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...

Join in the Fun at the 42nd Annual Piney Campers' Fair

KENTUCKY (8/29/15) – Piney Campground hosts its 42nd Annual Campers' Fair Sept. 16-20, 2015. Campers' Fair will… Read More

Commission Recommends Zoning Changes at Mahr Park, West Noel

MADISONVILLE, Ky. (8/30/15) – Hopkins County Joint Planning Commission had its regularly scheduled meeting on Thursday,… Read More
1 DOW 16,643.01
-11.76 (-0.07%)    
2 S&P 1,988.87
+1.21 (0.06%)    
3 NASDAQ 4,828.33
+15.62 (0.32%)    

Most Read This Week

August 24, 2015 11087

Teen Reports Slasher Attempted to Attack Him on…

by Doreen Dennis, SurfKY News
August 24, 2015 6140

Alleged Burglar Calls 911 to Report Fire

by SurfKY News
August 24, 2015 5069

UPDATE: Four Dead, Two Survive Boating Accident

by SurfKY News
August 27, 2015 4608

All is Well after MNHHS Lockdown

by Doreen Dennis, SurfKY News
August 24, 2015 4295

MPD Coducting Sobriety Checkpoints

by SurfKY News

Most Read This Month

August 06, 2015 16259

Muhlenberg Woman Reportedly Suffers Violent…

by SurfKY News
August 24, 2015 11087

Teen Reports Slasher Attempted to Attack Him on…

by Doreen Dennis, SurfKY News

Stories Trending Now

August 30, 2015 2051

UPDATED: 'He Fought the Law ... but, the Law Won'

by Doreen Dennis, SurfKY News
August 29, 2015 1244

UK Part of First Study on Marijuana Compound…

by SurfKY News
August 29, 2015 1148

Happenings, Meetings Listed for Following Week

by Tammy Holloway, SurfKY News
August 29, 2015 1069

All Occasions Formals to Host Celebration to…

by Rita Dukes Smith, SurfKY News Director
August 29, 2015 916

Kentucky State Park Camping Deal Offered in…

by SurfKY News
August 29, 2015 880

UK Student Gaming System to Support Learning for…

by SurfKY News
August 29, 2015 756

Police Searching for Suspect for Attempted ATM…

by SurfKY News
August 29, 2015 451

Keeping the Faith - 'The Wisdom to Wait'

by SurfKY News
August 29, 2015 404

Hooked on Science - 'Inertia Antenna'

by SurfKY News
August 30, 2015 328

Dave Says - Aug. 30, 2015

by SurfKY News