The Fight to Change the Predicate Date

As the majority of vapers are well aware, the FDA came down hard on the vaping industry with the implementation of its “Deeming Regulations” which claimed authority over vapor products. The regulations treat vapor products just like tobacco products without even considering their differences, nor the potential for tobacco harm reduction as we have seen in other parts of the world. The regulations also come with some burdensome costs that could destroy the vaping industry in the U.S. by August of 2018.

Politicians Fight to Save the Vaping Industry

Although there is building fear of what is to become of the vaping industry under the FDA's control, there are U.S. politicians who do see the importance of embracing e-cigs for tobacco harm reduction, and they continue to fight for more sensible regulations. From legislation proposing to change the FDA's predicate date to new legislation proposing the regulation of vapor products completely separate from tobacco products, there is still hope for saving the vaping industry.

The Fight to Change the Predicate Date

To truly understand the most recent legislation proposing a change to the FDA's predicate date under the Tobacco Control Act of 2009, let's take a look at the history behind its creation.

The FDA Deeming Authority Clarification Act of 2015

Representative Tom Cole (R-OK 4th District) has been fighting for the vaping industry since 2015 when he introduced the first bill to change the FDA's predicate date for vaping regulations: The FDA Deeming Authority Clarification Act of 2015 (H.R. 2958). Although the regulations were not finalized until 2016, it was common understanding that the FDA intended to regulate vapor products in the same manner as tobacco products; therefore, politicians in support of vaping saw the need to start proposing legislation to amend the predicate date before the regulations could take effect.

The current predicate date of February 15, 2007, was established with the passing of the Tobacco Control Act of 2009, when the FDA was given authority over tobacco products. Now that the FDA has claimed authority over vapor products, they are now categorized as tobacco products and are subject to the same regulations and predicate date – despite the fact that 99% of current vapor products didn't even exist prior to 2007. As a result, in order for the majority of current vapor products to remain on the market, they must go through the extensive and costly Premarket Tobacco Application (PMTA) process. The FDA estimates the cost per application would be around $300,000 per product, while tobacco harm reduction experts estimate the cost per product could run into the millions.

To put this into perspective, let's say a vape company sells just one product – a disposable electronic cigarette. The company most likely also offers quite a few nicotine strengths and flavors. Each combination of flavor and nicotine strength would be considered 1 product. So, if there are 24 flavors and 6 different nicotine strengths, that would be 144 different products, according to the FDA. So now let's say the PMTA cost is at the FDA's estimated $300,000 mark: that means the vape company would have to pay $300,000 multiplied by 144 (plus another $300,000 for the disposable e-cigarette itself) – that would be about $43 MILLION just to stay in business with 1 product in 24 different flavors and 6 different nicotine strengths!

So here's the kicker: most vape companies sell way more products and flavors – some even equal up to more than a thousand. So let's say a company needs to submit PMTAs for a thousand products, that would be a total of $300 million based on the FDA's estimates. And, as if that isn't bad enough, the PMTA approval is not guaranteed – that means a vape company could spend millions of dollars in PMTA applications, only to have the FDA deny their approval. Now you can see why experts estimate that if the FDA's Deeming Regulations remain unchanged, then 99% of the vaping industry will be forced to shut down, leaving only those owned by Big Tobacco.

Now back to H.R. 2058: Although the legislation did gain bipartisan support with 77 cosponsors, it never made it past the House.

The Cole-Bishop Amendment

In an effort to move things along in the fight to change the predicate date, Representative Cole, along with cosponsor Representative Sanford Bishop (D-GA 2nd District), introduced a new piece of legislation referred to as the Cole-Bishop Amendment. Like H.R. 2058, the main goal of the amendment was to change the predicate date. The amendment was voted on during the Agricultural and Rural Development Appropriations bill hearing in April of 2016, and was adopted by the House Appropriations Committee by a 31-19 vote. Unfortunately, the amendment was abandoned after the election of the Trump Administration. Since the Republican Congress was given the option to avoid rushing through the budget bill at the end of the year and the legislative process requires legislation to be acted upon during one Congressional session, the bill would have to be reintroduced during the next Congressional session.

The Cole-Biship Amendment was expected to be attached to the FY17 Omnibus Budget, with the deadline for voting set for midnight on May 5, 2017; however, house Democrats released the FY17 Omnibus Appropriations Act press release early Monday morning which states:

“The Omnibus does not include a House provision allowing thousands of unregulated tobacco products to escape full FDA review. The House provision would have exempted e-cigarettes, little cigars, cigarillos, hookah, cigars and other products from the Tobacco Control Act's pre-market review requirement, allowing products to escape regulations and requirements that Congress enacted to protect the public health from the nation's leading preventable cause of death.”

