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Understanding REACH - European Union chemical regulation October 28 2016

The following information was made available by ECHA. ECHA is The European Chemicals Agency. Click here for more info about REACH.

Understanding REACH

REACH is a regulation of the European Union, adopted to improve the protection of human health and the environment from the risks that can be posed by chemicals, while enhancing the competitiveness of the EU chemicals industry. It also promotes alternative methods for the hazard assessment of substances in order to reduce the number of tests on animals. 

In principle, REACH applies to all chemical substances; not only those used in industrial processes but also in our day-to-day lives, for example in cleaning products, paints as well as in articles such as clothes, furniture and electrical appliances. Therefore, the regulation has an impact on most companies across the EU.

REACH places the burden of proof on companies. To comply with the regulation, companies must identify and manage the risks linked to the substances they manufacture and market in the EU. They have to demonstrate to ECHA how the substance can be safely used, and they must communicate the risk management measures to the users.

If the risks cannot be managed, authorities can restrict the use of substances in different ways. In the long run, the most hazardous substances should be substituted with less dangerous ones.

REACH stands for Registration, Evaluation, Authorization and Restriction of Chemicals. It entered into force on 1 June 2007.

How does REACH work?

REACH establishes procedures for collecting and assessing information on the properties and hazards of substances.

Companies need to register their substances and to do this they need to work together with other companies who are registering the same substance.

ECHA receives and evaluates individual registrations for their compliance, and the EU Member States evaluate selected substances to clarify initial concerns for human health or for the environment. Authorities and ECHA's scientific committees assess whether the risks of substances can be managed.

Authorities can ban hazardous substances if their risks are unmanageable. They can also decide to restrict a use or make it subject to a prior authorization.

REACH's effect on companies

REACH impacts on a wide range of companies across many sectors, even those who may not think of themselves as being involved with chemicals.

In general, under REACH you may have one of these roles:

Manufacturer: If you make chemicals, either to use yourself or to supply to other people (even if it is for export), then you will probably have some important responsibilities under REACH.

Importer: If you buy anything from outside the EU/EEA, you are likely to have some responsibilities under REACH. It may be individual chemicals, mixtures for onwards sale or finished products, like clothes, furniture or plastic goods.

Downstream users: Most companies use chemicals, sometimes even without realising it, therefore you need to check your obligations if you handle any chemicals in your industrial or professional activity. You might have some responsibilities under REACH.

Companies established outside the EU: If you are a company established outside the EU, you are not bound by the obligations of REACH, even if you export their products into the customs territory of the European Union. The responsibility for fulfilling the requirements of REACH, such as pre-registration or registration lies with the importers established in the European Union, or with the only representative of a non-EU manufacturer established in the European Union.


E-cigarette maker files for bankruptcy September 20 2016

NJOY, one of the biggest electronic cigarette makers, is going up in smoke.

The company filed for bankruptcy protection on Sept. 16 in Delaware federal court, burning some high-powered Silicon Valley investors, including Sean Parker, co-founder of the now-defunct Napster, and PayPal founder Peter Thiel, who were part of a $70 million capital round that valued NJOY at $1 billion in 2013. Singer Bruno Mars is also an investor in NJOY and a fan of the e-cigarettes, which heat nicotine-laced liquid into vapor.

Parker, who ponied up $10 million to put into the company, said at the time that electronic cigarettes had the potential to make regular cigarettes “and all the harm they cause obsolete.”

The filing comes just five months after new federal regulations from Food and Drug Administration threaten the fast-growing multibillion-dollar industry that includes tobacco giants Altria and Reynolds, which own MarkTen and Vuse, respectively.

The Scottsdale, Ariz.-based firm is the first e-cigarette company to file for bankruptcy, according to Jude Gorman, general counsel at Reorg Research. “All of the e-cigarette companies are affected by the regulations, but NJOY has a lot of debt it can’t pay.”

It has an accumulated deficit of $234.4 million, according to the filing. NJOY also solicited buyers, hiring Barclays in January, but it had no takers.

Among its biggest downfalls was a product called King, disposable e-cigarettes that generated a lot of product returns. Gross sales of King declined to $7.4 million last year from a peak of $93 million in 2013, according to the filing.

 


Beginning of the ENDS August 07 2016

What are ENDS?

Starting August 8th, the vaping industry is entering the era of ENDS (Electronic Nicotine Delivery System). This marks a new chapter in the vaping industry as the FDA subjects ENDS to its authorities. Under this final rule, ENDS as well as its components and parts such as e-liquids, will be considered a Tobacco Product. ENDS, of which electronic cigarettes are the most common prototype, are devices that do not burn or use tobacco leaves but instead vaporize a solution the user then inhales.
 
Rest assured, Liquid Barn is working diligently to make sure our products receive market authorization, and will also be providing the FDA with Master Files for all of our affiliate business clients to use for submission of their product’s market authorization.
 
Final rule deems all products meeting the statutory definition of tobacco product, including components or parts to be subject to FDA’s tobacco product authorities.

Click here for more information about important dates to know.

Click here for more information on the FDA’s New Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products.

Deemed Products include, but are not limited to:

ENDS Liquid Barn FDA deeming regulation

 
ENDS (Electronic Nicotine Delivery System)
  • eCcigarettes
  • eCigars
  • eHookah
  • Vape pens
  • Personal vaporizers
  • Electronic pipes
 
Cigarettes
  • Combusted, Filtered
  • Combusted, Non-Filtered
  • Combusted, Other
  • Non-Combusted
 
Roll-Your-Own Tobacco Products
  • Roll-Your-Own Tobacco Filler
  • Rolling Paper
  • Filtered Cigarette Tube
  • Non-Filtered Cigarette Tube
  • Filter
  • Paper Tip
  • Roll-Your-Own Co-Package
  • Other
 
Smokeless Tobacco Products
  • Loose Moist Snuff
  • Portioned Moist Snuff
  • Loose Snus
  • Portioned Snus
  • Loose Dry Snuff
  • Dissolvable
  • Loose Chewing Tobacco
  • Portioned Chewing Tobacco
  • Smokeless Co-Package
  • Other
 
Cigars
  • Filtered, Sheet-Wrapped Cigar
  • Unfiltered, Sheet-Wrapped Cigar
  • Leaf-Wrapped Cigar
  • Cigar Component
  • Cigar Tobacco Filler
  • Cigar Co-Package
  • Other
 
Pipe Tobacco Products
  • Pipe
  • Pipe Tobacco Filler
  • Pipe Component
  • Pipe Co-Package
  • Other 

With the most trusted name in vaping, your safety and satisfaction is important to us.

ENDS Liquid Barn FDA deeming regulation


Winter is coming... August 05 2016

On August 8 2016, the FDA's strict new rules & regulations for the vaping industry will go into effect. 

You can find a complete list of new legislation here, but here’s what matters to you now:

Winter is coming

August 8 marks the beginning of the “Freeze Period.” All ENDS (Electronic Nicotine Delivery Systems) must be submitted to the FDA for clearance before then, or face stiff penalties. No new/unregistered products can be sold after this date.

No need to worry

Whether you use Liquid Barn liquids in your eLiquid or your favorite recipe, rest assured that the product you’re enjoying is of the absolute best quality and will continue to be available to you. Before these new FDA measures were even in place, Liquid Barn was – and will continue – complying with all regulations.

