The DEA issued a letter Monday directed at online retailers selling pill presses, informing them that they are required to report sales of these presses to the DEA.

According to the DEA, pill presses are commonly used to disguise the deadly opioid fentanyl by replicating existing prescription medications. These replicated pills are then sold to people who are typically unaware they’re buying fentanyl. These pill presses are incredibly easy to find online and sell for as little as 40 dollars. This, in part, has fueled a scourge of overdoses in the last several years, 110,757 in 2022 alone by the DEA’s count.

“With these tools, criminal actors are able to produce pills that look like legitimate prescription medication—like oxycodone, Xanax, and Adderall—but are not,” the DEA said. “Those pills actually contain fentanyl and other deadly drugs.  Criminals then sell those pills on social media and in our communities, often to people who do not know that the pills are not real or that they contain deadly drugs.”

The DEA implicitly stated that pursuant to the Controlled Substances Act, e-commerce retailers responsible for selling these pill presses are required to keep records of everybody who buys and sells a press, and also required to report this information to the DEA.

“DEA has found that pill presses and stamps that can be used to make fentanyl pills are being offered for sale on various e-commerce platforms.  E-commerce entities selling pill press machines are generally ‘regulated persons’ under the Controlled Substances Act, 21 U.S.C. § 802(38), and therefore, subject to the recordkeeping, identification, and reporting requirements of 21 U.S.C. § 830,” the DEA said. “As regulated entities, e-commerce platforms are required to comply with CSA recordkeeping and reporting requirements on the distribution, importation, and exportation of pill press machines.  This means that they must collect information on the buyer and seller and provide notice to the DEA of any sale, import, export, or transfer.”

The DEA said that the vast majority of these fake pills are produced by two particular Mexican cartels. The United States government has put increasing pressure on Mexico in recent years to curb the flow of fentanyl, including fentanyl disguised in these fake pills, from crossing over the United States Mexico border. Even after signs were posted all over Sinaloa appearing to ban the production and sale of fentanyl by the authority of the cartels, fentanyl overdoses and seizures have not slowed down at all.

“The drug cartels primarily responsible for manufacturing fentanyl and smuggling it into the United States are the Sinaloa Cartel and Jalisco Cartel.  These cartels, their members and associates, and other drug traffickers are using pill presses to shape fentanyl powder into pills, and they are using stamps to imprint markings and logos onto those pills as they are pressed,” the DEA said.

According to the DEA, over 79 million fake fentanyl-containing pills were seized in 2023, which marked a 33% increase over pill seizures in 2022. DEA lab tests have shown that 70% of seized pills are pressed and contain fentanyl. Seventy percent of all drug overdoses in 2022 were also due to ingestion of fentanyl.

“Drug traffickers are killing Americans by selling fentanyl hidden in fake pills made to look like real prescription medicines. This is possible because drug traffickers are able to buy the tools they need, like pill presses and stamps, online,” said DEA Administrator Anne Milgram. “E-commerce platforms cannot turn a blind eye to the fentanyl crisis and to the sale of pill presses on their platforms.  They must do their part to protect the public, and when they do not, DEA will hold them accountable.”

The DEA said that they launched the Industry Liaison Project in 2019, in which they communicated with over two dozen of the largest online retailers about pill press sales on their websites. They said that several, including Amazon and Etsy, banned the sale of pill presses on their platforms outright. However, as the hyperlink I included at the top of this article proves, dozens and dozens of pill presses are very much still for sale on Amazon. I also found several pill presses for sale on Etsy with about five seconds of effort on Google.

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Due to a shortage in stimulant-based drugs for ADHD (attention-deficit/hyperactivity disorder), the U.K.’s limited medical cannabis industry is seeing a spike in patients using cannabis for relief as an alternative. The exodus of patients resorting to medical cannabis shows its growing need.

The Guardian reported last September that doctors in England were told not to prescribe ADHD drugs to new patients because of a national shortage. The medications affected include four out of the five top stimulants prescribed to ADHD patients in the U.K.: methylphenidate, lisdexamfetamine, guanfacine,  and atomoxetine.

It’s been compared to the Adderall (amphetamine/dextroamphetamine salts) shortage impacting the U.S. U.S. brand-name drug makers behind Adderall, Vyvanse and Concerta are able to keep up with the shortage, but the generic versions of all three drugs are struggling to keep up. Is it time to panic? Even with these shortages in medication, doctors still say ADHD is under-diagnosed and patients are under-prescribed.

Some of them are turning to cannabis. BBC reports that a medical cannabis clinic said the U.K.’s medical cannabis industry had seen an 86% increase in ADHD patients nationally over the last year.

