Tag: regulation

Alaska Senate Again Sends Tobacco 21 Bill to House

Credit: Yossarian6
Last week, the Alaska Senate voted 14-6 in favor of S.B. 89, a bill that would change the state’s minimum age to purchase and possess vaping and other tobacco products from 19 to 21 years old.
If approved, the bill would align Alaska’s state law with the federal standard.
The bill also would impose a statewide tax of 25 percent on e-cigarettes. A similar bill was vetoed by Gov. Dun Mike Dunleavy last fall.
The 25 percent statewide tax would add to Alaska municipal nicotine taxes already in place, such as Juneau, which currently taxes 45 percent, or $3 a pack, on the wholesale price of tobacco products, according to City and Borough of Juneau Finance Director Jeff Rogers.
The action would also allow local law enforcement to enforce the federal Tobacco 21 standard and ensure the state doesn’t lose out on grants and other funds it can receive for having its tobacco laws in line with the federal standard, reports Charlie Minato with Halfwheel.
S.B. 89 would make it illegal for anyone to sell or give tobacco or vaping products to anyone under the age of 21 years old. Those caught selling or giving tobacco or vaping products to someone under the age of 21 would be subject to a fine of at least $300.
The bill would also introduce fines for those under the age of 21 years old caught possessing tobacco or vaping products. They would be subject to a fine of no more than $150 and could be subject to a tobacco education program.
In December 2019, President Donald Trump signed a large federal spending bill that also included a provision increasing the minimum age to purchase tobacco products from 18 to 21 years old at the federal level.
While the federal law already exists, its enforcement is restricted to those who sell tobacco products and not the consumers. The vast majority of U.S. states have updated their laws to make them consistent with the federal standard.
S.B. 89 now moves onto the Alaska House of Representatives.
Last year, Alaska’s governor vetoed a Tobacco 21 bill because it included a 35 percent tax increase on vaping products.
May 23, 2023
CTP Hires Its First Senior Advisor for Health Equity
Charlene Le Fauve (Credit: NIH)
The tobacco and nicotine product regulatory arm of the U.S. Food and Drug Administration has hired a senior advisor for health equity for the first time. The Center for Tobacco Products (CTP) announced Charlene Le Fauve will fill the role.
“Beginning today, she will join CTP’s Senior Leadership Team within the Office of the Center Director,” a release states. “Dr. Le Fauve is a behavioral scientist and addiction researcher with 25 years of federal work experience related to health equity and health disparities research. She has dedicated her career to advancing health equity and the health of underserved and underrepresented populations through research and research workforce development.”
Most recently, Le Fauve served as the senior advisor to the Chief Officer for Scientific Workforce Diversity at the National Institutes of Health (NIH). In this role, she educated national audiences about NIH’s role in scientific workforce diversity and health equity research, according to the release.
Prior to her NIH role, Le Fauve held various leadership roles, such as the deputy director of Disparities Research and Global Mental Health at the National Institutes of Mental Health and the senior policy coordinator and lead for the Center for Medicare and Medicaid Services Team at the Department of Health and Human Services.
“Diversity, Equity, Inclusion, and Accessibility (DEIA) are core values of CTP, and efforts are underway to ensure that the full scope of the Center’s work is reflective of these principles. In this new position, which is the first of its kind for any Center at FDA, Dr. Le Fauve will work with all of CTP’s Offices to ensure health equity is integrated into the Center’s programmatic plans and priorities,” the release states, “She also will serve as CTP’s primary representative in a variety of activities that promote and facilitate the reduction of tobacco-related health disparities, including during external meetings, conferences, and presentations.”
May 22, 2023
Fuma Fire Launches ‘Fire’ Vape Brand in Costa Rica

Credit: Fuma Fire
Hollywood, California-based Fuma Fire has launched its new “Fire” brand vaping products in Costa Rica.
“We’re excited to say that FIRE has received all necessary approvals from the Ministry of Health and the University of Costa Rica, making it the first exclusive vape brand designed specifically for the Costa Rican market,” a company press release states. “With its exceptional quality and undeniable appeal, FIRE is set to become a staple of the Costa Rican vaping scene.”
The Fire 2-in-1 vape is the only approved vape on the market that has been approved by the Ministry of Health and the University of Costa Rica.
“At Fire, we believe in igniting the senses and delivering a truly unforgettable vaping experience,” the release states. “Our vapes are crafted with care to provide you with the very best in flavor and quality, and we’re confident that you’ll love every single puff.”
May 22, 2023
Flavor Ban Bill Dies in Vermont General Assembly

