EDITOR’S NOTE: NJ Cannabis Insider is hosting an in-person day-long conference and networking event Sept. 23 at the Carteret Performing Arts Center, featuring many of the state’s leading power players. Early-bird tickets are now on sale.
By Stacey Worthy
FDA oversight and standards give consumers confidence in the safety and efficacy of medical treatments for complex and hard-to-treat diseases. Yet, New Jersey lawmakers are ignoring the health and safety rigor of that oversight in calling for mandates on coverage of non-FDA-approved marijuana products to treat medical conditions without considering the serious legal and patient safety risks it brings.
In 2020, the New Jersey General Assembly introduced A1708, a bill that would require the state Medicaid program and private health insurance plans to provide coverage of non-FDA-approved marijuana products. And just this May, lawmakers introduced A5760, a bill that would apply the same requirement to several state-funded healthcare programs, including programs for children. Both of these bills should raise concern for every New Jersey lawmaker because of the significant health and safety risks they impose on New Jersey residents and employers, as highlighted in a new Aimed Alliance analysis of non-FDA-approved cannabis products published in the Seton Hall Legislative Journal.
Patients may look to these marijuana products to treat complex medical conditions. Yet, non-FDA-approved cannabis products are not supported by clinical evidence. FDA-approved products must uniformly meet quality and purity standards. FDA also requires substantial scientific evidence to prove a drug is safe and effectively treats a particular medical condition before it is approved.
In contrast, non-FDA-approved cannabis products do not need to go through clinical studies to prove they are safe or that they work as advertised. Studies have found higher than advertised amounts of THC and unsafe metals, toxins, and mold in these products. One study found synthetic, psychoactive adulterants, such as “spice” / “K2,” and other dangerous illicit substances in one-third of the cannabidiol (CBD) vape oils that it tested. Another study from 2019 showed that 70% of the CBD products tested were “highly contaminated” with heavy metals, such as lead and arsenic, herbicides, and pesticides.
As a result, FDA has noted that non-FDA-approved products “can have unpredictable and unintended consequences,” including harmful side effects such as liver injury. The U.S. Surgeon General and American Heart Association (AHA) have both issued warnings on the use of marijuana, noting that it can damage the brain and lead to heart attack or even stroke.
Moreover, non-FDA-approved products are often ordered without any physician oversight, which increases the risks of adverse events. An individual only needs to find someone willing to “certify” that the individual has a medical condition that could benefit from cannabis. Some companies in New Jersey advertise that they will provide these certifications online in 15 minutes or less. Some even offer a money-back guarantee if the individual does not get certified, saying “everything should be this easy.” From there, the certified patient goes to a dispensary and is guided by a retail clerk with no medical training on the type of product, amount, or dosing regimen appropriate for the patient.
Also, consider what a mandate could mean in the workplace. The same Aimed Alliance analysis found these non-FDA-approved marijuana products present health and safety risks to employees and liability risks for their employers. Employees who take products that may contain higher levels of THC than advertised, or even undisclosed THC, may show up to work impaired. This can be particularly risky for employees in safety-sensitive jobs.
New Jersey legislators – and frankly, legislators in every state across the country – should oppose efforts to mandate coverage of medical marijuana and any other non-FDA-approved product. Lawmakers should not advance A1708 or A5760, which would both put New Jersey patients, taxpayers, and the state in jeopardy and ignore the critical safety standards we uphold for so many other treatments.
Stacey Worthy is counsel to Aimed Alliance, a non-profit health policy organization that seeks to protect and enhance the rights of health care consumers and providers.
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