Some people believe cannabis can alleviate many of the symptoms associated with ADHD as research advances.

Medical Cannabis Is Better Than No Medicine

Medical cannabis, when prescribed by a registered specialist doctor, was legalized in the U.K., mostly in the form of oils and flower, in November 2018. Since then, treatments, including medical cannabis, that meet “appropriate standards” have been reclassified under Schedule 2, meaning that they have medical value. And while the U.K. has very limited availability for medical use, exports are another story: the U.K. was the world’s largest exporter of legal cannabis in 2016.

Research director Dr. Simon Erridge, who also works at Curaleaf Clinic, said it was “natural for people to explore other options” amid the shortage.

The Department of Health and Social Care (DHSC) told the BBC that while there were no cannabis-based medicines licensed for the treatment of ADHD on the NHS, specialist clinicians “can prescribe cannabis-based products where clinically appropriate and in the best interests of patients.”

“Other ADHD products remain available but cannot meet excessive increases in demand,” the DHSC alert states. “At present, the supply disruptions are expected to resolve at various dates between October and December 2023.”

Suddenly losing access to a stimulant-based drug that patients rely on leaves them with few options.

“A lot of people with ADHD may try a number of different medications to find the one that works best for them, if that is suddenly taken away by shortages it’s only natural for people to explore other options and there’s no reason why that might not include medical cannabis,” Erridge said.

Cannabis for ADHD

Depending on the person, cannabis can both help and distract people from focusing.

A January 2020 study called “Cannabinoid and Terpenoid Doses are Associated with Adult ADHD Status of Medical Cannabis Patients” arrived at mixed results, finding that whole-plant cannabis seemed to be more effective.

“The use of purified THC:CBD in a 1:1 ratio (nabiximols) showed no effect on ADHD symptom severity; however, in a qualitative study, 25% of responses indicated that whole-plant cannabis was therapeutic for ADHD,” researchers wrote. “Here, we demonstrated an association between higher CBN and lower ADHD symptoms frequency. It has been previously demonstrated that the combination of CBN and THC is associated with increased psycho-activity of THC in humans. This indicates a more complex story than simply stratifying treatment based on THC and CBD alone.”

Researchers acknowledged that there’s no one-size-fits-all solution to tackling ADHD when it comes to cannabis. 

“There is no ‘simplistic’ method for tracking only the dominant constituents of cannabis to better understand the medical potential of a cannabis cultivar,” researchers continued. “Thus, the novel perspective of our study is extremely valuable for the [medical cannabis] research field.”

Medical professionals who spoke to High Times for an October 2019 article agreed that ADHD treatments are not one-size-fits-all. Brooke Alpert is a licensed cannabis practitioner and founder of Daily Habit. Alpert touched on the correlation between CBD and ADHD. “The studies that focus on ADHD and CBD have shown some conflicting evidence.” 

She added, “I think more research needs to look at what relief people are finding with cannabis so we can have a better picture of how to further recommend CBD and cannabis for those with ADHD.”

Energizing strains like Sour Diesel, Jack Herer, Green Crack have been reported to actually have calming effects on people living with ADHD, even if they make others jittery.

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Unfortunately, the same drugs with high potential for abuse are also the ones that work best for certain individuals with neurobehavioral conditions. According to GlobalData, penetrating the stimulant-dominated pharmaceutical market remains challenging without comparable efficacy from non-stimulants. 

The attention deficit hyperactivity disorder (ADHD) market is a lucrative business: Stimulants, amphetamines, and methylphenidates continue to dominate the ADHD drug market across the seven major markets, Express Pharma reports. (The seven major markets are in France, Germany, Italy, Spain, the UK, the US, and Japan.)

Non-addictive drugs demonstrate a “crippling lower” efficacy in treating ADHD.

Drug makers are in a race to develop safer alternatives. Three out of the four late-stage pipeline drug candidates in Phase III development within those markets have non-stimulant properties: Axsome Therapeutics Inc’s solriamfetol, Otsuka Pharmaceutical Co Ltd’s centanafadine and Neurocentria Inc’s L-Threonate Magnesium Salt. 

The lower abuse potential of solriamfetol and centanafadine is a major selling point created by developers, but without displaying efficacy comparable to stimulants, they will struggle to penetrate the market—even if they are approved.

The use of stimulants for ADHD treatment is increasing.

The key opinion leaders (KOLs) in the treatment of ADHD say that patients and parents have been hesitant to use stimulants for the treatment of ADHD in children and adolescents, but this is changing with time, and the use of stimulants for ADHD treatment is increasing.

