Tag: ENDS

Unintended Consequences

Credit: Lost in Midwest
Harm reduction advocates worry about the effects on vapers when the USPS implements PACT Act requirements for ENDS.
By Vapor Voice staff
The United States Postal Service (USPS) has delayed the implementation of a requirement to place electronic nicotine-delivery systems (ENDS) under the same shipping rules as combustible cigarettes. As of this writing, the USPS has not published its final rule for mailing ENDS products in the Federal Register. The USPS has stated that the rules will take effect immediately when the final rule is published.
The rule has been delayed because the USPS is still determining how it will handle the broad definition of ENDS set by the U.S. Congress and how the USPS will process and determine eligibility for companies seeking an exception to the Prevent All Cigarette Trafficking (PACT) Act rules. For example, CBD vaping devices fall under the ENDS definition, but it is believed that it was not the intent of Congress to ban the mailing of hemp products. No date has been announced for when the USPS intends to publish the final rule.
Emily Burns, of counsel for the Green Light Law Group, noted that while the USPS could have banned vaping products altogether as part of the new rule, the USPS is now taking time to revisit the implications of an all-encompassing prohibition on shipments of vaping products. She wrote in the firm’s blog that the USPS must not exceed its own legal authority under the PACT Act by regulating vaping products that fall outside the definition of tobacco product as such a rule could be subject to challenge by various industry groups.
Credit: Aleksandr Yu
“If lawmakers intended to truly change the way the federal government defines ENDS to include nontobacco and non-nicotine products, it is rational to assume that Congress would have also amended the [Tobacco Control Act] to allow the FDA to regulate these other substances. The strategy moving forward should be to encourage USPS to specifically focus on the ENDS market … anything done in relation to cannabis or hemp should be seriously challenged by the industry.”
The USPS confirms Burns’ concerns and has stated that the process is turning out to be more complicated than just ending all vape mail of vapor products. On April 19, the USPS issued guidance for exemptions to the requirements for mailing all vapor products, including cannabis. The USPS was inundated with exemption applications, none of which will be addressed until the final rule is published, according to the USPS.
The USPS refers to possibly exempting cannabis products in its guidance. Other exceptions include intrastate shipping within Alaska and Hawaii, shipments between businesses engaged in tobacco product manufacturing, distribution, wholesale, export, import, testing, investigation or research, shipments by individuals for noncommercial purposes (including return of goods to manufacturer), limited shipments by manufacturers to adult smokers for consumer testing, and limited shipments by federal agencies for public health purposes.
For cannabis-based product exemptions, the guidance states that “mailers must retain, and prepare to make available upon request, records establishing compliance with all applicable federal, state and local laws pertaining to hemp production, processing, distribution and sales, including the [2014 Farm Bill] and [2018 Farm Bill].” The guidance says such records may include “laboratory test results, licenses and compliance reports.”
Burns stated that the USPS guidance also indicates that cannabis products with greater than 0.03 percent THC would be nonmailable if they are deemed to be drug paraphernalia for purposes outlined under the Controlled Substances Act (CSA), which includes a federal ban on mailing drug paraphernalia that already exists outside of the PACT Act. However, the CSA prohibition on drug paraphernalia does not apply to “any person authorized by local, state or federal law to manufacture, possess or distribute” such items.
“In the case of medical and recreational cannabis states that have removed criminal statutes penalizing drug paraphernalia used to consume cannabis, anyone who is shipping from one legalized state to another would technically fall under the paraphernalia definition exception, thus providing a legal basis for exception from the PACT Act requirements,” Burns states.
The move to place ENDS under the PACT Act has been heavily scrutinized. Several harm reduction advocates say the new rule will bring unintended and deadly consequences. During a seminar sponsored by Hall Analytical in mid-May titled “PMTA and Beyond: A Global Outlook on ENDS Regulatory Requirements,” David Lawson, CEO of Inter Scientific, said that placing vaping products under the PACT Act only serves to benefit large tobacco companies and could push former smokers who shop for vaping products online back to combustible cigarettes.
