FDA takes small step in tobacco product backlog

  • Associated Press
  • Tuesday, June 25, 2013 1:37pm
  • Business

RICHMOND, Va. — The Food and Drug Administration is taking a small step to whittle away a backlog of 4,000 tobacco product applications, some of which have lingered for more than two years.

The federal agency said Tuesday it has authorized two non-menthol versions of Lorillard Inc.’s flagship Newport brand under a 2009 law that gave the FDA authority over tobacco.

It also said it has rejected four applications submitted to the agency for review, but did not disclose the products.

In addition to regulating a number of aspects of tobacco marketing and manufacturing, the FDA’s Center for Tobacco Products also must review new cigarette or smokeless tobacco products.

An Associated Press review in December found that the agency hadn’t ruled on thousands of those applications for more than a year despite the 90-day review process the industry expected.

While only two products have been authorized to be marketed, the vast majority of those awaiting review are for products already being sold in the U.S.

A grandfather clause in the law allows products introduced between February 2007 and March 2011 that are similar to those previously on the market to be sold while under review. They can be removed from store shelves if they don’t pass muster with the agency. But about 500 products submitted for review since March 2011 are being kept off the market.

According to data obtained by the AP under a Freedom of Information Act request, about 90 percent of the applications submitted to the FDA have been with the agency for more than a year.

The FDA had said the review process was taking so long because the applications from manufacturers lacked the information the agency deemed necessary to complete its analysis.

On Tuesday, Mitch Zeller, the center’s director, said the FDA recognizes the review process “has taken time, with a learning curve both for manufacturers and the agency.”

“As all involved parties continue to gain more experience, FDA expects the process to move much more quickly,” Zeller said in a conference call with reporters.

Zeller also said in a blog post on the agency’s website that the review decisions do not reflect whether the FDA “considers a product to be safe.”

Lorillard, the nation’s third-biggest tobacco company, is pleased with the FDA’s actions and believes the agency has “carried out is evaluation process in a deliberate manner reflecting sound science,” CEO Murray Kessler said in a statement. Lorillard is based in Greensboro, N.C.

Kessler had previously criticized the agency’s backlog, saying it wasn’t “exercising common sense.”

“These are cigarettes. They haven’t changed in 50 years. They’ve had the most minor changes,” Kessler had said in an interview with the AP. “I don’t think the spirit of the law ever envisioned this type of cumbersome scrutiny.”

Talk to us

> Give us your news tips.

> Send us a letter to the editor.

> More Herald contact information.

More in Business

Black Press Media operates Sound Publishing, the largest community news organization in Washington State with dailies and community news outlets in Alaska.
Black Press Media concludes transition of ownership

Black Press Media, which operates Sound Publishing, completed its sale Monday (March 25), following the formerly announced corporate restructuring.

Maygen Hetherington, executive director of the Historic Downtown Snohomish Association, laughs during an interview in her office on Thursday, Feb. 15, 2024, in Snohomish, Washington. (Ryan Berry / The Herald)
Maygen Hetherington: tireless advocate for the city of Snohomish

Historic Downtown Snohomish Association receives the Opportunity Lives Here award from Economic Alliance.

FILE - Washington Secretary of State Steve Hobbs poses in front of photos of the 15 people who previously held the office on Nov. 22, 2021, after he was sworn in at the Capitol in Olympia, Wash. Hobbs faces several challengers as he runs for election to the office he was appointed to last fall. (AP Photo/Ted S. Warren, File)
Secretary of State Steve Hobbs: ‘I wanted to serve my country’

Hobbs, a former Lake Stevens senator, is the recipient of the Henry M. Jackson Award from Economic Alliance Snohomish County.

Mark Duffy poses for a photo in his office at the Mountain Pacific Bank headquarters on Wednesday, Feb. 14, 2024 in Everett, Washington. (Annie Barker / The Herald)
Mark Duffy: Building a hometown bank; giving kids an opportunity

Mountain Pacific Bank’s founder is the recipient of the Fluke Award from Economic Alliance Snohomish County.

Barb Tolbert poses for a photo at Silver Scoop Ice Cream on Thursday, Feb. 29, 2024 in Arlington, Washington. (Annie Barker / The Herald)
Barb Tolbert: Former mayor piloted Arlington out of economic brink

Tolbert won the Elson S. Floyd Award, honoring a leader who has “created lasting opportunities” for the underserved.

Photo provided by 
Economic Alliance
Economic Alliance presented one of the Washington Rising Stem Awards to Katie Larios, a senior at Mountlake Terrace High School.
Mountlake Terrace High School senior wins state STEM award

Katie Larios was honored at an Economic Alliance gathering: “A champion for other young women of color in STEM.”

The Westwood Rainier is one of the seven ships in the Westwood line. The ships serve ports in the Pacific Northwest and Northeast Asia. (Photo provided by Swire Shipping)
Westwood Shipping Lines, an Everett mainstay, has new name

The four green-hulled Westwood vessels will keep their names, but the ships will display the Swire Shipping flag.

A Keyport ship docked at Lake Union in Seattle in June 2018. The ship spends most of the year in Alaska harvesting Golden King crab in the Bering Sea. During the summer it ties up for maintenance and repairs at Lake Union. (Keyport LLC)
In crabbers’ turbulent moment, Edmonds seafood processor ‘saved our season’

When a processing plant in Alaska closed, Edmonds-based business Keyport stepped up to solve a “no-win situation.”

Angela Harris, Executive Director of the Port of Edmonds, stands at the port’s marina on Wednesday, Jan. 24, 2024, in Edmonds, Washington. (Ryan Berry / The Herald)
Leadership, love for the Port of Edmonds got exec the job

Shoring up an aging seawall is the first order of business for Angela Harris, the first woman to lead the Edmonds port.

The Cascade Warbirds fly over Naval Station Everett. (Sue Misao / The Herald file)
Bothell High School senior awarded $2,500 to keep on flying

Cascade Warbirds scholarship helps students 16-21 continue flight training and earn a private pilot’s certificate.

Rachel Gardner, the owner of Musicology Co., a new music boutique record store on Thursday, Jan. 18, 2024 in Edmonds, Washington. Musicology Co. will open in February, selling used and new vinyl, CDs and other music-related merchandise. (Olivia Vanni / The Herald)
New Edmonds record shop intends to be a ‘destination for every musician’

Rachel Gardner opened Musicology Co. this month, filling a record store gap in Edmonds.

MyMyToyStore.com owner Tom Harrison at his brick and mortar storefront on Tuesday, Sept. 6, 2022 in Everett, Washington. (Olivia Vanni / The Herald)
Burst pipe permanently closes downtown Everett toy store

After a pipe flooded the store, MyMyToystore in downtown Everett closed. Owner Tom Harrison is already on to his next venture.

Support local journalism

If you value local news, make a gift now to support the trusted journalism you get in The Daily Herald. Donations processed in this system are not tax deductible.