“Marketing emphasis on abuse potential is common in non-stimulates both marketed and pipeline; this is despite KOLs viewing the abuse potential of ADHD stimulants as overstated,” said Lorraine Palmer, Pharma Analyst at GlobalData. “The KOLs interviewed by GlobalData were not concerned about whether a treatment is a stimulant or a non-stimulant, rather they are focused on the pharmaceuticals efficacy and side-effect profile.”

Four non-stimulants are commonly marketed: guanfacine, clonidine, atomoxetine and viloxazine. Sleep disturbances and a decreased appetite have been reported from both clonidine and atomoxetine. 

“All four display cripplingly lower efficacy in the treatment of ADHD than stimulants,” Express Pharma reports.

“Rather than an emphasis on abuse potential, a better alternative strategy to penetrate the saturated ADHD market would be to target key unmet needs in ADHD treatment such as improving compliance or providing coverage into the evening without affecting sleep.”

Part of this challenge likely includes the impact of addiction itself.  Regarding the popular ADHD drug Adderall, adults and children 6 years of age and older are eligible to take Adderall, beginning at 5 milligrams, while children 3 to 5 years of age are able to start at 2.5 mg per day. Only children under the age of 3 are prohibited from being prescribed the drug in all cases.

Adderall’s active ingredients are dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate. Columbia University psychiatry professor Carl Hart famously wrote for Vice in 2016 that meth is “almost identical to Adderall” in terms of chemistry and its effects on the brain.

A 2016 study published in the Journal of Clinical Psychiatry indicates that an increasing number of young adults have been checking into emergency rooms over the past few years due to accidental overdoses on Adderall and similar drugs.

Other Reasons for Stimulant Alternatives

High Times reported last September that leading drug makers and pharmaceutical companies are having little luck addressing nationwide shortages of stimulant-based ADHD medications like Adderall, Vyvanse, and Ritalin.

The Adderall shortage began in Fall of 2022, marked by an FDA notice acknowledging the shortages with an estimate that things would be resolved in a month or two. That is not the case, however, as issued a joint notice on August 1 acknowledging that the shortage had been “understandably frustrating” for patients and providers.

“The current shortage of stimulant medications is the result of many factors. It began last fall due to a manufacturing delay experienced by one drug maker,” the joint notice said. “While this delay has since resolved, we are continuing to experience its effects in combination with record-high prescription rates of stimulant medications. Data show that, from 2012 to 2021, overall dispensing of stimulants (including amphetamine products and other stimulants) increased by 45.5 percent in the United States.” 

Teva Pharmaceuticals, Adderall’s biggest manufacturer, reported shortfalls. Teva CEO Richard Francis told Bloomberg that the company is operating at “full capacity” at the moment and blamed their decreased output in previous years to COVID-induced work shortages which they have only just barely recovered from. Should they wish to increase the amount of Adderall they produce, they would have to buy or build more factories as their current infrastructure cannot handle bigger output. The company has declined to comment on whether or not they plan to invest in such infrastructure.

This adds to the multiple reasons less addictive non-stimulant drugs are needed to treat ADHD.

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The biggest manufacturer of Adderall will not be increasing production to address national shortages of ADHD medication, despite a call from the U.S. government for drug makers to do exactly that.

Teva Pharmaceuticals Chief Executive Officer Richard Francis told Bloomberg that they are operating at “full capacity” at the moment and blamed their decreased output in previous years to COVID-induced work shortages which they have only just barely recovered from. Should they wish to increase the amount of Adderall they produce, they would have to buy or build more factories as their current infrastructure cannot handle bigger output. The company has declined to comment on whether or not they plan to invest in such infrastructure.

The pharmaceutical giant valued at just under $11 billion manufactured about 565 million Adderall tablets in 2021 but that was not enough, even with all the other producers in the market, to supply an exponential growth in national demand for ADHD medication or to address what drug makers have alleged are shortages in the materials needed to synthesize such medications. 

The Adderall shortage began in Fall of 2022, marked by an FDA notice acknowledging the shortages with an estimate that things would be resolved in a month or two. That is not the case, however, as issued a joint notice on August 1 acknowledging that the shortage had been “understandably frustrating” for patients and providers.

“The current shortage of stimulant medications is the result of many factors. It began last fall due to a manufacturing delay experienced by one drug maker,” the joint notice said. “While this delay has since resolved, we are continuing to experience its effects in combination with record-high prescription rates of stimulant medications. Data show that, from 2012 to 2021, overall dispensing of stimulants (including amphetamine products and other stimulants) increased by 45.5 percent in the United States.” 

The joint notice did not give any kind of an estimated date this issue is expected to be resolved by, but instead urged drug makers to increase production to meet their allotted limits for production of a controlled substance. In fact, by the estimate provided, drug manufacturer’s only sold 70% of their collective allotment for these particular types of medications, which by the government’s own estimate equated to about a billion doses that did not get produced or sold.