“If you’re a large tobacco company in the U.S., you most likely sell directly to the likes of Walgreens and these kinds of stores. They then sell them to consumers. Many of the independent vaping companies and manufacturers, they sell online. The PACT Act doesn’t really impact store sales. It only impacts online sales,” explains Lawson. “So a company who relies entirely on online sales may have gone through the [submitting a premarket tobacco product application (PMTA) to the U.S Food and Drug Administration] process. They’re now risking the potential for not being able to ship to their clients at all. I think from that perspective, it’s quite negative and damaging.”
Lawson said that what lawmakers failed to realize when moving ENDS under the PACT Act is that online retail has the advantage of being able to do more thorough ID checks than a local mom-and-pop shop. A credit card is needed for an online purchase, for example, along with a photo ID. At a brick-and-mortar store, a youth simply needs a fake ID and cash. “It’s much easier to do detailed checks on people online than it is to do them in store,” he said. “It is a growing concern for the U.S., the ability of youth to get access to ENDS, but I think, from the experience I’ve had, from what I’ve seen from our clients in the U.S., the kids aren’t getting the products online.”
Credit: Michael Vi
Another consequence of the PACT Act is that when adult consumers who purchase vaping products online can’t get their products anymore, they may go back to smoking combustible cigarettes, which are more readily available in local stores, according to Lawson.
“In the U.S., if you’re buying a specific product online, certainly it’s not going to be available anymore. You have the option there to try and find an alternative brand or risk going back to cigarettes. I think there’s a huge risk impact that will result in adult smokers who are currently vaping going back to smoking again, which is, obviously, not good for public health,” said Lawson. “I don’t personally see the value of the PACT Act. I think it’s kind of a step backwards. It does risk impacting public health negatively.”
While the industry continues to wait for the USPS to publish its finalized rule and what a PACT Act exemption might entail, Burns recommends that concerned business owners “reach out to a regulatory attorney about the compliance process ahead of time in preparation of the forthcoming regulatory changes.”
Coupled with the requirement to submit premarket tobacco product applications to the FDA, the PACT Act and flavor bans, ENDS regulations have become overly stringent, and the complex rules can turn smokers away from the idea of switching to ENDS products, said Lawson, especially when that regulation doesn’t allow for clarification of the science behind vaping products.
“The issue here really is around all this information from the perspective of science, perhaps. When ENDS first entered the market back in 2006 … there was a lot of bad science and bad data generated. When you generate a bad set of data and it becomes publicly available, people don’t necessarily question and interpret how the information has been generated or the validity of that data,” said Lawson. “I think there’s a huge risk with the media and with the interpretation of science that it can certainly switch people away from using ENDS.”
There are other regulatory challenges coming too. The Tobacco Tax Equity Act Of 2021, a bill that would establish the first federal e-cigarette tax, increase the traditional tobacco tax rate and close tax loopholes, is currently making its way through the U.S. Senate. The rule would follow the lead of 21 states, and Washington, D.C., that have set their own state taxes on vapor products by setting a federal tax on ENDS products.
Senator Dick Durbin, who sponsored the bill, said tobacco-related disease accounts for one out of every five deaths in America. He did not mention that there has never been a reported death associated with vaping of legal nicotine products.
“Data shows that the most effective strategy to prevent children from starting this deadly habit is to price it out of their range. This bill would help reduce tobacco and e-cigarette use by ending loopholes that the industry has exploited to target our children,” he said in a statement. “If America can kick its nicotine addiction, it would go a long way to improving our public health for generations to come.”
The repercussions of the USPS vapor mail ban on the vaping industry will not be realized for some time. While the PACT Act requirements have forced many businesses to close, the vapor industry is used to dealing with a great amount of uncertainty. With numerous regulatory hurdles on the horizon, it does not seem like that is going to change any time soon.

