E-Cigarettes May Get Advantage for Not Containing Tobacco

Electronic cigarettes may be closer to smoking cessation devices than regular smokes and regulators are keeping “an open mind” on their potential health benefit, said the top U.S. official overseeing their use.
In comments that may boost the developing $3 billion e-cigarette market, Mitch Zeller, head of the Food and Drug Administration’s Center for Tobacco Products, said the agency is exploring expedited reviews for tobacco products based on risk and toxicity as it prepares its e-cigarette regulations.

The statements come almost two months after the FDA said it would regulate the new products. Zeller said he wants both advocates and foes to view nicotine-containing products as a continuum -- from cigarettes, to their electronic counterparts, to cessation gums and patches.

“Cigarettes are designed to create addiction,” Zeller said at a Washington conference. “Ultimately it’s not the nicotine that kills. It’s all about the delivery mechanism.”

Most e-cigarettes deliver nicotine while leaving out the tars, arsenic and other chemicals common in tobacco products. The tubular devices, which produce an inhalable vapor to mimic smoking, were added at the end of last year to a New York ban on smoking in restaurants, bars, offices and parks. Chicago and Los Angeles followed with similar prohibitions.

The FDA is focusing on tobacco product standards that would ban or restrict levels of some ingredients to address addiction, toxicity and appeal, Zeller said. The agency has already said it would ban the sale of e-cigarettes to minors.

“It’s time for us to start looking at nicotine differently,” he said.

 

Scientific Data

U.S. regulators don’t have good scientific data on e-cigarettes, made by companies including Lorillard Inc. (LO) and Njoy Inc., and their ability to help smokers quit or entice new ones, according to Zeller. “We have to have an open mind on the potential for these emerging technologies to benefit public health,” he said.

Cigarette smokers who used an e-cigarette were 60 percent more likely to stop smoking than those who used traditional nicotine replacement therapies, researchers in the U.K. reported last month in the journal Addiction.

The FDA and National Institutes of Health intend to commit $4 million in fiscal 2014 to nicotine research and other tobacco priorities.

 

Drug Review

Products such as GlaxoSmithKline Plc (GSK)’s Nicorette gums and lozenges that claim to help smokers quit must go through the FDA’s rigorous drug approval process. Zeller highlighted the U.K.’s approach in which e-cigarettes will be regulated as medicines and health agencies can encourage use of for smoking cessation.

In the FDA’s April 24 proposal to regulate e-cigarettes, they questioned whether it should expedite review for a product that “contains no tobacco leaf, but contains nicotine, such as some electronic cigarettes.” The proposal also asks for public comment about whether low or nicotine-free products should be included in any faster review process.

Along with banning their sale to children, the FDA’s draft proposal would require e-cigarettes undergo agency review to sell new products.

The agency has said it is weighing whether it will extend the comment period on the proposal beyond July 9 after requests from within the industry and others.

Some Good News for the E-Cig Industry: Vaping Can Help Smokers Quit

By 

 

The e-cigarette industry got some good news this week: A survey of almost 6,000 smokers in Britain trying to quit found that those who used electronic cigarettes were more likely to stop using smoking tobacco than those who used over-the-counter quitting aids or had no help at all.

The study, accepted by the journal Addiction and published online Tuesday, comes as U.S. regulators weigh new rules for nicotine vaporizers. The e-cig industry and public health officials are battling over whether the devices should be treated as less-harmful cigarettes that help smokers give up tobacco or as a gateway that will lead adolescents to a deadly habit. Investigators from a cancer research center at the University College London conducted the study, which was partially funded with government and drug industry grants. None of the authors reported financial ties to e-cigarette companies, which adds to the report’s credibility.

The latest analysis drew on surveys of British households from 2009 to 2014 and counted smokers who had tried to quit within the past 12 months. A majority used no help, about one-third tried over-the-counter aids, such as nicotine patches or gums, and 8 percent used e-cigarettes. The study excluded people who used prescription medicines or counseling to quit smoking, as well as those who used both e-cigs and nicotine replacement. E-cig users were more likely to have stopped smoking tobacco by the time of the survey than either of the other groups.

While surely welcome news for fans of vaping, these survey results are not the kind of evidence that proves e-cigarettes are effective quitting aids and would let the industry market them as such. For that, regulators want to see rigorous, randomized control trials that compare e-cigs with placebo treatments. E-cigarettes are also an evolving technology, with varying formulas and designs that may have different effects on users. And the research doesn’t address whether smokers relapse more when using e-cigs than other quitting methods.

