0
**
It appears that the FDA may soon (perhaps in the next several weeks or months) follow through with the agency's April 25 stated intent (in red below) to propose a regulation that would apply Chapter IX of the FSPTCA to e-cigarette products (that contain nicotine) and other currently unregulated tobacco products, including: small cigars, large cigars, pipe tobacco, hookah/shisha tobacco, dissolvable tobacco/nicotine products (that aren't smokeless tobacco products), nicotine water, tobacco/nicotine skin cream and patches, non electronic nicotine inhalers, tobacco/nicotine nasal sprays, etc.
April 25, 2011
Regulation of E-Cigarettes and Other Tobacco Products
Quote
The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act. The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”
June 16, 2011
Sens. Merkley, Brown and 10 other Democrats pressure FDA to reverse ruling that Star's Ariva BDL and Stonewall BDL aren't smokeless tobacco products (as defined by FSPTCA), grossly exaggerate health/safety risks of dissolvable tobacco (that now includes nicotine lozenges), falsely claim products are marketed to youth, call them candy.
New Senator Brown and Senate Colleagues to FDA: It's Time To Close The Door On Tobacco Candy
http://www.ktvz.com/...863/detail.html (6/16/11 Dem Sens. letter to Margaret Hamburg)
Quote
Although we recognize that FDA has not yet asserted jurisdiction over the full range of tobacco products potentially subject to regulation under the statute, FDA does have authority over smokeless tobacco products. For this reason, we do not understand why Ariva-BDL and Stonewall-BDL should not be categorized as “smokeless tobacco products” and subjected to immediate FDA regulation. We fear that this action will encourage other tobacco companies to introduce new forms of dissolvable tobacco products in an effort to avoid regulation as smokeless tobacco products, an outcome that Congress intended to prevent. Already, another tobacco manufacturer, R.J. Reynolds, recently reintroduced dissolvable, candy-like Camel products, including Sticks, Strips and Orbs, in Charlotte and Denver. Yet another manufacturer, Altria has debuted its “smokeless tobacco stick” and is test marketing it in Kansas. The recent proliferation of dissolvable tobacco products—which can easily end up in the hands of children—in the marketplace, makes FDA’s decision particularly disturbing.
October 14, 2011
US Senate Democrats Blumenthal, Lautenberg & Brown urge FDA to "swiftly" expand tobacco regulations, falsely accuse tobacco industry of undermining FSPTCA, urge agency to apply Chapter IX to all cigars, pipe tobacco, hookah/shisha, dissolvables, e-cigarettes and other tobacco products, criticize companies for marketing exponentially less hazardous smokefree alternatives to smokers, grossly misrepresent health risks/benefits and marketing of smokefree products.
Senators Send Letter to FDA on Other Tobacco Products
http://www.cspdigita.../tom-letter.pdf (Oct. 14, 2011 letter to Margaret Hamburg from Sens Lautenberg, Blumenthal, Brown)
Quote
Now, we respectfully request that FDA build on these successes and move swiftly to issue a strong regulation that would legally treat or deem all tobacco products, including cigars, pipe tobacco, and hookah tobacco and accessories, as subject to the Tobacco Control Act. We appreciate FDA's past work to issue this important regulatin. Now we ask that you provide us with an update on the agency's progress and anticipated timeline for completion of this regulation, commonly known as the "deeming" rule. In addition, we would appreciae the opportunity to discuss the specifics of this new rule with yout, and would also ask that you respond to this letter with a date indicating your availability for such a meeting.
On July 13, 2011, Dr. Lawrence Deyton, Director of FDA's Center for Tobacco Products, met with Senators Blumenthal, Sherrod Brown, and Merkley to discuss FDA's regulatory decision around Star Scientific's products Ariva-BDL and Stonewall-BDL, two recently-developed dissolvable tobacco lozenges. In June, FDA deemed both products to be outside the direct regulatory authority afforded the agency under Chapter IX of the FSPTCA, thus requiring FDA to issue an additional regulation in order to assert authority over such products. While we continue to respectfully disagree with this decision, we were encouraged during this meeting to hear of FDA's commitment to swiftly issue such a "deeming" regulation, and were pleased to hear of an anticipated October release.
