As its government rolls out its plan for tobacco plain packaging, New Zealand is also eyeing legalizing nicotine-laced e-cigarettes, according to a story on the New Zealand news website Newshub.
Currently if the products contain nicotine or claim to help people give up smoking, they are illegal. Many smokers have credited e-cigarettes with helping them to quit the habit, according to the story.
The proposal has received the backing of ACT leader David Seymour and Maori Party co-leader Marama Fox. “There’s no downside for legalizing e-cigarettes,” says Seymour.”The reality is it’s the tar that kills you from smoking, and if I had a choice from being addicted to tar or to vapor, I’d choose vapor every time.”
However, the original advocate of plain packaging in New Zealand who initiated the war on tobacco, Dame Tariana Turia, says e-cigarettes and vaping are not the solution. “I’ve never believed at any time that we should be legalizing anything that continues to facilitate cigarette smoking, and that’s what e-cigarettes does,” she said.
He may as well have just asked them what the real reason is for such onerous restrictions. The U.S. Food and Drug Administration (FDA), after all, freely admits it doesn’t have enough “scientific evidence” on e-cigarettes to “fully determine what effects they have on the public health.”
Sen. Ron Johnson, chairman of the Senate Homeland Security and Governmental Affairs Committee, sent a letter to Food and Drug Administration (FDA) Commissioner Robert Califf raising concerns about the agency’s recent e-cigarette regulation, which could create undue burdens on small businesses and possibly lead to negative unintended health consequences.
Johnson asked the FDA whether it will revise its rule if scientific findings indicate that e-cigarettes are safer than traditional cigarettes.
“Unfortunately, the FDA’s attempt to improve the public’s health by scrutinizing the e-cigarette industry could ultimately result in negative unintended health consequences,” Johnson wrote in the letter.
“The costly impact the rule will have on e-cigarette manufacturers will stifle innovation and make it harder for e-cigarette companies to continue to offer products that serve as an alternative to smoking. It is possible that without a cost-effective alternative, some consumers will resort to traditional cigarettes.”
The letter is below:
May 17, 2016
The Honorable Robert M. Califf, MD
Commissioner
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
Dear Dr. Califf:
The Committee on Homeland Security and Governmental Affairs is examining the regulatory burdens that federal agencies place on small businesses. On May 5, 2016, the U.S. Food and Drug Administration (FDA) finalized a new regulation that expanded its authority over electronic cigarettes, commonly known as “e-cigarettes.” I write to request your assistance in understanding the consequences that this new regulation may have on small businesses and the public’s health.
According to the FDA, the final rule extends “the Agency’s ‘tobacco product’ authorities in the [Federal Food, Drug, and Cosmetic Act],” as amended by the Family Smoking Prevention and Tobacco Control Act, to include other products such as e-cigarettes. The new rule prohibits the sale of e-cigarettes to people under the age of 18.
The regulations also require e-cigarette manufactures to submit premarket applications to the FDA in order to obtain federal approval for their products. According to recent reports, the new requirements would force e-cigarette companies to complete a burdensome and costly application process. Some manufacturers could spend more than 5,000 hours to complete an application, with a minimum cost of $330,000 per e-cigarette product, according to some estimates. As a result of these expensive and time-consuming applications, many e-cigarette manufacturers—most of which are reportedly small businesses—could close down.
According to Christian Berkey, the Chief Executive Officer of Johnson Creek Vapor Company located in Hartland, Wisconsin, the FDA e-cigarette regulations would “extinguish a multi-billion dollar industry and put tens of thousands of people out of business.” Mr. Berkey also stated that the new FDA rule would have more than just a burdensome impact on the e-cigarette industry, the effect of the rule would be “catastrophic.” In its regulatory analysis, the FDA itself acknowledged that the cost of the rule “would be high enough to expect additional product exit, consolidation, and reduction in variety compared with the baseline.”
