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PRESS RELEASE: New GAO Report Confirms Systemic Challenges with FDA’s Premarket Tobacco Review Framework
WASHINGTON, D.C. – A new U.S. Government Accountability Office (GAO) Report highlighted the challenges at the U.S. Food and Drug Administration (FDA) regarding the premarket tobacco and nicotine product application review framework. The report underscored significant performance issues at the agency and the need for greater accountability, while also acknowledging FDA’s more recent strides to improve its regulatory performance. FDA’s failure to authorize smoke-free products
2 days ago2 min read


PRESS RELEASE: Regulate Smarter Applauds FDA Reevaluation of PMTA Framework
Chairman Burr: The choice before the Agency is clear: accelerate authorization of legal, smoke-free alternatives so adult consumers can find what they want in the regulated marketplace or continue with a status quo that is fueling a massive illicit market WASHINGTON, D.C. – Today, Richard Burr, chairman of the Coalition for Smarter Regulation of Nicotine (Regulate Smarter) and former U.S. Senator, issued the following statement after the U.S. Food and Drug Administration (F
Sep 302 min read


PRESS RELEASE: Regulate Smarter Statement On Trump-Xi Meeting
Coalition praises Trump Administration on enforcement gains, urges continued action to curb illicit market coming from China WASHINGTON, D.C. – The Coalition for Smarter Regulation of Nicotine (Regulate Smarter) today issued the following statement on President Donald Trump’s meeting with Chinese leader Xi Jinping: "As President Trump sits down with Xi Jinping, the flood of illicit Chinese nicotine products remains a clear threat to American consumer safety and national s
Sep 241 min read


Regulate Smarter Concludes “Smarter Regulation Now” Video Series
As Regulate Smarter continues its work supporting the modernization of the U.S. Food and Drug Administration (FDA) approach to smoke-free nicotine products, the Coalition is releasing the final installment in its multi-part video series, “Smarter Regulation Now.” Watch the video here. Featuring insights from voices across the law enforcement community and Coalition Chairman Richard Burr, this episode underscores the scope of the illicit nicotine product market and the consequ
Sep 213 min read


Chairman Burr Featured In “Smarter Regulation Now” Series
As Regulate Smarter ramps up its fall advocacy push for modernizing U.S. Food and Drug Administration (FDA) approach to smokefree nicotine products, the Coalition is releasing the latest installment in its multi-part video series, “Smarter Regulation Now.” Watch the video here. Featuring a direct to camera testimonial from Coalition Chairman Richard Burr, this episode takes viewers back in time to 2009 when Congress passed the bipartisan Tobacco Control Act. The legislati
Sep 92 min read


Ripped From The Headlines: “Vapes Help More People Quit Smoking Than Other Methods”
The closing weeks of summer have brought encouraging news on multiple fronts in the pursuit of smarter regulation of nicotine products. Not only has the U.S. Food and Drug Administration (FDA) authorized additional smoke-free products for adult consumers, but the news has been dominated by headlines from a Cochrane study showing nicotine e-cigarettes as more effective at helping adults quit smoking than other FDA-approved nicotine replacement therapies. Cochrane: “Vapes hel
Aug 311 min read


Tom Lesnak: Illicit Nicotine Market Is an International Money Laundering Issue
The latest installment of Regulate Smarter’s multi-part video series, “Smarter Regulation Now” features Tom Lesnak, a former special agent with the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) with deep expertise infiltrating black-market smuggling rings, outlining the links between the illicit nicotine market and sophisticated criminal networks. Watch the video here. Lesnak warns that the scale of the illicit market cannot be understated: billions of dollars in
Aug 252 min read


Regulate Smarter Continues “Smarter Regulation Now” Series with former ATF Assistant Director Rich Marianos
As Regulate Smarter continues its work to help the U.S. Food and Drug Administration (FDA) modernize its approach to nicotine products, the Coalition is releasing the fourth installment in its multi-part video series, “Smarter Regulation Now.” Featuring behind-the-scenes testimonials from expert panelists at a recent Coalition-sponsored event in Washington, D.C., the latest episode highlights remarks from Rich Marianos, a retired Assistant Director of the U.S. Bureau of Alcoh
Aug 141 min read


PRESS RELEASE: As Youth Vaping Hits Historic Lows, PROTECT Act Misses the Real Problem
Progress against underage vaping depends on eliminating the illicit market, not recycling failed prohibitionist approaches of the past WASHINGTON, D.C. – The Coalition for Smarter Regulation of Nicotine (Regulate Smarter) today issued the following statement on the Preventing Opportunities for Teen E-Cigarette and Tobacco Addiction (PROTECT) Act introduced by U.S. Senator Richard Blumenthal (D-CT) and U.S. Representative Debbie Wasserman Schultz (D-FL): “Underage vaping h
Aug 122 min read


Regulate Smarter Continues “Smarter Regulation Now” Video Series with Rana Saoud
Regulate Smarter is continuing its “Smarter Regulation Now” video series with Rana Saoud, an expert on illicit trade and intellectual property protection who spent nearly 30 years with Homeland Security Investigations (HSI), the principal investigative arm of U.S. Immigration and Customs Enforcement (ICE). Watch the third installment here. During her career at HSI, Saoud held several leadership roles focused on global trade investigations, counterfeit goods, and transnati
Aug 72 min read


