Happy Easter! Would it be mean to not color the eggs and just toss them in the yard white? [emoji38]
Hello all - Some news I found and would like to share. Keeping fingers and toes crossed till April 10th! 
** FDA to decide on General Snus MRTP Application 10 Apr 2015 **
(Reuters) - In a decision that could reshape U.S. tobacco regulation, a health advisory panel will vote next week on whether Swedish Match AB, a Stockholm-based maker of smokeless tobacco products known as snus, can claim they are less harmful than cigarettes.
The closely watched vote could pave the way for the first Food and Drug Administration approval of a modified risk tobacco product and set a precedent for companies seeking to make similar claims. The two-day discussion will culminate in a vote on April 10th.
Snus is a moist smokeless tobacco product that users place underneath the upper lip. It can be bought loose, or in small teabag-like pouches. It does not involve chewing or spitting.
Swedish Match is asking permission to remove required warnings about mouth cancer, gum disease and tooth loss from its product packaging, saying there is no evidence to support a link between mouth disease and Swedish snus. It proposes retaining the risk of nicotine addiction.
The company also wants to replace a warning that smokeless tobacco is not a safe alternative to cigarettes with one that acknowledges no tobacco product is safe, but states its own products are substantially less risky than cigarettes.
LEERY OF INDUSTRY PAST
The hurdles for winning approval are high.
In crafting the 2009 law giving the FDA authority to regulate tobacco, Congress, leery of the industry's misleading marketing of implicitly safer "light" and "low tar" cigarettes, set rigorous standards for approving modified risk products.
Companies must show a product significantly reduces the risk of disease for individual tobacco users. It must also show a health benefit to the population as a whole, taking into account tobacco and non-tobacco users.
Products such as snus and e-cigarettes are generally considered safer than combustible cigarettes and may benefit a smoker who switches. But if smokers use both products instead of switching, or if the less risky products are taken up by people who otherwise would not have used any tobacco product, the calculus might be different.
Swedish Match believes it has a strong case.
Snus use in Sweden, particularly among men, has risen over the past 30 years. It is now the country's most popular tobacco product. At the same time, smoking rates have plunged to the lowest in Europe. Smoking related diseases, including lung cancer and heart disease, have also fallen.
Azim Chowdhury, a partner at the law firm Keller and Heckman LLP, said regulators should not ignore such statistics. If FDA were to deny Swedish Match's application, Chowdhury said, "they would basically be saying no-one will ever be approved."
Scott Ballin, a health policy consultant based in Washington, D.C., agrees. He sees a 60 percent chance the advisory panel will vote in favor of Swedish Match but concedes opposition from public health groups is strong.
"If the committee responds to pressure from tobacco control advocates who believe that all tobacco is equally harmful then I think we will see it punting and suggesting more research needs to be done," he said.
WRANGLING OVER THE LAW
Opponents of approval argue FDA does not have legal authority to permit changes to government-mandated warning labels. Moreover, they say, the proposed label changes do not appropriately capture potential risks associated with snus.
"We don't know yet whether or not we are going to see people use both products, or whether kids take up snus who would not otherwise have smoked," said Erika Sward, an advocate with the American Lung Association.
Critics also say it is unclear whether the population-level benefits seen in Sweden would translate to the United States. Other factors, including more restrictive bans on advertising, could be at play.
"The real question isn't whether a well done application for Swedish snus could qualify for a modified risk claim, it is whether this specific request should qualify," said Matthew Myers, president of the Campaign for Tobacco-Free Kids.
Sandy Fowler-Jones, a Swedish Match spokeswoman, said the FDA "fully vetted" the legal issue before the company filed its application. The agency can permit changes to an individual product's warning label, she said.
SMOKELESS TOBACCO
Adult smokeless tobacco use was 3.6 percent in 2012, according to the Centers for Disease Control and Prevention, with the highest rates among 18 to 25-year-old males.
