Department of Health and Human Services Archives

In the most unexpected development to hit the cannabis industry in years, the U.S. Department of Health and Human Services’ (HHS) Secretary Xavier Becerra shared his agency’s recommendation that, based on data and scientific analysis, cannabis, a Schedule I drug under the Controlled Substances Act, should be reclassified as a Schedule III drug. The announcement was made on Wednesday, August 30.

The Background

HHS’ conclusion was sent by letter to the Drug Enforcement Administration (DEA), the agency with authority to reclassify how various substances are treated under federal drug laws. The HHS recommendation means that the nation’s top health agency no longer considers cannabis a drug that lacks medical value and carries the high potential for abuse.

The announcement comes just under a year after President Biden and his administration made a statement on cannabis reform. In that statement, which he made on Oct. 6, the president requested that the Secretary of HHS and the Attorney General (AG) initiate an administrative process to review how cannabis is scheduled under federal law, in addition to pledging to pardon all prior federal offenses of simple cannabis possession, directing the AG to develop an administrative process for the pardons and urging all governors to follow suit for state and local offenses. In a statement, Secretary Becerra said the agency acted “expeditiously” and completed the rescheduling process in less than 11 months, “reflecting the department’s collaboration and leadership to ensure that a comprehensive scientific evaluation be completed.” Indeed, the agency’s announcement reflects the administration’s desire to quickly resolve the country’s failed approach to cannabis reform, as prior rescheduling efforts have taken years. Few thought the federal government would move quickly on cannabis, let alone under a year.

The White House has chosen not to comment on the HHS recommendation as the “administrative process is an independent process led by HHS and DOJ and guided by the evidence.” During a press conference, White House Press Secretary Karine Jean-Pierre reiterated the administration’s position, saying that the administration is taking a more hands-off approach and allowing the federal agencies to determine cannabis’s classification without political influence.

What Does This Mean for the Cannabis Industry?

Although a historic announcement, many industry members hoped for a report that would completely remove cannabis from the CSA. Rescheduling cannabis as a Schedule III drug could provide a route for the FDA to assume a more hands-on regulatory role, and it could open up opportunities for interstate commerce in cannabis. A Schedule III designation does not amount to federal legalization, which means the industry will continue to lack a comprehensive regulatory framework addressing the conflicts between federal and state cannabis laws. Rescheduling cannabis also does not address long-overdue concerns about decriminalization and the effect the war on drugs has had on incarceration rates and racial disparities among the imprisoned.

With the HHS recommendation out in the open and the ball firmly in the DEA’s court, concerns have shifted to the DEA’s timeline for considering rescheduling. No hard deadline exists for the agency to complete its review, and industry stakeholders already know that the rescheduling process can be grueling and lengthy. The last time the DEA rescheduled a drug, hydrocodone combination products (HCPs) in 2004, the process took nearly a decade. In fact, each time the DEA has previously considered rescheduling cannabis, in 2001 and 2006, the process took over two years and resulted in no changes.

While many stakeholders speculate that a decision will be made ahead of the November 2024 presidential election, others remain skeptical given the strict anti-drug posture hardwired into how the DEA operates. In fact, the HHS recommendation coupled with the DEA’s approach to drug policy has led some to speculate that the DEA may compromise by moving cannabis into Schedule II, a category reserved for medicines with high potential for abuse and dependence, including most common opioids.

Either way, the agency’s recommendation is a momentous moment for an industry that has been reeling from falling sales and rising costs. Rescheduling cannabis could open the floodgates to more and better research into cannabis. The Schedule I designation has severely limited scientists’ access to cannabis for research purposes. A Schedule III designation would also have a significant financial impact on cannabis companies that have been deprived of tax deductions and banking services on which most companies depend.

The DEA has confirmed that it received the HHS letter and recommendation and will initiate its five-factor review, which differs from HHS’s eight-factor criteria. It remains to be seen what the DEA will do or when it will be done, but thousands of cannabis companies across the country will be watching closely.