Our Commitment

We’ve taken extra measures to surpass the guidelines by working closely with industry leaders, regulatory firms, and work groups set in place to meet with the FDA/CTP.

Your safety and satisfaction is important to us. As the most trusted name in vaping, we guarantee it’ll stay that way.

For Tastemakers

Liquid Barn is here to give you the creative control of your vaping experience.

Whether you’re a DIY’er, a casual user, or a frequent vapor, we want you to customize your experience and take control.

YOU are the Tastemaker.

What’s next

We'll continue to keep you updated as the FDA implements these changes. More than just compliance – we have some great updates ahead.

In the coming weeks, you’ll also notice a few changes to our products and site. Stay tuned.

Thank you for your loyalty.


This Caused Smoking to Drop 10% in a Year; Why Isn’t the CDC Cheering July 15 2016

By Brad Rodu

The Centers for Disease Control and Prevention’s 2015 National Health Interview Survey – the source for national smoking estimates – reveals surprising e-cigarette facts, summarized in the chart below.

The figures demonstrate a 7 percent drop in current vapers from the 8.9 million reported in 2014 (here), due largely to a 29 percent decline in the number of current smokers who vape. In the NHIS survey respondents were current smokers and/or vapers if they used products every day or some days. In both years, 22-23 percent of current smokers vaped every day; the rest reported vaping, on average, about 7.7 days in the past month.

Year to year, the number of former smokers who vape increased 26 percent, from nearly 2 million in 2014, to almost 2.5 million in 2015. The majority of former smokers (63 percent in 2014, 66 percent in 2015) vaped daily.  Former smokers who vaped some days averaged 7.8 days in the past month.  

Vaping US 2014-2015

In 2015, there were nearly 1 million current vapers who had never smoked cigarettes, a 61 percent increase from the previous year. Most of this group vaped only on some days (5.5 days in the past month), although daily vaping increased from 16 percent in 2014, to 21 percent in 2015.

As for cigarette smoking, the NHIS recorded a large decline in prevalence, from 16.8 percent in 2014, to 15.1 percent in 2015 – a 10 percent drop in just one year.

As I noted previously (here), in 2014 the number of Americans who smoke dropped below 40 million for the first time in the 50 years that the NHIS has provided smoking statistics.  In 2015, that number declined further, to 36.5 million.

The fact that there were 2.5 million former smokers using e-cigarettes in 2015 does not prove that vaping is driving the steep decline in smoking. Similarly, the data fails to prove the claim that vaping is “renormalizing” smoking. 

So what is responsible for the sharp decline in smoking prevalence?  This table points to one possible contributing factor:

Prevalence (%) of Current Smoking in the U.S. According to Age, National Health Interview Surveys 2014-2015
Age (years) 2014 2015 Change
18-24 16.7 13.0 -22%
25-34 20.6 18.1 -12%
35-44 19.5 17.4 -11%
45-54 19.3 18.3 -5%
55-64 16.7 15.5 -7%
65-74 11.3 11.1 -2%
75-84 5.6 5.7 +2%
85+ 2.0 1.7 -18%
All 16.8 15.1 -10%

The largest single-year decline in adult smoking was seen in the youngest age group, and it follows the substantial recent decline in teen smoking reported in this blog (here) but ignored by the CDC and other federal agencies. The 13 percent smoking rate among 18-to-24-year olds in 2015 represents a decline of almost half from 24.4 percent in 2005. This will eventually translate into significant public health gains, as lower smoking rates among young adults today will result in lower smoking-attributable disease and death rates in the future.

Note that my previous research showed that NHIS-derived smoking rates may be underestimates (here), because they are always lower than those calculated from other federal surveys such as the National Survey on Drug Use and Health. For example, in 2012 there were 10 million fewer smokers reported in NHIS than in NSDUH (here). 

The inescapable fact is that e-cigarettes, used by, among others, 2.5 million former smokers, are not impeding the dramatic, welcome decline in cigarette smoking.

###

*Research note:
Information about e-cigarette use was missing for 6 percent of respondents in the 2015 NHIS, so population estimates were adjusted accordingly. 

I would like to thank Carl Phillips for his insights and assistance with this post.

Republished from Tobacco Truth: How Many Americans Vape? CDC Data Show Fewer Vapers & Smokers in 2015


POV: New FDA Regulations on Vaping Products a Failure July 15 2016

They do not protect public’s health, do impose a public safety hazard

On May 5, the US Food and Drug Administration (FDA) released its long-awaited regulations on electronic cigarettes and vaping products. These rules, which require every one of the more than 10,000 vaping products on the market to submit a pre–market approval application simply to stay on the market, were widely applauded by antismoking and health groups. What may not have been apparent at the time, but what I have discovered through a detailed analysis of the 499-page regulations, is that these regulations not only fail to protect the public’s health, but they impose a public safety hazard.

One key hallmark of the FDA regulations is that as of August 8, 2016, no new vaping products will be allowed on the market. Because the FDA considers virtually any change in a product to constitute a new product, this means that the deeming regulations will essentially freeze the vaping market as it exists on August 8. From that date forward, not only will companies not be able to introduce new products, but they will also be unable to make changes in their existing products. Such changes would require a new product application, which is prohibitively expensive for most companies. Moreover, these regulations will discourage companies from undertaking any revisions to their products.

And therein lies the problem. In prohibiting all changes in existing products, the FDA is specifically prohibiting even critical safety improvements that may be necessary to address reported safety hazards.

To be clear, even small changes in products will not be allowed. For example, changes to the battery will not be allowed. If a company wanted to change to a new type of battery in a rechargeable model it produces so the risk of battery explosions is reduced, this will not be allowed because it would represent the introduction of a new tobacco product into the market for interstate commerce. Similarly, if a company wanted to change its propylene glycol supplier and use a purer grade of propylene glycol to prevent diethylene glycol—a poison—from getting into the e-liquid, this would also be prohibited.

In essence, the FDA is freezing all defective batteries, impure e-liquids, and overheating coils, preventing companies from addressing these impending safety hazards. Far from protecting the public’s health, the FDA is putting the public’s safety at great risk.

I can think of no other consumer product manufacturer that is prohibited by federal regulators from introducing critical safety improvements to its products. This demonstrates just how nonsensical these regulations are.

But the lack of common sense doesn’t end there. By banning new and improved products from the market, the FDA is going to greatly stifle product innovation, thus ensuring that the products that remain on the market are the most hazardous and least effective vaping products possible. After all, it is through product innovation that the e-cigarette industry would have been able to refine vaping products to make them even more effective for smoking cessation and to reduce their associated health risks to even lower levels than now exist.

This is obviously not in the interests of protecting the public’s health. To the contrary, it actually introduces safety concerns that would not otherwise have been present if companies were permitted to make improvements in their products without preauthorization.

However, the most nonsensical aspect of the e-cigarette regulations is the way they protect the sales of the real tobacco cigarettes that are killing hundreds of thousands of Americans each year. While easily tens of thousands of vaping products will be required to submit onerous, expensive applications estimated to cost no less than $1 million each, what will cigarette manufacturers—like the makers of Marlboro, Camel, Newport, and Kool—have to do?

The answer: absolutely nothing.

