Star Scientific Files Application with FDA for Ariva-BDL(TM) Approval as First Modified Risk Tobacco Product

Star Scientific, Inc. (Nasdaq: CIGX) announced that on Friday, February 19 the company filed an application with the Food & Drug Administration for approval to market Ariva-BDL™ as a “modified risk” tobacco product under the Family Smoking Prevention and Tobacco Control Act of 2009. This submission is the first such application to be filed with the Tobacco Products Center of the FDA, which has been established to oversee all aspects of tobacco regulation outlined in the 2009 Act.

What are your thoughts?

Have you tried the “NEW” Ariva product?

Any expectations of others to follow Star’s lead.

Will the process work? Is harm reduction going to work?

PR Newswire Feb 22 2010 BDL Filing

9 comments ↓

#1 Larry Waters on 03.13.10 at 2:32 PM

Thanks, Lou….something else to make me sick to my stomach today.

If you substitute ‘General’ or any other Swedish snus manufacturer’s product for Ariva or Stonewall in the video, the video works even better. What a travesty.

I smoked heavily for 35 years before I discovered Swedish snus. There is no way in the world that I would stick any Disgusting Tobacco-like Product (DTP) in my mouth and body.

Likewise all the other American ‘complimentary products to cigarette’s like American made snus (when you can’t smoke; snus!), nicotine gum (which Mr. Obama has been chewing for over a year and a half…while still smoking), nicotine patches (now recommended for long time use as a nicotine replacement) or any of RJR’s DTP products like Camel Orbs or Camel sticks.

I could go on…especially concerning current e-cigarettes which, when inhaled, deliver virtually no nicotine but I have a head-ache.

FDA, The PACT Act, garbage products; All of this is like watching a bullet train speed towards a blown-up bridge. All you can do is scream and watch it happen.

Larry

#2 TAZ on 03.18.10 at 11:32 AM

Larry – Someone has to test the process. By the way I do know that Star with the NEW Ariva did a very good job with the flavor profile. I am a great supporter of Swedish Snus.

#3 bertram52 on 03.31.10 at 3:04 PM

Star’s existing products are terrible. No reason to expect better. Reduced harm only works if product is good.

#4 TAZ on 03.31.10 at 3:39 PM

Bertram,

Have you tried the new formulated Ariva?
Early indications are that consumers like the taste.
Now we will see if the product delivers.

#5 bertram52 on 04.02.10 at 9:39 AM

Taz, I have not. Is it sold and where? If so, I’ll pick some up. Bought some marlboro snus yesterday at supermarket — I think I was the first customer there as they had to open up the boxes for me.

#6 Copenhagen Charlie on 04.14.10 at 6:46 PM

It’s coming. I saw it at the big Mclane show in Florida! I heard that it’s very liked by women but from my perspective we will see because somehow the anti-zealots are only on RAI’s case. They have yet to see this new product. Comes in a neat little blister like gum pack!

#7 Jim on 04.21.10 at 12:01 PM

I have a question that maybe someone can answer? Is there a difference between the Ariva/Stonewall product and the Orbs by Reynolds? I never seen the Reynolds product so I was wondering.

#8 Bill Godshall on 04.21.10 at 5:54 PM

Per Jim’s inquiry, Camel Orbs, Strips and Sticks are “substantially equivalent” to Star’s Ariva and Stonewall, although the nicotine level and taste varies among the products.

All of these tobacco lozenges are also very similar to GSK’s Commit nicotine lozenge, which is marketed as smoking cessation aid, as in 2001 GSK (and CTFK/ACS/AHa/ALA, etc) petitioned the FDA to declare Ariva a “drug device” in an attempt to ban the product.
GSK’s petition essentially acknowledged that Ariva was nearly the same as Commit. Thankfully, the FDA rejected those petitions citing the SCOTUS decision prohibiting FDA from regulating tobacco products.

Whiel the new FDS tobacco law requires FDA approval of new tobacco products, it exempts new products that are “substantially equivalent” to tobacco products that were on the market before February 2007.

#9 TAZ on 09.30.10 at 5:54 PM

http://finance.yahoo.com/news/Firm-makes-itself-test-case-apf-3022085415.html?x=0&.v=2

Recent info on the topic!

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