Tag: regulation

Amicus Brief Supports Limiting ‘Chevron Deference’

Image: Tobacco Reporter archive
Keller and Heckman has filed an amicus brief with the U.S. Supreme Court on behalf of members of the electronic nicotine-delivery system (ENDS) industry in support of petitioners in a case to overturn or limit the so-called Chevron deference.
Named after a landmark Supreme Court decision dating from 1984, the Chevron deference is a legal doctrine that generally requires courts to defer to an administrative agency’s interpretation of ambiguous statute so long as that interpretation is reasonable.
In practice, Chevron deference often gives agencies broad leeway to reach beyond the limits of a statute’s plain language, often bypassing the rulemaking process otherwise required under the Administrative Procedure Act and making it more difficult to challenge an agency action in court.
In the years since ENDS became subject to Food and Drug Administration regulation, the vast majority of courts reviewing ENDS industry challenges to premarket application denials, as well as FDA rulemakings and guidance documents, have rubber-stamped the agency’s interpretation of the Family Smoking Prevention and Tobacco Control Act (TCA) and the “appropriate for the protection of the public health” standard, Keller and Heckman wrote on its blog.
Critics contend that the Chevron deference has enabled the FDA to impermissibly interpret the TCA to implement a de facto ban on all nontobacco-flavored ENDS products without any requisite notice and comment rulemaking or congressional amendments to the TCA.
The filers on the amicus brief urge the Supreme Court to at least restrict the application of Chevron deference so that it is the exception, not the rule. The Supreme Court will hear oral arguments in the case in its fall 2023 term.
The petition to overturn or limit the Chevron deference was brought by a group of fishing companies challenging the National Marine Fisheries Service’s construction of the Magnuson-Stevens Act to require the industry to pay the salaries of federal monitors.
The ENDS industry amici include the American Vaping Manufacturers Association, the American Vapor Group and Bidi Vapor.
July 25, 2023
FDA Makes Next TPSAC Meeting Materials Available

The U.S. Food and Drug Administration’s Tobacco Products Scientific Advisory Committee (TPSAC) met on May 18 to discuss the “Requirements for Tobacco Product Manufacturing Practice” proposed rule. All the meeting materials, including the recording, transcript and summary minutes, are now available online.
The proposed rule, if finalized, lays out the FDA’s requirements for tobacco product manufacturers regarding the manufacture, design, packing and storage of tobacco products.
Comments on the proposed rule must be submitted by 11:59 p.m. Eastern Time on Sept. 6, 2023.
July 25, 2023
U.S. Congress Committee to Discuss CBD Thursday

A U.S. congressional committee is scheduled to talk about hemp this week as lawmakers presumably will increase pressure on the U.S. Food and Drug Administration to establish guidelines to regulate the CBD market.
A hearing set for 2 p.m. Thursday will look at “Hemp in the Modern World: The Yearslong Wait for FDA Action.”
The House Oversight and Accountability Subcommittee on Health Care and Financial Services session is open to the public and also may be viewed online, according to Hemp Today.
The session is also likely to address what some say is a lack of regulatory clarity and concern about the safety of synthetic delta-8 THC products.
The oversight committee, chaired by Rep. James Comer, is investigating the FDA’s failure to regulate hemp-derived CBD products as dietary supplements.
Lawmakers and the FDA have danced around CBD for nearly five years, with Congress repeatedly calling on the agency to set rules for the unregulated products, which emerged beginning late last decade and grew into a flourishing gray market.
“We are going to investigate why exactly the FDA has decided to ignore their regulation responsibilities related to CBD and other areas of jurisdiction,” said Rep. Lisa McClain, who serves on the committee.
“Without these regulations, dangerous products could make their way to the shelves while safe and credible CBD products could be prevented from entering the market,” McClain said.
July 25, 2023
Michigan Recalls THC Vapes for Banned Chemical