The FDA has grandfathered these products in, meaning that they can continue on the market without having to spend one dime on an application to stay on the market. It is only their competitors—much safer e-cigarettes—whose very existence is being threatened by these onerous and misplaced regulations. The FDA could have done no greater favor to the continued profits of manufacturers of toxic tobacco cigarettes.

What makes the tragic consequences of the FDA regulations most unfortunate is that there is an effective alternative that would protect the public safety from e-cigarette hazards while at the same time allowing these products to compete with combustible tobacco products in order to save lives. That approach is to treat electronic cigarettes as consumer products, not as tobacco products, and to directly set uniform safety standards for these products—standards that address battery safety, overcharge protection, temperature control, safety of flavorings, and basic quality control and manufacturing safety. Congress must act quickly to carve out such a separate regulatory framework for e-cigarettes. We need to reduce cigarette consumption in this country, not protect cigarettes from competition from a much safer alternative.

Michael Siegel, a School of Public Health professor of community health sciences, can be reached at mbsiegel@bu.edu.

“POV” is an opinion page that provides timely commentaries from students, faculty, and staff on a variety of issues: on-campus, local, state, national, or international. Anyone interested in submitting a piece, which should be about 700 words long, should contact John O’Rourke at orourkej@bu.edu. BU Today reserves the right to reject or edit submissions.


Why E-Cigarettes Explode, and How You Can Vape Safely June 21 2016

In 2015, a man was hospitalized with critical injuries after his e-cigarette exploded in his face. Another victim suffered severe burns on his hands, a hole in his tongue, and knocked out teeth. Here’s why and how e-cigarettes can literally blow up on you, and what you can do to minimize your risk.

Admittedly, to say that e-cigarettes “explode” sounds over the top, but this video shows that something is clearly catching on fire. This concern over fire and consumer safety prompted the U.S. Fire Administration (USFA) to conduct an investigation, which they published in late 2014, aptly titled Electronic Cigarette Fires and Explosions (PDF). The big caveat here is that their investigation rests on collected reports about e-cigarette accidents that occurred between 2009 and August 2014 (a total of 25).

The Battery In Your E-Cigarette Is The Big Problem

Most e-cigarettes are powered by a lithium-ion battery, and that’s where the fire danger comes from. Lithium-ion batteries are found everywhere, from our cell phones to our cameras to our hybrid cars. When you puff on an e-cig, a battery powers the heating element that then turns the chemical solution in the canister into a vapor. In other, more manual e-cigs, you have to press a switch to take a drag. Either way, a lithium-ion battery is involved.

We know that lithium-ion batteries can pose a fire hazard if left in certain pressurized areas, like the baggage compartment of a plane. In early 2015, theFederal Aviation Association prohibited e-cigs and other spare lithium-ion batteries from being kept in checked baggage. Under normal conditions though, the possibility of a lithium-ion battery failing is pretty darn low (about one in a million). In the rare instance it does, the USFA report explains:

During the typical failure mode for a lithium-ion battery, the electrolyte is heated to its boiling point, the internal pressure in the battery builds to a point where the seal at the end of the battery ruptures, and the pressure is abruptly released through the sealed end of the battery case.

However, the cylindrical design of e-cigs and its structurally weak end points make it a bigger fire risk.

When the battery seal (at the end of the battery) ruptures, the pressure within the e-cigarette cylinder builds quickly and instantly ruptures, usually at the end. As a result of the battery and container failure, one or the other, or both, can be propelled across the room like a bullet or small rocket. In contrast to e-cigarettes, the cylindrical lithium-ion batteries used in laptop computers and portable tools are contained in rigid plastic cases that are generally strong enough to prevent the failing battery from “rocketing” away. Fires do occur as a result of battery failure, but most fires initially involve only the device that the battery pack is installed in.

In general, lithium-ion batteries cause problems when they’re overheated from outside heat sources (like direct sunlight), short circuits, or overcharging. In 20 of the 25 cited incidents in the USFA report, the battery malfunctioned while the e-cigarette was plugged into a USB port and recharging.

Normally, batteries have safety features to prevent short circuits and overcharging. However, e-cigarettes typically have a USB port that appears to be compatible with any USB cable and charger. People often assume that any charger will do, including manufacturer-approved ones and other non-sanctioned, third-party ones, as long as it fits and the device responds, but that’s not the case.

According to the USFA and the Consumer Product Safety Commission (CPSC), charging an e-cigarette with non-approved power adapters “could subject the battery to a higher voltage than is deemed safe” and increase the risk of overheating (called thermal runaway). During thermal runaway, the battery can melt, radiating lots of heat, and the electrolytes can reach a boiling point...and well, you can probably guess what could happen next.

 

How You Can Minimize the Risk of an E-Cig Meltdown

The Food and Drug Administration (FDA) recently said they will regulate vaping. Although the emphasis is on the ingredients and packaging, the FDA’s expanded authority includes “components and parts”, including “certain batteries.”

The Federal Register confirms that the FDA has been concerned by reports of exploding e-cigarettes, and has provided a draft guidance on the safety requirements that companies will need to follow. For example, the FDA says that the product labeling should include text or a graphic to show users should recharge the product only with specified chargers to minimize the risk of battery failure. But as of right now, these guidelines haven’t been finalized yet.

In the meantime, you can keep yourself safe with a little more education. Most importantly, handle your e-cigarette batteries (or any lithium-ion battery, for that matter) with care. Here are a few key pointers:

  • Stick with the manufacturer’s provided charger: Always use the charging appliance that comes with the unit and follow the manufacturer’s instructions. This way, you know the battery is compatible with the charger. Avoid leaving it connected to the charger overnight.
  • Be careful about what you plug your e-cig into: Avoid plugging the e-cig into any old USB port. The manufacturer’s user manual usually includes technical specifications for the proper voltage.
  • Buy from reputable companies and suppliers: There are a lot of homemade “mods”, or basically DIY, low-cost modifications of e-cigs. This isn’t exactly the safest way to go because homemade mods simply may not have the built-in safety mechanisms to prevent overheating.
  • Check to see if the battery is “safe”: The battery shouldn’t be more powerful than what the device is designed for. Plus, there are different quality of batteries. Poorly manufactured, low-cost, counterfeit ones typically do not perform as well and would be more likely to have problems. Internet forums like this one in Planet of the Vapes often share information on product recalls, safety notices, and what batteries not to buy.
  • Take care of your battery: The Ashtray blog (full disclosure, the blog is a subsidiary of a site that sells e-cigs) suggests that you clean the battery and terminal contents with tissue or alcohol wipes if it’s dirty. When you’re not using the e-cigarette, be sure to turn the battery off. Finally, they recommend that you don’t over tighten when attaching the battery to your clearomizer (the clear plastic or glass body of an e-cig if that’s the kind you have). If you suspect damage to your battery, get a new one or take it to an electronics service center for inspection.

In case a battery overheats, Battery University recommends moving the deviceaway from other flammable objects (if it’s safe to handle) and placing it on a hard, non-combustible surface. If it’s even possible, remove the battery and let it “burn out” outdoors. If a fire occurs, grab a fire extinguisher (only if it’s a lithium-metal battery) or just use water or another non-alcoholic liquid (soda works!) to prevent the fire from spreading.

