping trip. She bought 14 products from four shops in Santa Fe and another three in Albuquerque. At the end of the day, armed with sealed packages, Schmidt delivered the shopping bags to Page Analytical in Placitas.

The lab results are in, and patients who rely on the medication for sleep, pain relief and anxiety reduction may be disappointed to learn what they reveal: A majority of the products SFR had tested contained THC levels well below their stated values. But not all. Declarations on two packages were close to the actual dosages while two others had slightly more medication than listed.

In the seven years since medical cannabis became legal in New Mexico, our test appears to be the first and only spot check to determine whether edibles sold to people suffering debilitating medical symptoms contain the amounts of THC claimed.

So, why hasn't the Department of Health done its own testing and alerted patients to potentially inaccurate dosage claims?

We don't know, because while SFR made multiple requests to talk with state program managers, a Health Department spokesman refused to grant an interview. Instead, Kenny Vigil would only answer questions in writing.

The upshot of his response: The law doesn’t require tests for THC content. The department expects and “had hoped” producers would perform the tests and has now proposed new rules to require them. Further, he says no patients have lodged formal complaints about potency.

WHAT WE FOUND

Page Analytical lab owner Jeremy Applen has education and professional experience that spans biochemistry, pharmacy practice, clinical research and drug development. It took him less than three days to analyze the 14 samples.

Some of the most surprising results came from products sold at the popular Albuquerque-based R Greenleaf Organics. The products we tested from this store varied in terms of the accuracy of their claims.

The Sativa Sherwood Chocolate Bar, for example, is labeled for 180 milligrams of THC, but testing showed it has only 80.5 percent of that amount. Lower than advertised, but nothing compared to Jake's Yummy Gummies. A counter attendant told Schmidt the gummies had 10 to 12 mg of THC, but Page Analytical was only able to detect trace amounts of THC in the candy.

After hearing the results, J Chris Romero, R Greenleaf's director of operations, told SFR he planned to remove more than a dozen of the $12.50 packages from the clinic's refrigerator.

"I take this very seriously," Romero says, "I'm not out to trick our customers."

Romero also insisted the company has received different test results from Phyto-Pharma Testing, a lab connected with New Mexico State University in Las Cruces. Romero promised to share reports showing the higher THC with SFR.

While we waited for Phyto-Pharma's numbers, Applen retested the gummies. After two runs, he could not quantify the amount of THC in the gummies because it fell below his equipment's lower measurement limit of .0025 mg of THC per gram.

Several days later, Phyto-Pharma's Jack Noel sent SFR a table of THC numbers for R Greenleaf's cannabis-infused glycerin, an ingredient used to make their gummies. Noel's analysis showed THC levels as high as 13 mg of THC per milliliter, but he concedes his results are not a representative sampling of a completed batch of gummies.

Romero's boss Willie Ford says the difference in lab results may be equipment related. Page Analytical uses a process called liquid chromatography while Phyto-Pharma uses gas chromatography. Whatever equipment is used, industry data posted on nationally recognized cannabis lab Steep Hill Halent's website shows glycerin has a poor ability to hold more than 2 mg of THC per milliliter.

Back on the shopping trail, and just east of the railroad tracks near West San Mateo Road in Santa Fe, Schmidt found New MexiCann Natural Medicine. Inside, a cashier named Randy rang up a single two-ounce bottle of Canna Glycerin Medical Tincture. The label on the $18 bottle shows a combined total of 150 mg of THC/CBD. Page Analytical detected only trace amounts of CBD and a little more than 12.5 mg of THC—only 8 percent of what the label claims

Concerned about his tincture's test result, New MexiCann founder Len Goodman tells SFR he had his employees remove labels from all their old glycerin products.

"And we are disclosing to patients that although the content in the bottle is 150 milligrams of THC and CBD combined, very little of that is being delivered by dropper," says Goodman.

Goodman didn't stop with disclosure. He has reformulated his product with a mix of glycerin, water and alcohol. Initial results show the new recipe does a better job of absorbing the medication, which had been adhering to the side and bottom of the glass bottle or inside the dropper itself.

Goodman says the formula Applen got from Steep Hill Halent and shared with him worked "phenomenally."

"We set a goal of 100 milligrams of THC in the new formula and hit 110 milligrams," says Goodman after the first test was conducted late last week. He expects to begin making all new tinctures this week.

"If you had not been working on this story, we would never have known about the problem or created the solution to it," says Goodman.

But Goodman will have to find a few more solutions. One of his baked products also tested below its advertised potency level. New MexiCann's Sativa Brownie came back with 37.10 mg of THC, only 74 percent of the 50 mg of THC printed on the package's label.