Unfortunately, the FDA’s attempt to improve the public’s health by scrutinizing the e-cigarette industry could ultimately result in negative unintended health consequences. The costly impact the rule will have on e-cigarette manufacturers will stifle innovation and make it harder for e-cigarette companies to continue to offer products that serve as an alternative to smoking. It is possible that without a cost-effective alternative, some consumers will resort to traditional cigarettes.
In order to assist the Committee in better understanding the FDA’s decision to expand its authority on e-cigarettes, I ask that you please provide the following information and materials:
1. The final rule notes that the FDA does “not currently have sufficient data about e-cigarettes and similar products to fully determine what effects they have on the public health.” Further, the final rule states that “comments were divided on the safety and toxicity of e-liquids, e-cigarettes, and the exhaled aerosol.”
Will the FDA issue a revised rule if there is sufficient data that finds that e-cigarettes are a safer alternative to traditional cigarettes? Please explain.
How is the FDA’s regulation of e-cigarettes not a premature restriction on an industry given the FDA’s admission that it does not have “sufficient data” about e-cigarettes to determine the effects on the public’s health?
2. Some stakeholders claim that the FDA’s rule on e-cigarettes will stifle innovation and result in the closure of many small businesses that create and sell e-cigarette products.
Did the FDA determine how many e-cigarette businesses will be affected by the rule? If not, why?
If so, please provide that data.
Of the e-cigarette businesses that will be affected by the rule, how many of those businesses does the FDA predict will exit the market as a result of the new requirements?
3. Has the FDA considered the unintended consequences if decreased access to e-cigarettes leads to increased consumption of traditional cigarette and tobacco products? Please explain.
Please provide this material as soon as possible but no later than 5:00 p.m. on May 31, 2016. When delivering production sets, please produce to Majority staff in room 340 of the Dirksen Senate Office Building and to Minority staff in room 613 of the Hart Senate Office Building.
The Committee on Homeland Security and Governmental Affairs is authorized by Rule XXV of the Standing Rules of the Senate to investigate “the efficiency and economy of operations of all branches of the Government.” Additionally, S. Res. 73 (114th Congress) authorize the Committee to examine “the efficiency and economy of all branches and functions of Government with particular references to the operations and management of Federal regulatory policies and programs.” For purposes of responding to this request, please refer to the definitions and instructions in the enclosure.
If you have any questions about this request, please contact Scott Wittmann or Josh McLeod of the Committee staff at (202) 224-4751. Thank you for your prompt attention to this matter.
The Smoke-Free Alternatives Trade Association (SFATA), the largest trade association representing and protecting the interests of the vapor industry, announced it has grown to more than 1,000 business members while establishing 27 local chapters in 25 states throughout the country.
“We are proud to continue to represent the small businesses that primarily make up our industry, which is creating jobs and billions of dollars in revenues and economic activity,” said Cynthia Cabrera, president and executive director of SFATA.
“Advocating with a united and informed voice at the state and federal levels is paramount to the industry’s success, and we are committed to providing the resources to help our organization’s members navigate the increasingly difficult regulatory and legislative environments.”
Founded in 2012 with only a handful of members, SFATA today has grown into the largest vapor trade association, supported by businesses across the entire supply chain, including online retailers, brick and mortar vendors, distributors, manufacturers, professional service providers, importers and wholesalers.
SFATA also maintains committees comprised of members and leading industry thought leaders, including political, regulatory policy advisors, as well as top academics and scientists. The association also retains the foremost legal and public relations firms nationally, and employs top-tier state and federal lobbyists to advocate for the industry and educate legislators, health and regulatory agencies, and media, on vaping products.
“As we fight regressive policies that threaten our industry and the lives of smokers by treating vapor products, which contain no tobacco, more harshly than combustible cigarettes, it is vital now more than ever that the industry come together to fight for the preservation of this category, and not let the FDA hand the industry over to big tobacco,” added Cabrera.
It was funny because it was too close to being true. Twitter suspended a spoof account of the Food and Drug Administration’s (FDA) Center for Tobacco Products after the account mocked the FDA’s e-cigarette policy.