Scientists also haven’t established what risks e-cigarettes might pose to long-term users. It’s impossible to know how these products will affect people over decades, because the products are less than 10 years old. Other risks associated with e-cig use: They occasionally explode, and children or pets may accidentally consume thepoisonous liquid if it’s left unsecured.

While vaping is widely believed to be safer than inhaling tobacco smoke, it’s “not safer than just breathing clean air,” as Dr. Richard Hurt, former director of the Mayo Clinic’s Nicotine Dependence Center, said in a recent interview. Otherresearch in the U.S. suggests that smokers’ perception that e-cigarettes are less harmful is declining.

Still, many people report anecdotally that e-cigs help them trade a habit known to be deadly for one presumed to be less dangerous, even when other approaches failed. To the extent that e-cigs help people quit inhaling tobacco, the study says, “e-cigarettes may substantially improve public health because of their widespread appeal and the huge health gains associated with stopping smoking.”

May 30, 2014 by Michael Nicholson

New FDA E-cigarette Regulations: Killing an Industry, Killing Smokers

By Gilbert Ross, M.D.


If the FDA's proposed regulations go into force, the likely outcome is a severe reduction in consumer choice, and thus fewer smokers quitting and more dying needlessly.

At last, after months of anticipation, the FDA finally unleashed the proposed regulatory plan — the “deeming regulations” — that the drug agency will apply to electronic cigarettes (ecigs). If these regulations go into force — and that may take years — the likely outcome is a severe reduction in consumer choice, and thus fewer smokers quitting and more dying needlessly.

The devil in the 241-page long proposed regulations is the requirement for new tobacco products to get what amounts to pre-market approval via a “new tobacco product application” (NTPA). The FDA estimates that such NTPAs will require thousands of man-hours of data collection and hundreds of thousands of dollars or more, a burden few current ecig companies will be able to survive.

The irony is that older, less reliable ecig products are grandfathered in. The Family Smoking Prevention and Tobacco Control Act (FSPTCA), the 2009 law which devolved tobacco oversight to the FDA, specifies February 15, 2007 as the cut-off date for grandfathered products: any ecigs on the market as of that date are automatically approved. Newer products can get approval by piggy-backing on those older products, if a company can show to the FDA’s satisfaction that a newer product is essentially equivalent to a grandfathered product, but perhaps only 1 percent of all ecigs and vapor products will qualify. For both the older, grandfathered products as well as new products, it’s unclear what type or level of change will trigger the NTPA requirement: it may be a modification as minor as a new flavor or an improved battery.

Some ecig marketers will likely have the wherewithal to play the FDA’s regulation game and come out the other side: those sold by the Big Tobacco companies, all of whom are either in the reduced-harm ecig market, or soon will be. Big Tobacco companies, and perhaps a few of the bigger ecig companies, have the financial resources and the regulatory expertise to get their products approved to remain on the market.

While the proposed regulations are not as catastrophic as they might have been — if the agency had deemed the devices as medicines, requiring years of clinical trials, the whole market would have shut down for years — the slow-motion strangling of this vibrant and innovative technology may have been written in the federal code.

 

The truly tragic aspect of these regulations is that the heavy hand of government is coming down on the neck of a product with huge potential to be a groundbreaking technology in the long, bitter fight against cigarette smoking. While the FDA trumpets its “success,” thanks to the FSPTCA and the “public health” nonprofits warning smokers to stay the course and stick with ineffective FDA-approved cessation aids, the war on smoking has nearly ground to a halt: The CDC’s own datasheets show that the smoking rate has fallen 3 percentage points over seven years (from 21 percent in 2005 to 18 percent in 2012).

The real problem facing responsible public health authorities remains today as it has been for decades: how to reduce the toll of preventable deaths from smoking. Half of smokers try to quit each year, yet less than one in ten succeed. Forty-two million smokers remain addicted, among whom almost half a million succumb to smoking-related illnesses each year (and another 8 million or so suffer from smoking-related illnesses). The FDA-approved cessation aids “succeed” only slightly more often than cold-turkey quitting, so eventually half of all smokers will succumb to their habit. Yet, despite these inconvenient facts, the CDC and the FDA stick to the same line: “Keep on using only the FDA-approved products, do not even try ecigs.” This amounts to a “quit or die” fundamentalist philosophy: smokers should not only quit, but according to the authorities, they must quit “in the right way,” abstinence only.