"What we didn't know could happen is that you can get a breakdown in cannabinoid content when you heat this stuff up," says Goodman. "I know that we're putting the right amount of THC extract in, but we weren't aware what we were getting on the back end had broken down."

That's a problem for state Sen. Gerald Ortiz y Pino, D-Bernalillo, who tells SFR the Department of Health should have been asking for finished product test results and posting them online for patients to review.

"If people ever wonder what governments should do, this is a good example," says Ortiz y Pino.

After learning about Applen's test results, Ortiz y Pino is concerned that patients could end up consuming too much THC from products sold by one producer if they're used to buying improperly marked products from other producers.

"Patients should have an assurance they're getting the correct dose of THC in all their purchases. When we passed the law, we didn't just permit its [cannabis] use, we wanted it regulated and safely sold," says Ortiz y Pino.

After a short lunch break, Schmidt's shopping trip continued. At Sacred Garden on Luisa Street in Santa Fe, a young man working behind a sliding glass window suggested Nurse Nicole might like the company's Mega Doomer Sativa Brownie, labeled with a vague "100 mg." Applen's test showed this popular edible only had 31 mg of THC.

"These test results have taken me by surprise," says Sacred Garden Manager Scott Berdell.

Yet, Berdell points to other cannabinoids that showed up in Appen's test that have "significant medicinal qualities" and bring the amount of active cannabis ingredients in the brownie to 153.6 mg.

Berdell says he's confident in their process, yet he plans to reduce the price on his remaining brownies and begin testing batches at Page Analytical this month. The $100 potency tests, Berdell says, could lead to price increases.

At Fruit of the Earth Organics on Early Street in Santa Fe, Schmidt had to register as a new patient. When her forms were completed, a cashier named Al invited her into another area, walking her past a music room and pointing to a drum set that he plays there.

Lyra Barron, who manages the dispensary with her son, says a newly hired assistant manager misspoke when he told Schmidt the company's tincture included 100 mg of THC. The amount was not printed on the label, but a man named Rob confirmed the original 100 mg of THC claim during a follow-up telephone call.

Barron claims her $22 Pain Relief Formula remains a good value because even though Page Analytical determined it has 31 mg of THC, she says that amount helps potentiate a dozen other medicinal herbs, like kava kava, infused into the tincture.

"It's good for patients who need relief, but don't want to be high at work," says Barron, who believes state regulators are trying to kill the program.

While Gov. Susana Martinez, a former prosecutor, hasn't pushed legislation to repeal the law, industry insiders say the Medical Cannabis Program is understaffed and underfunded. Producers themselves worry that new proposed regulations, with stricter testing requirements and fee increases, which could be used to improve regulatory oversight, will make it even more difficult for them to operate.

Kris Hermes, a spokesman for patient-advocacy group Americans for Safe Access, says that's exactly what has happened in other states where testing requirements have been used as a pretext to "disrupt, slow down or stop implementation of medical marijuana laws."

"However, if testing requirements are not onerous in terms of their expectations or costs and can help provide patients with therapeutic products based on better standards of quality, purity and consistency, then they should be supported," says Hermes.

Minerva Canna Group founder Erik Briones, who opened a stand-alone edible kitchen in Santa Fe and markets edibles under the brand name Canna Café in Albuquerque's North Valley, says after hearing an analysis of his $8 candy gems—which showed less than half of the 20 mg of THC claimed—he's also likely to start doing more testing. He assured SFR the price for the candy will be knocked down too.

Nurse Nicole is disappointed with the overall test results.

"But I'm not surprised" says Schmidt, who's on a fixed income and relies on family members to help her pay for her medication. She doesn't think the dosing shortages are deliberate. "I just don't think that the producers know what they're doing."

Experience and know-how are the two reasons why Top Organics President Peter Ferrara purchases his edibles from Trevor Newburn's Budder Pros in Albuquerque. His Triple Strength Serenity Chocolate Bar test showed 7 extra milligrams of THC over the food's listed 180 mg. Karma Triches, a hard candy produced by Budder Pros, also had five more milligrams than the 250 mg of THC the label suggests.

Newburn's tincture, like most of the other glycerin tinctures, didn't perform as well. The label on his Bud Nectar tincture claims the bottle contains 150 mg of THC, but test results showed the finished product only has 16.5 mg of THC.

"I'm a firmer believer if the label says something the product should match," says Newburn, who says he may remove tincture products until he reformulates his recipe.

Tim Van Rixel of Bhang Chocolates New Mexico is, according to Applen, the only edibles manufacturer who has been testing his products both for dosage and microbiological contaminants since the announcement of new product standards for cannabis-derived products in January.

Van Rixel tells SFR he hasn't raised his prices because of the testing. Instead he says he's had to absorb them as a "cost of doing business."

He supports mandatory testing, and after working with Applen, has been able to refine his production to get consistent potency levels.

