TobaccoReporter logo

Tag: trump

  • Trump Administration Looking to Change PMTA Process

    Trump Administration Looking to Change PMTA Process

    The Trump administration is reportedly preparing changes to the FDA’s review process for new tobacco products that could make it faster and easier for products such as flavored vapes and nicotine pouches to receive marketing authorization, according to The Wall Street Journal. The FDA is expected to revisit requirements established in 2021 for Premarket Tobacco Product Applications (PMTAs), following years of industry criticism over lengthy reviews.

    Reuters reported it could not independently verify the report, but quoted an HHS spokesperson as saying, “The Trump administration is committed to keeping nicotine out of the hands of kids, getting ⁠counterfeit vaping products off the streets and providing safer alternatives for adults who want to quit smoking cigarettes.”

    Industry groups and companies welcomed the potential changes. Laura Leigh Oyler, vice president of regulatory affairs at Haypp Group USA, said the FDA has not met congressional review deadlines for noncombustible products and has authorized fewer than 100 reduced-risk products compared with thousands of combustible products. “An overhaul isn’t just welcome, it’s necessary,” Oyler said, adding that the current process has contributed to the influx of foreign, illicit products.

    Charlie’s Holdings also supported the reported changes, saying it has been seeking FDA authorization for certain tobacco-derived nicotine e-liquids since 2020 and hundreds of synthetic nicotine products since 2022. CEO Henry Sicignano said the PMTA process has imposed high costs on smaller U.S. businesses while illicit products have entered the market. Charlie’s said it currently retains 678 timely filed PMTA assets and expects a streamlined authorization process to increase the value of its portfolio.

  • DEA Backs Cannabis’ Medical Utility at Hearings

    DEA Backs Cannabis’ Medical Utility at Hearings

    Today (June 29), the U.S. Drug Enforcement Administration administrative law judge opened formal hearings to determine whether cannabis should be moved from Schedule I to Schedule III under the Controlled Substances Act. The proceedings, scheduled to run through July 15 with a brief Independence Day recess, stem from President Donald Trump’s December 2025 executive order and will determine whether Schedule III status should be extended to all cannabis, building on an April 2026 interim order that reclassified only FDA-approved cannabis products and state-licensed medical marijuana. A final rule extending Schedule III to all cannabis would provide broad tax relief to state-licensed operators by exempting them from the Section 280E federal tax provision.

    The hearings have drawn criticism from cannabis reform advocates, who protested outside DEA headquarters after the agency limited participation to organizations and individuals opposed to rescheduling, arguing that supporters did not meet the legal definition of an “interested person.” Advocacy groups, including Students for Sensible Drug Policy and NORML, criticized the exclusion of medical experts, legal cannabis businesses, and reform organizations, while also objecting to the DEA’s decision not to livestream the proceedings. Although the agency said it will publish transcripts after the hearings conclude, critics argued that the lack of real-time public access undermines transparency.

  • Report Accuses Trump of Cashing in on FDA Changes

    Report Accuses Trump of Cashing in on FDA Changes

    A report by KFF Health News accuses President Donald Trump of expanding his personal investments in major tobacco companies and benefiting from substantial political donations from industry interests as his administration simultaneously pursued policies favorable to the tobacco and nicotine industry. The report alleges that Trump increased his holdings in several tobacco companies, including Philip Morris International and Altria Group, as his administration pushed the FDA for regulatory changes, drawing criticism from public health advocates and former regulators who argue the measures benefit tobacco companies at the expense of tobacco-control efforts.

    The report also highlights more than $20 million in contributions from tobacco and vaping interests to Trump-aligned political groups and inauguration activities since late 2023, including multimillion-dollar donations from industry players such as Reynolds American. While the White House rejected suggestions of improper influence and said its nicotine-related policies are based on scientific evidence supporting harm reduction for adult smokers, critics cited in the report contend that the administration’s actions represent one of the most industry-friendly tobacco policy shifts in recent years.

  • Trump Reclassifies/Downgrades Marijuana

    Trump Reclassifies/Downgrades Marijuana

    President Donald Trump signed an executive order today (December 18) directing the reclassification of marijuana as a less dangerous drug, marking a significant shift in U.S. federal drug policy. The move would downgrade cannabis from a Schedule I substance—alongside heroin and LSD—to Schedule III, a category that includes ketamine and some anabolic steroids. While the change would not legalize recreational marijuana nationwide, it could ease regulations, lower tax burdens on the cannabis industry, and expand opportunities for medical research.