This is very unfortunate for the industry and for the consumers who have come to rely on the vapor products they have been using for years. If the FDA's grandfather date remains unchanged, vape companies must submit the costly PMTA's for all of their products by August 8, 2018.

The FDA Deeming Authority Clarification Act of 2017

Luckily for the vaping industry, Representatives Cole and Bishop also proposed stand-alone legislation for changing the predicate date. Enter H.R. 1136: The FDA Deeming Authority Clarification Act of 2017. Similar to the abandoned Cole-Bishop Amendment, H.R. 1136 would move the FDA's predicate date to the effective date of the Deeming Regulations of August 8, 2016. While this would allow vapor products introduced to the market after February 15, 2007, to remain on the market without PMTA approval, innovation in the vaping industry will remain stifled, as any new products introduced after August 8, 2016, would be required to obtain PMTA approval. Still, the passing of H.R. 1136 is vital for the vaping industry to keep current products on the market after August 8, 2018. You can show your support for H.R. 1136 by sending an email to your elected officials via the form provided on CASAA's website.

The Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017

Like Representatives Tom Cole and Sanford Bishop, Representative Duncan Hunter (R-CA 50th District) has also been fighting for the vaping industry and the idea that e-cigs should be used for tobacco harm reduction. One of the most notable moments of Rep. Hunter showing his support for vaping was during a Capitol Hill hearing in February of 2016. In an effort to protest a proposed ban on vaping inflight, Rep. Hunter took a puff from an e-cigarette and proceeded to explain to other House members what vaping is and how it differs from traditional tobacco cigarettes. Unfortunately, the ban still passed by a 33-26 vote and vaping on airplanes has been prohibited ever since.

On April 27, 2017, Rep. Hunter introduced The Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017 (H.R. 2194). This piece of legislation would be a serious game changer for the FDA and the vaping industry: it would remove vapor products from the category of tobacco products to be regulated separately as an alternative to tobacco – something that all tobacco harm reduction experts have agreed should have been considered by the FDA in the first place. The legislation would also require the FDA to rename its center for tobacco products to “The Center for Tobacco Products and Tobacco Harm Reduction”, and would require the organization to adopt safety standards for e-liquids and vaping devices established by the American E-Liquid Manufacturing Standards Association (AEMSA) and the American National Standards Institute (ANSI), which would go into effect one year after the enactment of the legislation. There are quite a few other provisions within this piece of legislation, all of which would be beneficial to the vaping industry and tobacco harm reduction in general. Tobacco Harm Reduction expert Dr. Michael Siegel provides a great breakdown and explanation of this new legislation on his blog titled “The Rest of the Story”.

To show your support for this game-changing legislation, you can sign the petition available on change.org.

What's Next for the Vaping Industry in the US?

While there is no guarantee that any piece of legislation will change the FDA's Deeming Regulations for vapor products, it seems certain that we can rest assured there are politicians on our side, along with other parts of the world that have finally embraced vaping. All we can do is hope for the best and take every opportunity to voice our opinions to our members of Congress to ensure they have the best interests for public health.

The post Will FDA Vaping Regulations Change? appeared first on Electronic Cigarette Blog | White Cloud.

Mon, May 01, 2017
The Quest for Tobacco Harm Reduction

While the United States FDA and CDC have been treating e-cigarettes as a new public health threat, scientists and health officials in other parts of the world are embracing vaping for its potential to wean people off of tobacco. These e-cig advocates have rallied together behind a revolutionary strategy aimed at ending the global smoking epidemic: tobacco harm reduction.

The Quest for Tobacco Harm Reduction

No one disputes the terrible impact that tobacco has on society. Illnesses related to smoking and chewing tobacco kill millions of people every year. Nonetheless, users remain trapped in their addictions.

We also know that scientific research continues to suggest that vaping is far less dangerous than smoking. Studies have also shown that smokers have better luck transitioning from tobacco cigarettes to e-cigs than they do quitting smoking cold turkey or using nicotine replacement therapies like patches or gums. If smokers switched to vaping, it would be better for smokers and everyone around them.

Tobacco harm reduction, or THR, is the belief that people who use tobacco should be encouraged to adopt less dangerous habits. While this sounds uncontroversial, misconceptions and misinformation about e-cigs have led to misguided policies and regulations. Government agencies in some parts of the world, however, are encouraging THR as official public policy.