“We (DEA and the FDA) have called on manufacturers to confirm they are working to increase production to meet their allotted quota amount,” the joint notice said. “If any individual manufacturer does not wish to increase production, we have asked that manufacturer to relinquish their remaining 2023 quota allotment. This would allow DEA to redistribute that allotment to manufacturers that will increase production. DEA is also committed to reviewing and improving our quota process.”

The American Society of Health-System Pharmacists also reported last week that 141 different doses or formulations of ADHD medications were in short supply. The shortage was originally isolated to Adderall but as buyers and patients alike sought alternatives, supply of competing drugs like Vyvanse and Ritalin quickly dwindled. The ASHSP also indicated there were no estimated times for the majority of the shortages to be resolved, other than a short list of select medications produced by Sandoz Pharmaceuticals which are estimated to be back in stock sometime around mid-October.

No matter the cause, the shortages don’t appear to be going away anytime soon, especially with Teva unable to produce more than they currently are. Patients everywhere have reported issues refilling their prescriptions. A friend of mine told me she often ends up getting charged extra (double or triple the usual amount) for out-of-network pharmacies and extra doctor visits because pharmacies either don’t have the medication in stock or refuse to fill prescriptions for controlled substances. This process often delays access to medication that, without getting too redundant, is very unpleasant to go without when you have to take it regularly.

“We are calling on key stakeholders, including manufacturers, distributors, pharmacies, and payors, to do all they can to ensure access for patients when a medication is appropriately prescribed,” the FDA/DEA joint notice said. “We want to make sure those who need stimulant medications have access. However, it is also an appropriate time to take a closer look at how we can best ensure these drugs are being prescribed thoughtfully and responsibly.”

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Anyone who is prescribed the ADHD and narcolepsy medication Adderall has been advised to seek alternative medication after a nationwide shortage was confirmed by the FDA last week, but the reasons behind the shortage remain a bit of a mystery.

The FDA didn’t give much of an explanation for the shortage other than to say one of the main manufacturers of Adderall (which is the brand name given to a particular combination of amphetamine and dextroamphetamine salts), Teva, was experiencing “ongoing intermittent manufacturing delays” and “other manufacturers continue to produce amphetamine mixed salts, but there is not sufficient supply to continue to meet U.S. market demand through those producers.”

The good news is, at the moment most of those delays are scheduled to be resolved by October or November, which is an updated ETA originally slated for March of 2023. This means we will likely avoid running out entirely. Nonetheless, the FDA did advise patients to seek alternative treatments all the same. 

A New York Times article cited the nationwide rise in ADHD as the main cause of the shortage, and it cannot be overstated that reported cases of ADHD are indeed on the rise. As a heavily regulated Schedule 2 drug, Adderall manufacture is often slow in response to demand because of the red tape required in order to produce it, so the rise in ADHD may indeed be to blame but in terms of the shortage of Adderall itself, it is likely a bit of a mixed bag.

The usual suspects when things are in short supply lately are COVID-related supply chain issues or the ongoing war in Ukraine, but Hamilton Morris, a journalist and scientific researcher known for his TV show Hamilton’s Pharmacopeia, indicated on Twitter that the Adderall shortage could be due to a shortage of nitroethane, one of the potential raw ingredients used to make it. One of the main distributors of nitroethane, Sigma Aldrich, has it listed as unavailable on their website. A phone call to the media department at Sigma Aldrich was, alas, not returned fast enough to meet my deadline.

Others disagreed, saying there’s no reason to believe there is a nitroethane shortage quite yet, but it would certainly explain things if it turns out to be true. Chemjobber, a blog dedicated to chemistry news and chemistry jobs, told High Times that while low nitroethane supply may be a potential factor, it’s essentially way more complicated than that.

“I strongly believe it is rarely API (active pharmaceutical ingredient) manufacturing that is the problem,” Chemjobber said. “That is a problem at the back of the chain, and there are 4-5 steps in front of it i.e. you could have a problem with tableting, or shipping, or labor etc.”

To that point, Teva did report earlier this year that they were having issues with labor shortages, a common complaint in the era of COVID-19. Thus, it’s not necessarily a shortage of one chemical as much as it seems to be a perfect storm of bad luck and the basic production limitations of any heavily regulated industry.

In terms of whether or not America will run out of Adderall, Chemjobber likened it to the toilet paper craze of early COVID and projected this too shall pass. It does also appear to be a good sign that Teva moved up its ETA by several months in the span of a week. Unfortunately, they didn’t call me back either.

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