The Cannabis Regulatory Agency in Michigan is recalling certain THC vape cartridges due to the possible presence of banned chemical residue exceeding the established limits, the agency announced.
The vape cartridges — manufactured under the name “FLIGHT LIVE RESIN DISPOSABLE” — were manufactured by the Mount Morris-based marijuana processor Sky Labs near Flint and include three batches called “Grease Monkey,” “Space Ether” and “Bubblegum,” according to the Detroit Free Press.
More than 13,000 of these vape cartridges have been sold, David Harns, a spokesperson for the CRA said, and about 2,200 of them are currently available for sale at 59 dispensaries.
The banned chemical residues that are possibly in the products include Bifenthrin (an insecticide), Myclobutanil (a chemical used as a fungicide), Bifenazate (a pesticide), Paclobutrazol (an organic compound used as a plant growth retardant and fungicide) and Permethrin (an insecticide), he said.
July 25, 2023
Bangladesh Mayors Commit to Smoke-Free Future

Mayors from Bangladesh’s municipalities met for a two-day summit with national and international tobacco control experts, where they pledged to aim for Prime Minister Sheikh Hasina’s vision of a tobacco-free Bangladesh by 2040, reports the Dhaka Tribune.
The goal of the summit was to discuss implementation of tobacco control laws and local government guidelines. The country’s tobacco control law was enacted in 2005 after ratification of the World Health Organization Framework Convention on Tobacco Control. The law was amended in 2013, introducing pictorial health warnings and including smokeless tobacco. It took over three years to put the law into practice, and during that time, the health ministry drafted an amendment banning vaping products, lifting the provision of designated smoking zones to prevent secondhand smoke and controlling point-of-sale advertising. The draft is pending Cabinet approval.
Tobacco use is not declining as expected, according to anti-tobacco activists. The latest data shows that 35.3 percent of adults ages 18 and older used tobacco in any form in 2017. Experts warn that if the trend continues, the tobacco-free goal will not be met.
“The key is to have strong local leadership in terms of policy development, policy implementation and mobilizing funds at the local level for the prevention of tobacco use and noncommunicable diseases,” said Tara Singh Bam, regional director of The Union Asia Pacific, who spoke at the summit. “Mechanisms need to be established that ensure mayors are held accountable for safeguarding the development and implementation of public health policies from the undue influence of unhealthy commodity industries.”
“We, the Ministry of Local Government, issued tobacco guidelines for all the municipalities and cities to assist them,” said Joint Secretary Jasim Uddin. “We have distributed these guidelines.” He noted that the mayors attending the summit are “very committed” to preventing tobacco-related diseases and deaths.
The guidelines direct the mayors to improve tobacco control law enforcement, build public awareness, allocate funds for tobacco control and limit the availability of tobacco products.
July 24, 2023
China Releases Guideline for Vaping Product Exports
Credit: Zapp 2 Photo
China’s State Tobacco Monopoly Administration released the Guidelines for Promoting the Building of Quality Assurance Systems for Exported Electronic Cigarette Products on July 20, according to 2Firsts, which published a translated version of the release.
The guidelines consist of 18 articles covering the following:

clarifying that enterprises are the main responsible entities for the building of quality assurance management systems for exported electronic cigarette products;
specifying the main content for the building of quality assurance management systems for exported processes, allocation of production resources, the establishment of sound systems, standardization of product packaging, traceability of logistics and transportation, and export declaration and registration requirements; and
specifying the requirements for the building of quality assurance management systems for exported electronic cigarette products.
The guidelines are interpreted by the State Tobacco Monopoly Administration (STMA). The guidelines “shall be implemented” from the date of issuance, according to the STMA.
July 21, 2023
FDA Seeks Input on 5-Year Tobacco Center Strategic Plan