Jeff Stier, senior fellow at the National Center for Public Policy Research (NCPPR) and one of the nation’s leading critics of the FDA’s e-cigarette crackdown, set up the account to mock the agency’s monotonous Twitter feed.
“I set up a spoof twitter account- clearly identified as such- called FDATobaccoBot to parody the FDA’s absurd bot-like twitter account,” Stier told The Daily Caller News Foundation via email. “To avoid any confusion, I explained in the account’s bio: This is the #FDA Tobacco Bot Spoof Account. Send me questions about your tobacco #Ecig products,” Stier added.
“The account is obviously a spoof,” said NCPPR. “But it is also incisive political parody. For instance, when someone asked the spoof account about the Royal College of Physicians report that recommends doctors widely publicize e-cigarettes to their smoking patients, the spoof account responded: “RCP #Ecig report irrelevant rubbish to U.S. policy-making: English English differs from U.S. English significantly.”
No reason was stated in the story as to why Twitter shuttered the parody account.
Lost Art Liquids, producers of many premium e-liquids sold in the United States and abroad, has filed a lawsuit against the U.S. Food & Drug Administration (FDA) in the Central District of California.
Lost Art Liquids’ suit challenges FDA’s purported authority to deem and regulate e-liquids and other vapor products as “tobacco products” under the Tobacco Control Act and asserts claims against FDA for violations of the Regulatory Flexibility Act, the 1st and 5th amendments to the Constitution of the United States and the Administrative Procedures Act.
“Lost Art Liquids is and has always been committed to producing the highest quality, safest, and most innovative premium e-liquid products and in serving as a voice for the vapor community. FDA, with its deeming regulation, has ignored our voice and the voices of millions of others, leaving us no choice but to seek judicial relief,” said Brian Worthy, CEO of Lost Art Liquids. “We are disappointed that the FDA continues to confuse and conflate vapor products with tobacco and chooses to ignore years of well-established research that shows the relative safety of the products compared to combustible cigarettes and the public health benefit they may offer to millions of Americans who use them as an alternative to tobacco.”
Lost Art Liquids’ complaint alleges that FDA’s regulation of vapor products is illegal in that it exceeds the very limited and specific scope of authority Congress granted FDA to regulate “tobacco products” under the Tobacco Control Act in 2009.
“Vapor products are technology products, not tobacco products,” said Ryan Thomas, Lost Art Liquids’ Co-Founder and COO. “The legislative history and factual findings that serve as the predicate to the Tobacco Control Act make clear that Congress never intended to give FDA authority to regulate vapor products when it enacted the Tobacco Control Act in 2009. It was created to regulate products like cigarettes and smokeless tobacco, not vapor,” he continued.
“FDA has introduced one of the most burdensome, misguided and harmful regulations in its history without adequately sound science, or adhering to required, lawful procedures. These regulations will harm Lost Art Liquids’ business and customers by eliminating vapor products from the market, forcing consumers to resort to more harmful products like cigarettes and cigars,” added Thomas.
New regulations for vapor products across the UK are set to come into force on Friday. The rules will require warnings for e-cigarettes, limit their nicotine levels to 20 grams and restrict advertising and sponsorship by their makers.
The rules will be enforced under the Tobacco and Regulated Products Regulations 2016 with a one-year transitional period for the sale of old stock.
Here’s everything you need to know about the new rules:
The amount of nicotine vapers inhale in each container is set to be reduced in two ways. First, the new maximum size of each refill container will be set at 10ml. There are currently no limitations on the size of refill containers. The changes could result in a price increase for consumers as it will not allow them to buy large amounts in. Secondly, the maximum strength of e-cigarette cartridges will drop to 20mg per milliliter (2 percent) from 24mg
All vapor packaging will also now be required to carry health warnings. The front and back of e-cigarette packaging will contain health warnings much like regular cigarettes.The warnings will state: ‘This product contains nicotine which is a highly addictive substance’. All packaging must be child resistant and tamper-proof, as well.