Not all battery failures can be prevented, but the likelihood of an e-cigarette battery failing is statistically low. Still, with the growing popularity of vaping (last count was more than 2.5 million Americans, according to the USFA report), it is a very real possibility. If you vape, vape with care.


How Will The New FDA Ruling On E-Cigarettes Help Altria? June 02 2016

Trefis Team
Trefis Team, Contributor

As a result of a dramatic rise in e-cigarette usage among youths between 2011 and 2015, the FDA passed a ruling to limit the e-cigarette industry. While the rule prohibiting the sale of e-cigarettes to minors has been well received, there are doubts whether the other regulations may inadvertently benefit the big tobacco companies.

Screen Shot 2016-06-01 at 9.15.52 pm

Small producers of vaping devices, which are battery operated devices that turn nicotine into inhalable vapor, may not be able to bear the costs associated with the approval process initiated by the FDA. However, larger companies, such as Altria, would be able to easily afford these expenses. These rules are stated to go into effect on August 8, 2016. While the e-cigarette companies have two years to submit their product applications to the FDA, they must wait a year after that for a review by the agency. This applies to all products which were introduced after 2007, which includes nearly all of them. Details on all ingredients and their production process have to be submitted, along with any health risks associated with the device and whether the product “presents less risk than other tobacco products.” Many companies have more than one vaping product that they sell; this would mean incurring costs which run into millions.

Screen Shot 2016-05-30 at 2.25.07 pm

Bonnie Herzog, managing director of Beverage, Tobacco, and Convenience Store Research for Wells Fargo, also recommended a buy on tobacco companies as a result of the FDA regulations. Even if small manufacturers are able to meet the requirements, they would be forced to pass the cost on to their customers. This increase in the price of the product would end up reducing the savings smokers receive by switching to e-cigarettes, which is one of the main reasons cited for switching. Not only will the FDA regulations kill off the smaller producers, it would also increase the barriers to entry. Many fear that it would also stifle innovation, which would not only be harmful to the companies, but also for public health. A study conducted by the Department of Health in the U.K. stated that reduction in the choice available for consumers may lead to the development of a black market with potentially harmful e-cigarette products. Such regulations also go against a report published by the U.K.’s Royal College of Physicians, wherein it was stated that the use of e-cigarettes should be promoted in the interest of public health.

Have more questions on Altria? Have a look at the link below:


Why Deleting The FDA’s Ban Of E-Cigarette Flavors Is Good For Public Health June 02 2016

Why Deleting The FDA’s Ban Of E-Cigarette Flavors Is Good For Public Health

In what should be taken as a note of common sense amid the highly contentious debate surrounding the Food and Drug Administration’s oversight of tobacco products, reports have surfaced that the White House intervened to delete sections of draft FDA regulations promulgated early last month that would have required flavored e-cigarette liquids be removed from the market almost immediately.

This is good news. As I detailed in a recent policy study for the R Street Institute, vapers use flavors to help sustain the level of nicotine they derive from e-cigarettes. Many vapers rotate flavors through the day to allow them to continue vaping. And most importantly, these vapers report that without flavors, they are likely to return to smoking.

This is crucial, because evidence demonstrates that e-cigarettes pose less than 5 percent of the risk of potentially fatal illness presented by combustible tobacco cigarettes. Encouraging smokers to switch to e-cigarettes offers the opportunity to improve public health outcomes tremendously.

Nonetheless, some in the U.S. public health community point to what they allege is selective marketing of e-cigarettes to young people, and focus in particular on the role of flavors they say are targeted at children. The proposed FDA rules wisely address this concern by requiring that e-cigarettes may not be sold to children in any state. But proposals to remove flavored e-liquids from the market are misguided.



Read more: http://dailycaller.com/2016/06/02/why-deleting-the-fdas-ban-of-e-cigarette-flavors-is-good-for-public-health/#ixzz4ASvtAesX

For one thing, surveys of confectioners and candy makers reveal that there is no such thing as “children’s flavors,” per se. E-cigarette flavors identified by critics as attractive to children are by no means the most popular with that audience. And there is no evidence that curiosity about a specific flavor has compelled children to try e-cigarettes. Despite this lack of evidence, the FDA recommended a ban on flavoring in their original submission to the White House.

With the change in the rules, flavored e-liquids will join other vaping products in enjoying a two-year grace period, during which their manufacturers may submit marketing applications to continue to sell their products. Without the change made by the White House Office of Management and Budget as part of the interagency review process, flavored e-liquids would have had a grace period of only 90 days.

The news highlights radically divergent paths taken by health regulators on both sides of the Atlantic with regard to the role of e-cigarettes in smoking cessation and tobacco harm reduction. In the United Kingdom, e-cigarettes are dispensed by the National Health Service. Meanwhile in the United States, e-cigarette products introduced since February 2007 – representing almost 99 percent of the market – could effectively be banned within two years under the current FDA regulations.

The U.S. House currently is considering H.R. 2058, legislation that seeks to modify the “grandfather” date for products included in the current FDA regulations. One hopes that Congress would go one step further and amend the FDA tobacco law in a way that would mandate the FDA to consider the substantial public health benefits that e-cigarettes offer both to current smokers and to teens who otherwise would become lifelong smokers.

By deleting references to flavor in the otherwise exhaustive FDA regulations, the White House has shown a degree of insight into an important public health problem. Adult smokers could benefit from flavors in e-cigarettes.

Read more: http://dailycaller.com/2016/06/02/why-deleting-the-fdas-ban-of-e-cigarette-flavors-is-good-for-public-health/#ixzz4ASve4lJU


NEJM Commentary Written by Anti-Tobacco Researchers Hides Conflicts of Interest with Big Pharm October 10 2015

Thursday, October 01, 2015

An article published today in the New England Journal of Medicinediscusses the results of a clinical trial of low-nicotine cigarettes for reducing smoking. The article recommends that low-nicotine cigarettes should be a part of a national strategy to reduce tobacco use. However, it fails to recommend that electronic cigarettes be considered as a part of this strategy, even though e-cigarettes are much more effective in getting smokers to cut down on the amount they quit, much more effective in getting smokers to quit completely, and much safer. But e-cigarettes are a threat to pharmaceutical companies that manufacture smoking cessation drugs. Therefore, readers may naturally be curious whether the authors of this commentary have any history of financial conflicts of interest with pharmaceutical companies.

Fortunately, readers can be rest assured that there were no relevant conflicts to disclose. Both of the co-authors - Dr. Michael Fiore and Dr. Timothy Baker - completed disclosure forms indicating that they have nothing to disclose, which implies that there is no relevant history of financial relationships of any of these authors with pharmaceutical companies.

Specifically, in completing section 5 of the form, each of the authors proclaimed that there were: "No other relationships/conditions/circumstances that present a potential conflict of interest." This section refers to financial interests that were not disclosed earlier in the form. The disclosures earlier in the form relate to financial interests present during the past 36 months. Importantly, however, the additional disclosures in section 5 do not have any stated time frame. The directions indicate that authors must "use this section to report other relationships or activities that readers could perceive to have influenced, or that give the appearance of potentially influencing, what you wrote in the submitted work."

Since both authors indicated in section 5 that there are no other relationships or activities that readers could perceive to have influenced their work, we are led to believe that neither of these authors has any significant history of financial relationships with Big Pharma.