On July 13, 2011, Dr. Lawrence Deyton, Director of FDA's Center for Tobacco Products, met with Senators Blumenthal, Sherrod Brown, and Merkley to discuss FDA's regulatory decision around Star Scientific's products Ariva-BDL and Stonewall-BDL, two recently-developed dissolvable tobacco lozenges. In June, FDA deemed both products to be outside the direct regulatory authority afforded the agency under Chapter IX of the FSPTCA, thus requiring FDA to issue an additional regulation in order to assert authority over such products. While we continue to respectfully disagree with this decision, we were encouraged during this meeting to hear of FDA's commitment to swiftly issue such a "deeming" regulation, and were pleased to hear of an anticipated October release.
November 29, 2011
Cigars | FDA | Obama Administration | Regulations | The Daily Caller
Quote
Cigar smokers are mad as hell, and they aren’t going to take it anymore. Faced with an unprecedented assault on their guilty pleasure from President Barack Obama’s Food and Drug Administration, aficionados and industry insiders told The Daily Caller that they’re picking up their torch lighters and revolting.
Quote
Usually divided by their preferences for mild, medium and full-bodied smokes, they’re uniting against regulations that threaten to make cigars prohibitively expensive, shut down scores of small cigar shops, jeopardize tens of thousands of jobs and erase the traditionally bright line between Camels and Cohibas.
Cigar lovers are also recruiting members of Congress to defend what public health activists and anti-cancer crusaders see as little more than gentrified cigarettes smoked by economic one-percenters.
“Only a couple weeks remain,” one apocalyptic online pitch warns, “to stop the FDA from ruining cigars.” If that seems like a stretch, don’t bother telling Famous Smoke Shop. The e-tailer has sent 1.7 million emails to customers on its mailing lists, asking them to encourage their representatives in Congress to co-sponsor legislation designed to tie the FDA’s hands.
Cigar industry representatives told TheDC that efforts like this have already generated more than 113,000 messages to Congress.
It’s no surprise, then, that 125 House members and four senators are on board. They include 26 Democrats, along with six of Congress’ 20 physicians and two of its seven nurses — all strange bedfellows for a pro-tobacco law in the making.
Sen. Mary Landrieu, a Louisiana Democrat, announced Wednesday that she will join them. Landrieu chairs the Senate Committee on Small Business & Entrepreneurship, a crucial position from which to influence an issue that affects mostly mom-and-pop retailers.
Cutting an Exception
The Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011 arrived in the House in April and the Senate in August. Much of the domestic cigar supply enters the United States in the Sunshine State, and two Florida legislators — Republican Rep. Bill Posey and Democratic Sen. Bill Nelson — are leading the charge.
The bill’s focus is to carve out an exception for premium cigars in the Family Smoking Prevention and Tobacco Control Act, signed into law by President Obama in 2009.
The Tobacco Control Act (TCA) gave the FDA new authority to regulate tobacco, and the agency has most famously wielded that power by requiring garish photographic warnings this year on cigarette packs. But the law, an FDA spokesperson told The Daily Caller in an email, “also permits FDA to deem other ‘tobacco products’ subject to the TCA’s general controls by regulation.”
The FDA spokesperson explained that a “proposed rule deeming cigars to be subject to FDA’s jurisdiction” could be “finalized” after a public-comment period expires, giving the agency the authority to regulate “any product that meets the definition of a ‘tobacco product’ under the TCA, including cigars, little cigars, and certain novel nicotine containing products (such as certain electronic cigarettes).”
The FDA seems to be taking its longer leash seriously. On three occasions since December 2010, the agency has already put the cigar industry on notice that it intends to propose a rule to “deem cigars subject to the Tobacco Control Act.”
