The Food and Drug Administration (FDA) is considering a petition raising concerns about the alleged “significant harm” that a drug testing device for marijuana metabolites in hair could cause if employers or law enforcement administer it under the mistaken impression it proves a person actually used cannabis rather than was exposed to secondhand smoke from someone else.
The petition was submitted last week by Harmed Americans for Reform in Medical-Device Safety (HARMS), a non-profit organization focused on medical device safety founded by three experts at Northeastern Law and Tufts Medical Center. HARMS isn’t exclusively focused on cannabis issues, but the organization said an FDA-approved cannabinoid hair testing device created by the Psychemedics Corporation raises serious concerns that the agency should address.
“Our petition requests that the FDA require clearer labeling to specify that the device can be used to detect only the presence of cannabinoid metabolites in hair and cannot be used for ‘identifying marijuana use,’” as the label implies,” HARMS’s Hooman Noorchashm said in a press release. “If firms use this 510(k) device for the express purpose of ‘identifying marijuana use,’ they are not using the device properly.”
Unlike conventional saliva, urine and blood tests for THC metabolites, determining whether a person used cannabis based on hair samples is uniquely complicated because secondhand smoke exposure could be enough to lead to a positive result. HARMS is advising FDA to exercise its authority to revise the device’s labeling requirements to clarify that point.
Making that labeling change is “particularly important,” the experts said, because “the Psychemedics Device is marketed for identifying marijuana use in employment and insurance contexts, including by federal, state, and municipal law enforcement agencies.”
Cannabinoid metabolites “are detectable in hair in both purposeful use and in the case of inadvertent exposure,” the petition, which FDA has acknowledged it received, said. “So while hair testing can detect cannabinoids, it cannot definitively confirm marijuana use because ‘external contamination’ is always possible.”
While other standard THC tests can more definitively demonstrate past usage of cannabis, “hair testing of the kind used in the Psychemedic’s Device detects THC-COOH over a longer period (months) and faces additional challenges, including false positives from passive exposure (e.g., inadvertent inhalation of marijuana smoke), as well as variability in cannabinoid incorporation due to hair type, hair treatments, and growth rates.”
“Given the unreliability of hair testing to accurately identify marijuana use, the FDA should evaluate the Psychemedics label or labeling of hair testing for cannabinoids,” it says. “These concerns have real-world impact. For example, the Psychemedics Device is used in employment settings, particularly for law enforcement officers.”
“Because positive test results may reflect only passive exposure rather than intentional marijuana use, consumers (employers) may erroneously believe that a positive result definitively proves marijuana use when it showed only marijuana exposure. This kind of misunderstanding can cause significant harm to individuals who are deemed marijuana users, and may result in inappropriate medical care or adverse employment decisions. To ensure consumers and users understand the limitations of the Device, the FDA should undertake the requested actions.”
HARMS’s David Simon said that the ‘labeling and instructions for use are a crucial component of a device that is supposed to provide accurate information to consumers and users.”
“The current instructions for use are confusingly worded, and do not achieve this goal,” he said. “Most worryingly, people’s livelihoods may be on the line if the test is not used properly.”
The petition asks FDA to recommend or order Psychemedics to revise the device’s instructions for use to read: “The Psychemedics Microplate EIA for Cannabinoids in Hair is an enzyme immunoassay (EIA) for the preliminary qualitative detection of cannabinoid metabolites in hair using a 11-nor-9-Carboxy- Δ9-THC calibrator at a cut off of 10 pg/10 mg hair.”
As an alternative, it suggests that FDA could order the company to “provide a disclaimer on the Device that it does not identify whether any test subject used marijuana but only detects the presence or absence of cannabinoid metabolites in hair, which could have occurred without the subject using marijuana.”
Marijuana Moment reached out to Psychemedics for comment, but a representative was not immediately available.
As the state legalization movement has continued to expand, the complications around cannabis drug testing policies have also gained increased attention.
In July, for example, a Rutgers University law professor published a commentary investigating how roadside tests for marijuana impairment that are widely used by police departments across the U.S. are “inadequate.” He urged policymakers to take a more scientifically robust approach to transportation safety while relying less on law enforcement’s ostensible expertise.
There’s another wrinkle to the cannabis testing debate: As acknowledged by a U.S. Department of Justice (DOJ) researcher, it’s unclear whether a person’s THC levels are even a reliable indicator of impairment.
Last October, a study preprint posted on The Lancet by an eight-author team representing Canada’s Centre for Addiction and Mental Health, Health Canada and Thomas Jefferson University in Philadelphia identified and assessed a dozen peer-reviewed studies measuring “the strength of the linear relationship between driving outcomes and blood THC” published through September 2023.
The issue was also examined in a federally funded study last year that identified two different methods of more accurately testing for recent THC use that accounts for the fact that metabolites of the cannabinoid can stay present in a person’s system for weeks or months after consumption.
Photo courtesy of Martin Alonso.
The post FDA Weighs Petition On ‘Significant Harm’ Of Marijuana Hair Testing Device’s Positive Results From Secondhand Smoke appeared first on Marijuana Moment.
Comments are closed, but trackbacks and pingbacks are open.