The Rest of the Story

The rest of the story is that both authors are hiding relevant financial conflicts of interest with Big Pharma that I believe should have been disclosed in the paper.

Dr. Fiore

The truth is that Dr. Fiore actually has a long history of significant financial relationships with pharmaceutical companies that manufacture smoking cessation drugs, none of which are acknowledged in his disclosure. Here is what is being hidden from readers:

1. According to his own 2008 JAMA article: "In the past 5 years, Dr Fiore reports that he has lectured and consulted for Pfizer and has served as an investigator on research studies at the University of Wisconsin (UW) that were supported by GlaxoSmithKline, Nabi, Pfizer, and sanofi-aventis."

2. According to his own sworn testimony, at the time of his chairing in 2008 of an expert NIH panel to make recommendations about the recommended clinical strategies for promoting smoking cessation, Dr. Fiore received up to $50,000 in annual resources from GlaxoSmithKline to support his educational, research, and policy activities.

3. In 2006, Dr. Fiore acknowledged that "I have done some consulting work for pharmaceutical companies over the years. Over the past five years, my outside consulting work on an annual basis has ranged between about $10,000 and $30,000 or $40,000 per year."

4. In 1998, the University of Wisconsin appointed him to a named chair, made possible by an unrestricted gift to the University from GlaxoWellcome.

5. In the past, "Dr. Fiore has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Ciba-Geigy, SmithKline Beecham, Lederle Laboratories, McNeil Consumer Products, Elan Pharmaceutical, Pharmacia, and Glaxo Wellcome."

6. Dr. Fiore directs a tobacco research center that received nearly $1 million in funding from makers of quit-smoking medicine in 2004 and $400,000 in 2005.

7. In a recent set of two articles on treatment for smoking cessation published in the Annals of Behavioral Medicine in April 2011 (article 1; article 2), the conflict of interest statement regarding Dr. Fiore acknowledges that: "Over the last 3 years, Michael C. Fiore served as an investigator on research studies at the University of Wisconsin that were funded by Nabi Biopharmaceuticals."

8. In a December 2010 article on treatment for smoking cessation published in the Wisconsin Medical Journal, the conflict of interest statement regarding Dr. Fiore acknowledges that: "Over the last 3 years, Dr Fiore has served as an investigator in research studies at the University of Wisconsin that were funded by Pfizer and Nabi Biopharmaceuticals."

Amazingly, none of these conflicts of interest are reported in the paper and the reader has no way of knowing this long history of financial conflicts of interest with Big Pharma. I imagine that most readers would be shocked to find out about this intense and long history of financial conflict with Big Pharma, given that Dr. Fiore reported no conflicts of interest.

Dr. Baker

The truth is that Dr. Baker also has a long and significant history of financial relationships with pharmaceutical companies that manufacture smoking cessation drugs. Here is what is being hidden from readers:

1. In 2008, Dr. Baker reported that: "he has served as a co-investigator on research studies at the University of Wisconsin that were sponsored by four pharmaceutical companies."

2. In 2000, Dr. Baker disclosed as follows: "Timothy Baker has served as a consultant for, given lectures sponsored by, or has conducted research sponsored by Elan Pharmaceutical, SmithKline Beecham, Glaxo Wellcome, and Lederle."

3. As recently as 2012, Dr. Baker disclosed in an article that his research involved financial support from GlaxoSmithKline in the form of free medication provided to study participants.

4. In another 2012 paper, Dr. Baker also acknowledged that GlaxoSmithKline provided financial support in the form of free study medication. The same disclosure was made in another 2012 paper. And in another paper as well.

5. According to a 2011 paper: "Timothy B. Baker has served as a consultant, given lectures sponsored by, or has conducted research sponsored by GlaxoSmithKline, Nabi Biopharmaceuticals, Pfizer, and Sanofi-Synthelabo."

6. In a 2010 paper, Dr. Baker acknowledged "research grants from Pfizer, GlaxoSmithKline, Nabi Biopharmaceuticals, and Sanofi."That paper itself involved research with financial support from GlaxoSmithKline in the form of free study medication.

Again, amazingly, none of these conflicts of interest are reported in the paper and the reader has no way of knowing this long history of financial conflicts of interest with Big Pharma.

Summary

For years, we in tobacco control have attacked tobacco industry-funded scientists or researchers who consulted for tobacco companies for not disclosing their conflicts of interest. It is therefore quite unfortunate, and ironic, that tobacco control researchers do not appear to take their own conflicts of interest seriously and that they, too, are hiding these conflicts from the public.

As I previously articulated, the hiding of these conflicts of interestdamages public health in four ways:

  1. It violates public health ethics and could be damaging to the entire field of tobacco control;
  2. It degrades the research integrity of tobacco control;
  3. It makes us hypocrites when we criticize failed tobacco industry disclosures; and
  4. It hides the influence of Big Pharma money on the field of tobacco control and hinders smoking cessation efforts.

Big Tobacco's Attempt to Cash In on the Custom Vaping Craze is a Drag October 10 2015

Written by

JASON KOEBLER

November 17, 2014 // 03:05 PM EST

Blu electronic cigarettes, which was recently sold by one tobacco giant to another tobacco giant, just released Blu Plus+™, a rechargeable, refillable cigalike. It’s the first Big Tobacco ecig that isn’t disposable, and it looks like a clear attempt to capture some of the market share gained by smaller, independent vaping companies that offer customizable devices that give users more freedom of choice. Problem is, Big Tobacco’s version is a closed platform that offers no customization whatsoever—Blu Plus+ will work only with other Blu products.

The Blu Plus+'s nic-juice tank. Image: Author

That should come as no surprise, considering that big tobacco is in a bit of a rough spot. It wants to compete for a share of the vaping market, which has made it clear that it specifically prefers refillable mods that can be filled with all sorts of different flavors of nic-juice—even flavors mixed at home. It also wants to completely destroy that market by asking the Food and Drug Administration to enforce strict regulations in order to force vapers to smoke its own cigalikes (disposable e-cigarettes that look like regular cigarettes and are usually sold at gas stations).

Consider, for a moment, that earlier this fall, RJ Reynolds submitted a 119-page document asking the Food and Drug Administration to ban "open system" vaporizers (the ones that most vapers prefer), while simultaneously trying enter the market itself.

That's how you end up with the hybrid Blu Plus(Plus!), a cigalike that is refillable (in the sense that you can buy additional closed tanks for it) and rechargeable, but not customizable in the slightest.

I got one of these mailed to me the other day, and, sure, it's a departure from regular ol' Blu cigalikes, which you buy for a couple bucks at a gas station, use until either the battery is dead or it's out of puffs, then throw away. Blu ++, on the other hand, lets you use the same cigalike (I hesitate to call it a mod, because it's not modifiable, at all) to vape nic juice specifically made by Blu, and nic juice made by Blu only. These tanks are quite obviously not interchangeable with other vape mods or other vape juice tanks. In fact the tanks are built into a part of the cigalike that you have to screw into the device.

This is what it looks like when you vape a Blu Plus+. Image: Author

I'm personally not much of a vaper, but the product does seem better than standard Blu cigalikes, which are notoriously hard to pull from because the battery in it sucks. It still tastes pretty blah, though.