Under the new laws, e-cigarette and vapor companies will no longer be able to make claims about vaping being beneficial to people’s health. This includes a ban on comparisons between the merits of vaping compared to smoking cigarettes. Celebrities will also not be allowed to endorse e-cigarettes and free samples cannot be given out in promotional campaigns.
Lastly, manufacturers are required to submit information to the government on exactly what their products contain in order to be allowed to sell them.
Let the litigation begin. The first of what is expected to be a plethora of companies has filed suit against the U.S. Food and Drug Administration (FDA) challenging its recently released deeming rules for the vapor industry.
Florida-based Nicopure Labs, represented by the international law firm of Covington & Burling, filed suit in the U.S. District Court for the District of Columbia in response to new FDA regulations that would subject e-cigarettes and other vaping products to more onerous restrictions than combustible cigarettes under the Tobacco Control Act.
In its court filing, Nicopure Labs argues that the FDA’s rulemaking process violated the Administrative Procedure Act, and that the deeming rule violates the First Amendment to the Constitution of the United States.
“Once the Deeming Rule goes into effect on August 8, 2016, the overwhelming majority of Nicopure’s products—including hundreds of products that are neither made nor derived from tobacco nor intended for human consumption—will be subject to the premarket approval, reporting, record-keeping, inspection, labeling, manufacturing, testing, and other requirements imposed by the Act,” the suit states. “Such regulation will severely burden Nicopure and its operations— costing millions of dollars. The Deeming Rule’s premarket approval requirements will force Nicopure to discontinue existing product lines and will also prevent Nicopure from introducing new product lines after the Rule’s effective date.”
Nicopure Labs general counsel and chief compliance officer Patricia Kovacevic, said the company felt it had no other options other than to turn to the justice system to protect its rights and the rights of its customers. “The government’s role is not to regulate for the sake of regulation,” she said. “Regulation must be based on sound science and robust procedure, and it must accomplish certain public health goals.”
Jeff Stamler, CEO and co-founder of Nicopure Labs, said that since 2009, Nicopure revolutionized the way e-liquid was manufactured and packaged, forever changing the vapor industry as few knew it. “Today, Nicopure Labs is again at the forefront of the industry as revolutionaries … through one voice, Nicopure Labs has taken a stand to ensure the voices of all [vapers] are heard and that [vapers] are treated fairly and not with a single stroke of a broad brush by the FDA,” he said “We fully support reasonable regulation that protects consumers, accomplishes the public health priority to reduce the grave harm caused by conventional cigarette smoking, and allows businesses to survive and innovate for a greater [public-health] vision for our society as a whole.”
Jason del Giudice, CTO and co-founder of Nicopure Labs, said the company is committed to responsible manufacturing based on superior product standards and stringent quality requirements. “[The] FDA’s rule does not protect the consumer from low quality products; instead, it places a disproportionate and unjustified regulatory burden on compliant companies,” he said.
Local vape shop operators, whether chain or mom and pop, have known for several years that federal regulators wanted their business to go up in smoke — and not in a good way.
Yet, most of the vape shops contacted by the Winston-Salem Journal were not sure how to react to the final regulatory rules disclosed May 5 by the U.S. Food and Drug Administration.
Some operators expressed surprise that their products — electronic cigarettes, water pipe/hookahs and vaporizers — were at risk for being shelved if they don’t meet new regulations that go into effect Aug. 8, according to an article in the North Carolina-based Winston-Salem Journal.
Many of the smaller vape shops make their liquid nicotine on the premises or order it from suppliers.The FDA is requiring that products from all three categories that debuted after Feb. 15, 2007, undergo a heightened regulatory review process to determine whether the product has a negative impact on public health unless there is a substantially equivalent product available before that predicate date.
The FDA allows for up to a three-year exception for products whose manufacturer enters the regulatory gauntlet by Aug. 8.
Preston Puckett, with the Avail store in Winston-Salem, said he believes the company likely has the financial resources to comply with the FDA standards. Avail, based in Richmond, has more than 70 stores in six states, including two in Greensboro and one each in Burlington and Winston-Salem.
