FDA rejects millions of e-cigarette marketing applications, but fails to rule on most popular brands
As the Food and Drug Administration (FDA) hit last week’s deadline for reviewing e-cigarette marketing applications, it said it had rejected applications for nearly 950,000 products, mainly due to their potential to appeal to youth. However, it failed to rule on Juul and some of the other most popular brands. To stay on the market, companies must show that their e-cigarettes benefit public health, proving that adult smokers who use them are likely to quit or reduce smoking, while teens are unlikely to become addicted. FDA previously said it would prioritize Juul and other key players, and the delay was panned by anti-vaping groups. FDA received applications for more than 6 million products and has taken action on 93%, including for 4.5 million products that were immediately rejected because they were missing key information. FDA is still reviewing applications for other non-traditional tobacco products like hookah, pipes and mini cigars, as well as larger vaping devices with refillable tanks that are mainly popular with adults and sold at specialty vape shops.
Source: FDA delays decision on e-cigarettes from vaping giant Juul (Associated Press)
Child Tax Credit can help address the addiction crisis
Allison Bovell-Ammon (Children’s HealthWatch at Boston Medical Center) and Scott Hadland (Mass General, Harvard Medical School) argue that extending the American Rescue Plan’s expansion of the Child Tax Credit should be viewed as a tool to address overdose deaths. Youth are more likely to develop addiction when they grow up experiencing stress caused by household financial hardship and parental substance use. Addiction has especially devastated communities where poverty, unemployment, and housing and food insecurity are high. The Child Tax Credit can prevent financial ruin and despair that can lead to addiction. For families already affected by addiction, the credit provides resources for recovery, including for medical bills, high insurance premiums, and legal expenses. Some have argued that parents with addiction will spend the money on drugs or alcohol, but research shows decreased spending on alcohol and tobacco when families receive cash benefits, likely due to the reduction in stress. Most parents spend their payments on basic needs and other expenses for their children.
Source: How the Child Tax Credit Can Break Cycles of Addiction (Newsweek)
Senators release white paper on reimagining the behavioral health system
Senators Michael Bennet of Colorado and John Cornyn of Texas released a white paper outlining a framework for redesigning how behavioral health care is delivered. It proposes establishing a national strategy to modernize the behavioral health system based on principles designed to integrate mental health more seamlessly throughout delivery and financing options; enhance delivery within local communities through innovative workforce and program modernization and coordination; update behavioral health care programs to improve availability, cost management, and quality; and improve how federal funds and other resources are planned and allocated to increase the return on investment through better outcomes. It outlines key steps Congress must take this year to improve behavioral health – rapid response, relationship adjustment, redesigning the system and reevaluating continuously. Bennet and Cornyn are seeking input from experts, community leaders, and constituents on polices to help achieve intended outcomes in their paper. Feedback to firstname.lastname@example.org is due October 8.
Source: Bennet, Cornyn Call on Congress to Drastically Reimagine America’s Mental and Behavioral Health Care System (Senator Michael Bennet)
SAMHSA awards $123 million to combat the overdose crisis
The Substance Abuse and Mental Health Services Administration is awarding more than $123 million through six grant programs to combat the overdose crisis. The Medication Assisted Treatment (MAT) for Prescription Drug and Opioid Addiction grant expands and enhances communities’ access to MAT. The Tribal Opioid Response program increases access to culturally appropriate and evidence-based treatment, including MAT, in tribal communities. The Screening, Brief Intervention, and Referral to Treatment (SBIRT) program guides clinicians in screening for addiction, providing brief intervention and referring individuals in primary care and community health settings to treatment. The Strategic Prevention Framework for Prescription Drugs program provides funding to states, territories and tribal entities to raise awareness and bring prescription drug misuse prevention and education to schools, communities, parents, prescribers and patients. The First Responder-Comprehensive Addiction and Recovery Act grants encourage first responders and other key community members to administer naloxone by providing training and establishing protocols for referral to services. The Providers Clinical Support System – Universities grant will expand and enhance access to MAT services by funding education and training in MAT for medical, physician assistant and nurse practitioner students.
Source: SAMHSA Awards $123 Million in Grants for Multifront Approach to Combat the Nation’s Overdose Epidemic (Substance Abuse and Mental Health Services Administration)
CDC and FDA warn about delta-8 THC
The Centers for Disease Control and Prevention issued a Health Advisory to alert public health departments, health care professionals, first responders, poison control centers, laboratories and the public to the increased availability of cannabis products containing delta-8 THC and the potential for adverse events due to insufficient labeling of products containing THC and CBD. It provides recommendations for the public and consumers, public health departments and poison control centers, retailers selling cannabis products and health care providers. The Food and Drug Administration (FDA) also released a consumer fact sheet on delta-8 THC outlining 5 things to know: delta-8 THC products have not been evaluated or approved by the FDA for safe use and may be marketed in ways that put public health at risk; the FDA has received adverse event reports involving delta-8 THC; delta-8 THC has psychoactive and intoxicating effects; delta-8 THC products often involve potentially harmful chemicals; and delta-8 THC products should be kept out of the reach of children and pets.