Vaping and Tobacco Harm Reduction in the UK

Back in 2015, Public Health England looked at all of the available research regarding e-cigs and published a conclusion that shocked most of the medical world: Vaping is at least 95 percent less harmful than smoking. In the following year, the UK's Royal College of Physicians issued a report claiming “e-cigarettes are likely to be beneficial to UK public health” and called upon doctors to encourage their smoking patients to try vaping instead. Just a year later, the UK has already seen about a three percent decline in the smoking population according to the Office for National Statistics.

Vaping and Tobacco Harm Reduction in France

The French government has also warmed up to vaping. Tabac Info Service, the agency tasked with protecting public health, has conceded that vaping reduces and possibly even eliminates smokers' risks for developing tobacco-related illness. The agency's website claims that e-cigs can help people quit smoking or smoke less, and it goes as far as recommending dual use because it can help tobacco users cut their daily intake by up to nine cigarettes.

Vaping and Tobacco Harm Reduction in New Zealand

New Zealand is an example of a country that has very quickly changed its policies to accommodate the demand for e-cigs. The sale of e-liquids containing nicotine has been illegal within the country for years, but the government announced in March 2017 that e-cigs will be legalized in New Zealand for the purpose of tobacco harm reduction. This reversal in policy was announced shortly after the film A Billion Lives, a documentary criticizing government opposition to e-cigs and tobacco harm reduction, which debuted at the Doc Edge Festival in New Zealand. The New Zealand government has since started withholding funds from anti-smoking groups that oppose less harmful alternatives like e-cigs.

Vaping and Tobacco Harm Reduction in Australia

Unfortunately, many other governments are dragging their feet on tobacco harm reduction, and some are making it even harder to obtain e-cigs. For example, Australia has traditionally classified nicotine as a poison, so e-liquids with nicotine cannot be bought or sold within the country; however, they may be imported for personal use Despite the growing evidence that e-cigs are safer than tobacco, the Therapeutic Goods Administration recently rejected a proposal to reconsider its nicotine policies, which makes it impossible for vapers living down under to buy supplies locally. Meanwhile, tobacco cigarettes remain on store shelves.

Vaping and Tobacco Harm Reduction in the US

As discussed in previous posts, the US is a global leader in both medical and technological research. Unfortunately, the US is also an exporter of shoddy science funded by groups who want to impose taxes and restrictions on e-cigs while allowing tobacco companies to keep profiting of off cigarette addicts.

You've likely seen these controversial claims: Vaping is a gateway to smoking; e-cigs cause popcorn lung; e-liquids contain formaldehyde. All of these accusations have been dismantled on White Cloud's blog and elsewhere, yet confusion persists due to carefully orchestrated anti-vaping campaigns.

Sadly, public health organizations in the US have made the situation even worse by embracing junk science despite that e-cigs are more effective smoking cessation tools than NRTs like nicotine gums and patches. We've also covered the FDA's history of approving pharmaceutical drugs with deadly side effects, yet most e-cigs companies can't afford to even apply for approval of their products.

A full year after Public Health England's landmark report, the American CDC compared e-cig users to sheep in a public service campaign. The organization ran an advertisement in Pasadena bearing the phrase, “Don't follow the herd. Vaping effects are unknown, stupid sheep.” Where is all of this vitriol and hypocrisy coming from?

It's tempting to blame ignorance, but it's hard to believe that public health officials in the US are simply unaware of research being conducted across the ocean. In fact, plenty of research on the benefits of vaping has been performed in the US. Sadly, deep seated fear and prejudice against nicotine trumps science. We would like to see America follow the examples of countries that have embraced THR, but history casts doubt on such a future.

The post How is Vaping Viewed Around the World? appeared first on Electronic Cigarette Blog | White Cloud.

Fri, Apr 28, 2017
The Role of Nicotine in Tobacco Products

When comparing vaping vs. smoking, all experts agree that e-cigarettes are far safer than traditional tobacco cigarettes. This doesn't mean that e-cigs pose no health risks, but medical research has yet to identify any such risks. On the contrary, everyone knows that smoking is a deadly habit responsible for countless cancers and other health problems. Why do public health officials in the US continue to conflate vaping with smoking?

The Role of Nicotine in Classifying E-Cigs as Tobacco Products

The majority of e-liquids contain nicotine, which in its natural form derives from the tobacco plant. Does this mean that e-cigs and e-liquids are tobacco products? It technically depends on what part of the world you're in.