PRESS RELEASE: ICYMI: JAMA Urges Integration Of FDA-Authorized E-Cigarettes into Patient-Centered Conversations About Smoking Cessation
Regulate Smarter: “Leading public health authorities agree that it’s time to include e-cigarettes in patient-centered conversations regarding cessation that can help adult smokers leave cigarettes behind. It’s time for FDA to catch up.” WASHINGTON, D.C. – A groundbreaking analysis published in JAMA, one of the nation’s most well-respected medical publications, calls for the integration of U.S. Food and Drug Administration (FDA)-authorized e-cigarettes into patient-centered
Aug 62 min read


Regulate Smarter Continues “Smarter Regulation Now” Series with former DEA Agent Aaron Graham
As Regulate Smarter continues its work to modernize the U.S. Food and Drug Administration (FDA) approach to nicotine products, the Coalition is releasing the latest installment in its multi-part video series, “Smarter Regulation Now.” Featuring behind-the-scenes testimonials from expert panelists at a recent Coalition-sponsored event in Washington, D.C., the latest episode highlights remarks from Aaron Graham, a retired Special Agent with the U.S. Drug Enforcement Administrat
Jul 302 min read


Regulate Smarter Launches New Video Series: “Smarter Regulation Now”
As Regulate Smarter continues our important work seeking to modernize the U.S. Food and Drug Administration (FDA) approach to nicotine products, the Coalition is launching a multi-part video series called “Smarter Regulation Now.” Featuring behind-the-scenes testimonials from expert panelists at a recent Coalition-sponsored event in Washington, D.C., the first installment features Jon Adler, President of the Federal Law Enforcement Officers Association Foundation. Watch the v
Jul 202 min read


PRESS RELEASE: Regulate Smarter Hails Historic Lows Of Youth Tobacco Use
FDA’s 2025 National Youth Tobacco Survey Finds Continued Declines in E-Cigarette and Overall Tobacco Use, Underscoring Progress in Reducing Underage Tobacco Use WASHINGTON, D.C. – The Coalition for Smarter Regulation of Nicotine (Regulate Smarter) today welcomed the latest findings shared by the U.S. Food and Drug Administration (FDA) from the 2025 National Youth Tobacco Survey (NYTS) confirming that youth tobacco use has reached historic lows. Notable findings from the 2
Jun 252 min read


ICYMI: “Trump FDA’s Chance To Crack Down On Chinese Black Market Harming Our Children”
In new op-ed for the Washington Examiner, Regulate Smarter Chairman Richard Burr praises recent FDA action to prioritize enforcement of illicit Chinese vapes flooding the U.S. market and targeting kids WASHINGTON, D.C. – In a new op-ed for the Washington Examiner, Richard Burr, chairman of the Coalition for Smarter Regulation of Nicotine (Regulate Smarter) and former U.S. Senator, praised the increased enforcement actions taken by the Trump Administration against the illicit
Jun 92 min read


PRESS RELEASE: Regulate Smarter Commends Trump Administration’s “Operation Red Mist”
Massive federal crackdown on illicit vapes — especially Chinese products targeting kids — hailed as critical step for protecting consumers and combatting the illicit nicotine product crisis WASHINGTON, D.C. –Today, Richard Burr, chairman of the Coalition for Smarter Regulation of Nicotine (Regulate Smarter) and former U.S. Senator, praised U.S. Customs and Border Protection’s (CBP) seizure of more than 18 million units of illicit electronic nicotine delivery systems (ENDS)
May 181 min read


PRESS RELEASE: Regulate Smarter Urges FDA to Embrace Fundamental Reforms, Outlines Three-Pronged Plan
Coalition files formal comments in response to March 2026 “Draft Guidance for Industry: Flavored Electronic Nicotine Delivery Systems (ENDS) Premarket Applications – Considerations Related to Youth Risk” WASHINGTON, D.C. – In response to the U.S. Food and Drug Administration’s (FDA) March 2026 Draft Guidance addressing how it reviews flavored e-cigarettes (ENDS) for authorization, the Coalition for Smarter Regulation of Nicotine (Regulate Smarter) filed comments urging FDA to
May 132 min read
Decline Of Youth Vaping Signals a New Era, Exposes Outdated Arguments Of Opponents
Data from the latest National Youth Tobacco Survey (NYTS) delivers unequivocal good news: youth e-cigarette use continues its sharp decline. Not only is youth cigarette smoking at a historically low 1.4%, but also youth vaping at its lowest level in a decade, a reduction of 74% from its peak around 2019. Yet arguments from opponents of reduced harm strategies remain stubbornly stuck in the past. They are fixated on blanket opposition, ignoring the new data in favor of their o
May 122 min read


PRESS RELEASE: Regulate Smarter Praises FDA Authorization of New ENDS Product, Urges Further Action
FDA must advance reforms to its review process and harness the potential of innovation and technology of lower-risk smoke-free products for adult consumers while continuing to enforce against the illicit market WASHINGTON, D.C. – Today, former U.S. Senator Richard Burr (R-NC), chairman of the Coalition for Smarter Regulation of Nicotine (Regulate Smarter), issued the following statement after the U.S. Food and Drug Administration (FDA) authorized four flavored electronic ni
May 72 min read


Regulate Smarter Praises Cotton’s ENDS Chinese Vapes Act
Regulate Smarter commends U.S. Senator Tom Cotton (R-AR) for introducing the Eliminating Nefarious Distribution of Smuggled Chinese Vapes Act, or the ENDS Chinese Vapes Act. This legislation takes direct aim at the flood of unauthorized, illicit vapes pouring into the United States from Communist China, evading U.S. Food and Drug Administration (FDA) oversight and overwhelming communities with products that pose serious risks to public health—especially to underage users draw
Apr 282 min read
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