July 1, 2021
Philippine House Committees Endorse Vapor Rules
In the Philippines, three committees of the House of Representatives have endorsed to the plenary the approval of a measure that will regulate all vapor products, whether they contain nicotine or not. The rule will also apply to heated tobacco products (HTPs).
House Committees on Trade and Industry, on Health and on Appropriations has submitted Committee Report 873 for the proposed Non-Combustible Nicotine Delivery Systems Regulation Act (House Bill 9007), according to politics.com.ph. The rule applies to electronic nicotine- and non-nicotine-delivery systems (ENDS/ENNDS).
The measure provides that the allowable minimum wage to purchase, sale and use ENDS/ENNDS or HTPs shall be 18 years old, although there is debate to raise that age to 21 or even 25. The seller would also be required to verify the age of the buyer by requiring any valid government-issued identification card bearing the picture, age or date of birth.
“It shall not be a defense for the person selling or distributing that oneself did not know or was not aware of the real age of the purchaser. Neither shall it be a defense that oneself did not know nor had any reason to believe that the product was for the consumption of a person below 18 years old,” the committee report read.
The use of ENDS/ENNDs or HTPs will be banned in all enclosed public places except in designated vaping areas if passed, and the use of product will be prohibited in schools, hospitals, government offices and facilities intended particularly for minors. The bill prohibits the sale or distribution of ENDS/ENNDS or HTPs within 100 meters from a school, playground or other facility frequented by minors.
It also prohibits manufacturers of ENDS/ENNDS or HTPs from sponsoring any sport, concert, cultural or art event, as well as individual and team athletes or performers where such sponsorship shall require or involve the advertisement or promotion of the products.
Violators of the proposed law will be fined P500,000 for the first offense and P750,000 for the second offense. On the third offense, a fine of P1 million and/or imprisonment of not more than six years. The business permit and licenses of the company will also be revoked or cancelled.
If the offender is a foreign national, they will be deported only after serving their sentence.
March 19, 2021
Public Comment Begins for USPS ENDS Mail Rules
Interested parties will have 30 days to comment on the U.S. Postal Service rules for mailing electronic nicotine-delivery systems (ENDS). The USPS posted the rules on Wednesday and they were published in the Federal Register today. Comments must be submitted by March 22. The rules will presumably go into effect on March 27.
Credit:USPS
“The Postal Service proposes to revise Publication 52, Hazardous, Restricted, and Perishable Mail, to incorporate new statutory restrictions on the mailing of electronic nicotine delivery systems,” the listing reads. “Such items would be subject to the same prohibition as cigarettes and smokeless tobacco, subject to many of the same exceptions.”
The Preventing Online Sales of E-Cigarettes to Children Act, which placed ENDS under the PACT Act, was enacted on December 27, 2020 and becomes effective 90 days after enactment (March 27, 2021). The USPO rule states that the agency will only mail ENDS products under narrowly defined circumstances:

Noncontiguous States: intrastate shipments within Alaska or Hawaii;

Business/Regulatory Purposes: shipments transmitted between verified and authorized tobacco industry businesses for business purposes, or between such businesses and federal or state agencies for regulatory purposes;

Certain Individuals: lightweight shipments mailed between adult individuals, limited to 10 per 30-day period;

Consumer Testing: limited shipments of cigarettes sent by verified and authorized manufacturers to adult smokers for consumer testing purposes;

Public Health: limited shipments by federal agencies for public health purposes under similar rules applied to manufacturers conducting consumer testing.
Many business were unsure if B2B mailing would be allowed. The unpublished rules say they will be allowed. According to Azim Chowdhury, a partner at Keller and Heckman, the PACT Act has historically exempted businesses-to-business deliveries from the USPS ban.
Specifically, the USPS ban does not extend to tobacco products mailed only for business purposes between legally operating businesses that have all applicable state and federal government licenses or permits and are engaged in tobacco product manufacturing, distribution, wholesale, export, import, testing, investigation, or research.
“Companies seeking to use USPS for business-to-business deliveries must first submit an application to the USPS Pricing and Classification Service Center and comply with several other shipping, labeling, and delivery requirements,” said Chowdhury.
Email comments, containing the name and address of the commenter, may be sent to: PCFederalRegister@usps.gov, with a subject line of “E-Cigarette Restrictions.” Faxed comments are not accepted.
February 19, 2021
U.S. FDA has Processed PMTAs for 4.8 Million Products
The U.S. Food and Drug Administration (FDA) said it received thousands of premarket tobacco product application (PMTA) submissions covering millions of tobacco products, the majority of which came in very close to the Sept. 9, 2020 deadline. The submissions varied substantially in number of tobacco products contained in each submission, size, format and organization, including paper submissions and even hard drives and CDs, according to a press release.
Mitch Zeller speaking at a TMA annual meeting. Photo: Taco Tuinstra
FDA Center for Tobacco Products (CTP) director Mitch Zeller stated as of mid-January 2021, the agency has completed the Processing step of applications for more than 4.8 million products from over 230 companies. “We have accepted applications for about 84,000 products and refused to accept applications for about 3,100 products submitted through the PMTA pathway,” wrote Zeller. “As of mid-January 2021, of the applications submitted by Sept. 9, we have filed applications for about 29,000 products and refused to file applications for about 1,650 products submitted through the PMTA pathway.”
He also stated that several factors have slowed the agency’s progress in getting application’s into the system. Companies submitted PMTAs differently, for example some applicants provided information on one product per submission while other applicants provided information for all of the company’s products within one submission.
“One firm submitted information on more than 4 million tobacco products within a single submission,” Zeller wrote. “The amount of content in each submission also greatly varied, with some applications including up to 2,000,000 files where each file contains multiple pages of content for FDA to review.” The letter is part of a pledge Zeller made that the agency would keep interested stakeholders updated on the agency’s progress.
FDA is prioritizing enforcement against any ENDS product that continues to be sold and for which the agency did not receive a product application. To date, the FDA has sent warning letters to 30 firms who manufacture and operate websites selling electronic nicotine delivery system (ENDS) products, specifically e-liquids, which lack premarket authorization, according to the letter.
The agency also stated that the likelihood of FDA reviewing all the applications by Sept. 9, 2021 is low. Because of the sheer number of applications, the agency has set aside the products with the greatest market share and will push those products through the process more quickly. “[We will] focus resources on products where scientific review will have the greatest public health impact, based on their market share, while also committing to providing an opportunity for review to all companies,” Zeller wrote. This could prove positive or negative as a quick denial would force the product off the market.
The agency can still not confirm when it would release a list of products that are approved to be on the market. Zeller wrote that the agency continues to work on processing submissions and verifying the dates of initial marketing and current marketing status of products that submitted a timely PMTA.
“We have already verified this information for around 86,000 products received through the PMTA pathway,” he wrote. “Due to the size and volume of the PMTA submissions and the variable quality, format and presentation of these submissions, processing these submissions and verifying this information will take more time.”

