Professors Hooman Noorchashm and David A. Simon Petition FDA to Require Clear Labeling for Use of Cannabinoid Hair Testing Device
10.17.2025— Professors Hooman Noorchashm and David A. Simon, co-directors of the Amy J. Reed Collaborative for Medical Device Safety (AJRC), have filed a petition with the U.S. Food and Drug Administration (FDA) concerning the labeling of Psychemedics Corporation’s cannabinoid hair testing device, which is used in employment testing. The petition explains that the current labeling could confuse consumers and users, and may have unintended negative effects, including inappropriate termination of employment and educational opportunities for some public servants and employees.
“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. If firms use this 510(k) device for the express purpose of ‘identifying marijuana use,’ they are not using the device properly,” said Noorchashm, an internationally recognized medical device safety expert.
The petition asserts that the test can’t tell the difference between someone who deliberately ingested marijuana and someone who was around marijuana smoke (e.g., among people in a group where someone smoked). Both scenarios can make the test turn “positive.” In comparison, urine, blood and saliva tests have been carefully studied and have reliable standards for detecting actual marijuana use.
“The labeling and instructions for use are a crucial component of a device that is supposed to provide accurate information to consumers and users,” said Simon. “The current instructions for use are confusingly worded, and do not achieve this goal. Most worryingly, people’s livelihoods may be on the line if the test is not used properly.”
The petition is also signed by Michael K. Paasche-Orlow, a professor of medicine at Tufts Medical Center and a co-director of the AJRC. The three experts, who are also founders of Harmed Americans for Reform in Medical-Device Safety (HARMS), signed the petition asking the FDA to make the company change its label to clearly say the test can’t prove someone used marijuana, only that marijuana chemicals are in their hair; send a letter to employers and police explaining this limitation; and share more information about how the FDA approved this test.
The Amy J. Reed Collaborative for Medical Device Safety, a joint venture of Northeastern Law and Tufts Medical Center, is a pioneering academic and activist initiative focused on advancing medical device safety through increased awareness, fostering collaboration and facilitating resource sharing among patients and industry experts. Its mission is to drive positive change in the field by advocating for safer medical devices and promoting transparency and accountability.
The petition was submitted by HARMS, a 501(c)(3) not-for-profit corporation affiliated with the Amy J. Reed Collaborative, that advances medical device safety through advocacy, outreach and organizing.
About Northeastern University School of Law
The nation’s leader in experiential legal education since 1968, Northeastern University School of Law offers the longest-running, most extensive experience-based legal education program in the country. Northeastern guarantees its students unparalleled practical legal work experiences through its signature Cooperative Legal Education Program. More than 1,100 employers worldwide in a wide range of legal, government, nonprofit and business organizations participate in the program. With a focus on social justice and innovation, Northeastern University School of Law blends theory and practice, providing students with a unique set of skills and experiences to successfully practice law.
For more information, contact [email protected].