US: Totally Wicked Urges FDA to Establish Alternative Premarket Tobacco Application Procedure for E-Cigarette Products

Source from:  BUSINESS WIRE 08/14/2014

Totally Wicked-ELiquid (USA), Inc., a Bradenton, Florida-based distributor and retailer of premium vaping products submitted comments to the United States Food & Drug Administration on August 8, 2014, in response to the FDA's proposed "deeming" rule that would extend FDA's regulatory authority over tobacco products to e-cigarettes, e-liquids, and other vaping products.

When it published the proposed deeming rule on April 25, 2014, FDA sought feedback from industry participants and the general public on the regulatory framework it should apply to novel nicotine product such as those sold by Totally Wicked. In its comments filed with the FDA on August 8, 2014, Totally Wicked emphasized the significant differences between the products it sells and the traditional combustible tobacco products that Congress had in mind when it enacted legislation authorizing FDA regulation of tobacco products in 2009. Totally Wicked urged FDA to establish a regulatory framework that would continue to allow consumers ready access to vaping products as an alternative to traditional cigarettes without the accompanying smoke, tar, smell, and known carcinogens.

In its comments, Totally Wicked emphasized that some analysts expect the size of the e-cigarette industry to eclipse that of the traditional tobacco industry within ten years and described the company's own growth based on its premier product offering, including its proprietary Odyssey product range and its high-quality e-liquids manufactured in the United Kingdom. Totally Wicked noted that even the U.S. Small Business Administration has criticized the proposed deeming rule for not adequately accounting for the regulatory burden it would place on small businesses.

In its comments, Totally Wicked emphasized that scientific studies have demonstrated that e-cigarettes are safer than traditional tobacco products and are comparable to FDA-approved nicotine replacement therapy products as regards potential safety concerns. Totally Wicked also cited studies showing that concerns that vaping products are a "gateway" to traditional tobacco products are overblown. For these reasons, Totally Wicked urged FDA not to extend proposed requirements for premarket approval to vaping products without significantly streamlining the approval process as compared to that to be applied to traditional combustible products. Totally Wicked also urged FDA to establish manufacturing and product standards that will ensure product safety and high-quality ingredients while also not overly restricting the variety of e-cigarette and e-liquids available on the market.

"We are fully dedicated to ensuring the continued availability of our best-in-class products for our customers and are thus playing an active role in attempting to shape the FDA's regulatory regime for new and existing vaping technologies," said Totally Wicked's CEO, Fraser Cropper.

The full text of Totally Wicked's comments to the FDA is available here: http://www.totallywicked-eliquid.com/news/2014/august/twel-comments-to-fda-on-proposed.html

About Totally Wicked-ELiquid (USA), Inc.

Totally Wicked-ELiquid (USA), Inc. is a distributor and retailer of premier vaping products with retail stores in Bradenton, Sarasota, Tampa, St. Petersburg, Largo, and Altamonte, Florida, and internet sales nationwide. Totally Wicked offers a wide variety of e-cigarettes, e-liquids, and vaping accessories, including its proprietary, precision-manufactured Odyssey line. For additional information on Totally Wicked, please visit www.totallywicked-eliquid.com. Enditem