“But I can see a lot of little shops going away because of the regulatory costs,” Puckett said. “The local market is pretty saturated as it is. We all want the products to be safe to the consumer, so we’re not opposed to additional regulations.”
Puckett said he can envision some of the smaller vape shops selling all their supplies before the Aug. 8 time frame for new regulations. “They’ll try to make as much money as they can if they determine they can’t afford the review costs,” Puckett said.
Despite a ban on selling electronic cigarettes in the United Arab Emirates (UAE), several retailers at the Chinese-themed Dragon Mart in Dubai told The National newspaper that they could get the devices.
Although they did not have the devices in their possession, the retailers said they could get them within five minutes.
Much like the EU, many parts of the world see electronic cigarettes as hugely less-risky substitutes for traditional tobacco cigarettes.
Two years ago, The National reported that retailers at the mall were flouting the ban by selling the devices in their shops, many of them unaware that a ban was even in place.
Now, it seems they are being more careful, but electronic cigarettes are still available for between Dh200 and Dh300.
One Dragon Mart retailer, who had pictures of different types of electronic cigarettes on his phone, said that he sold at least a few of the devices a week but that he kept them at another location to avoid being fined.
A spokesman for Nakheel Retail, which operates Dragon Mart, said in 2014 that it did not condone the actions of such retailers.
“Tenants are always required to be in compliance with the applicable rules and regulations,” the spokesman said.
“Any instances of non-compliance brought to the attention of the mall management is dealt with in accordance with the tenancy contract, including advising the appropriate officials of the law enforcing agencies.”
The vapor industry is readying for battle. On May 5, the U.S. Food and Drug Administration (FDA) finalized its rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco. This rule helps implement the Family Smoking Prevention and Tobacco Control Act of 2009.
One of the most questionable aspects of the controversial rule is the requirement of all manufacturers of all newly regulated products to show that the products meet the applicable public health standard set forth in the law and receive marketing authorization from the FDA, unless the product was on the market as of Feb. 15, 2007. The tobacco product review process gives the agency the ability to evaluate factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.
In 2007, e-cigarettes were in their infancy and the first generation iPhone was introduced. Imagine being told that all new smartphones had to be just like the first generation iPhone or makers would have to jump through regulatory hoops not applied to competing products. “Now imagine your life depended on it. You can understand why so many former smokers from across the political spectrum are dead set against this rule,” said Jeff Stier, senior fellow, National Center for Public Policy Research. “They just want to keep their vapes so they can reduce their risk.”
The FDA’s decision to use the Feb 2007 predicate date was not a surprise, the agency considered itself “bound by that date because of the Tobacco Control Act,” according to Stier. “The publication of the rule only gives more urgency to the Cole/Bishop amendment to change the predicate date.”
The Cole/Bishop amendment to appropriations legislation wending through the U.S. House would change the predicate date so more e-cigarettes would be grandfathered into the market.
Vapor industry manufacturers are finding more than a few faults with the FDA regulations, especially the seeming lack of consideration from the industry input the regulatory agency so desperately sought. Anthony Dillon, spokesperson for Purilum, a U.S.-based e-liquid manufacture, said that “on a quick early reading, the Administration appears to have made few if any concessions to industry or incorporated any industry comments.” Although, “the FDA is trying to reduce the barrier of the PMTA (a little) for e-product manufacturers who cannot use the SE pathway,” he said.
Dillon isn’t the only one who felt the FDA ignored industry input. Christian Berkey, founder of the first e-liquid company in the U.S., Johnson Creek Enterprises, said his company was also still reviewing the published regulations, however, “it would appear that the FDA had taken into account virtually none of the commentary” from the vaping industry. “That said, I expect that the Cole/Bishop amendment will pass and that the FDA’s unavailing February 2007 grandfather date will be changed to a reasonable date that allows our industry to grow and innovate,” he said.
The new legislation would prevent the FDA from requiring retroactive safety reviews of e-cigarettes that are already on the market and exempt some premium and large cigars from those same regulations. E-cigarette products introduced in the future would still undergo the safety reviews.
