The Trump administration on Monday proposed creating a new federal agency to regulate tobacco products while removing that authority from the Food and Drug Administration (FDA.)
The White House’s budget request for the upcoming fiscal year proposes making the Center for Tobacco Products independent of the FDA, with a director to be confirmed by the Senate.
The White House’s 2020-21 budget recommendations include shifting the FDA’s Center for Tobacco Products into a separate agency with its own director within the U.S. Department of Health and Human Services.
The proposal says that “a new agency with the singular mission on tobacco and its impact on public health would have a greater capacity to respond strategically to the growing complexity of new tobacco products.”
“In addition, this reorganization would allow the FDA Commissioner to focus on its traditional mission of ensuring the safety of the Nation’s food and medical products supply,” it continues.
The FDA regulates tobacco products, including cigarettes and e-cigarettes, as well as prescription and over-the-counter drugs, food, dietary supplements, vaccines, medical devices and more.
The new agency would still be under the purview of the Department of Health and Human Services. The president’s budget request is just a proposal and is unlikely to pass Congress in its current form. The idea of removing tobacco regulation authority, which was granted to the FDA in a 2009 law passed by Congress, from the agency does not have broad support among lawmakers.
Joe Grogan, head of the White House Domestic Policy Council, lamented last November to reporters that tobacco regulation was a “huge waste of time” for the FDA.
“Tobacco has no redeeming qualities and it should not be regulated by a health agency like this … (It is a) huge distraction.”Joe Grogan said last year.
Former FDA Commissioner Scott Gottlieb pushed back at the time, tweeting that tobacco regulation is one of the agency’s “most important public health missions.”
The FDA has cracked down on the e-cigarette and tobacco industry in the past year, banning the sale of flavored products it argues are fueling a youth vaping “epidemic.” But anti-tobacco advocates argued the Trump administration did not go far enough, leaving thousands of products on the market that could appeal to kids, including single-use, disposable e-cigarettes.
Free-market groups and conservatives have also been critical of the FDA’s actions, arguing that banning flavors is harmful to adults who use e-cigarettes to switch from traditional cigarettes.
Tobacco Control Act
The FDA was handed oversight of the industry by Congress in June 2009 — early in the Obama administration — through the Tobacco Control Act.
The risk with an FDA “seal of approval” for electronic and heat-not-burn cigarettes and snus is that it would be perceived that the tobacco products are appropriate to consume, rather than being less harmful than traditional-cigarette products that contribute annually to more than 400,000 premature deaths in the U.S. alone.
The FDA was given the authority to: remove ingredients considered as hazardous; restrict the marketing and distribution of cigarettes and smokeless tobacco; focus on limiting the impact of advertising on youth; expand warning labels, and stop the use of such characterizations as “light” or “low tar.”
Until the past six months, the FDA had been accused by public-health advocates of dragging its feet in creating and enforcing heightened regulations.
In September, President Donald Trump pushed for significantly tighter FDA regulations over tobacco, though within weeks he softened his appeal after getting feedback from vapers and small business owners.
Donald Trump Takes Office
When Trump was elected president in November 2016, an era of federal deregulation was projected for many industry sectors, particularly tobacco.
The FDA was projected to shift into a lower gear, if not halt, its slow-walk of asserting its regulatory authority.
Instead, the FDA accomplished in the past two months two once-improbable goals sought by public-health and anti-tobacco advocacy groups:
- Congress and Trump approved raising the federal minimum age for buying and consuming tobacco products from 18 to 21, effective Dec. 20.
- The FDA established a ban — potentially temporarily — on flavored closed/cartridge electronic-cigarette products outside menthol and tobacco that went into effect Feb. 6.
The FDA also determined that makers of nicotine liquids are manufacturers, and thus required to submit a premarket application by a federal court-mandated May 12 deadline in order to be included in a 12-month FDA review process.
The premarket standard requires the FDA to consider products’ existing risks and benefits to the population as a whole, including users and non-users, particularly as it compares with traditional cigarettes.
If e-liquid manufacturers don’t apply, their products would be deemed as illegal to sell. However, being in the process allows their product to stay in the marketplace for up to a year during the review process.
The nicotine liquids for use with open-pod e-cigarettes will remain available for now in tobacco and vape shops — in large part because FDA and other Trump administration officials believe those products lack appeal to individuals under age 21, and that those shops are more responsible at age-verification policies than other retail outlets.
Gregory Conley, president of American Vaping Association, had warned small vape shops dependent on large nicotine-liquid makers could begin closing in mid-May from lack of product from legal sources.
The FDA has estimated the review cost at about $500,000 per application, while analysts, industry officials, and advocates have said for years it could cost millions of dollars for each product to go through the pre-market regulatory pipeline.
However, Azar has since said that the FDA does not plan to close vape shops and small vaping companies and that it will “streamline approval” for those groups.
The Campaign for Tobacco-Free Kids criticized the proposal, calling it “the wrong idea at the wrong time.”
“By disrupting the current structure for regulating tobacco products, this proposal is a recipe for delay and distraction at precisely the time when the FDA must take decisive action to remove the many flavored e-cigarette products that are still on the market and when the FDA is about to begin its first-ever review of e-cigarettes.”Matthew Myers, the campaign’s president.
Public health groups have pushed the administration to immediately remove all flavored e-cigarette products from the market.
Any e-cigarette company that wants to sell their products in the U.S. after May must receive approval from the FDA and prove their products benefit public health.
According to a government survey, the percentage of teenagers who are vaping has doubled in the past two years, with 25 percent of high school seniors saying they had vaped in the past month.
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