The overall rate of snus use was 2.5 percent during the same period. Among high school boys it was 3.9 percent.
U.S. smokeless tobacco products include Altria Group's Copenhagen, Skoal and Red Seal brands.
Altria also sells Marlboro snus and Reynolds American Inc sells Camel snus. These products would not be covered by any FDA decision on the Swedish Match product, but some anti-tobacco groups fear that consumers would not differentiate.
Swedish Match's products follow standards for reducing heavy metals and other toxic substances that U.S. products are not bound by. In an odd twist, Swedish snus is banned in Europe outside Sweden for health reasons.
** FDA to decide on General Snus MRTP Application 10 Apr 2015 **
(Reuters) - In a decision that could reshape U.S. tobacco regulation, a health advisory panel will vote next week on whether Swedish Match AB, a Stockholm-based maker of smokeless tobacco products known as snus, can claim they are less harmful than cigarettes.
The closely watched vote could pave the way for the first Food and Drug Administration approval of a modified risk tobacco product and set a precedent for companies seeking to make similar claims. The two-day discussion will culminate in a vote on April 10th.
Snus is a moist smokeless tobacco product that users place underneath the upper lip. It can be bought loose, or in small teabag-like pouches. It does not involve chewing or spitting.
Swedish Match is asking permission to remove required warnings about mouth cancer, gum disease and tooth loss from its product packaging, saying there is no evidence to support a link between mouth disease and Swedish snus. It proposes retaining the risk of nicotine addiction.
The company also wants to replace a warning that smokeless tobacco is not a safe alternative to cigarettes with one that acknowledges no tobacco product is safe, but states its own products are substantially less risky than cigarettes.
LEERY OF INDUSTRY PAST
The hurdles for winning approval are high.
In crafting the 2009 law giving the FDA authority to regulate tobacco, Congress, leery of the industry's misleading marketing of implicitly safer "light" and "low tar" cigarettes, set rigorous standards for approving modified risk products.
Companies must show a product significantly reduces the risk of disease for individual tobacco users. It must also show a health benefit to the population as a whole, taking into account tobacco and non-tobacco users.
Products such as snus and e-cigarettes are generally considered safer than combustible cigarettes and may benefit a smoker who switches. But if smokers use both products instead of switching, or if the less risky products are taken up by people who otherwise would not have used any tobacco product, the calculus might be different.
Swedish Match believes it has a strong case.
Snus use in Sweden, particularly among men, has risen over the past 30 years. It is now the country's most popular tobacco product. At the same time, smoking rates have plunged to the lowest in Europe. Smoking related diseases, including lung cancer and heart disease, have also fallen.
Azim Chowdhury, a partner at the law firm Keller and Heckman LLP, said regulators should not ignore such statistics. If FDA were to deny Swedish Match's application, Chowdhury said, "they would basically be saying no-one will ever be approved."
Scott Ballin, a health policy consultant based in Washington, D.C., agrees. He sees a 60 percent chance the advisory panel will vote in favor of Swedish Match but concedes opposition from public health groups is strong.
"If the committee responds to pressure from tobacco control advocates who believe that all tobacco is equally harmful then I think we will see it punting and suggesting more research needs to be done," he said.
WRANGLING OVER THE LAW
Opponents of approval argue FDA does not have legal authority to permit changes to government-mandated warning labels. Moreover, they say, the proposed label changes do not appropriately capture potential risks associated with snus.
"We don't know yet whether or not we are going to see people use both products, or whether kids take up snus who would not otherwise have smoked," said Erika Sward, an advocate with the American Lung Association.
Critics also say it is unclear whether the population-level benefits seen in Sweden would translate to the United States. Other factors, including more restrictive bans on advertising, could be at play.
"The real question isn't whether a well done application for Swedish snus could qualify for a modified risk claim, it is whether this specific request should qualify," said Matthew Myers, president of the Campaign for Tobacco-Free Kids.