 

Over its five-year existence, the FSPTCA has accomplished little other than erecting barriers to the entry of truly effective new cessation products, such as ecigs. When a promising alternative product such as the ecigarette comes along, the FDA expends vast amounts of energy trying to contain this technology and impede truthful discussion of it, instead of figuring out how to make it more accessible to desperate smokers. Ecigs or “vapor products” have shown promise in helping addicted smokers finally quit. They provide smokers’ craved drug — nicotine — along with many of the comforting rituals of smoking, but without the toxins and carcinogens in the deadly, addictive products of tobacco combustion: the smoke. Last century, the tobacco control movement, including the FDA and the CDC, fought Big Tobacco’s duplicitous manipulation of science. Big Tobacco sought to distract the public from the obvious fact: cigarettes are deadly. Today, it is the tobacco control movement whose messages are laden with misinformation and distortions of their own data, aiming to scare smokers away from ecigs.

On a more positive note, the FDA did manage to ignore the hysterics from some politicians about nicotine poisoning and child-friendly flavors ostensibly seducing young people into a lifetime of nicotine addiction and smoking. Nor did the FDA address advertising or Internet sales: both hot-button issues would have clearly approached or transgressed constitutional dicta and spurred litigation, delaying implementation for years.

One possible upside of the long-delayed publication of the FDA regulations is that they might form the basis for more forceful resistance to the plague of restrictions and bans being contemplated in various cities and states against ecigs — lately including New York state. One rationale given by local and state health officials advocating banning ecigs or sending vapors outdoors is the perceived “regulatory vacuum” at the federal level. Now that vacuum is on the way towards being filled (for example, the tobacco center wisely ruled that minors should not be allowed to purchase ecigs; several cities and states have come to the same conclusion).

Given these new proposed regulations, what will the ecig and vapor landscape look like several years hence? Desperate, addicted smokers who might have been released from cigarette bondage via these devices may find the cupboard bare. And who will be left standing at the end of this bureaucratic nightmare? A few of the biggest ecig companies, most likely — and almost definitely, the relatively new players in the ecig business: Big Tobacco. So the new regulations will harm smokers and deliver most of the ecig market into the waiting arms of Big Tobacco. One wonders if this is the result those who crafted the FSPTCA wanted to see.

How did we come to this state, where the most benign, effective product for nicotine delivery became the prime target of over-zealous, destructive regulation? The urge to regulate first and evaluate the scientific data later must be resisted.

If these regulations go into force, the likely outcome is a severe reduction in consumer choice, and thus fewer smokers quitting and more dying needlessly. It is not too late for the FDA to issue a course correction after reviewing the thousands of public comments it is sure to receive between now and the July 9 deadline. If enough public health experts and ex-smoking vapers write in, maybe the agency will see the error of its ways and use its vast powers to exempt more vapor products from these oppressive requirements.

Dr. Gilbert Ross is the executive and medical director of the American Council on Science and Health, a public-health nonprofit.

May 15, 2014 by Michael Nicholson

First Call to Action for FDA Proposed Regulations - Consumer Request for an Extension of Comment Period

Through forums, Facebook groups, blogs and websites, US vendors and vapers alike are spreading a call to action. They are requesting an extension to the "grossly inadequate" 75 day comment period on the FDA's proposed regulations.

 

On Thursday, May 8th, CASAA released the Overview of its Action Plan Regarding Proposed FDA Regulations. This is the first of several Calls to Action anticipated in CASAA's Action Plan. (You will recall from the Action Plan that we are not going to publish our suggestions for substantive comments until a few weeks before the deadline, and we urge consumers to wait until then to offer substantive comment.)

FDA, which took more than three years to issue its 241-page Proposed Regulation (and accompanying 81-page regulatory impact analysis), has given us a mere 75 days to comment. While responding in that timeframe is challenging under any circumstances, the FDA has also posed, by our count, 99 requests for information about THR products (this does not include repeat questions or questions specifically pertaining to cigars). Given the length of time FDA has taken to release the proposed regulations, the massive amount of information FDA is requesting, the length of the document itself, and the devastating impact these regulations will have on a product that is estimated to be approximately 99% less hazardous than combustibles, the 75-day comment period is grossly inadequate.