In the US, the FDA has the final say about what legally constitutes a tobacco product. According to the FDA's Deeming Regulations and the Tobacco Control Act of 2009, a tobacco product is “any product made or derived from tobacco that is intended for human consumption.” Although nicotine can be synthesized without tobacco, the FDA uses the fact that tobacco contains nicotine to justify the classification of e-liquids as tobacco products. The FDA's definition also includes “any component, part, or accessory of a tobacco product,” which is how e-cig hardware also gets lumped into this category. While this may all sound arbitrary, it has important consequences for how statistics about smoking are calculated and reported, which in turn has a huge impact on public policy.

Related: How the FDA Regulates Vapor Products

What are Tobacco Products?

Nicotine is just one of hundreds of compounds present in the tobacco plant. While nicotine was long believed to be the chief driver of tobacco addiction, modern research has discovered that the other chemicals in cigarettes are responsible for the many health maladies associated with smoking. Nonetheless, the FDA currently makes no distinction between vapor products and tobacco products; even e-liquids without nicotine are classified as tobacco. What is the rationale behind such a bizarre policy?

Related: Where Does Nicotine Come From?

By subjecting the vape industry to the same regulations as the tobacco industry, the FDA can require pre-market approval, which is an expensive process that big tobacco companies can afford yet many e-cig manufacturers cannot. Therefore, the only e-cigs that easily make it to market are those made by the tobacco corporations. Meanwhile, smaller operations struggle to meet financial and administrative hurdles, which stifles competition and innovation.

The FDA and Tobacco Products

The FDA's policies have been met with harsh criticism from tobacco harm reduction advocates around the world. Tobacco harm reduction is the practice of steering tobacco users toward less risky behaviors. It's easier for smokers to switch to vaping than to give up nicotine cold turkey, and since an overwhelming amount of scientific research has found vaping to be safer than smoking, e-cigs can play a role in ending the smoking pandemic. Critics argue that imposing strict regulations on e-cigs is irresponsible considering that they could potentially save lives.

If e-cigs are considered tobacco products, then you would assume that nicotine replacement therapies like nicotine gums, patches and lozenges would fall under the same category as well. However, the FDA classifies these over-the-counter alternatives as drugs, so they are neither subject to tobacco regulations nor included in smoking statistics. Consequently, several double standards exist; for example, flavored e-liquids are accused of appealing to children while nicotine gums are readily sold over the counter in a variety of flavors, often on bottom shelves within reach of children

The CDC and Smoking Statistics

The CDC, which is responsible for tracking national smoking statistics, has been criticized for including data about e-cig users in their reports. For example, in April 2015 the CDC claimed “there was no decline in overall tobacco use between 2011 and 2014,” which is only true if you disregarded people who gave up smoking for vaping and you counted everyone who tried an e-cig even once as a regular tobacco user. The 2013 National Youth Tobacco Survey notoriously failed to distinguish between youth who tried vaping once and regular e-cig users, which led to highly inflated claims about the number of teens who vape. When relying upon statistics from an academic study or a government agency, always pay close attention to the methodology.

The Surgeon General's View on E-Cigarettes

The U.S. Surgeon General isn't immune to e-cig hysteria. In December 2016, the Surgeon General's office published a reported titled “E-Cigarette Use Among Youth and Young Adults,” which relies upon faulty data from the CDC to argue that e-cigs, “are now the most commonly used form of tobacco among youth in the United States.” That's a pretty bold statement considering that e-cigs are technically only tobacco products because the FDA deems them as such; however, when it comes to actual health outcomes, there is no comparison between vaping vs smoking.

How is Vaping Viewed in Other Parts of the World?

Different countries have traditionally dealt with technological advancements in different ways, so it's unsurprising to see contradictory vaping policies popping up across the globe. The UK has by far been the most accepting of e-cigs. Public Health England's 2015 evidence-based report on the subject concluded that vaping is at least 95 percent less dangerous than smoking tobacco cigarettes. Consequently, the Royal College of Physicians now urges doctors to recommend e-cigs to patients who smoke as a strategy for harm reduction. After acknowledging the potential public health benefits of e-cigs, the New Zealand Ministry of Health recently decided to regulate vapor products as consumer goods. More countries will hopefully follow suit and embrace e-cigs as a safer tobacco alternative.

Sadly, while the United States remains a global leader in technological and scientific innovation, conservative policies are preventing e-cigs from reaching their full potential as smoking cessation tools. The next and final installment of this series about nicotine will look at how other parts of the world are responding to the evolution of e-cigs.

The post How Does Vaping Fit into Smoking Statistics? appeared first on Electronic Cigarette Blog | White Cloud.

Thu, Apr 20, 2017