Category: Regulation

Small Vapor Businesses to Bear Brunt of U.S. Mail Ban

The outlook for many small vapor companies and online retailers looks bleak following the enactment of new rules that prohibit the U.S. Postal Service (USPS) from shipping e-cigarettes, according to Keller and Heckman’s Azim Chowdhury and Galen Rende.
Writing on The Continuum of Risk law blog, the attorneys discuss the fallout of a recent amendment to the 2009 All Cigarette Trafficking (PACT) Act.
In late December, Congress overturned a veto from former President Trump and voted into law a $2.3 trillion coronavirus relief and government funding bill that contains a provision banning the USPS from delivering vapor products. The USPS was already prohibited from delivering cigarettes and smokeless tobacco products to consumers under the PACT Act. The law passed in December extends the Act’s original definition of “cigarette” to include electronic nicotine delivery systems (ENDS).
Azim Chowdhury
Tobacco and vapor companies may use private services to ship their products to consumers, but the PACT Act requires them to register with the Bureau of Alcohol, Tobacco, Firearms and Explosives and the tobacco tax administrators of the states into which a shipment is made. Delivery sellers are further required to verify the age and identity of the customer at purchase and maintain records of delivery sales for a period of four years after the date of sale, creating substantial administrative burdens.
Critically for the vapor industry, the most popular carriers, Federal Express and United Parcel Service, have recently announced that they would cease all deliveries of vapor products.
The prohibition on the mailing of ENDS is scheduled to take effect after the USPS promulgates regulations clarifying the mail ban, which it is required to do within 120 days of the enactment—i.e., by April 27, 2021.
February 4, 2021
Hall Analytical Offers Free Webinar on PMTA Process