Source: Increases in Availability of Cannabis Products Containing Delta-8 THC and Reported Cases of Adverse Events (Centers for Disease Control and Prevention); 5 Things to Know about Delta-8 Tetrahydrocannabinol – Delta-8 THC (Food and Drug Administration)
State and local news
California using Medicaid to provide whole-person care
California plans to move Medi-Cal beyond traditional doctor visits into the realm of social services. Over the next five years, California is plowing nearly $6 billion into the plan, which will target homeless people or those at risk of losing their homes, heavy users of emergency rooms, children and seniors with complicated physical and mental health conditions, and people in or at risk of landing in institutions like jails, nursing homes or mental health crisis centers. Through the California Advancing and Innovating Medi-Cal (CalAIM) program, beginning next year, public and private managed care plans will pick high-need enrollees to receive nontraditional services from among 14 broad categories, including housing and food benefits, addiction care and home repairs, to provide “whole person care.” Insurers will receive incentive payments to offer new services and boost provider networks, and the program will expand to more people and services over time. For example, Native Americans will eventually be eligible to receive addiction treatment from natural healers, and inmates will be enrolled in Medi-Cal automatically upon release.
Source: California Set to Spend Billions on Curing Homelessness and Caring for ‘Whole Body’ Politic (Kaiser Health News)
Washington receives $5 million to improve rural health care access
The Centers for Medicare and Medicaid Services awarded the Washington State Healthcare Authority an initial $2 million to address disparities in health equity by improving access to quality health care in rural communities. The funds will help determine whether the Washington State Healthcare Authority would maintain or improve quality of care and lower health care costs by testing evidence-based community standards, addiction and dependence treatment, patient safety initiatives and a collaborative care model that adds behavioral health management and psychiatric consultants to support primary care. The award is part of the CMS Innovation Center’s Community Health Access and Rural Transformation (CHART) model. The $2 million is for the pre-implementation phase, and the state is eligible for as much as $3 million more upon completion of milestones over the course of six performance periods.
Source: Biden-Harris Administration Awards Washington Up to $5 Million to Transform Delivery of Rural Health Care (Centers for Medicare & Medicaid Services)
New York settles with Endo
The state of New York and Suffolk and Nassau Counties agreed to a $50 million deal to end their lawsuits with Endo. Under the deal, Endo and subsidiary Par are to pay $22.3 million to the state attorney general’s office and $13.85 million to both Suffolk and Nassau Counties. Endo admits no wrongdoing. The trial, which has been going on for about two months, will continue against the remaining defendants, Teva and Allergan. Johnson & Johnson settled just before the trial, and the distributors have since settled as well.
Source: Endo latest company to settle with New York over opioids (Associated Press)
Other news in addiction policy
Marijuana use at historically high levels among college-aged adults
The Monitoring the Future survey found that marijuana use continued to rise among college students over the past five years and remained at historically high levels among same-aged peers who are not in college in 2020. This represents the highest level of marijuana use recorded since the 1980s. 44% of college students reporting using marijuana in the past year in 2020, compared to 38% in 2015 and 43% of young adults not in college (same as in historically high 2018 and 2019). Daily or near daily use also continued to rise among college students (5% to 8%), while it remained steady (13%) among non-college students. Marijuana and nicotine vaping leveled off in 2020 after increases every year since 2017 for both college students and those not in college. Among college students, there was also a significant increase in the annual use of hallucinogens (5% to 9%) and drop in current alcohol use (62% to 56%) from 2019-2020. Cigarette smoking, nonmedical use of amphetamines and prescription opioid misuse continued to decline.
Source: Marijuana use at historic high among college-aged adults in 2020 (National Institute on Drug Abuse)
New workforce for police-free behavioral health crisis response needed
Presenting New Directions for Substance Use Prevention
Substance use prevention, along with treatment and recovery support, is a key component of the public health approach needed to transform how our nation addresses addiction. Yet, prevention historically has been underfunded and initiatives have been narrow, drug-specific and concentrated on the adolescent years, when youth risk behaviors are most likely to manifest.
A growing body of research on the effects of adverse and positive childhood experiences, along with neuroscientific evidence emerging from the National Institute on Drug Abuse’s Adolescent Brain Cognitive Development Study on the importance of social and structural determinants of health, have made it increasingly clear that the roots of addiction risk and resilience are planted very early in life.
Friends of NIDA, the Partnership to End Addiction, and the American Psychological Association invite you to join us for a free webinar on new directions for substance use prevention on Monday, September 27th from noon to 1:15pm.