And, well, that's the problem. Besides being a better alternative for your lungs than actually smoking, vaping has become huge specifically because it has put the power of designing and creating nic juice and mods in the hands of small companies and hobbyists who care very much about the quality of their products and the culture they've helped create. Big tobacco, on the other hand, has tried to shove cigalikes down that community's throat by actively trying to make the barrier to entry so high that small companies can't compete.

The Blue +Plus is just the next step here: It's an imitator that might appeal to the casual e-cig smoker and yes, an upgrade over the original—but make no mistake, the vape community doesn't want or need this. This is a cigalike pretending to be a mod, nothing more. Any truly open platform mod or nic juice from big tobacco would be anexplicit acknowledgement that it has truly lost the market to small vape companies.

There’s no indication that RJ Reynolds, or Lorillard, or Imperial Tobacco Group are going to do that—instead, they’ll keep making pale imitations, which aren’t going to win them any fans. At this point, lobbying and the fear mongering that goes with it are still its best weapons.

 


New Study Refutes E-Cigarette Formaldehyde Scare May 23 2015

A new study published yesterday in the journal Addiction refutes an earlier New England Journal of Medicine article which claimed that because of their high levels of formaldehyde, e-cigarettes are actually more hazardous than tobacco cigarettes. That study concluded that vaping could be as much as 15 times more hazardous as smoking in terms of cancer risk:


"If we assume that inhaling formaldehyde-releasing agents carries the same risk per unit of formaldehyde as the risk associated with inhaling gaseous formaldehyde, then long-term vaping is associated with an incremental lifetime cancer risk of 4.2×10−3.This risk is 5 times as high (as compared with the risk based on the calculation of Miyake and Shibamoto shown in Figure 1), or even 15 times as high (as compared with the risk based on the calculation of Counts et al. shown in Figure 1) as the risk associated with long-term smoking."

The new study, by Farsalinos et al., reports that third generation e-cigarettes can produce high levels of formaldehyde, but only under "dry puff" conditions. These are conditions where the e-liquid is overheated and produces a strong, unpleasant taste that no vaper could tolerate for more than one puff. This would be a signal to the vaper to reduce voltage levels. Dr. Farsalinos and colleagues found that under normal vaping conditions, even high power devices produced only minimal amounts of formaldehyde.

The study concludes that:

"Electronic cigarettes produce high levels of aldehyde only in dry puff conditions, in which the liquid overheats, causing a strong unpleasant taste that e-cigarette users detect and avoid. Under normal vaping conditions aldehyde emissions are minimal, even in new-generation high-power e-cigarettes."

The Rest of the Story

This story illustrates the damage that is being done by anti-smoking researchers and groups which are exaggerating the risks of electronic cigarette use. In this case, the researchers actually argued that vaping might be 15 times worse than smoking in terms of cancer risk! Yet it turns out that their conclusion was invalid and that while e-cigarettes can produce formaldehyde under normal conditions, the levels appear to be minimal and certainly do not produce a risk that compares to that of smoking.

The problem, however, is that this misinformation has already been widely disseminated through the media and by electronic cigarette opponents who picked up on the story. It is too late to take these claims back because the public has already been scared. Moreover, the anti-smoking groups which made these claims will never retract their statements and admit their mistake. They are interested in demonizing e-cigarettes, not finding and telling the truth.

Why is the American Cancer Society Promoting Cancer by Favoring Real Cigarettes Over Fake Ones? May 12 2015


Top 50 Liquids November 14 2014


The Future of E-Cig and the Tobacco Industry October 02 2014





According to a survey by the Wells Fargo Securities Tobacco Talk, electronic cigarettes just might stand a fighting chance in the tobacco industry. Retailers and wholesalers alike are thoroughly impressed with the e-cig product and even more with their revenues.

While the business waits for regulation by the Food and Drug Administration, sales have skyrocketed up to $350 million, so far. Murray Kessler, the CEO of Lorillard, Inc., says that with very little effort, the industry is predicted to earn over $1 billion in just a few short years. Since the FDA has yet to establish a tax on electronic cigarettes, these little electrical vapor devices are currently the cheapest option, compared to buying a pack of cigarettes.

Lorillard Inc. became the first of the three largest tobacco companies to acquire an electronic cigarette manufacturer, with their recent purchase of Blu ecigs for $135 million.

“We continue to believe [Lorillard's] e-cig acquisition is very positive and expect [Reynolds American] to be the next mover into this growing category, most likely organically, but we wouldn’t rule out a potential acquisition,” says Bonnie Herzog.

Herzog believes that the massive growth of the e cig industry is remarkably similar to the boom of another profitable consumable—energy drinks. “We think e-cigs are to tobacco what energy drinks are to beverages. In other words, similar to energy drinks, e-cigs are profitable, growing quickly, gaining shelf space and consumer acceptance; therefore e-cigarettes are an important new niche category for retailers.”

Herzog predicts that as the expansion continues and the FDA finalizes some ground rules for electronic cigarette manufacturing, some consolidation is expected to bring together the myriad of brands on the market.

 

SFATA. "The Future of E-Cig and the Tobacco Industry." http://sfata.org/blog/2013/01/08/the-future-of-e-cig-and-the-tobacco-industry. Jan 8, 2013

 


New Study: No Evidence E-Cigs Cause Cell Damage or Death by Klaus Kneale September 12 2014

A new study in the medical journalInhalation Toxicology has found that 20 out of 21 electronic cigarette brands showed no signs of cytotoxicity (that is, toxicity that causes cell damage or death).  The study makes yet another compelling argument that electronic cigarettes do not cause an amount of harm necessitating harsh regulations and bans.

The study came from Italian and Greek researchers and was led by Dr. Konstantinos Farsalinos who has been researching electronic cigarettes since 2008 and finding promising results.

You can find the abstract here.

The study found that only in one coffee-flavored electronic cigarette brand did any evidence of cell damage or death appear and only at the highest dilution tested.  All other brands and all lower dilutions of the coffee-flavored brand showed no evidence of cytotoxicity.  In the one instance that cytotoxicity was found, it was two orders of magnitude lower than that of cigarette smoke.

This raises two strong points for the electronic cigarette world.  First, the damage electronic cigarettes do to the user may actually be even lower than researchers and experts had previously thought.  Having previously rated electronic cigarettes between 1 and 5% as dangerous as conventional cigarettes, that may need to be revised to something closer to .1%.  But we’ll let the real experts decide on that.

Second, the researchers behind the study theorize that the reason cytotoxicity was only found in the one coffee-flavored brand was likely flavor additive related.  It seems likely that something in the flavor ingredients had more to do with cytotoxicity than any of the other ingredients since those ingredients existed in 20 other brands and none showed signs of cell death or damage.

This certainly means that ingredients quality control and testing needs to occur in the world of electronic cigarettes.  While this isn’t something anybody argued against, it highlights the issue more than ever before.  Ingredient choice — if it is indeed the culprit — can determine whether an e-cig exhibits no cytotoxicity or some cytotoxicity.


Drumbeat Intensifies for Electronic Cigarette Regulations September 12 2014

Federal and state officials are pushing for a rapid end to the current laissez faire regulatory environment for electronic cigarettes, which is characterized by hundreds of companies vying for customers with diverse device and flavor options.