Credit: FDA
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) will hold a virtual listening session on Aug. 22 to give the public an opportunity to comment on the five-year plan it developed to advance its mission.
As part of its response to the Reagan-Udall Foundation evaluation, the CTP plan includes five proposed goal areas that are interconnected with the themes of health equity, science, transparency and stakeholder engagement.
The proposed goals and the questions that the CTP would like commenters to address are on the agency’s virtual listening session event page.
Following receipt and consideration of public input, the CTP intends to publish its strategic plan by the end of 2023.
After introductions, the center will begin the listening session with an overview of the process used to develop the CTP’s strategic plan. Registered speakers will then have approximately four minutes each to verbally share their comments on any topics related to the strategic plan.
Request to verbally provide open public comment must be submitted by Aug. 14 at 11:59 p.m. Eastern Time.
In addition to this listening session, the public can submit electronic or written comments to the Federal Register notice. Electronic comments must be submitted and written comments must be postmarked by Aug. 29.
July 21, 2023
Juul Labs Seeks FDA Authorization for Juul2 System
Credit: Juul Labs
Juul Labs has submitted a premarket tobacco product application (PMTA) for its next-generation vapor platform to the U.S. Food and Drug Administration. The company says its submission includes comprehensive science and evidence for a new device and new tobacco-flavored pods at 18 mg/mL nicotine concentration, as well as information on novel, data-driven technologies to restrict underage access.
“Our company DNA is product innovation,” said Chief Product Officer Kirk Phelps in a statement. “With our next-generation platform, we have designed a technological solution for two public-health problems: improving adult-smoker switching from combustible cigarettes and restricting underage access to vapor products. This is only the beginning of new tech being developed and refined for the U.S. market and abroad to eliminate combustible cigarettes and combat underage use.”
Launched initially in the U.K. in 2021 as the JUUL2 System, the new vapor platform delivers an improved vapor experience for adult smokers, utilizes unique Pod ID authentication to address illicit products and incorporates age-verification technology capabilities.

Our next-generation vapor platform PMTA is built on new technology that advances public-health objectives and compelling science that demonstrates a clear public-health benefit, as required to secure a marketing authorization.
Joe Murillo, chief regulatory officer, Juul Labs
According to Juul, features of the next-generation platform include:
A more consistent vapor experience that better competes with combustible cigarettes
A Bluetooth-enabled device with a larger, long-lasting battery and a “smart light system” that communicates battery life and e-liquid level to the user
Newly designed, tamper-resistant pods that enable improved aerosol delivery
An innovative heating element that improves product performance and temperature-control precision
A unique Pod ID chip that, among other tech capabilities, prevents the use of illicit counterfeit and compatible pods with the next-generation device
A mobile and web-based app that enables age-verification technology, including device-locking, and real-time product information and usage insights for age-verified consumers with industry-leading data-privacy protections
Initial behavioral research of the new platform in the U.K. has demonstrated compelling adoption and switching among adult smokers. Over 32 percent of JUUL2 System users had switched completely from combustible cigarettes six months after purchasing the product. While the currently marketed Juul System has switched over 2 million adult smokers in the U.S., the company looks forward to bringing this new technology to over 28 million adult smokers in the country who continue to smoke combustible cigarettes.
“Our next-generation vapor platform PMTA is built on new technology that advances public-health objectives and compelling science that demonstrates a clear public-health benefit, as required to secure a marketing authorization,” said Juul Chief Regulatory Officer Joe Murillo. “We look forward to engaging with FDA throughout the review process while we pursue this important harm-reduction opportunity.”
Juul said it continues to pursue its administrative appeal of the FDA’s stayed decision for the Juul System and believes that it too will receive marketing authorization once a decision is made on science and evidence.
July 20, 2023
PMI to Aquire Medical Marijuana Inhaler Company

Syqe Inhaler (CNW Group/Syqe Medical)
Philip Morris International plans to acquire Syqe Medical, an Israeli company, according to Calcalist. The deal could reach $650 million.
Syqe’s main product is a metered-dose inhaler for pain reduction using medical marijuana.
PMI will initially invest $120 million to aid in the process of obtaining U.S. Food and Drug Administration approval for Syqe’s inhaler. If approval is received, PMI will purchase all shares of Syqe for $650 million.
PMI subsidiary Vectura will conduct the transaction.
In 2016, PMI invested $20 million in Syqe.
July 19, 2023
Health Ministry in India Warns 15 for Online Sales

Credit: K Kolosov
The Union Health Ministry in New Delhi, India, has sent warnings to 15 websites for selling e-cigarettes and ordered them to stop selling and advertising the items. The websites were not announced.
If those sites do not comply with the law, they will face legal consequences. The government has its eyes on six more websites that may also receive notices soon.
The Ministry is monitoring online media to ensure that no one is violating the ban on e-cigarettes that was put in place in 2019.
The notice states that “it has been discovered that your platform is displaying, broadcasting, and sharing information related to the sale of e-cigarettes, which is against the law,” according to The News Agency.
Four websites have already acknowledged the warning and taken action, while the rest are yet to respond.
Those who fail to do so within 36 hours may be subjected to fines as stipulated by the IT Act and/or the Electronic Cigarette Prohibition Act.
July 19, 2023