The Food and Drug Administration (FDA) is considering a petition raising concerns about the alleged \u201csignificant harm\u201d 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.<\/p>\n
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\u2019t 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.<\/p>\n
\u201cOur 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 \u2018identifying marijuana use,\u2019\u201d as the label implies,\u201d HARMS\u2019s Hooman Noorchashm said in a press release. \u201cIf firms use this 510(k) device for the express purpose of \u2018identifying marijuana use,\u2019 they are not using the device properly.\u201d<\/p>\n
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\u2019s labeling requirements to clarify that point.<\/p>\n
Making that labeling change is \u201cparticularly important,\u201d the experts said, because \u201cthe Psychemedics Device is marketed for identifying marijuana use in employment and insurance contexts, including by federal, state, and municipal law enforcement agencies.\u201d<\/p>\n
Cannabinoid metabolites \u201care detectable in hair in both purposeful use and in the case of inadvertent exposure,\u201d the petition, which FDA has acknowledged it received, said. \u201cSo while hair testing can detect cannabinoids, it cannot definitively confirm marijuana use because \u2018external contamination\u2019 is always possible.\u201d<\/p>\n
While other standard THC tests can more definitively demonstrate past usage of cannabis, \u201chair testing of the kind used in the Psychemedic\u2019s 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.\u201d<\/p>\n
\u201cGiven the unreliability of hair testing to accurately identify marijuana use, the FDA should evaluate the Psychemedics label or labeling of hair testing for cannabinoids,\u201d it says<\/a>. \u201cThese concerns have real-world impact. For example, the Psychemedics Device is used in employment settings, particularly for law enforcement officers.\u201d<\/p>\n \u201cBecause 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.\u201d<\/p>\n HARMS\u2019s David Simon said<\/a> that the \u2018labeling and instructions for use are a crucial component of a device that is supposed to provide accurate information to consumers and users.\u201d<\/p>\n