The Food and Drug Administration is preparing draft regulations, with a target release date sometime in October, for the battery-powered vapor machines marketed as a healthy alternative to carcinogen-packed conventional cigarettes.

If the FDA chooses to apply the Tobacco Control Act of 2009 to e-cigarettes, advertising would be tightly regulated and popular flavors may be banned. That law, enacted with the support of cigarette company Phillip Morris, banned flavored cigarettes and restricted advertising and health claims.

Sen. Sherrod Brown, D-Ohio, told reporters during a Wednesday conference call he believes the FDA already has authority under the Tobacco Control Act to regulate e-cigarettes. He said he would be meeting with FDA Commissioner Margaret Hamburg and two unnamed Senate colleagues later in the day “to press [the FDA] to regulate tobacco products to the full extent of their power.”

Brown alleged that e-cigarette makers are directly linked to the conventional cigarette industry and said flavored liquid is being used to recruit a new “crop of customers.”

“Cigarette smoking, we know, kills close to a half million people in the United States every year,” Brown said. “The tobacco industry, they know that between 400,000 and 500,000 customers die every single year and that means… they have to find 400,000 to 500,000 new smokers every single year [and] they set their sights on the latest nicotine market.”

He added: “The longer they can be marketed to children, the more our hard-fought gains to prevent teens from being addicted to tobacco are lost. If more young people get hooked on e-cigarettes, the chances of their smoking – when they are older – regular cigarettes increase. … If making cigarettes is addicting children and killing them, that’s the most important factor here.”

Brown joins other Democratic senators in urging regulation of e-cigarettes. Sen. Richard Blumenthal, D-Conn., told U.S. News last week he would like the FDA to ban flavor options and the online sale of e-cigarettes. It’s “completely disingenuous,” Blumenthal claimed, for e-cigarette advocates to say fruity flavors are primarily used by adults.

Brown and Blumenthal both said they would support legislation if the FDA doesn’t act first.

Advocates of e-cigarettes say they support age restrictions, but they are urging officials to hit the brakes before enacting regulations.

“Like Sen. Blumenthal, Sen. Brown is acting without adequate data,” said Gregory Conley, legislative director of the Consumer Advocates for Smoke-free Alternatives Association. “Sen. Brown is encouraging a ban on flavored e-cigarettes without having asked for evidence showing that flavored e-cigarettes are actually being targeted or marketed to teens, or actually being used by teens. He certainly doesn’t seem to have any regard for electronic cigarettes as ways to get smokers to stop inhaling burning smoke.”

Conley added: “Mr. Brown sure knows from the negotiations back [in 2009] that eliminating flavored cigarettes from the market made no measurable impact on public health because no adolescents were actually using them.”

The urging by Brown comes one day after 37 state attorneys general signed a letter asking the FDA to apply the Tobacco Control Act to e-cigarettes. The state officials, led by Democrat Martha Coakley of Massachusetts and Republican Mike DeWine of Ohio, alleged children are enticed by flavors. They also pointed to two small companies that have used animated monkeys in their marketing and another company that offers various “skins” to modify the appearance of their e-cigarettes.

“E-cigarettes contain fruit and candy flavors – such as cherry, chocolate, gummy bear, and bubble gum – that are appealing to youth,” the state attorneys general wrote. “The FDA has banned such flavors from cigarettes and should take the same action regarding e-cigarettes.”

The FDA has not yet responded to the letter, but aims to unveil proposed regulations for e-cigarettes sometime in October. “FDA is moving to release for public comment a proposed rule to regulate additional categories of tobacco products,” FDA spokesperson Jennifer Haliski told U.S. News. “FDA cannot comment on the contents of the proposed rule.”

The latest push for regulation was boosted by data released Sept. 5 by the Centers for Disease Control and Prevention, which found 10 percent of high school students tried an electronic cigarette at least once. The “current” use rate – defined as use in the preceding month – was 2.8 percent for e-cigarettes. More than 92 percent of high school students who tried an e-cigarette had also smoked a tobacco cigarette, but the CDC did not ask which they tried first. The data was released weeks ahead of corresponding data for conventional tobacco products. Data is not routinely collected on the percentage of students who have ever tried a tobacco cigarette, CDC spokesman Joel London told U.S. News, but it’s estimated that between one-third and one-half of students have done so. In 2011, the most recent year for which data is available, the CDC found 18.1 percent of high school students were “current” conventional cigarette users.

Leaders of the Smoke Free Alternatives Trade Association, an e-cigarette industry group, are conducting a “fly in” October 3-4 to meet with federal lawmakers in Washington, D.C.

SFATA President Phil Daman told U.S. News & World Report he opposes “simply rolling [e-cigarettes] under the purview of federal and state statutes designed for tobacco products,” such as the Tobacco Control Act.

“They do not fit the mold of a tobacco product and the Tobacco Control Act was not created to address issues concerning these types of products,” Daman said. “These products are technology products, not tobacco products [and] adult consumers want and should have access to this technology, and a diverse variety of flavors if they so choose.

Amid the frenzied push for new regulation, Daman advises “greater and increased communication between the industry, our elected officials, consumers and the FDA to best understand this new technology so that fair and reasonable regulations, if any, are tailored to what these unique products actually are.”

E-cigarettes don’t meet the strict definition of a “cigarette” in the Tobacco Control Act, because that law defers to a standing definition of cigarettes as “any roll of tobacco wrapped in paper or in any substance not containing tobacco” or “any roll of tobacco wrapped in any substance containing tobacco which, because of its appearance, the type of tobacco used in the filler, or its packaging and labeling, is likely to be offered to, or purchased by, consumers as a cigarette.” But the FDA claims authority to regulate e-cigarettes under a 2010 ruling by the U.S. Court of Appeals for the District of Columbia in Sottera v. FDA. The court said products “made or derived from tobacco” can be regulated as “tobacco products” under the Tobacco Control Act.

Possible regulation of e-cigarette flavors hits a particularly raw nerve for many users. Conley, who blends his own flavor to mimic the taste of Hi-C, observed “flavors are such a big deal for a lot of people, including myself. … When they’re coming out saying, ‘these flavored e-cigarettes are targeted to children’,” he said, “there are so many people out there who immediately have a visceral reaction because they are using the flavors.”


E-Cigarettes: Rush To Regulate Could Destroy Effective Alternative September 12 2014

WASHINGTON, Sept. 24, 2013 /PRNewswire-USNewswire/ — Last week, several organizations sent a joint letter to the President, asking him to order the Food and Drug Administration (FDA) to promptly assert authority over all tobacco products not currently under its jurisdiction. The organizations imply that the delay is resulting in negative health consequences. However, they never mention any specific consequences, and for a good reason: They are proposing a “solution” where no problem exists. Instead, enacting regulations without sufficient scientific evidence has the potential to do a great deal of harm to public health.

The Consumer Advocates for Smoke-free Alternatives Association (CASAA) is writing the president today to urge him to advise the FDA to take the time needed to develop science-based regulations that will serve the interests of public health. CASAA is a non-profit organization that works to ensure the availability of low-risk alternatives to smoking and to provide smokers and non-smokers alike with truthful information about such alternatives.