"It's important, because patients can buy a Bhang Bar and stay properly titrated. If something isn't, they'll eat too many and risk being overmedicated," says Van Rixel.

As a group, producers whose products were tested for this story appeared surprised at the scientific results, but they shouldn't have been completely in the dark. Last summer, SFR rode along with then-medical cannabis courier Josh Zapata, who used to deliver bud and edibles to patients in rural parts of the state. He says in a recent interview that complaints about different products weren't common, but over the years he's returned several packages to producers.

"Hell yeah, there have been bad batches, that's why I support double testing and 100 percent product guarantees. Producers need to test their extracts and get their formulas right, but they also need to test products before they are sealed. Patients deserve to know their edibles are properly dosed," says Zapata.

Joel White, with the New Mexico Medical Cannabis Patient's Alliance, agrees.

"Patients are already fragile. The last thing we want is someone to get hurt with medication that we believe is safer than prescription drugs," says White. "Safety is our priority and we want accurate testing of our drugs' efficacy and potency."

All the edible products for this investigation passed microbiological tests, but Applen says he's identified problems with producers' plants in the past.

The Department of Health says it's never recieved a patient complaint about getting sick from plant or edible products and has never received a complaint about potency of cannabis-derived products.

Spokesman Vigil says two patients complained about suspected contamination from butane and pesticides, but testing proved both complaints were unfounded.

WHERE DO WE GO FROM HERE

While New Mexico is ahead of California in terms of uniform state regulations, the San Francisco-based policy manager for the Drug Policy Alliance, Amanda Reiman, would like to see New Mexico regulators, producers and patients engage to create better rules and focus on building a sustainable and safe marketplace.

"If they partner, they won't being fighting each other every step of the way," suggests Reiman.

Applen agrees with Reiman and says it's time for the industry to evolve.

Collecting test data, Applen believes, allows problems to be traced and reduces costs through improved production efficiency. To move quickly, Applen suggests producers implement good manufacturing processes.

"We'll have a lot more happier patients," says Applen. "By industry participants and regulators coming together now to build a regulatory framework around what's been proven to work, we can prevent the magnification of current problems when plant counts are increased."

Those processes could be a good road map for others entering the market later.

While he doesn't expect overnight success, Applen hopes time is spent rebuilding relationships. Open dialog, he suggests, will allow the stakeholders to easily respond to issues and capitalize on emerging trends. That might already be starting. On Monday, state Medical Cannabis Program Manager Ken Groggel asked Applen to submit comments on the proposed rule changes.

"This is the only way we can develop a functional regulatory system," says Applen.

He hopes it's a thoughtful process. If it's not, Nurse Nicole says she might move to Colorado.

No Test Needed?

While producers were required to include plans to ensure purity and quality with their license applications, surprisingly, there are few mandatory rules in place regarding cannabis testing. In fact, New Mexico Department of Health officials up to now have relied on producers to conduct their own testing.

For instance, until the beginning of this year, there were no production standards for cannabis-derived products, which included edibles and tinctures. The new standards, signed off on by producers last fall, say producers’ testing plans must address “at a minimum, the purity, consistency of dose and quality for all CDPs before the product is offered to patients and caregivers.”

The phrasing of the derived product standards elicited some confusion, according to producers SFR talked to for this story, especially what tests need to be performed to ensure purity and dose consistency.

As we learned reporting this story, some producers have thought if they test their THC extracts before adding them to baked goods, tinctures and other cannabis-derived products they would get the correct dosages in their final products.

The Department of Health, Applen says, should have made it clear that finished products must be tested in order to meet the requirements for purity, consistency of dose and quality.

State standards say package labels must contain eight elements, but potency isn’t one of them.

Health Department spokesman Kenny Vigil says officials now believe they need to adjust some of the rules “to ensure patient safety.”

“Patients need to know what they’re getting and licensed nonprofit producers need to be held accountable for the products they are selling to their patients,” he writes to SFR.

New proposed rules include a requirement that producers test for the quantity of THC contained in concentrates prior to sale. They also address labels, calling for display of the number of units of usable cannabis contained within the product and approved laboratory analysis, including the results of strength and composition within 10 percent of numbers shown on the package.

To see a list of proposed rules, visit the New Mexico Department of Health’s website. Officials have schedule a public hearing in Santa Fe at 9 am, June 16 at the Harold Runnels Building, 1190 St. Francis Drive.

In the meantime, Vigil says patients who believe they’ve purchased impotent products should make a written complaint to the department. Without that, he says, an investigation can’t be launched.

Peter St. Cyr is an independent reporter based in Albuquerque. Earlier this year he earned a one-time media consultation fee from R Greenleaf Organics. He has been writing about the New Mexico’s medical cannabis program since 2007.