Big Tobacco Comes Out on Top After FDA Shake-Up
The new guidance could let companies sell certain nicotine products before full review, a break from long-standing FDA policy.
- Senior FDA officials were blindsided earlier this month when the agency published new guidance allowing unauthorized electronic cigarettes and nicotine pouches onto the U.S. market, bypassing the federally required public comment period and posting days before former Commissioner Dr. Marty Makary resigned.
- President Donald Trump came to power last year after vowing to 'save' the vaping industry, with major tobacco companies including Reynolds American and Altria contributing millions to his political priorities. Makary resigned last week following months of complaints from industry lobbyists close to the White House.
- The six-page memo breaks with longstanding FDA policy requiring scientific verification of health benefits before new products launch. Former FDA tobacco director Mitch Zeller, who retired in 2022, stated "that goes to the ability of the public to have trust and faith in institutions like FDA."
- Under the new guidance, the FDA will publish a list of unauthorized e-cigarettes and pouches subject to "enforcement discretion," allowing sales without regulators targeting removal. Juul vice president Robyn Gougelet argued "the choice is whether those products should be regulated and responsibly marketed-- or illegal, untested, and smuggled into the country."
- The guidance disproportionately benefits larger tobacco companies with resources to complete scientific review, while smaller competitors fear exclusion. Tony Abboud of the Vapor Technology Association warned "the big companies would love nothing more than to see their largest swath of competitors out of the marketplace." Juul and others now see opportunity to compete with disposable Chinese vapes accounting for an estimated 80% of U.S. sales.
36 Articles
36 Articles
The FDA's about-face on flavored vapes will prove deadly for kids
The decline in youth smoking is one of the great public-health achievements of the 21st century, celebrated by conservatives and liberals alike, yet the White House is now in the process of endangering it. Unless it reverses course, millions of American children will suffer the consequences. Tobacco-related death and disease do not discriminate by party. Everyone knows someone who has been affected by the ravages of tobacco use, but thanks to sm…
Omaha World-Herald
Big Tobacco comes out on top after FDA shake-up
The FDA's new, looser regulation of new vapes and nicotine pouches will potentially unleash hundreds more such products on the market, according to current and former officials.
FDA Staff Blindsided by Move Allowing More E-Cigs, Nicotine Pouches Onto Market
(MedPage Today) -- Senior officials in the FDA's 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...
More Minnesota communities consider banning fruity vapes as Trump’s FDA loosens restrictions
Over a quarter of Minnesotans live in cities or counties that have restricted the sale of some flavored tobacco and nicotine products. Communities are taking action, arguing cotton candy, mango and other sweet flavored vapes are targeting kids. Despite this push at the local level, the FDA announced this month that it will allow a vape company to sell new fruit-flavored e-cigarettes.
What did FDA’s rule change allow?
FDA staff flagged issues as more nicotine products enter the market A reported FDA staffing concern centers on a move that enabled additional e cigarettes and nicotine pouches onto the U.S. market . The piece frames the decision as having left FDA staff “blindsided,” suggesting internal processes…
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