February 16, 2021
The Wrong Lessons
The EU’s ban of snus provides a cautionary tale for U.S. regulators considering restricting consumer access to electronic nicotine-delivery systems.
By Josh Church
As the proverbial Armageddon for electronic nicotine-delivery systems (ENDS) in the United States draws closer, it has become apparent that the vapor industry as a whole has been found guilty without fair trial. Maybe it’s due to the constant presence of unsubstantiated science and fraudulent claims, or maybe it’s because public health and regulatory bodies both refuse to allocate resources to non-biased research.
It’s almost as if these organizations are selectively blind to the research and science that is happening around the globe, especially if that research enforces the fact that ENDS can be of any benefit to the health of this nation. One thing is certain: The burden of truth is placed squarely on the shoulders of the vapor industry. It is now the job of the industry to prove that ENDS do not represent the decimation of public health, as much of the media and certain public health groups in the U.S. would have you believe.
AS IT CURRENTLY STANDS
Without the allocation of federal resources, the ENDS industry must fund and complete extensive research into combustible tobacco products. This includes but is not limited to the behavioral patterns in regard to users transitioning from combustible products to ENDS products as well as the potential health risks to a person using both products simultaneously.
It’s important to remember in this context that most ENDS manufacturers have no connection to large tobacco companies and have no way to complete this robust amount of research into combustible products. The ENDS industry already has a massive burden in proving that it will not initiate new users of nicotine products, on top of developing methods to eliminate the usage of ENDS among minors.
These two requirements on their own are difficult enough to substantiate without the addition of having to conduct research on combustible tobacco usage patterns. U.S. regulars will not accept any evidence for ENDS without the combustible tobacco research. If this requirement continues past the 2021–2022 deadlines, the U.S. is certain to see an entire product sector be all but eliminated as an option for American smokers.
LOOKING AT OTHER NATIONS
If we look at Europe’s approach to substantiating the public health benefit or threat of ENDS, we see a basis of sound science and a transparent reporting of findings. Studies both for and against ENDS have been available not only for the regulatory bodies and public health departments but also for the general public in many countries.
Millions of dollars have been allocated throughout the EU with the purpose of understanding exactly what this new tobacco technology can mean for public health. While many of these studies highlight that more research needs to be done, a good portion of preliminary findings are showing that there is a positive effect for a person transitioning completely to an ENDS device and continuing to abstain from all use of combustible tobacco products. Cancer research in the U.K. has gone as far as producing informational packets for general practitioners to educate patients about the possible health benefits of transitioning completely to ENDS. This is a far cry from what we see happening in the U.S. It begs the question: “Are European lungs different than American lungs?
New Zealand has set an aggressive goal of becoming a smoke-free country by 2025. While a good portion of this effort is being executed through higher taxation and stricter regulations on combustible tobacco products, ENDS have been given a role as well.
New Zealand is the only country other than the U.S. that allows for the commercial advertisement of pharmaceuticals through public media outlets. While it is still a long way away from allowing ENDS manufacturers to advertise their products as approved smoking cessation devices, it allows the advertisement of ENDS as alternatives to traditional tobacco products.
These advertisements occur not only through radio broadcasts but also on television and other visual outlets. Such actions allow the public to understand both the potential risks and benefits of transitioning to an alternative to the proven deadly combustible cigarette.
PROHIBITION OF HARM REDUCTION
EU regulators’ openness to ENDS is even more remarkable given their history of overreach in tobacco-related issues. In 1992, for example, the EU banned snus in all member states except Sweden. In 1980, Sweden’s smoking rate was 34 percent—in line with adult smoking rates throughout the rest of the EU at the time. Through societal influence and education, among other factors, smoking rates have since declined across the EU. However, in Sweden—where snus remained legal—smoking rates fell much faster. While snus manufacturers were not allowed to sell their product as a reduced-risk alternative, Swedish consumers were able to educate themselves and come to their own conclusion.
Over the next three decades, EU smoking rates leveled off between 23 percent and 36 percent. In Sweden, by contrast, they plummeted to an unrivaled low rate of 5 percent. Many health officials consider a society with a smoking rate of 5 percent or lower smoke-free. You may question whether this transition from combustible cigarettes to snus was due to government marketing campaigns, but this was not the case.
The product and the consumer were left to their own devices. With this reduction of combustible tobacco use, Sweden now boasts Europe’s lowest levels of lung cancer in males, cardiovascular disease and other tobacco-related illnesses.
Some may speculate that the increase in oral tobacco use resulted in more incidences of oral cancer, but this was not the case. Studies across Sweden found that oral cancer rates in snus users were similar to those of never users. It is critical that global regulators, public health groups, and people who either use combustible tobacco products or know a person who does take note of this. Despite such evidence for harm reduction, many still believe abstinence of nicotine and tobacco is the only answer to the public health crisis.
NOT MAKING THE SAME MISTAKES
The U.S. risks learning the wrong lessons from the EU. Regulators should observe these examples and apply them to ENDS. U.S. regulators, health officials and public health groups must be extremely cautious about depriving combustible tobacco users of viable options to reduce their health risks.
History has shown that traditional nicotine-replacement therapies and approaches promoting abstinence have little to no effect on consumers who enjoy or are addicted to nicotine. The example of snus regulations in the EU suggests that prohibition would be the worst option. Regulators and industry representatives need to work together to make sure that this will not be known as the era where perfect is the enemy of better.

