Policy News Roundup: June 29, 2023

Key reads

Thousands of illegal flavored vapes coming to the U.S. from China

The number of different e-cigarette devices sold in the U.S. has nearly tripled to over 9,000 since 2020, driven by unauthorized disposable vapes from China. The numbers demonstrate the Food and Drug Administration’s (FDA) inability to control the vaping market more than three years after declaring a crackdown on flavors. Instead of reviewing individual products that might help adult smokers quit, regulators must now claw back thousands of illegal products sold by under-the-radar importers and distributors. Most disposables mirror a few major brands (such as Elf Bar and Puff Bar), but hundreds of new varieties appear each month and blur the line between real and counterfeit. More than 5,800 unique disposable products are being sold, up 1,500% from 365 in early 2020, when the FDA banned flavored cartridge-based e-cigarettes. The policy excluded disposables. Foreign manufacturers do not have to register with the FDA, giving regulators little visibility into the Chinese industry. The FDA recently sent warning letters to more than 200 stores selling popular disposables, including Elf Bar, Esco Bar and Breeze, and issued orders blocking imports of those brands, but these companies accounted for just 14% of disposable sales last year.

Source: Thousands of unauthorized vapes are pouring into the US despite the FDA crackdown on fruity flavors (Associated Press)

States increasingly enacting ineffective substance-induced homicide laws and enhanced fentanyl penalties

Dozens of states have been enacting substance-induced homicide laws and other laws increasing penalties for fentanyl. In the 2023 legislative session alone, hundreds of fentanyl crime bills were introduced in at least 46 states. Some states are attaching higher mandatory minimum penalties to ever-smaller amounts of fentanyl, and some 30 states have substance-induced homicide statutes. Such law enforcement approaches to addressing a public health crisis do not work. States and the federal government have recently allocated more funds for treatment and prevention, and the Biden administration has embraced harm reduction, but the state fentanyl laws revert to war-on-drugs approaches. Experts worry mostly low-level dealers, particularly people of color, who may be selling to support their addiction, will be incarcerated. Many of the laws have bipartisan support, which may be partly because many have been publicly championed by families who have lost children to fentanyl. Substance-induced homicide laws clash with the principles of Good Samaritan laws.

Source: Harsh New Fentanyl Laws Ignite Debate Over How to Combat Overdose Crisis (The New York Times)

Senate passes TRANQ Research Act

The Testing, Rapid Analysis, and Narcotic Quality (TRANQ) Research Act passed the Senate with unanimous support. The bill will direct the National Institute of Standards and Technology to support research and other activities related to identifying xylazine, novel synthetic opioids and other emerging substances that have become increasingly common in the illicit drug supply. The bill already passed the House.

Source: Welch’s Bipartisan Bill to Combat New Street Drug Tranq Passes Senate (Peter Welch)

CDC studies show rise in e-cigarette sales and e-cigarette exposures reported to poison centers

A Centers for Disease Control and Prevention study based on retail sales data found that e-cigarette monthly unit sales increased by 46.6% between January 2020 and December 2022, from 15.5 million to 22.7 million. The number of brands increased by 46.2%. Prefilled devices decreased, while disposable devices increased, following the Food and Drug Administration’s (FDA) January 2020 announcement prioritizing enforcement against flavored prefilled cartridges. Sales of youth-appealing flavors increased. During December 2022, the five top-selling brands were Vuse, Juul, Elf Bar, NJOY and Breeze Smoke. Elf Bar was the top-selling disposable brand. Another study found that e-cigarette exposure cases reported to poison centers increased 32% between April 2022 and March 2023, with 7,043 exposures in that span. The study found 87.8% occurred in children under five, 0.6% resulted in hospital admission, and 8.3% required treatment at a health care facility. The most common brand was Elf Bar. The number of reports is approximately double the number in 2018. The FDA issued warning letters to 189 retailers for selling unauthorized Elf Bar and Esco Bar tobacco products.

Source: U.S. E-cigarette Sales Climbed during 2020-2022 (Centers for Disease Control and Prevention); Notes from the Field: E-Cigarette–Associated Cases Reported to Poison Centers — United States, April 1, 2022–March 31, 2023 (Centers for Disease Control and Prevention); FDA Inspection Blitz Leads to More Than 180 Warning Letters to Retailers for the Illegal Sale of Youth-Appealing Elf Bar and Esco Bars E-Cigarettes (Food and Drug Administration)

Study shows xylazine may worsen effects of opioids

A National Institute on Drug Abuse study suggests that xylazine can worsen the life-threatening effects of opioids in rats. Findings imply that when used in combination with opioids such as fentanyl or heroin, xylazine may damage the ability of the brain to get enough oxygen. Even with low doses of xylazine, researchers observed sedation, muscle relaxation and decreased body temperature. They observed a modest decrease in brain oxygen levels, which was long-lasting and dose-dependent. In contrast to the modest and prolonged decrease in brain oxygen levels observed with xylazine, administering fentanyl or heroin on their own generated an initial rapid and strong decrease in brain oxygen levels, resulting in slowed breathing, followed by a slower and more prolonged brain oxygen increase. However, when xylazine and an opioid were administered together, the rebounding increase in oxygen was eliminated, and brain oxygen levels remained lower for a longer period compared to an opioid alone. Findings suggest that the addition of xylazine to opioids disrupts the brain’s mechanism to counteract a rapid loss of oxygen after opioid exposure.