“Our industry has a long history of supporting sensible science-based regulations, including license requirements, as well as banning sales to minors and adopting child-resistant packaging. (This) final rule pulls the rug out from the nine million smokers who have switched to vaping, putting them in jeopardy of returning back to smoking, which kills 480,000 Americans each year and costs the U.S. more than $300 billion in annual health care expenses,” said Cynthia Cabrera, president of the Smoke-Free Alternatives Trade Association, a vapor advocacy group. “These new regulations create an enormously cost-prohibitive regulatory process for manufacturers to market their products to adult smokers and vapers. It also limits access to the 40 million adult smokers in the U.S. yet to make the switch to vaping and cripples a multi-billion dollar job-creating industry, the majority of which are made of small businesses.”
Wells Fargo vapor industry analyst Bonnie Herzog said that most new products will require a pre-market tobacco application (PMTA), which could take an average of 1,500 hours to complete. “Which is clearly a burden to the industry and could realistically slow down or stifle innovation,” she said “A PMTA is required if a product doesn’t meet the ‘substantial equivalence’ (SE) definition, which is narrowed to mean tobacco products must have ‘all’ of the same characteristics as the predicate tobacco product to be found substantially equivalent or the product doesn’t ‘raise different questions of public health.’”
Under staggered timelines, the FDA expects that manufacturers will continue selling their products for up to two years while they submit PMTAs and an additional year while the FDA reviews a new tobacco product application. The FDA will issue an order granting marketing authorization where appropriate; otherwise, the product will face FDA enforcement.
The FDA staggers compliance periods for different product classes based on continuum of risk. “The staggered periods depend in part on the product’s placement on the ‘continuum of risk.’ Thus, products that are believed to qualify for: (1) SE exemption will have 12-months to submit a request; (2) SE application – 18-months to submit; and (3) PMTA application – 24-months to submit. The FDA then has 12-months from each period to approve or deny the application,” said Herzog. “We are encouraged that the FDA recognizes the continuum of risk but believe these compliance periods could prove challenging for many manufacturers.”
Mitch Zeller, director of the FDA’s Center for Tobacco Products, said the final rule is a foundational step that enables the FDA to regulate products young people were using at alarming rates – like e-cigarettes, cigars and hookah tobacco – that had gone largely unregulated, although several recent studies dispute the statement.
“The agency considered a number of factors in developing the rule and believes our approach is reasonable and balanced,” said Zeller. “Ultimately our job is to assess what’s happening at the population level before figuring out how to use all of the regulatory tools Congress gave the FDA.”
The final deeming regulations are broadly as anticipated and industry experts agree the legislation as written would be burdensome for small manufacturers to comply with while increasing the barriers to entry and entrenching large tobacco companies.
“As such, we anticipate litigation from several manufacturers, which could unfortunately prolong the uncertainty plaguing the entire industry,” said Herzog. “Our main concern is that these final deeming regs could realistically stifle innovation, which could dramatically slow industry growth by dis-incentivizing consumer conversion from combustible (cigarettes). This would ultimately have a net negative impact on public health, which is clearly in direct opposition to the FDA’s goal.”
During a press conference announcing the regulations, Zeller estimated the average cost of an application at “several hundreds of thousands of dollars.” Numerous industry experts have placed that figure at well over $1 million. The FDA has conservatively estimated the cost of a PMTA to be $330,000, according to Dr. Micheal Siegel, a professor in the Department of Community Health Sciences, Boston University School of Public Health.
“While I think this is a gross underestimate, even if we accept this as accurate, a manufacturer of 20 e-liquid flavors with three nicotine strengths each is looking at a capital cost of $19.8 million,” said Siegel. “Quite clearly, this is a cost that only a very small number of manufacturers (the tobacco companies and the very largest of the independent manufacturers) can afford. This is why the e-cigarette industry will be devastated and thousands of companies will be forced out of business.”
ey are illegal. Many smokers have credited e-cigarettes with helping them to quit the habit, according to the story.
