FDA’s tobacco unit pledges reset after criticism

Feb 24, 2023, 11:19 AM | Updated: Feb 26, 2023, 11:21 pm
FILE - In this April 23, 2014 file photo, a man smokes an electronic cigarette in Chicago.  Food an...

FILE - In this April 23, 2014 file photo, a man smokes an electronic cigarette in Chicago. Food and Drug Administration officials on Friday, Feb. 24, 2023 pledged a reset in the agency’s tobacco program, responding to criticisms that a lack of direction has hampered federal efforts to regulate cigarettes, vaping devices and other industry products.(AP Photo/Nam Y. Huh, File)

(AP Photo/Nam Y. Huh, File)

WASHINGTON (AP) — Food and Drug Administration officials on Friday pledged a reset in the agency’s tobacco program, responding to criticisms that a lack of direction has hampered efforts to regulate cigarettes, vaping devices and related products.

The head of the agency’s tobacco center promised to deliver a five-year strategic plan by year’s end outlining priorities, including efforts to clean up a sprawling market of largely unauthorized electronic cigarettes. The agency also said it would provide more transparency to companies about its decisions, following the rejection of more than 1 million applications from e-cigarette makers seeking to market their products as alternatives for adult smokers.

The announcement comes as the tobacco center is besieged by criticism from all sides — including lawmakers, anti-smoking advocates and tobacco companies.

FDA chief Dr. Robert Califf commissioned separate, external reviews of the agency’s tobacco and food programs last summer, amid controversies in both units.

The blistering report on the tobacco program, issued in December, described the FDA as “reactive and overwhelmed,” with a demoralized workforce that struggles to oversee both traditional tobacco products and a freewheeling e-cigarette market.

The report mainly channeled long-standing grievances from groups on opposing sides of the tobacco issue. Public health groups want the FDA to more aggressively police regular cigarettes and flavored e-cigarettes that appeal to teenagers. Tobacco companies complain that the FDA is unwilling to approve new alternative products — including e-cigarettes — that might help adults quit smoking.

FDA’s tobacco chief, Brian King, said Friday that regulators are looking at ways to “better communicate” with companies about how the FDA makes decisions. The agency is also working to streamline the review process, when possible.

“Some things will take longer than others, but we’re committed to getting everything done that we’ve outlined as expeditiously as possible,” King said in an interview.

Vaping industry representatives said they were unimpressed by the FDA update, which they said would continue to result in denials for most vaping products.

“While the devil is in the details, nothing in today’s announcement hinted at any material shift in FDA’s perpetual attack on every nicotine-containing product,” said Tony Abboud of the Vapor Technology Association, in an emailed statement.

The FDA has OK’d a handful of tobacco-flavored e-cigarettes from several large companies. But many industry players are pushing for approval of menthol and other flavors.

Responding to a recommendation in the December report, King said the FDA would convene a meeting with the Department of Justice on its efforts to crack down on unauthorized e-cigarettes, particularly fruit- and candy-flavored products that are popular among teens.

The FDA has sent hundreds of warning letters to vape shops and e-cigarette manufacturers in recent years, calling on them to remove products. But the letters are sometimes ignored. King pointed out that the FDA relies on the Justice Department to make decisions about when to bring lawsuits against bad actors.

In recent months, the FDA and the Justice Department have announced the first lawsuits and fines targeting vape shops and manufacturers selling unauthorized products.

“Those are the first of their kind and I hope they’re a wake-up call to industry that if you are violating the law we are going to use the full portfolio of our enforcement activities to ensure that you comply,” King said.

The FDA’s tobacco center was created by Congress in 2009 and granted sweeping powers to remake the industry, including banning harmful ingredients from traditional products and authorizing new, less-harmful alternatives.

But FDA has been stalled by “near constant” litigation, the December report noted.

Tobacco industry lawsuits have repeatedly blocked FDA actions designed to help smokers quit, including adding graphic warnings to cigarette packs.

“Unfortunately, the tobacco industry has fought the agency on many of the science-based actions we’ve taken, putting profits over public health,” King said.

Meanwhile, lawsuits brought by anti-tobacco groups forced the FDA to speed up its timeline for reviewing more than a million e-cigarette applications from four years to 10 months. The agency has repeatedly pushed back its deadline for completing its review, prompting criticism from parent groups and members of Congress. The agency now says it will take until 2024 to review the remaining products.

King said the FDA will look at whether changes to the law are needed to help the agency accomplish its work.

Among other steps, the FDA has repeatedly asked Congress to collect user fees from e-cigarette makers to help hire more staff and fund product reviews. So far, Congress has not granted that request.


The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

Copyright © The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.


(Facebook Photo/Superior Court of Arizona in Yavapai County)...
Associated Press

Arizona judge has cases reassigned following DUI arrest

The Arizona Supreme Court has ruled that all cases currently assigned to a Yavapai County Superior Court judge recently arrested on suspicion of extreme DUI will be reassigned to other judges.
3 days ago
Haitian migrant Gerson Solay, 28, carries his daughter, Bianca, as he and his family cross into Can...
Associated Press

US, Canada to end loophole that allows asylum-seekers to move between countries

President Joe Biden and Canadian Prime Minister Justin Trudeau on Friday announced a plan to close a loophole to an immigration agreement.
6 days ago
Expert skateboarder Di'Orr Greenwood, an artist born and raised in the Navajo Nation in Arizona and...
Associated Press

Indigenous skateboard art featured on new stamps unveiled at Phoenix skate park

The Postal Service unveiled the “Art of the Skateboard" stamps at a Phoenix skate park, featuring designs from Indigenous artists.
6 days ago
(Facebook Photo/City of San Luis, Arizona)...
Associated Press

San Luis authorities receive complaints about 911 calls going across border

Authorities in San Luis say they are receiving more complaints about 911 calls mistakenly going across the border.
12 days ago
(Pexels Photo)...
Associated Press

Daylight saving time begins in most of US this weekend

No time change is observed in Hawaii, most of Arizona, Puerto Rico, the U.S. Virgin Islands, American Samoa, Guam and the Northern Marianas.
20 days ago
Mexican army soldiers prepare a search mission for four U.S. citizens kidnapped by gunmen in Matamo...
Associated Press

How the 4 abducted Americans in Mexico were located

The anonymous tip that led Mexican authorities to a remote shack where four abducted Americans were held described armed men and blindfolds.
20 days ago

Sponsored Articles

(Photo: OCD & Anxiety Treatment Center)...

Here’s what you need to know about OCD and where to find help

It's fair to say that most people know what obsessive-compulsive spectrum disorders generally are, but there's a lot more information than meets the eye about a mental health diagnosis that affects about one in every 100 adults in the United States.
(Desert Institute for Spine Care in Arizona Photo)...
Desert Institute for Spine Care in Arizona

5 common causes for chronic neck pain

Neck pain can debilitate one’s daily routine, yet 80% of people experience it in their lives and 20%-50% deal with it annually.
(Photo via MLB's Arizona Fall League / Twitter)...
Arizona Fall League

Top prospects to watch at this year’s Arizona Fall League

One of the most exciting elements of the MLB offseason is the Arizona Fall League, which began its 30th season Monday.
FDA’s tobacco unit pledges reset after criticism