{"id":8756,"date":"2026-05-22T16:32:27","date_gmt":"2026-05-22T16:32:27","guid":{"rendered":"https:\/\/siliconvalleymovingpost.com\/?p=8756"},"modified":"2026-05-22T16:32:27","modified_gmt":"2026-05-22T16:32:27","slug":"fda-staff-blindsided-by-move-allowing-more-e-cigarettes-and-nicotine-pouches-onto-us-market","status":"publish","type":"post","link":"https:\/\/siliconvalleymovingpost.com\/?p=8756","title":{"rendered":"FDA staff blindsided by move allowing more e-cigarettes and nicotine pouches onto US market"},"content":{"rendered":"
\n

By MATTHEW PERRONE,\u00a0AP Health Writer<\/strong><\/p>\n

WASHINGTON (AP) \u2014 Senior officials in the Food and Drug Administration\u2019s tobacco center were blindsided by a recent decision that opens the door to allowing more unauthorized electronic cigarettes and nicotine pouches onto the U.S. market, The Associated Press has learned.<\/p>\n

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The guidelines, posted online earlier this month before former FDA Commissioner Marty Makary resigned, will allow companies to launch certain nicotine-based products before they\u2019ve been fully vetted by regulators.<\/p>\n

Some FDA officials tasked with enforcing vaping regulations were not consulted on the changes and only learned of them the night before the document was published, according to two staffers who spoke to the AP on condition of anonymity to discuss confidential agency matters. The document\u2019s sudden appearance sparked internal confusion about how the policy came about and who authorized it, the staffers said.<\/p>\n

In recent days, agency officials have convened hourslong meetings grappling with how to implement the six-page memo, which breaks with longstanding FDA policy requiring scientific verification of health benefits for smokers before any new products are introduced.<\/p>\n

It\u2019s highly unusual for the FDA to draft new policies without input from the staffers who oversee them.<\/p>\n

\u201cIt begs the question of whether the true subject matter experts may have actually opposed this policy and were ordered to do it anyway,\u201d said Mitch Zeller, who retired as FDA\u2019s tobacco director in 2022. \u201cAnd that goes to the ability of the public to have trust and faith in institutions like FDA.\u201d<\/p>\n

The vaping guidelines bypassed a federally required period that allows for public comment and revisions. Instead, the FDA published the finalized policy after months of complaints about Makary from industry lobbyists close to the White House. He resigned from the agency last week.<\/p>\n

\n<\/div>\n

A Health and Human Services spokesperson did not address the origins of the guidance in a written statement.<\/p>\n

\u201cThis approach strengthens protections against youth nicotine addiction while supporting evidence-based alternatives for adult smokers seeking to move away from combustible tobacco products,\u201d Andrew Nixon said in a statement.<\/p>\n

Messages seeking comment from Makary were not immediately returned Friday.<\/p>\n

FDA eyes new approach to vaping flavors<\/h4>\n

Most health researchers agree that e-cigarettes are significantly less harmful than traditional cigarettes, and the products have been promoted in the U.K. and other European countries as an alternative for smokers.<\/p>\n

\n<\/div>\n

In the U.S., the FDA has struggled to police the market for over a decade. The agency has authorized vaping products from five companies while rejecting millions of other applications, mainly due to the presence of fruit, candy and other sweet flavors that were deemed appealing to kids. And yet, unauthorized vapes are widely available.<\/p>\n

But recent changes in Washington and across the U.S. reflect a shifting landscape.<\/p>\n

Underage vaping among U.S. teenagers has fallen to its lowest level in more than 10 years, following the disruptions of the pandemic and new state and federal restrictions.<\/p>\n

President Donald Trump came to power last year after vowing to \u201csave\u201d the vaping industry. Major tobacco companies, such as Reynolds American and Altria, have contributed millions to political action committees supporting Trump and other administration priorities, including Trump\u2019s inauguration and his proposed White House ballroom.<\/p>\n

Despite the influence campaign, vaping issues took a backseat at FDA under Makary. On rare occasions when Makary addressed e-cigarettes, he voiced skepticism about the data showing declining underage use.<\/p>\n

Even as FDA staffers were poised to shift course on flavors, Makary and other agency leaders intervened.<\/p>\n

In February, one of Makary\u2019s deputies blocked an FDA decision that would have authorized the first fruit-flavored vapes, according to internal memos later released by the agency. FDA reviewers had determined the products were unlikely to be used by children when combined with digital age-verification technology.<\/p>\n