Credit: The Blinc Group
Hall Analytical is offering a virtual seminar on Feb. 11, 5-6 pm GMT about the U.S. Food and Drug Administration’s premarket tobacco product application process.
E-liquid and device manufacturers will have an opportunity to take part in a live Q&A session with subject matter experts.
Panelists include David Lawson, CEO, Inter Scientific; Patricia Kovacevic, founder and principal, Regulation Strategy; and Sally McGuigan, principal scientist, Hall Analytical
This session is limited to the first 50 registrants, and therefore places will be offered on a first come, first served basis.
Participants can register here.
February 4, 2021
Broughton Publishes Summary of FDA’s Final PMTA Rule
Illustration: Broughton Nicotine Services
Broughton Nicotine Services has published a summary of the U.S. Food and Drug Administration’s rule for the premarket review of new tobacco products.
Released on Jan. 19, the FDA’s final rule makes amendments and recommendations to the previous rule and helps ensure that PMTAs contain sufficient information for the agency to determine whether a marketing granted order should be issued for a new tobacco product.
The purpose of the rule is to improve the efficiency of the submission and review of PMTAs as well as providing applicants with a better understanding of the information a PMTA must contain.
Amongst other topics, the rule addresses:
The submitting of detailed information regarding the physical aspects of the new tobacco product and full reports of information regarding investigations that may show the health risks of the new tobacco product.
Whether the product presents the same or different risks compared to other tobacco products. The FDA requires the submission of these health risk investigations to ensure it understands the full scope of what is known about the potential health risks of a new tobacco product.
Electronic submission of the PMTA.
Post-market reporting requirements for applicants that receive marketing granted orders.
Retention of records requirements for PMTAs
Procedures by which the FDA reviews a PMTA
Broughton Nicotine Services summarized the 516-page recommendations and requirements report into a digestible guide, which is available for download here.
February 4, 2021
Missoula, Montana Delays Vaping Ban Enforcement
Leadership for the city of Missoula, Montana Missoula’s have recommended that the city not enforce its ban against flavored vaping products until May. Enforcement was to begin Monday.
Credit: Nadine Shaabana
The decision comes after two Missoula vape shops and the Montana Smoke Free Association filed suit against Mayor John Engen, Missoula County health officer Ellen Leahy and the city of Missoula.
The lawsuit claims the city’s ordinance flies in the face of state law because the ban applies to adults as well as juveniles, according to NBC Montana. Engen told the Council he’d like to postpone that until May to see what the legislature might do and to prevent unnecessarily spending taxpayer money on litigation. No one objected.
January 27, 2021
Vape Shop Owner Fighting Nova Scotia Restrictions
The latest round of restrictions for the vaping industry by Nova Scotia’s government has caught the ire of the co-owner of a vape shop in Dartmouth. William MacEachern of the Cloud Factory Vape Shop is seeking an injunction against the eastern Canadian province’s newest restrictions on vaping, arguing they unfairly burden adults who are trying to kick a bad habit.
Credit: Fraser Institute
MacEachern launched a constitutional challenge against increased taxes on vaping products, a ban on flavored e-cigarettes and e-liquids, and a prohibition on sampling items in vaping shops, according to Global News. His lawyers say the case is about Nova Scotians’ access to a valuable harm reduction tool in the war against a “No. 1″ killer: cigarettes.
“In basically doubling the cost of our applicant’s vaping products, it greatly reduces their access,” said MacEachern’s lawyer, Sarah Emery. “We’re not arguing that he has an economic interest to cheap vape products as a recreational use, we’re arguing this is a matter of access and that goes to Section 7 rights to security of the person.”
Emery and her partners at Patterson law are seeking an immediate suspension of vaping rules that came into effect in 2020 — rules that earned the province a good deal of praise from Canadian health advocates when first announced in 2019.
In April 2020, Nova Scotia became the first Canadian province to ban the sale of flavored vape juices and e-cigarettes in an effort to reduce their appeal to youth. Higher taxes went into effect in September that year, bringing the rate to 50 cents per ml of e-liquid, and 20 percent of the retail price of all devices.
January 27, 2021
OFR Removes Final PMTA Rules From Federal Register
The Biden administration has announced a regulatory freeze on all new and pending rules introduced in the last part of the Trump administration. Included in the freeze are the new finalized rules for premarket tobacco product applications (PMTA) and substantial equivalence (SE) that were announced on Jan. 19, the last full day of the Trump administration.
The FDA’s CBD enforcement policy draft guidance, which had been under review at the White House Office of Management and Budget (OMB) since July, was also withdrawn.
Stakeholders and lawmakers have been anticipating the guidance for two years, since the 2018 Farm Bill gave FDA authority over hemp-derived CBD. Representatives from the U.S. Hemp Roundtable and the National Industrial Hemp Council, both of which met with OMB to discuss the draft guide in late July, say the lack of regulatory clarity from the FDA has led to uncertainty in the hemp and CBD industry.