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A bill that would have banned the sale of flavored tobacco products and flavored e-liquid products has died after the Vermont General Assembly adjourned for the year.
S.B. 18 would have banned the sale of vaping products such as e-liquids and other tobacco products that have a characterizing flavor other than tobacco.
Like bills recently introduced in other states, the bill contained a provision that said if a company claims that the product has “a distinguishable taste or aroma other than the taste or aroma of tobacco, ” it would be considered flavored, according to Halfwheel.
The Vermont Senate passed S.B. 18 in late March, but it failed to get out of the Vermont House Committee on Human Services.
Several states in the Northeast have or are considering flavor bans. Connecticut also introduced a bill that would ban flavored e-cigarettes. New York, New Jersey and Rhode Island have barred the sale of flavored vaping products. Massachusetts banned all flavored tobacco items, including flavored cigars, cigarettes and vaping goods.
Vermont’s ban was originally proposed in early 2020 as a way to prevent youth use, but was sidelined after the Covid-19 pandemic began to impact the country.
May 21, 2023
Study: Legal Marijuana States See Lower Tobacco Use

Credit: J Doms
While some public health experts have expressed concerns that the legalization of marijuana could fuel a rise in the use of tobacco products, a new study instead concludes that state-level cannabis reforms are mostly associated with “small, occasionally significant longer-run declines in adult tobacco use.”
Researchers did find “consistent evidence” that the adoption of state recreational marijuana laws (RMLs) led to a slight uptick in cannabis use among adults—of between about two and four percentage points, depending on the data source—but tobacco didn’t follow that trend.
If the apparent substitution effect from cigarettes to marijuana that’s being driven by legalization were extended nationally, it could result in healthcare cost savings worth more than $10 billion per year, the study concluded, reports Marijuana Moment.
“We find little empirical support for the hypothesis that RMLs increase the net consumption of tobacco, as measured across a wide range of combustible tobacco products as well as [e-cigarettes],” they wrote. “Rather, the preponderance of evidence points to small, occasionally significant longer-run declines in adult tobacco use.”
Authors at Bentley, San Diego State and Georgia State universities published the findings in the Journal of Health Economics last month, calling the report “the first to comprehensively examine the impact of recreational marijuana legalization on tobacco use.” The study draws on federal data from the Population Assessment of Tobacco and Health (PATH) and the National Survey on Drug Use and Health (NSDUH).
At a time of surging public support for cannabis legalization, the researchers write, “public health experts have taken a more cautious approach, urging more research to assess the health benefits and costs of marijuana use, as well as to understand potentially unintended consequences on other health behaviors.” Some have raised concerns that reform could lead to the “renormalization” of smoking, potentially reversing nearly half a century of declining cigarette use.
May 19, 2023
Mother’s Milk Denied Marketing for More Than 250 E-Liquids

Credit: Kraken Images.
The U.S. Food and Drug Administration on May 18 issued marketing denial orders to Mother’s Milk WTA for more than 250 flavored and tobacco-flavored e-liquids.
After completing an initial acceptance review and subsequently proceeding to and completing a substantive scientific review of the company’s premarket tobacco product applications (PMTAs), the FDA determined that the applications lacked sufficient evidence to show the products are appropriate for the protection of public health.
For example, the applications did not provide sufficient evidence to show comparative health risk data relative to other tobacco products on the U.S. market, information assessing the abuse liability of the new products, or that the new products could be manufactured consistently.
“One of our most important responsibilities is to ensure new tobacco products undergo scientifically rigorous premarket review,” said Matthew Farrelly, director of the Office of Science within the FDA’s Center for Tobacco Products, in a statement. “We remain committed to evaluating these applications based on a public health standard that considers the risks and benefits of the tobacco product to the population as a whole.”
The agency has received premarket tobacco applications for more than 26 million deemed products, most of which are e-cigarettes. The agency says it has made determinations on 99 percent of these applications. This includes more than 1 million applications for non-tobacco nicotine products, including those containing synthetic nicotine, after Congress clarified FDA’s authority to regulate these products in April 2022.
Further, FDA has authorized 23 tobacco-flavored e-cigarette products and devices, which are the only e-cigarettes that currently may be lawfully sold or distributed in the U.S. FDA has also denied marketing applications for millions of products that did not meet the requirements in the law.
May 19, 2023
U.S. FDA Issues ‘Import Alert’ to Seize Illegal Vapes