 

In 2009, four of the organizations that signed last week’s letter–the Campaign for Tobacco-Free Kids, the American Lung Association, the American Cancer Society Cancer Action Network, and the American Heart Association–jointly pressured the FDA to remove electronic cigarettes (e-cigarettes) from the market. The FDA tried to do so until a Federal Court Judge ruled that e-cigarettes cannot be regulated (and thus banned) as a drug unless therapeutic claims are made.

 

“Had these organizations succeeded in their efforts to prevent the sale of e-cigarettes in the U.S.,” stated CASAA president, Elaine Keller, “hundreds of thousands of former smokers would still be lighting up. Almost all e-cigarette consumers are former smokers who tried to quit by using some or all of the products and methods these organizations tout and kept relapsing. The option to switch to a low-risk product that is a satisfying substitute for smoking has made a smoke-free life possible for those who had almost given up all hope of ever being able to quit smoking.”

In their letter to the president, the organizations cite the recent report on youth use of e-cigarettes by the Centers for Disease Control and Prevention (CDC) as proof that students in grades 6 through 12 are taking up use of e-cigarettes at an alarming rate. This misrepresents the findings.

Only 2.1% of the youth had taken so much as one puff from an e-cigarette recently. As far as we know from that survey, none of them are using e-cigarettes daily, in contrast with the millions of youth who are known to smoke. The CDC did not report the daily use statistics for e-cigarettes, or even whether the e-cigarettes being tried contain nicotine.

How do these statistics compare to recent smoking of conventional cigarettes? The Substance Abuse and Mental Health Services Administration (SAMHSA) has published, “Results from the 2012 National Survey on Drug Use and Health: Summary of National Finding.” According to the SAMHSA report, past month cigarette use among youths aged 12 to 17 fell from 9.1 percent in 2009 to 6.8 percent by 2012 for males and from 9.3 percent to 6.3 percent for females. Furthermore, the rate of initiation of smoking among youths in the same age group fell from 6.3 percent to 4.7 percent for males and from 6.2 percent to 4.8 percent for females.

CASAA’s Scientific Director, Dr. Carl V. Phillips, pointed out, “Those who want to ban e-cigarettes make up any claim they can think of, regardless of whether there is evidence to support it. If e-cigarette use really caused kids to start smoking and there really was an alarming use of e-cigarettes by youth, we would see an increase in kids smoking, the opposite of the actual trend.

“Someone who would try an e-cigarette but would avoid smoking presumably is motivated by avoiding the risk of smoking. The only reason I can see for someone to make the unfortunate transition from e-cigarette use to smoking would be if e-cigarettes were to become less accessible or deliberately made less attractive, which, ironically, could be the result if the type of excessive regulations urged by these organizations is enacted.”

The CDC provided no data to suggest that youth were using candy or fruit flavors at all, let alone that those flavors have particular appeal to youth. Yet the organizations that have been trying to stop the sale of e-cigarettes claim that pleasant flavors are a clever ploy to attract youth to use the products. They tie this claim to the CDC results even though those results are completely silent on the issue and, indeed, there are no data to support the claim at all.

It should also be noted that most adults begin using tobacco or menthol flavor e-cigarettes, trying to match the taste of their favorite brand of conventional cigarettes. Many who give up on this (usually unreachable) goal of perfectly mimicking cigarettes switch to more interesting flavors, and  soon find that they no longer enjoy tobacco and/or menthol flavors. This appears to be an important part of why so many who have transitioned completely to e-cigarettes find they have no longer have any urge to smoke, even if they eventually wean all the way off nicotine.

“A rush to regulate, without having gathered sufficient scientific data, would have a devastating impact on public health,” notes CASAA President Elaine Keller. “Anything that would reduce the availability of the e-cigarettes to adults or reduce their acceptability as a replacement for smoking will cost lives, not save them.”

SOURCE Consumer Advocates for Smoke-free Alternatives Association


FDA Smoke Screen On e-Cigarettes September 12 2014

At a time when the government is ostensibly trying to cut health costs, why is it trying to ban something that might help people quit smoking tobacco, perhaps the most devastating health problem in the U.S.?

The Food and Drug Administration (FDA) held a press conference late last month to scare Americans about the so-called "e-cigarette" -- claiming it was loaded with harmful "toxins" and "carcinogens." The agency was implicitly saying: Stay away from these newfangled, untested cigarette substitutes -- better to stick with the real ones, the ones that we are more familiar with, the ones that cause over 450,000 deaths annually in the U.S.

In making its distorted, incomplete and misleading statement, FDA was violating its long-cherished tradition of sticking to sound science as the basis for its policies. And in doing so, it is putting the lives and health of millions of Americans at risk.

The truthful part of the FDA statement was that e-cigarettes have not been through formal efficacy and safety tests at the FDA, and they have only been around a few years. But in the press conference, here is what the FDA did not tell you but should have:

c Traditional cigarettes are lethal not because of the trace level presence of specific "carcinogens" and "toxins," but because by using them, smokers inhale enormous amounts of smoke -- otherwise known as "products of combustion." It is the inhaled smoke that kills in so many ways -- from cancers, cardiovascular and lung disease, and more.

c The cigarette was a relatively obscure product in our society until the invention of a cigarette rolling machine, and sales rose quickly prior to World War I.

Before that, tobacco was used relatively safely -- in chew, pipes, cigars -- because little if any smoke was inhaled. Cigarettes changed all of that.

c The e-cigarette -- a cigarette-mimicking device made up of a battery, an atomizer and a cartridge -- allows smokers to inhale, getting a dose of the nicotine they crave, and then sending steam out the other end (with little or no odor) to mimic the ritual and feel of smoking normal cigarettes.

c The FDA complained that the e-cigarette was a "nicotine-delivery system." Well, it got that much right. But again, it's the smoke that kills, not the nicotine. Yes, nicotine is highly addictive, and it is what keeps the smoker hooked. But getting the nicotine without the smoke is an enormous health advantage for cigarette smokers (the nicotine inserts come in various strengths and the users can adjust them downward as they wish).

c The FDA has approved other nicotine-delivery systems in the form of gums and patches -- and they have been abysmal failures. The smoking cessation rates using these devices is less than 15 percent after one year, condemning millions of addicted smokers to a lingering death. We desperately need other alternatives. But the FDA has now joined a long list of so-called public-health organizations -- including the Campaign for Tobacco Free Kids and the American Lung Association -- whose collective motto seems to be "quit or die." Not only do they reject e-cigarettes, but they also condemn other smokeless products like snus, which have a mere fraction of the health risks associated with smoking cigarettes.

c More than 1 million smokers are now using the e-cigarette -- a product that offers some, if not all, of the "social amenities" of the real thing -- holding the cigarette, taking a drag, seeing a plume of "smoke." The FDA, lacking data that e-cigarettes pose a health hazard, was so desperate, it called on consumers to phone in adverse side effects of e-cigarettes so they could begin to build a case against them and proceed with their intended ban. They neglected, however, to request smokers who successfully quit using the e-cigarette to also call in.

Cigarette smoking remains the leading cause of preventable disease and death in the United States today. Any alternative acceptable to addicted smokers should be taken seriously. Instead of condemning the e-cigarette, the FDA should be sponsoring studies to evaluate its safety and efficacy -- leaving it on the market in the interim.

Dr. Elizabeth Whelan is president of the American Council on Science and Health.