Pick Your Community: | Hopkins | Muhlenberg | Daviess | Christian | Henderson | Lakes | McCracken | Webster
Davis Motor Sales banner ad

FDA Issues First Orders to Stop Sale, Distribution of Tobacco Products

FDA 01 300KENTUCKY (2/21/14) – The U.S. Food and Drug Administration issued orders today to stop the further sale and distribution of four tobacco products currently on the market.

The action marks the first time the FDA has used its authority under the Family Smoking Prevention and Tobacco Control Act to order a manufacturer of currently available tobacco products to stop selling and distributing them.
 
The products – Sutra Bidis Red, Sutra Bidis Menthol, Sutra Bidis Red Cone, and Sutra Bidis Menthol Cone – were found to be not substantially equivalent to tobacco products commercially marketed as of Feb. 15, 2007, also known as predicate products.

This means they can no longer be sold or distributed in interstate commerce or imported into the United States.
 
Bidis are thin, hand-rolled cigarettes filled with tobacco and wrapped in leaves from a tendu tree that are tied with string. The manufacturer, Jash International, did not meet the requirements of the Tobacco Control Act to be able to continue selling these products.
 
“Historically, tobacco companies controlled which products came on and off the market without any oversight,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “But the Tobacco Control Act gave the FDA, a science-based regulatory agency, the authority to review applications and determine which new tobacco products may be sold and distributed under the law in order to protect public health.”
 
Under the Tobacco Control Act, regulated products were allowed to stay on the market if companies submitted an application to the FDA by March 22, 2011.

The law requires the FDA to review product applications so the agency can decide whether the products are substantially equivalent (SE) to valid predicate products. If a company fails to provide the necessary information to show that their product is SE to a predicate product, the FDA has the authority to declare a product not substantially equivalent, which means that it can no longer be sold or distributed in interstate commerce.
 
In this case, Jash International did not identify eligible predicate tobacco products as required for the FDA to perform an SE review. Also, the company did not provide information necessary to determine whether the new products had the same characteristics as a predicate product, or had different characteristics but did not raise different questions of public health, the basis used by the FDA to review SE applications for tobacco products.
 
“Companies have an obligation to comply with the law – in this case, by providing evidence to support an SE application,” said Zeller. “Because the company failed to meet the requirement of the Tobacco Control Act, the FDA’s decision means that, regardless of when the products were manufactured, these four products can no longer be legally imported or sold or distributed through interstate commerce in the United States.”
 
Existing inventory may be subject to enforcement action, including seizure, without further notice.

Companies that continue to sell and distribute these products in the United States may be subject to enforcement actions by the FDA.
 
With regard to retailers, FDA does not intend to take enforcement action for 30 days on previously purchased products that a retailer has in its inventory.

This policy does not apply to inventory purchased by retailers after the date of the order. FDA has issued draft guidance containing more information on the agency’s enforcement policy for certain tobacco products that the FDA finds not substantially equivalent. It will be open for public comment for 60 days, beginning Tuesday, Feb. 25.
 
The FDA encourages retailers to contact their supplier or the manufacturer to discuss possible options for the misbranded and adulterated product or products that the retailers have in current inventory.

Consumers and other interested parties can report a potential tobacco-related violation of the Food, Drug & Cosmetic Act, including NSE products that continue to be sold or distributed in the United States, by using the FDA’s Potential Tobacco Product Violation Reporting Form.

SurfKY News
Information provided by U.S. Food and Drug Administration

© Copyright 2014 SurfKY News Group, Inc. All rights reserved. This material may not be published, broadcast, or rewritten without permission. SurfKY News encourages you to share this story by using one of the social media links below.

Started 11/8/2013
Started 11/8/2013
Started 11/8/2013
Started 11/8/2013
Started 11/8/2013
Started 11/8/2013

In Other News...

Henderson County Police Reports

HENDERSON, Ky. (10/20/14) — The Henderson Police Department released the following reports. On Oct. 17, 2014, the… Read More

Banner Presented to Calloway Board of Education

PADUCAH, Ky. (10/20/14) — Elizabeth Alexander, a junior student in John Williams Technological Design class at Calloway… Read More
Started 11/8/2013
Started 11/8/2013

Most Read This Week

October 17, 2014 11454

UK Women's Soccer Welcomes Ole Miss, No. 5/4…

in General Sports For All Sites by UK Athletics
October 15, 2014 3514

Family Business, Graphics Pros to Open Friday

in Top News For All Sites by Shawn Freels
October 15, 2014 3369

Chamber Meeting and More Announced

in Local (Muhlenberg) Top News by Dorothy Walker
October 20, 2014 3276

Uncle Lee's in Greenville is Closing Its Doors…

in Local (Muhlenberg) Top News by www.unclelees.com
October 17, 2014 3254

Single Vehicle Collision Results in One Injury

in Local (Muhlenberg) Top News by Trooper S. C. Recke
October 15, 2014 3158

Madisonville Police Arrest Reports - Oct. 15, 2014

in Hopkins News by Madisonville Police Department
October 19, 2014 3054

Kentucky Energy Department Releases Virtual Solar…

in General News For All Sites by Dick Brown
October 15, 2014 2838

Woman Arrested for Domestic Dispute in the Street

in Local (Hopkins) Top News by Madisonville Police Department
October 17, 2014 2596

Woman Arrested at Taco Bell for DUI

in Local (Hopkins) Top News by Madisonville Police Department
October 16, 2014 2472

Madisonville Police Arrest Reports - Oct. 16, 2014

in Hopkins News by Madisonville Police Department

Stories Trending Today

October 20, 2014 3276

Uncle Lee's in Greenville is Closing Its Doors…

in Local (Muhlenberg) Top News by www.unclelees.com
October 20, 2014 2058

Man Charged for Assaulting Pregnant Wife

in Local (Hopkins) Top News by Madisonville Police Department
October 20, 2014 1378

Man Arrested for Shoplifting, Assaulting Police…

in Local (Hopkins) Top News by Madisonville Police Department
October 20, 2014 1058

Madisonville Police Arrest Reports - Oct. 20, 2014

in Hopkins News by Madisonville Police Department
October 20, 2014 1038

Hopkins County Sheriff's Arrest Reports Released

in Hopkins News by Sheila Hopper
October 20, 2014 1006

KU and LG&E to Fund Qualified Tree-Planting…

in General News For All Sites by Cliff Feltham
October 20, 2014 947

Paul Simon Headlines COPD Tribute for Phil Everly

in Top News For All Sites by Paul McRee, SurfKY News
October 20, 2014 941

Muhlenberg Community Hospital Prepares for…

in Local (Muhlenberg) Top News by Erin Warren
October 20, 2014 900

Fall Frolic at Nature Station

in Lakes News by Land Between The Lakes
October 20, 2014 863

Veterans Honored Nov. 8-11 at Land Between The…

in Lakes News by Land Between The Lakes

SurfKY News Group, Inc.
1125 Nebo Rd.  •  Madisonville, KY 42431
270.452.2727 (phone)
  •  270.452.2249 (fax)


Contact a member of our staff: www.surfky.com/contact
Copyright © 2014 SurfKY News Group, Inc.  •  Terms of Use  •  Site Map

social fbsocial twsocial yt
social gpsocial flrsocial rss