Credit: Photo Spirit
In a move that could be devastating to the vaping industry, the U.S. Food and Drug Administration has issued “Import Alert 98-06” that states the regulatory agency will detain new tobacco products such as e-cigarettes without marketing authorization at the border.
The companies impacted would include all importers, manufacturers and transporters of vaping product brands such as ELFBAR, EB DESIGN, Eonsmoke, Esco Bar and Stik that are on the agency’s “Red List.”
The alert covers China, South Korea and the United States.
“Divisions may detain, without physical examination, the tobacco products identified on the Red List of this Import Alert. If the division is not sure whether a tobacco product is the same product as one identified on the Red List, the division should consult with the Center for Tobacco Products (CTP)” the alert states. “CTP concurrence is required to add a product to the Red List.”
In order to remove a firm’s product from the Red List, companies must provide information to the FDA that adequately demonstrates that the firm has resolved the conditions that gave rise to the appearance of the violation.
“The purpose of this is so that the Agency will have confidence that future shipments/entries will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, ‘Detention without Physical Examination (DWPE),’” the alert states.
The FDA states that the import alert is to prevent the sale of potentially illegal goods in America; release agency resources to inspect other goods; provide uniform coverage across the country; shift the blame back to the importer to ensure that products imported into the United States comply with FDA laws and regulations, according to the agency.
In June 2009, the Family Smoking Prevention and Tobacco Control Act gave the FDA the authority to regulate tobacco products, recognizing that it is the primary federal regulator for the manufacture, marketing, and distribution of cigarettes, cigarette tobacco, and smokeless tobacco.
The designation rule, published in the Federal Register on May 10, 2016, and effective August 8, 2016, extends FDA’s authority to designated tobacco products, such as e-cigarettes, cigars, hookahs, and pipe tobacco, as well as their components and parts, but not their accessories.
This story will be updated as more news and industry reaction becomes available.
May 18, 2023
Bill to Toughen Vape Rules Heads to Alabama Senate

Credit: Allard1
The House of Representatives in the U.S. state of Alabama approved a bill to tighten restrictions on vaping products.
The bill makes it illegal for retailers to sell all vaping products to people under 21 years old. It also expands the definition of an electronic nicotine delivery system to include any product that delivers substances other than tobacco, according to WSFA.
Vending machines that sell tobacco in places that allow people who are younger than 21 years old to purchase it are also banned.
“It identifies the products that do not contain nicotine so that they can be regulated along with everything else. It regulates the sale of e-liquid,” Rep. Barbara Drummond said.
There was only one no-vote from the representatives.
The bill now moves to a Senate committee for further consideration.
A state senator in Alabama last week introduced a bill last week that would make it illegal for minors to be in possession of vapes, according to a release from the Drug Education Council.
May 18, 2023
Bill Threatens to Derail FDA Menthol and Nicotine Plans

Photo: Rechitan Sorin
The U.S. House Committee on Appropriations may spoil the Food and Drug Administration’s plans to ban flavored cigars, ban menthol cigarettes and limit nicotine levels in cigarettes, reports Halfwheel.
On May 17, the committee, which is responsible for allocating funds to various government entities, including the FDA and the Department of Agriculture, unveiled the draft of the Agriculture, Rural Development, Food And Drug Administration, And Related Agencies Bill.
The proposed language says that FDA cannot use any of the money Congress allocates for it to ban menthol or set nicotine levels, effectively preventing the agency from carrying out the regulations.
The relevant passages are:
SEC 768. None of the funds provided by this Act or provided from any accounts in the Treasury of the United States derived by the collection of fees available to the agencies funded by this Act, may be used by the Secretary of Health and Human Services to finalize, issue, implement, administer, or enforce any rule, regulation, or order setting a tobacco product standard that mandates a maximum nicotine level for cigarettes.
And:
SEC 769. None of the funds provided by this Act, or provided from any accounts in the Treasury of the United States derived by the collection of fees available to the agencies funded by this Act, may be used by the Secretary of Health and Human Services to finalize, issue, or implement any rule, regulation, notice of proposed rule- making, or order setting any tobacco product standard that would prohibit menthol as a characterizing flavor in cigarettes or prohibit characterizing flavors in all cigars and their components and parts.
Anti-tobacco activists were aghast. “This bill is a special interest gift to the tobacco industry that would result in more kids addicted to tobacco and more lives lost, especially Black lives,” wrote Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, in a statement. “These shameful provisions give the tobacco industry everything it wants from Congress in exchange for its campaign contributions.”
The bill is in its early stages and is likely to undergo many modifications.
May 18, 2023
TPSAC to Discuss Proposed TPMP Rule Tomorrow

Image: Tobacco Reporter archive
The Tobacco Products Scientific Advisory Committee (TPSAC) will hold a meeting to discuss the Requirements for Tobacco Product Manufacturing Practice (TPMPs) proposed rule Tomorrow, May 18, 2023, from 9 a.m. to 2 p.m.
The proposed rule is open for public comment until Sept. 6, 2023.
The TPSAC meeting will be available via a free webcast. Electronic or written comments on the meeting needed to be submitted by May 11 for consideration by the committee.
May 17, 2023