The memo, issued by White House Chief of Staff Ronald Klain, calls on the heads of executive departments and agencies to “propose or issue no rule in any manner – including by sending a rule to the Office of the Federal Register [OFR] – until a department or agency head appointed or designated by the president after noon on January 20, 2021, reviews and approves the rule.” Previous administrations, including those of Trump and Barack Obama, issued similar memos to stop last-minute actions by the outgoing administration.
What this means for the vapor industry is unclear. It does not change the rules concerning the Sept. 9 deadline to submit a PMTA to be eligible to stay on the market for year. Because the rule was not formally published in the Federal Register by the U.S. FDA before the end of Trump’s presidency, the Biden administration could move forward with the rule as is, make changes to the rule or scrap the rules entirely.
An editor’s note on the Federal Register website reads, ” The Food and Drug Administration withdrew this document while it was on public inspection. It will remain on public inspection until the close of business on January 27, 2021. A copy of the withdrawal request is available at the Office of the Federal Register.”
The White House memo also explains that it does not strictly apply to “rules” but also to “any substantive action by an agency (normally published in the Federal Register) that promulgates or is expected to lead to the promulgation of a final rule or regulation, including notices of inquiry, advance notices of proposed rulemaking, and any agency statement of general applicability and future effect that sets for a policy on a statutory, regulatory, or technical issue or an interpretation of a statutory or regulatory issue.”
Vapor Voice has reached out to the FDA for a response concerning the status of PMTAs for electronic nicotine delivery system (ENDS) products.
January 26, 2021
New Zealand Opens Public Vaping Consultation Today
Proposed vaping regulations are now open for public comment in New Zealand. The country’s Ministry of Health is encouraging New Zealanders to have their say and provide feedback on draft regulations for electronic nicotine delivery systems (ENDS) under the Smokefree Environments and Regulated Products Act. The online consultation opens today.
Credit: govt.nz
An amendment to the Smokefree Environments and Regulated Products Act 1990 (the Act) commenced on 11 November 2020. “The amendment means that vaping products are now controlled in a similar way to tobacco products,” Jane Chambers, group manager at the Ministry of Health, said in a press release. “However, new regulations are required to fully deliver the changes sought by the Government and to support the right settings for the legislation.”
The health agency is seeking public feedback on the draft regulations because “if we want to get it right, it’s important everyone has a chance to have their say.” Feedback is expected to help shape the final regulations.
“The proposed regulations cover a range of areas including the display of vaping products in retail stores and websites; the use of harm reduction statements in retail stores and websites; the display of R18 notices at vaping points of sale; packaging requirements for vaping products; and the responsibilities of manufacturers and importers who intend to sell vaping products or smokeless tobacco products.
“I encourage people to read the draft regulations and provide feedback using the online tool or download the feedback form and email it to vaping@health.govt.nz.
“This consultation is an important step towards better supporting smokers to switch to regulated products that are less harmful than smoking and to protect children, young people and non-smokers from the risks associated with vaping and smokeless tobacco products,” Chambers said.
The consultation closes at 5pm on March 15, 2021. The final regulations will be announced sometime after the close of consultation. It is expected they will take effect in August 2021, with anonymous submissions published on the Ministry of Health website.
January 26, 2021
USPS Mail Ban of ENDS Could Also Include Hemp Products
Words say a lot. It’s especially true in the rule of law. When Congress approved the recent appropriations bill to keep the government running, lawmakers also passed the “Preventing Online Sales of E-Cigarettes to Children Act,” which prohibits the United States Post Office (USPS) from shipping vaping products.
Credit Anne Onyme
While the legislation was geared towards nicotine vaping products, the law is so broadly defined that hemp businesses must also prepare to comply, according to Patricia Kovacevic, founder and president of PK Regulatory Strategy. The legislation takes effect in late March – 90 days after its published in the Federal Register. The USPS then has 120 days to issue its rules.
Speaking during a Smoke-Free Alternatives Trade Association (SFATA) webinar, Kovacevic said that the legislation states that an electronic nicotine delivery system (ENDS) is defined as any device that “delivers nicotine, flavor, or any other substance to the user inhaling from the device.”
“It’s very broadly defined. It really is any other substance. So even if you inhale, I’m being ridiculous, the air [if inhaled from] a device is still covered,” she said. “So, unfortunately, it’s very broad. That’s actually what makes it worrisome. But that also could be its flaw. [The definition being too inclusive] could be an opportunity to challenge the rule.”
According to the legislation, anyone selling vaping products must:

Register with the U.S. Attorney General

Verify age of customers using a commercially available database

Use private shipping services that collect an adult signature at the point of delivery

If selling in states that tax vaping products, sellers must register with the federal government and with the tobacco tax administrators of the states

Collect all applicable local and state taxes, and affix any required tax stamps to the products sold

Send each taxing state’s tax administrator a list of all transactions with customers in their state, including the names and addresses of each customer sold to, and the quantities and type of each product sold

Maintain records for five years of any “delivery interrupted because the carrier or service determines or has reason to believe that the person ordering the delivery is in violation of the [PACT Act]”
Both UPS and FedEx have rules against shipping traditional cigarettes and say they will extend those rules to include ENDS products. Violators can receive up to three years in prison, face steep fines and potentially lose their business.
January 22, 2021
Canadian Vapor Group Vows to Fight All Regulations
The Canadian Vaping Association (CVA) has vowed to fight any regulations for the vaping industry that it views as onerous. In a press release, the CVA states that the organization has been a consistent advocate for strong youth protection measures and that a balance of youth prevention with allowing adult access to harm reduction products is necessary.
“While the CVA has a history of advocating for reasonable measures to protect youth, policy that violates the right to integrity and personal security as well as freedom of expression will be challenged through the proper legal channels,” said Darryl Tempest, executive director of the CVA. “Science supports vaping as harm reduction and draconian measures have previously been found to be unconstitutional by the Superior Court, which heard the industry’s arguments against Bill 44. Our preference will always be to work with regulators to implement effective policy, however where regulators choose to ignore the data, the industry will challenge policy that is detrimental to public health.”
Provinces such as Ontario and British Columbia have taken adult harm reduction into consideration and implemented equitable policy. Yet, provinces such as Nova Scotia and Prince Edward Island have failed to follow the science and instead have jeopardized the health of thousands of smokers, according to the release.
The Canadian Constitution Foundation found that banning flavored vaping products or restricting nicotine content “may violate s. 7 of the Canadian Charter of Rights and Freedoms, which safeguards the right to life, liberty and the security of the person, because the nicotine ceiling and flavour restriction may potentially make vaping products a less attractive or effective quit-aid for smokers.”
The CVA states that it will continue to provide regulators with the science supporting flavors are the driver for adoption and the key to cessation success. “Canadian’s have a constitutional right to access harm reduction products and reduce the health risks presented by traditional tobacco,” the release states. “Judge Dumais who heard the industry’s case against Bill 44 wrote that while the provisions take into account the well being of non-smokers, it seemed to forget the rest of the population, including smokers trying to quit.”
Despite, the Canadian Constitution Foundation cautioning governments that action such as flavor bans may violate the rights of Canadians, “Nova Scotia proceeded to implement both excessive taxation and a full ban on flavors.” As a result, vape shop owner Bill McEachern has launched a constitutional challenge, that will be heard on January 25th. The CVA has given McEachern its full support and will continue to support all challenges to harmful legislation.
“As a society, we often wrongfully look at addiction as the result of one’s own actions. By viewing nicotine addiction as a choice, smokers are dehumanized and left behind by poor policy,” the release states. “Governments must acknowledge that in Canada all citizens are equal under the Charter of Rights and Freedoms. Vaping policy must respect the rights of all citizens as the lives of adult smokers quite literally depend on it.”
January 21, 2021
U.S. FDA Finalizes PMTA, SE Requirements for ENDS

Photo: Jhvephotos | Dreamstime.com
The U.S. Food and Drug Administration on Jan. 20 finalized two foundational rules for the premarket review of new tobacco products. These final rules provide additional information on the minimum requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports. PMTA and SE are two of the pathways through which a manufacturer can seek marketing authorization for a new tobacco product from the FDA.
Stephen Hahn
“The finalization of these foundational rules is an important milestone in the FDA’s regulation of tobacco products. The rules enable greater transparency and efficiency of the FDA’s critical task of reviewing applications for tobacco products before new products can be sold in the United States and they describe information that any company must provide if they seek to market a new tobacco product in this country, fulfilling the promise of the Tobacco Control Act,” said FDA Commissioner Stephen M. Hahn.
Mitch Zeller
“These final rules, together with our commitment to ongoing enforcement action against e-cigarettes and other tobacco products that illegally target youth, will help us continue to protect the public from the dangers of tobacco-related disease and death,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “These final rules will provide greater clarity and efficiency as we ensure that tobacco products are put through an appropriate series of regulatory gates so that products can be marketed only if they meet the standards under the law.”
Both of these final rules are effective 30 days after publication in the Federal Register.
More information about the two foundational rules is available on the FDA website.
January 20, 2021