Josh Church
Josh Church is the chief regulatory and compliance officer of Joyetech Group, the largest vapor industry manufacturer in the world.
April 30, 2019
Cherry Crush
Several bills at the local, state and federal levels of government aim to ban all flavors in vapor products.
By Timothy S. Donahue
The fight never ends. The fight for flavors in the vapor industry has battlegrounds at every level of government. Currently, at least five U.S. cities have proposed bans on flavors for vapor products: Sacramento; New York City; Chicago and Baltimore, according to the Vapor Technology Association (VTA), a vapor advocacy group. Suffolk County, New York, is also considering a ban.
There are at least eight U.S. states that have or intend to propose vapor flavor bans: California, Massachusetts, North Dakota, New York, New Jersey, Connecticut, Hawaii and New Mexico. However, there is one bill currently in the U.S. House of Representatives that could eliminate all flavors in vapor products everywhere: the Youth Vaping Prevention Act of 2019 (H.R. 293).
Introduced by Connecticut Rep. Rosa DeLauro on Jan. 8, H.R. 293 would ban the sale of all e-liquid flavors other than tobacco. The bill specifically references any constituent, additive, artificial or natural flavor (other than tobacco flavor), or an herb or spice “(including menthol, strawberry, grape, orange, clove, cinnamon, pineapple, vanilla, coconut, licorice, cocoa, chocolate, cherry and coffee) that is a characterizing flavor of the tobacco product, tobacco smoke or aerosol emitted from the product.”
The bill would also ban flavors in all vapor products even if the product does not contain nicotine. H.R. 293 defines e-cigarettes and electronic nicotine-delivery systems (ENDS) as “any electronic device that delivers nicotine, flavor or other substance via an aerosolized solution (including an electronic cigarette, cigar, pipe or hookah) to the user inhaling from the device (including any component, liquid, part or accessory of such a device, whether or not sold separately).”
However, the bill would allow for flavors if an ENDS is “approved by the [U.S.] Food and Drug Administration (FDA) for sale as a tobacco cessation product or for another therapeutic purpose and is marketed and sold solely for a purpose approved as [just] described.”
DeLauro serves in the Democratic leadership as co-chair of the Democratic Steering and Policy Committee, and she is a ranking member on the Labor, Health and Human Services, and Education Appropriations Subcommittee, where she oversees U.S. investments in education, health and employment, according to www.delauro.house.gov. Currently, H.R. 293 has no co-sponsors.
“The New England Journal of Medicine just reported that e-cigarettes are twice as effective as FDA-approved products in helping smokers quit smoking,” said Tony Abboud, executive director of the VTA. “Banning flavored vapor products, which are both 95 percent safer than cigarettes and a more effective tool for quitting, simply cannot be the answer for anyone committed to ending the death and disease associated with combustible tobacco. Congress should allow [the] FDA to follow the science: Flavored vapor products help adults quit deadly cigarettes.”
The VTA is also fighting the flavor ban bills in state and local governments. “Thanks to our growing network of state associations and VTA’s massive commitment of resources, our industry now has lobbying representation on the ground in almost 40 states,” says Abboud. “Our industry has dealt with an onslaught of legislation over the past two years. We’re taking on the most important issues, including those bills that present an existential threat to our industry, such as the over-taxation of vapor products and flavor bans, while we are focusing legislators on crafting responsible regulation to save our industry.”
As of this writing, H.R. 293 has been referred to the Committee on Ways and Means in addition to the Committee on the Judiciary, as well as the Committee on Energy and Commerce, for a period to be subsequently determined by the speaker of the house to be sent to the House floor for a vote. It would then have to pass the U.S. Senate before being signed into law by President Donald Trump.

Timothy S. Donahue
February 18, 2019