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

e-max.it: your social media marketing partner

LIKE SurfKY on Facebook - Click here to LIKE us now.

© Copyright 2015 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 on social media.

In Other News...

Owensboro Museum of Fine Art Riverfront Sculpture Unveiling

OWENSBORO, Ky. (6/3/15) — An unveiling of the fifth outdoor sculpture in the public art initiative, RiverArtes: The Art… Read More

South Main Accident Slows Northbound Traffic

MADISONVILLE, KY (6/2/15) ― Madisonville Police Department responded to a two-vehicle accident near the intersection of… Read More
1 DOW 18,076.27
+64.33 (0.36%)    
2 S&P 2,114.07
+4.47 (0.21%)    
3 NASDAQ 5,099.23
+22.71 (0.45%)    

Most Read This Week

May 30, 2015 7397

Study of Virus Attack on Cancer Sees Success

by Julie Heflin
May 28, 2015 6638

Four Charged with Burglary for Entering Elderly…

by SurfKY News
May 28, 2015 2927

Greenville Man Charged with Rockport Robbery,…

by SurfKY News
May 29, 2015 2658

Hopkins County Grand Jury Indictments

by SurfKY News
May 29, 2015 2582

KSP Seeks Public Help in Locating Wanted Man

by SurfKY News

Most Read This Month

May 15, 2015 11407

New Madisonville Business In Full Operation Soon

by Tammy Holloway, SurfKY News
May 23, 2015 9654

Missing 5-Year-Old Boy Found

by Doreen Dennis, SurfKY News

Stories Trending Now

June 02, 2015 2292

Woman Charged with Falsely Reporting Kidnapping

by SurfKY News
June 02, 2015 1890

Traffic Signal at Intersection in Downtown…

by Keith Todd
June 02, 2015 1785

Two Muhlenberg Women Injured in Collision

by SurfKY News
June 02, 2015 1622

Juveniles Accused of Falsely Reporting Masked…

by Rita Dukes Smith, SurfKY News Director
June 02, 2015 1419

South Main Accident Slows Northbound Traffic

by Doreen Dennis, SurfKY News
June 02, 2015 1373

Hopkins County Misdemeanor Indictments

by SurfKY News
June 01, 2015 1319

Human Relations Coordinator Identifies Possible…

by Tammy Holloway, SurfKY News
June 03, 2015 1314

Crime Stoppers Fugitive of the Week – June 3, 2015

by Hopkinsville – Christian County Crime Stoppers
June 02, 2015 1204

Pennyrile Soap Box Derby Hosts 34 Competitors

by Tammy Holloway, SurfKY News
June 02, 2015 1135

Madisonville Police Arrest Reports Released -…

by SurfKY News