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The mango- and blueberry-flavored products were finally OK\u2019d during Makary\u2019s last full week heading the FDA, just days before the agency posted the new guidelines allowing unauthorized nicotine products.<\/p>\n

Under the guidance, the FDA is supposed to publish a list of e-cigarettes and pouches that are not yet authorized but will be subject to \u201cenforcement discretion,\u201d meaning they can be sold without regulators targeting them for removal. While there is no public list of products that might qualify, the policy is expected to allow for new flavors that had previously been blocked by regulators.<\/p>\n

\u201cWhat we\u2019re seeing is a broader opening up and responsiveness to flavored products by the agency both in terms of a stronger appetite for authorization but also less appetite to take enforcement action against flavored products,\u201d said Brian King, former FDA tobacco director now with the Campaign for Tobacco-Free Kids.<\/p>\n

US stores are already packed with illegal flavored vapes<\/h4>\n

While FDA\u2019s new approach breaks with precedent, it may have little impact on the flavors already available at gas stations, vape shops and convenience stores.<\/p>\n

The U.S. market has been flooded for years by unauthorized vapes containing mango, gummy bear, strawberry and dozens of other flavors.<\/p>\n

These disposable e-cigarettes filled the vacuum left by Juul when it pulled its high-nicotine flavored products from the market, after they became ubiquitous in U.S. schools beginning around 2017. Currently the company only sells FDA-authorized e-cigarettes in tobacco and menthol flavors.<\/p>\n

Juul and other companies now see the chance to directly compete with disposable Chinese vapes, which by some estimates account for 80% of U.S. sales.<\/p>\n

\u201cThe choice we face is not whether flavored vaping products should be sold in the U.S. They already are,\u201d said Robyn Gougelet, a Juul vice president. \u201cThe choice is whether those products should be regulated and responsibly marketed \u2014 or illegal, untested, and smuggled into the country.\u201d<\/p>\n

Rather than targeting flavors, the FDA said its new enforcement approach will target vapes with specific youth-appealing features, such as designs that resemble children\u2019s toys.<\/p>\n

\u201cThe reality is they\u2019re just deluged by illegal products coming across the border,\u201d said Jonathan Foulds, a tobacco-addiction specialist at Penn State University. \u201cSo they\u2019re making it clear what should be common sense: \u2018We\u2019re going to focus on the worst actors.\u2019\u201d<\/p>\n

New policy may create winners and losers among vaping firms<\/h4>\n

It\u2019s far from clear whether FDA\u2019s new approach will be embraced by the vaping industry at large, which includes multinational tobacco companies alongside hundreds of smaller companies selling imported devices from China.<\/p>\n

As written, the guidance suggests only e-cigarettes that are under \u201cscientific review\u201d will qualify to launch without FDA authorization. Only a small number of applications typically reach that stage, which requires detailed health data on smokers who switch to the new product, King noted.<\/p>\n

\u201cThis is certainly going to benefit the larger tobacco companies, which have the resources to get far enough into the application review process and thus won\u2019t be prioritized for enforcement,\u201d King said.<\/p>\n

Lobbyists for smaller companies say it\u2019s too early to tell whether the policy will be help or hinder their clients, but they fear being left behind.<\/p>\n

\u201cThe big companies would love nothing more than to see their largest swath of competitors out of the marketplace,\u201d said Tony Abboud of the Vapor Technology Association.<\/p>\n

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute\u2019s Science and Educational Media Group and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.<\/em><\/p>\n

Read more Ukrainian protesters in Kyiv urge veto of a bill families fear could declare missing soldiers dead<\/a><\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"

The Associated Press has learned that officials at the Food and Drug Administration were blindsided by a recent policy change allowing more electronic cigarettes and nicotine pouches to hit the U.S. market.<\/p>\n","protected":false},"author":1,"featured_media":8755,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[36,2],"tags":[],"class_list":["post-8756","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-based-on-facts-either-observed-and-verified-directly-by-the-reporter-or-reported-and-verified-from-knowledgeable-sources","category-news"],"yoast_head":"\nFDA staff blindsided by move allowing more e-cigarettes and nicotine pouches onto US market - Silicon Valley Moving Post<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/siliconvalleymovingpost.com\/?p=8756\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FDA staff blindsided by move allowing more e-cigarettes and nicotine pouches onto US market - 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