    The order is expected to accelerate a review process already underway at the Drug Enforcement Administration, which typically involves extensive public consultation. A similar reclassification effort was proposed under former President Joe Biden, but Trump’s decision has drawn mixed reactions within his own party. Some Republicans strongly oppose any change, arguing marijuana remains harmful to public health and safety, while public opinion has shifted sharply in favor of legalization, with recent polling showing more than two-thirds of Americans support a less restrictive approach.

    Trump’s order also calls for expanded research into cannabis and increased access to CBD products. While the president has emphasized a tough stance on drugs such as fentanyl, he has framed marijuana policy as an area where federal rules should better reflect state-level changes. More than 20 states have legalized recreational marijuana or allow medical use, though federal law has continued to impose stricter limits and potential criminal penalties.

  • U.S. Tobacco Groups Urge Targeted Relief Amid Export Downturn

    U.S. Tobacco Groups Urge Targeted Relief Amid Export Downturn

    Fourteen U.S. agricultural and tobacco-sector organizations sent joint letters to President Donald Trump, Secretary Brooke Rollins, and Secretary Scott Bessent thanking the Administration for expressing willingness to support flue-cured tobacco farmers facing severe trade disruptions. The letters highlighted urgent challenges, including a 20–25% drop in exports, 15–20% decline in farm-gate prices, and shrinking demand from key markets like China. Rising input costs are also adding financial pressure as growers plan for 2026.

    “On May 29th, China wrote to the U.S. leaf merchants that it would not honor its purchase as much as 60 million pounds of flue-cured leaf in 2025. This exit resulted in adverse impacts on prices and values as the season progressed. The surplus created a soft demand that caused a market downturn of 27 cents per pound on average.”

    While the Administration recently announced the $12 billion Farm Bridge Assistance Program, tobacco is currently excluded. The coalition urged targeted relief, citing precedent from the first Trump Administration when tobacco was included in market facilitation programs. The groups emphasized the risk of lost family farms and the need for prompt inclusion of tobacco in relief measures.

    Tobacco Associates disseminated the letters to industry members and encouraged growers to contact local, state, and federal representatives to share personal experiences and the real impact of the downturn, stressing that these voices carry significant weight in shaping policy responses.

    The Honorable Donald J Trump_Tobacco TradeDownload
    Letter to USDA + Treasury – Tobacco TradeDownload

  • Ispire, IKE Tech Applaud FDA’s Illicit Vape Market Mandate

    Ispire, IKE Tech Applaud FDA’s Illicit Vape Market Mandate

    Ispire Technology Inc. and IKE Tech LLC issued statements welcoming the U.S. FDA’s newly funded mandate to crack down on the illicit vape market, following the passage of a continuing resolution signed by President Trump. The legislation directs the FDA to allocate at least $200 million toward electronic nicotine delivery system enforcement, including $2 million for a multi-agency task force with the DOJ and DHS to block illegal imports.

    IKE Tech President John Patterson called the strengthened enforcement a critical response to a market where “nine out of 10 vapes on shelves are illegal.” He said current border controls and tracking systems are failing, and highlighted the company’s development of blockchain-secured authentication tags and AI-driven age-verification tools to help regulators and manufacturers instantly verify product legitimacy.

    Ispire co-CEO Michael Wang said enforcement must be paired with proactive technology to protect consumers and level the playing field for compliant companies. He noted that Ispire and IKE Tech have submitted a blockchain-enabled age-verification System-on-a-Chip to the FDA as part of a PMTA, offering a potential framework for secure, verifiable, and interoperable compliance across the U.S. vape market.

  • Shutdown End Puts Hemp on the Clock

    Shutdown End Puts Hemp on the Clock

    This week, President Donald Trump signed a funding bill to end the government shutdown, but, according to Forbes and other industry experts, tucked inside the legislation is an amendment that has the potential to dismantle the country’s $28 billion hemp industry. The provision rewrites the federal definition of hemp, and, after a 12-month grace period, would effectively outlaw most hemp-derived THC products, including the booming market for THC beverages and edibles.

    Since the 2018 Farm Bill legalized hemp and its derivatives, hemp-derived intoxicating products have proliferated nationwide, sold online and in mainstream retailers without the restrictions placed on marijuana. The new amendment closes that loophole by banning synthetic cannabinoid conversion (such as CBD-to-THC processing) and capping THC content at 0.4 mg per package—far below the levels in virtually all current hemp products, many of which contain at least 5 mg and some up to 1,000 mg per package.

    “This is an extinction-level event for the CBD products industry, and the greater hemp and hemp beverage industry,” said Jim Higdon, cofounder of Louisville-based Cornbread Hemp. “If we can’t stop it, and we don’t pivot, it will destroy our business. Every product that we make currently will become a Schedule I narcotic when it is implemented.”