Sandy Fowler-Jones, a Swedish Match spokeswoman, said the FDA "fully vetted" the legal issue before the company filed its application. The agency can permit changes to an individual product's warning label, she said.
SMOKELESS TOBACCO
Adult smokeless tobacco use was 3.6 percent in 2012, according to the Centers for Disease Control and Prevention, with the highest rates among 18 to 25-year-old males.
The overall rate of snus use was 2.5 percent during the same period. Among high school boys it was 3.9 percent.
U.S. smokeless tobacco products include Altria Group's Copenhagen, Skoal and Red Seal brands.
Altria also sells Marlboro snus and Reynolds American Inc sells Camel snus. These products would not be covered by any FDA decision on the Swedish Match product, but some anti-tobacco groups fear that consumers would not differentiate.
Swedish Match's products follow standards for reducing heavy metals and other toxic substances that U.S. products are not bound by. In an odd twist, Swedish snus is banned in Europe outside Sweden for health reasons.
Too funny, I was just going to post a link to that article after reading it.
The FDA has got to be under a lot of pressure from TC and all their buddies in Pig Pharma on this one. My guess is that they'll kick it to the curb and send them back for more data. An outright denial would seem headed to the courtroom, but proving a population based benefit could tie the request up for years.
I'm going to cross my fingers for SM. It'd be nice to get those ridiculous warnings off the cans.
I couldn't care less about the labels, but removing the decades of lies would be priceless.
Well of course that too. Getting that crap off the labels would help I think.
I just can't see them reversing their stance on the lies. If they admit the truth, it would open them up to defending all the other lies. Pandora's box can't be closed once the lid is cracked open.
I truly hope that is not the case. If SM gets approved then that would open the door for V2 and other Swedish companies. Perhaps it would even lead to several brands becoming as available as general has become here.
That's my hope as well. I remember seeing photo's of a few snus stores in Sweden, rows upon rows of stock. It would be pretty awesome to have something like that in the US.
Hopefully this will pass and allow them to get around the PACT act also, lower shipping costs and great availability would be the bee's knee's.
Hopefully this will pass and allow them to get around the PACT act also, lower shipping costs and great availability would be the bee's knee's.
FDA questions evidence for lower-risk tobacco product - US News
"Food and Drug Administration scientists say they have "concerns" about how the company studied its snus tobacco product and its proposal to modify cancer warning language on the packaging."
"But in a scientific review posted Tuesday, FDA staff question whether that language "adequately reflects the health risks of using snus.""
"The agency will ask an advisory panel to weigh in on these and other issues. The FDA is not required to follow the advice of the group, which is composed of outside experts specializing in tobacco control, public health and cancer care."
This doesn't sound real strong on support.
"Food and Drug Administration scientists say they have "concerns" about how the company studied its snus tobacco product and its proposal to modify cancer warning language on the packaging."
"But in a scientific review posted Tuesday, FDA staff question whether that language "adequately reflects the health risks of using snus.""
"The agency will ask an advisory panel to weigh in on these and other issues. The FDA is not required to follow the advice of the group, which is composed of outside experts specializing in tobacco control, public health and cancer care."
This doesn't sound real strong on support.
I don't think a less harmful label gets a tobacco product around the PACT Act. It's still a tobacco product. [emoji35] It would be nice to pick up some Offroad at a store in a pinch, though.
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Lower shipping costs would be a dream come true. It's hard to believe that GetSnus used to ship for $5.
Even a $12 proiorty mail box would be great compared to UPS. I think the PACT will still apply to Snus as a tobacco product. I'd love to see more than one brand in a store, though. That would be awesome.
That is the big advantage of stopping the lies. If SM could get the designation, others will follow and big orders to Sweden would not be required. The only issue is getting the FDA to go against the grain and dispeasure their clients.
Roth, do cigars fall under the pact act also. I wasn't sure and was wondering if they have some sort of exemption then could snus also?
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