E-Cigarette Maker JUUL
JUUL settled its most recent, and largest lawsuit, brought by six states and the District of Columbia (April 12). Under the terms of the settlement, JUUL will pay $462 million and require retailers to secure Juul’s e-cigarette products behind counters and verify the age of purchasers. In addition, the company will be required to cease using people under 35 years old in its marketing materials that directly or indirectly target younger Americans.
Last June, the FDA issued a marketing denial order (June 23rd) for all products of JUUL Labs. JUUL filed a lawsuit against the FDA decision, and the judge granted a temporary stay preventing implementation of the FDA’s marketing limitations. The case remains pending and JUUL has continued to sell its products.
At the time of the FDA’s decision, the agency said it determined that JUUL’s products lacked sufficient evidence regarding the toxicological profile of the products; that, some of the company’s studies had “insufficient and conflicting data” related to toxicity and chemicals leaching into the company’s e-liquid pods. Concerns had not been “adequately addressed” by the company, and the FDA had consequently not been able to complete a full toxicological risk assessment of the company’s products.
With the passage of time and JUUL’s settlement of several lawsuits against the company’s marketing practices, it is not clear if, or when, JUUL will face further marketing and distribution decisions. What is likely is that the company has been working behind-the-scenes to address the FDA’s concerns and negotiate solutions that would permit the company to continue to operate.
In 2022, about 1 in 10 (more than 2.5 million) US middle and high school students used e-cigarettes (i.e., from a "use in the past 30 days" survey question).
Marijuana Possession Pardon
President Biden issued (October 6) what amounts to a broad-based “complete” and “unconditional pardon” of persons convicted, charged or could be charged in the future, on simple possession of marijuana in violation of existing Federal law.
The pardon applies to both U.S. citizens and non-citizen, lawful permanent residents. It does not apply to persons who were non-citizens not lawfully present in the United States at the time of their offense. For eligible persons, the pardon will restore such persons “full political, civil, and other rights.”
The Department of Justice (DOJ) will “administer and effectuate” the issuance of certificates to eligible applicants who have already been charged or convicted of offenses tied to this pardon. DOJ announced that it will begin a process “in the coming days.”
Nicotine Reduction Rulemaking
The FDA announced (June 21st) that it plans to undertake a rulemaking process intended to reduce the level of nicotine within cigarettes. The goal of the rule would be to help reduce the level of addictiveness of cigarettes, particularly for youth. The announcement cites analysis of the U.S. Surgeon General which found that 87 percent of adult smokers start smoking before age 18, and about two-thirds of adult daily smokers began smoking daily by 18 years of age. Reducing addictiveness will mean fewer adult smokers over the long term.
A rulemaking on this matter is likely to take a long time, and will face potentially lengthy legal challenges by the tobacco industry given likely strong opposition. A proposed rule is not expected to be issued until next spring, at the earliest.
The CDC released provisional data on drug overdose deaths in the United States for 2021. The number of deaths totaled nearly 108,000, nearly a 15% increase from 2020. They were 50% higher than in 2019. The growth of overdose deaths is being driven by synthetic opioids such as fentanyl and methamphetamine.
Marijuana Legalization Bill
The House of Representatives passed (April 1, 2022) marijuana legalization legislation on a vote of 220 to 204. The “Marijuana Opportunity Reinvestment and Expungement (MORE) Act” (primary sponsor: Jerry Nadler D-NY) would, among other things, remove marijuana from the Federal list of controlled substances and create a process to expunge convictions and conduct sentencing review hearings related to federal cannabis offenses.
The legislation also creates a federal tax on marijuana sales to fund programs aimed at helping communities harmed by drug policies that established harsh punishments for distributing and using drugs. Sales taxes would start at 5 percent and gradually increase to 8 percent over five years.
Senate leadership is reportedly working to develop a similar bill this year, but it is not clear legislation on this subject can garner sufficient support to pass the Senate.
Fentanyl-Related Substances (FRS) Scheduling
The Congress provided an extension of a Schedule I listing of FRS within FY 2022 Omnibus appropriations legislation, through December 31, 2022. The previous deadline for this listing was March 11, 2022.
Schedule I is the most stringent controlled substances schedule of the Controlled Substances Act (CSA). The Biden Administration has proposed to permanently list FRS under Schedule I, though with looser rules on mandatory minimum sentences. Some health/civil rights/ justice reform organizations sent a letter to Congress (October 2021) opposing the proposal arguing that temporary scheduling has not proven beneficial so far in reducing FRS and associated addiction and deaths, and that listing implies a reliance on the justice system to address this problem over healthcare-driven actions.
Addressing Opioid Addiction
In his state-of-the-union address to Congress (March 1, 2022), President Biden emphasized the need to address opioid addiction. In addition to broader efforts, including increased funding to treat opioid and other drug abuses, as well as stopping illicit drug flow, the President emphasized the need to “get rid of outdated opioid rules.” The President has called for “universal access” to medication for opioid use disorder (MOUD) by 2025.
According to the White House, most Americans who need treatment for opioid use do not get effective medication like buprenorphine and methadone. The White House says it will work to remove “unnecessary barriers” preventing medical providers from prescribing FDA-approved medications, including extending (and proposing to make permanent) emergency provisions implemented during the COVID-19 pandemic concerning MOUD authorizations. This will include allowing providers to begin treatment with MOUD patients via telehealth, including by audio only, as well as extend methadone take-home flexibilities.
The White House also says it will build on an action last year to release guidelines for medical professionals for administering Buprenorphine, which exempted eligible health care providers from Federal certification requirements related to training, counseling and other ancillary services necessary to obtain a waiver to treat up to 30 patients with buprenorphine. The White House says this action resulted in more providers registering to prescribe buprenorphine, thereby expanding access to evidence-based treatment.
Opioid Commission Results
The Commission on Combating Synthetic Opioid Trafficking established under the 2020 National Defense Authorization Act released its report (February 7, 2022). The summary conclusion of the Commission is that the trafficking of synthetic drugs is "not just a public health emergency but a national emergency that threatens both the national security and economic wellbeing of the country."
The Commission outlined what has changed in recent years that has made the situation more challenging such as geopolitical challenges making it more difficult to disrupt supply, the ease in making synthetic versions and the economic advantage of doing so, and the use of social media and encryption platforms that makes it easier to traffic and distribute the drugs.
Some of the key recommendations include ensuring a stronger central organization in the Federal Government to coordinate planning, implementation, and evaluation of all U.S. drug policies; disrupting drug supply through targeted oversight and enforcement; increasing/strengthening drug demand reduction activities; and improving bilateral efforts, particularly with Mexico.
WH Fact Sheet on Drug Addiction/Overdose Deaths
The Biden Administration released a Fact Sheet (November 2021) on what it says are the actions it has taken to address drug addiction and the rising number of overdose deaths.
No Results Found
Permanent CSA Listing of Fentanyl-Related Substances (FRS)
This is a policy proposal to the Congress of the Biden Administration to permanently list Fentanyl-Related Substances (FRS) permanently on Schedule I of the Controlled Substances Act (CSA). Substances listed on Schedule I (of five schedules) are subject to the most stringent controls. However, the proposal would exclude FRS offenses from mandatory minimum sentences, except in cases of death or serious bodily harm caused by FRS.
Status: some version of a permanent Fentanyl listing on Schedule I is anticipated during the current (117th) Congress, but via which legislative vehicle is not clear. A temporary Schedule I listing has been provided within 2022 Continuing Resolution (CR) funding legislation that will expire on February 18, 2022.