Source: Xylazine appears to worsen the life-threatening effects of opioids in rats (National Institute on Drug Abuse)

DOJ releases guidelines for managing withdrawal in jails

The Department of Justice’s Bureau of Justice Assistance and the National Institute of Corrections released Guidelines for Managing Substance Withdrawal in Jails: A Tool for Local Government Officials, Jail Administrators, Correctional Officers and Health Care Professionals. An expert committee of clinicians and jail administrators compiled recommendations for systemically identifying individuals at risk for withdrawal and determining appropriate levels of care. The guidelines outline steps all jails should take to implement withdrawal management. They are designed to inform the development of or revisions to existing withdrawal management policies and practices; stimulate development of policies and procedures reflecting the resources and capacity of jails; and support conversations among local officials, sheriffs and jail administrators, hospital administrators, correctional health care providers and community-based organizations on screening, transfers to higher levels of care, monitoring those who remain at the jail, providing access to addiction treatment and managing reentry. The agencies laid out the need for the guidelines in a legal brief.

Source: Justice Department Releases New Tool to Manage Substance Withdrawals in Jails (Department of Justice)

FDA issues guidance for clinical trials of psychedelics

The Food and Drug Administration (FDA) published draft guidance for researchers investigating the use of psychedelics for potential treatment of medical conditions, including psychiatric or substance use disorders. This is the first FDA draft guidance that presents considerations to industry for designing clinical trials for psychedelics. The guidance aims to advise researchers on study design and other considerations as they develop medications that contain psychedelics. It describes basic considerations throughout the development process including trial conduct, data collection, subject safety and new drug application requirements. The guidance also addresses the role of psychotherapy in psychedelic drug development, considerations for safety monitoring and the importance of characterizing dose-response and the durability of any treatment effect. It is open for comment for 60 days.

Source: FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs (Food and Drug Administration)

California bills would expand access to behavioral health treatment and housing and build workforce

California Governor Newsom announced two bills focused on reforming key behavioral health care funding to provide services to the most seriously ill and to treat substance use disorders (SUD); building a workforce to reflect California’s diversity; focusing on outcomes, accountability and equity; housing and behavioral treatment in unlocked, community-based settings; and housing for veterans with behavioral health challenges. One bill would modernize and reform the 2004 Mental Health Services Act to expand services to include treatment for those with SUD, in addition to care for those with serious mental illness, provide more resources for housing and workforce and continue community support for prevention, early intervention and innovative pilot programs. The other bill would put a $4.68 billion general obligation bond to build 10,000 new clinic beds and homes on the March 2024 ballot. It would create new, dedicated housing for people experiencing homelessness who have behavioral health needs, with a dedicated investment to serve veterans.

Source: Governor Newsom & Legislative Partners Unveil Transformation of California’s Mental Health Services Act (Office of Governor Gavin Newsom)

New York launches scholarship program for addiction services workforce

New York Governor Hochul announced the launch of a new scholarship program, which makes nearly $3 million available to individuals pursuing a bachelor’s degree in Addiction Studies or the education requirements for an Office of Addiction Services and Supports (OASAS) credential at Alfred State College, Stony Book University and Empire State University. The program is designed to help individuals working in OASAS, Office of Mental Health or Department of Health certified programs obtain a Credentialed Alcoholism and Substance Abuse Counselor, Credentialed Prevention Professional credential or a bachelor’s degree in addiction studies to enter or advance their careers in the addiction services profession. Funding is provided through the state’s Opioid Settlement Fund.

Source: Governor Hochul Announces Launch of New Nearly $3 Million Scholarship Program to Support Individuals Looking to Enter or Advance in Addiction Services Workforce (Governor Kathy Hochul)

San Francisco bill would require all pharmacies to have naloxone in stock

San Francisco could become the first city in the country to require every pharmacy to always carry naloxone. A bill being introduced would require every pharmacy to always have in stock at least two nasal sprays or face fines. A recent secret shopper study conducted by the San Francisco Department of Public Health found that approximately 20% of San Francisco pharmacies did not have naloxone in stock, despite having legal authorization to provide it upon request. The ordinance would allow a three-day grace period for pharmacies to reorder two boxes and would issue a fine of $250-$1,000 per violation.

Source: Struggling with a drug crisis, San Francisco wants Narcan available at every pharmacy (Associated Press)

New study provides prevalence estimates of mental health and substance use disorders

The new Mental and Substance Use Disorders Prevalence Study provides prevalence estimates of specific mental health disorders in the U.S. adult population, including schizophrenia spectrum disorders, bipolar I disorder, major depressive disorder, generalized anxiety disorder, post-traumatic stress disorder, obsessive compulsive disorder, anorexia nervosa and alcohol, opioid, cannabis, stimulant and sedative/hypnotic/anxiolytic use disorders. The sample included adults 18-65 residing in households, prisons, homeless shelters and state psychiatric hospitals. It addresses two gaps in prior research – inclusion of institutionalized populations and reliance on self-report measures or nonclinical interviews. The most common mental disorders were major depressive and generalized anxiety disorders, which had rates much higher than reported by prior studies. The most common substance use disorder (SUD) was alcohol use disorder, followed by cannabis, stimulant and opioid use disorders. SUD estimates are lower than found in prior research. One in four adults had mental disorder(s), one in 10 had SUD and one in 20 had both. The study found 60.8% of those with a mental health disorder and 12.2% of those with SUD received treatment in the past year.

Source: Mental and Substance Use Disorders Prevalence Study (RTI International)