The First Call to Action is for CONSUMERS to request a 105-day extension of the comment period, requesting a total of 180 days to make comments. We understand that SFATA, AEMSA, and other industry groups will be providing similar guidance for vendors and manufacturers.

We have prepared a suggested letter--which we encourage you to edit to accurately reflect your views and circumstances--along with instructions on how to request the extension. (Please note that submitting this request will not prevent you from later offering a substantive comment, and should not affect your subsequent comment in any way.)


I.
SUGGESTED LETTER REQUESTING EXTENSION
YOU SHOULD EDIT AS APPROPRIATE

Dear Mr. Zeller:

I am writing as an individual consumer to request an extension of the comment period for the Food and Drug Administration's ("FDA") Proposed Rule Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking and Prevention and Tobacco Control Act (the "Proposed Rule") published at 79 Fed. Reg. 23,142 and Federal Register No. 2014-09491. On behalf of myself, I am requesting that the comment period for the Proposed Rule be extended by the FDA for an additional 105 days, from its current 75-day period, to 180 days.

The Proposed Rule raises a number of significant issues and questions that are important and relevant to me, as a consumer of products that are proposed for regulation under the Proposed Rule. The Proposed Rule asks about a hundred different questions I might want to respond to. I want to provide my thoughts and comments on many of these issues, but my time to devote to researching and providing thoughtful comments on these important questions is limited. I have already spent many hours researching and dissecting these issues, but they take time. I know that the FDA took many years to even come up with the Proposed Rule, so I do not think it is at all unreasonable to allow the public a mere six months to comment on it. This is our only opportunity, as consumers, to provide our feedback.

I feel very strongly about e-cigarettes as an alternative to combustible cigarettes. Quite simply, I firmly believe that they saved my life. I wish to provide you with my personal story, as well as science- and evidence-based responses to your questions so that you can take my comment into account. I realize that the FDA has the authority under 21 CFR 10.40 to extend this time frame and that the FDA has exercised this authority on numerous occasions in the past. I would therefore ask that you do so here, so that all stakeholders have the opportunity to provide their comments on this proposed regulation.

I appreciate your consideration of my request and am happy to discuss this issue with you further.




II.
INSTRUCTIONS ON HOW TO MAKE THE REQUEST


Create a document with your comment. You can use the above sample letter as a template and edit to make it your own.
Access the comment form for the deeming regulation (FDA-2014-N-0189-0001): FDA Comment Form
Click in the Comment field and copy and paste your comment from Step 1 into the box.
Click in the First Name field and type your first name.
Click in the Last Name field and type your last name.
If you wish to allow FDA to contact you, click to check the "I want to provide my contact information" box. Otherwise, leave this box unchecked. When you check this box, fields are displayed for you to enter your ZIP code and email address.
Click to uncheck the box, "I am submitting on behalf of a third party."
Click the arrow next to the "Category" field to display a menu.
Select a category from the menu. We recommend "Individual Consumer" for individuals wishing to request an extension personally and not on behalf of any business or group.

NOTE: FDA has traditionally taken the position that "Individual Consumer" comments will not be published on the Regulations.gov website due to privacy concerns. There has been some criticism of this position, and FDA has indicated that it will be publishing "Individual Consumer" comments on the website, although it intends to only publish the individual's first name. Any identifying information you provide in the Comment field will potentially be visible on the website, so we recommend that you NOT include your name, address, phone number, or email address in the Comment field.
Click the Continue button. After clicking on the Continue button, you will have an opportunity to review your statement and, if you wish, edit it. (The Edit button is just to the right of the Submit Comment button in the lower right-hand side of the page.)
On the Your Preview page, click to check the box "I read and understand the statement above."
Click the Submit Comment button.
After submitting your comment using the comment form, a confirmation page will appear with your Comment Tracking Number. We recommend that you print the page AND email this comment number as directed in Step 14 below. (You may wish to copy the entire page into an email to yourself, which you can then forward as directed in Step 14 below. Copying the entire page and emailing it to yourself will ensure that you have a copy of your comment and comment number.)
Please send the comment number to casaa.fdacommentarchive@gmail.com. It is important that CASAA have a count of how many such requests have been made. (You may, if you wish, include a copy of your comment, but that is not necessary because all we really need is the comment number.)

 

http://blog.casaa.org/2014/05/first-call-to-action-for-fda-proposed.html

May 13, 2014 by Michael Nicholson