Cigar lovers are also recruiting members of Congress to defend what public health activists and anti-cancer crusaders see as little more than gentrified cigarettes smoked by economic one-percenters.
“Only a couple weeks remain,” one apocalyptic online pitch warns, “to stop the FDA from ruining cigars.” If that seems like a stretch, don’t bother telling Famous Smoke Shop. The e-tailer has sent 1.7 million emails to customers on its mailing lists, asking them to encourage their representatives in Congress to co-sponsor legislation designed to tie the FDA’s hands.
Cigar industry representatives told TheDC that efforts like this have already generated more than 113,000 messages to Congress.
It’s no surprise, then, that 125 House members and four senators are on board. They include 26 Democrats, along with six of Congress’ 20 physicians and two of its seven nurses — all strange bedfellows for a pro-tobacco law in the making.
Sen. Mary Landrieu, a Louisiana Democrat, announced Wednesday that she will join them. Landrieu chairs the Senate Committee on Small Business & Entrepreneurship, a crucial position from which to influence an issue that affects mostly mom-and-pop retailers.
Cutting an Exception
The Traditional Cigar Manufacturing and Small Business Jobs Preservation Act of 2011 arrived in the House in April and the Senate in August. Much of the domestic cigar supply enters the United States in the Sunshine State, and two Florida legislators — Republican Rep. Bill Posey and Democratic Sen. Bill Nelson — are leading the charge.
The bill’s focus is to carve out an exception for premium cigars in the Family Smoking Prevention and Tobacco Control Act, signed into law by President Obama in 2009.
The Tobacco Control Act (TCA) gave the FDA new authority to regulate tobacco, and the agency has most famously wielded that power by requiring garish photographic warnings this year on cigarette packs. But the law, an FDA spokesperson told The Daily Caller in an email, “also permits FDA to deem other ‘tobacco products’ subject to the TCA’s general controls by regulation.”
The FDA spokesperson explained that a “proposed rule deeming cigars to be subject to FDA’s jurisdiction” could be “finalized” after a public-comment period expires, giving the agency the authority to regulate “any product that meets the definition of a ‘tobacco product’ under the TCA, including cigars, little cigars, and certain novel nicotine containing products (such as certain electronic cigarettes).”
The FDA seems to be taking its longer leash seriously. On three occasions since December 2010, the agency has already put the cigar industry on notice that it intends to propose a rule to “deem cigars subject to the Tobacco Control Act.”
BILL GODSHALL
The reason I stated that an FDA regulation to apply Chapter IX of the FSPTCA to e-cigarettes could ban many/most e-cigarette products (that contain nicotine) is because Section 910 of the FSPTCA could allow the FDA to ban some/many/most/all e-cigarette products that were not available in the US market before February 15, 2007.
Under the provisions of Section 911, manufacturers/importers (of all tobacco products that weren't on the market prior to February 15, 2007) would need to submit an application to the FDA claiming that the product is "substantially equivalent" to another product that was already on the market prior to 2/15/2007, and the FDA would have sole discretion of determining whether the product is or isn't substantially equivalent to the other e-cigarette product.
Aslo, Section 911 would prohibit all e-cigarette manufacturers and importers from truthfully claiming that e-cigarettes are less hazardous than cigarettes, as such a claim would render the product as a "modified risk tobacco product". Section 911 requires any company desiring to make a MRTP claim to apply to the FDA to do so, and the FDA must approve the application.
Many other provisions in Chapter IX would basically require every e-cigarette manufacturer and importer to hire a team of lawyers just to comply with the currently pending provisions (as well as comply with regulations approved in the future).
***
Bill is supposed to start collaborating with CAASA to create an action letter as well as some sample letters so we can start email congress, news stations etc. CASSA doesn't directly talk to Vapor Talk but I'll try to post back anything new I come across here. I hope you all will do the same should you come across any new information.