Opiate abuse is a far-reaching international public health issue, impacting tens of thousands of people every year in the United States alone. As the epidemic continues to spread, the medical community is faced with the immense task of researching and developing safer, non-addictive treatment alternatives for patients of chronic pain and other ailments. The controversial and oft-debated notion of cannabis as an opiate alternative has become increasingly well-researched and gained considerable credibility in recent years. The new challenge lies in advancing the cannabis industry to the point of being a legitimate medicine that can be prescribed and administered by doctors.

Opioids are among the most commonly prescribed medical treatments for severe chronic pain, yet prescription opioid overdoses killed more than 165,000 Americans between 1999 and 2014 according to the Department of Health and Human Services. In fact, the health and social costs of opioids are estimated to be as much as $55 billion a year. As such, it has become more imperative than ever that mainstream medical practitioners take notice of the cannabis plant’s powerful healing properties and shift away from potentially harmful pharmaceutical medications.

Dr. Richard Kaufman, co-founder and chief science officer of Nanosphere Health Sciences.

The evidence of cannabis’ safety and efficacy is well established. For instance, in a literature review of 38 studies evaluating medical cannabis’ efficacy for treating pain, 71 percent concluded that cannabinoids had empirically demonstrable and statistically significant pain-relieving effects. In addition, a 2015 meta-analysis of 79 studies found a 30 percent or greater reduction of pain with the use of cannabinoids compared to placebos. Further, an analysis of a decade of randomized, double-blind placebo-controlled clinical trials on cannabis for treating pain concluded that cannabis should be a first line treatment for patients with painful neuropathy and other serious and debilitating symptoms, who often do not respond to other available medications.

Not only is cannabis demonstrably safe and effective, but numerous studies also present compelling evidence that the prescription of opiates has dropped sharply in U.S. states and countries that have legalized medical cannabis. For example, a study in the Clinical Journal of Pain followed 176 chronic pain patients in Israel over seven months. Researchers found that 44 percent of participants stopped taking prescription opioids within seven months after starting medical cannabis. Patients cited the following reasons for using cannabis instead of pharmaceutical drugs: 65 percent reported less adverse side effects, 57 percent cited better symptom management and 34 percent found that cannabis had less withdrawal potential than their other medications.The evidence of cannabis’ safety and efficacy is well established.

The tide is quickly turning as many respected doctors are beginning to advocate for the tremendous medical potential of cannabis as a replacement for prescription pills. That said, if the cannabis industry is to help solve the crisis inflicted by modern pharmaceutical painkillers, we must develop next-generation scientifically formulated products and advocate to improve their accessibility.

Inhalation and oral methods of cannabis consumption have no reliable dosage as medicine, rendering them unfit for administration by health professionals. These mainstream consumption methods also have extremely low bioavailability and bioactivity. Bioavailability for ingested cannabis products is only 6 percent and for inhalation methods can be as low as 2 percent. Oral absorption of THC is slow and unpredictable, with peak blood concentration occurring 1–5 hours post dose. Similarly, inhalation methods can take up to two hours to have any effect. The next phase of the medical cannabis industry must focus on fixing problems that prevent cannabis from being a universally recognized health tool. Fortunately, scientists are making major advancements in cannabis delivery technologies, offering novel and innovative administration methods that have proven both effective and reliable.

With products like Evolve’s NanoSerum™ representing a promising solution to help reduce the morbidity and mortality associated with prescription opioid use and abuse, meaningful progress is already underway. It’s been a long and challenging road to arrive at this point, but our efforts are only just beginning. Achieving long-term change on a national and international scale will require professionals from all levels of the cannabis, science and medical communities to push for advanced product offerings that provide consistent, standardized dosing in healthier, smokeless modes of delivery.

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Replacing Opiates with Cannabis is Finally Becoming a Reality: Where do we go from Here?