    Industry leaders, including beverage manufacturers and multistate cannabis operators, warn that the measure would wipe out companies built around hemp-derived THC and plan to lobby aggressively for revised regulations during the one-year window. The amendment has ignited political tension as well, with Senator Mitch McConnell—architect of the 2018 hemp legalization push—now leading efforts to curb intoxicating hemp products amid rising concerns about youth exposure.

    “Mitch McConnell, the man who gave us the seeds to grow hemp, now wants to burn the crop and salt the ground,” said Thomas Winstanley, the executive vice president of Georgia-based Edibles.com. “[We see] it as not one year to ban, it’s one year to regulate. We do not see this as the end. The clock started, but there’s still runway for better policy here. It was a tough battle to lose, but it’s not the end of the war.”

  • FDA to Allocate $200M Toward Combating Illicit Vapes

    FDA to Allocate $200M Toward Combating Illicit Vapes

    As part of the continuing resolution passed by Congress and signed yesterday (November 12) by US President Donald Trump to reopen the government, the Food and Drug Administration (FDA) will be required to allocate at least $200 million of its $712 million in user fees toward enforcing regulations on electronic nicotine delivery systems (ENDS). Of this amount, $2 million will support a multi-agency task force, including the Justice Department and Homeland Security, aimed at cracking down on illegal ENDS products imported from China and other countries.

    The FDA is also required to update its 2020 ENDS enforcement guidance within one year to include flavored disposable vapes and clarify the definition of disposable ENDS products. In addition, the law updates the Imports and Exports section of the Food, Drug, and Cosmetic Act to include tobacco products, strengthening the FDA’s authority to regulate their import alongside food, drugs, devices, and cosmetics.

    The agency must provide semi-annual reports to Congress on efforts to remove illegal ENDS products from the market, with the first report due within 180 days of enactment (November 12). The FDA is also expected to submit a report detailing its work to educate retailers on which products are legally allowed for sale.

  • Former CTP Director Says Tobacco Control Burden Shifts to States

    Former CTP Director Says Tobacco Control Burden Shifts to States

    Former director of the FDA’s Center for Tobacco Products Dr. Brian King, said the Trump administration’s reductions in federal funding, including millions of dollars previously allocated to tobacco control and prevention programs, have shifted the responsibility for such efforts to state and local governments. King, who is now the executive vice president of the Campaign for Tobacco-Free Kids, highlighted the implications during a keynote address at the Coalition for a Tobacco-Free Hawai‘i annual meeting, urging local leaders to document tobacco’s impacts and advocate for continued public health protections.

    King pointed to cuts affecting major agencies, including the CDC, NIH, and FDA, which traditionally provide funds for state-level tobacco control initiatives. Hawai‘i Public Radio said the CDC’s Office on Smoking and Health was eliminated, resulting in a loss of $70 million annually for tobacco control programs and $15.1 million for state quitlines. While the full impact of these federal cuts has yet to be felt, King warned that once programs lose funding entirely, many initiatives may face staffing reductions or elimination.

  • FDA Launches Pilot to Fast-Track Nicotine Pouch Reviews

    FDA Launches Pilot to Fast-Track Nicotine Pouch Reviews

    The U.S. Food and Drug Administration is set to fast-track reviews of nicotine pouches from Philip Morris International, Altria, Reynolds American, and Turning Point Brands in a pilot program launching Monday, according to Reuters. According to transcripts of an agency meeting last Friday, the agency aims to complete assessments by December, providing a quicker path to market for products like Zyn, on!, Velo, Fre, and Alp. The initiative comes amid pressure from the Trump administration to accelerate approvals and streamline the review process for the fastest-growing category of U.S. tobacco alternatives.

    The pilot program will reportedly feature reduced and expedited reviews, more frequent communication between FDA staff and companies, and a focus on essential scientific and safety data, including product characterization, manufacturing consistency, and abuse-liability information. For products already on the market without full authorization, the process could remove uncertainty over legality and potential enforcement actions. Tobacco firms have long lobbied for a faster FDA authorization route, noting that lengthy reviews have allowed competitors to capture market share in the meantime.

    “Adult nicotine and tobacco consumers are increasingly seeking nicotine pouches as a smoke-free alternative, and the industry is rapidly growing in response,” said Laura Leigh Oyler, vice president of U.S. Regulatory Affairs at Haypp Group, who will be speaking at GTNF 2025 in Brussels on the U.S. regulatory landscape. “These consumers deserve a marketplace of FDA-reviewed product choices to support their journey away from more harmful products. 

    “It makes sense that our government should also work to meet the demands of citizens, supporting a regulatory regime that quickly reviews well-designed and well-tested products from responsible and compliant manufacturers. This is a positive step not just for the regulator and the regulated industry, but for the millions of American adults looking for products they can trust.”