PHD Marketing has agreed to pay VPR Brands $85,000 to settle an intellectual property dispute. As part of the deal, VPR Brands has granted PHD a nonexclusive, non-assignable license to practice the invention set forth in the patent.
This U.S. patent includes claims covering electronic cigarette products containing an electric airflow sensor, including a sensor comprised of a diaphragm microphone. The sensor turns the battery on and off, and covers most auto-draw, e-cigarettes, cigalikes, pod devices and vaporizers using an airflow sensor rather than a button.
VPR previously filed a lawsuit in the U.S. District Court for the Central District of California alleging patent infringement of U.S. Patent by PHD.
“I want to once again thank our legal team at SRIPLAW for their hard work and diligence in settling this matter,” said VPR CEO Brands Kevin Frija in a statement. “It is a Win-Win for All parties when a dispute can be settled ahead of trial.”
Respira Technologies is likely using a website to spread misinformation about vaping in order to promote its own product. Jim McDonald of Vaping360 reports that a website promoted by Respira contains false allegations that a scientist commissioned by Public Health England (PHE) and an author of the “vaping is 95 percent safer” than combustible cigarettes study had financial ties to the tobacco industry.
The California-based company with plans to pursue drug approval for an inhaled nebulizer-style nicotine replacement therapy product has also engaged in a smear campaign suggesting Juul Labs and other vaping product manufacturers may be responsible for causing some of the “EVALI” lung injury cases, and has encouraged the U.S. Food and Drug Administration to adopt standards that would prevent most consumer vapor products from being authorized for sale, according to McDonald.
Respira links its own website to a site called “Vaping Fact Checker” that attempts to tie nicotine vaping to the 2019 “EVALI” lung injury outbreak. A page on the site titled “EVALI Linked Products” shows Juul, SMOK and Suorin products and implies that they have caused or could cause “EVALI.”
Under the heading “Myth Busting,” the Vaping Fact Checker website also claims that “one of the authors” of Public Health England’s 2015 e-cigarette evidence review has “financial ties” to tobacco company Philip Morris International.
British tobacco harm reduction advocate Clive Bates, who has followed and been part of the debate over the 2015 PHE report, is director of Counterfactual Consulting and a former director of Action on Smoking and Health (ASH) in the UK, said that it appears the author of the Vaping Fact Checker claim has (either misinformation or disinformation) confused the PHE review with a separate paper authored by a group of experts led by drug researcher David Nutt.
“It is both offensive and preposterous to claim that the experts undertaking Public Health England’s evidence reviews were somehow compromised by tobacco industry interests,” Bates told Vaping360. “They are all scientists of the highest standing with no conflicts of interest.”
Philip Morris International has launched the new IQOS Iluma Prime in Switzerland duty free, according to DFNI Frontier.
The announcement follows the market launch of IQOS Iluma in Japan in 2021.
The IQOS Iluma Prime is PMI’s first tobacco-heating system to introduce induction-heating technology, which utilizes no blade and requires no cleaning.
“Our objective is a world without cigarettes, a world where cigarettes are replaced by smoke-free alternatives that are a better choice than continued smoking,” said PMI CEO Jacek Olczak. “We have launched several generations of our IQOS heated-tobacco system, expanding our portfolio to offer constantly improved, science-backed solutions that take advantage of advancements in technology and address pain points heard from consumers.
“This commitment to continuous innovation plays a significant role in our ambition to deliver a smoke-free future. The launch of IQOS Iluma, our most innovative device yet, gives adult smokers another better choice and represents an important leap forward in our efforts to accelerate the end of smoking.”
“IQOS Iluma is our most innovative offering to date and the new flagship in our portfolio of science-backed, smoke-free products. Its breakthrough induction-heating technology heats tobacco from within, without burning, so there’s no smoke, no ash and, like previous IQOS devices, it emits, on average, 95 percent lower levels of harmful chemicals compared with cigarettes,” said Michele Cattoni, vice president of heated-tobacco platforms at PMI.
“However, unlike our previous tobacco-heating systems, IQOS Iluma has no blade. That means no tobacco residue or cleaning—ever. With this, and other product features, we aim to address consumer pain points that may have hindered some adult smokers from beginning or maintaining their journey away from cigarettes in the past.”
An inquiry into the extent of the illicit vaping and e-cigarette products market has revealed the scale of Liverpool, England’s growing black market. City council trading standards officers found large numbers of retailers in the city selling illegal vaping products.
Credit: SYCprod
Vaping devices are highly regulated by the government to control the amount of nicotine available and have to be approved by the Medicines and Healthcare Regulatory Agency (MHRA), according to a story in Liverpool’s Echo newspaper. The devices should contain no more than 2 percent nicotine or hold more than two millilitres of liquid, equivalent to 600 puffs or a packet of cigarettes.
However, in a recent test purchasing exercise across the city to check on compliance, officers were able to buy illegal products at 74 retailers – some containing up to 3,500 puffs, almost six times above the legal limit. Now council is offering the retail trade the opportunity to contact Trading Standards for advice on their products with the proviso that compliance visits will be carried out in the New Year and any illegal products still on sale will be seized.
The council have also been receiving a large number of complaints over the sale of these products to children and is asking parents with information and evidence to contact them. Councilor Abdul Qadir, cabinet member for Neighborhoods, said: “E-cigarettes and vaping products are seen by many people as a way of giving up smoking.”
End Cigarette Smoke Thailand (ECST) wants Thailand to legalize vapor products to enable smokers to legally switch to less harmful nicotine products, according to an article in The Bangkok Post.
This vaper in Koh Samui, Thailand could face fines or even jail. (Timothy S. Donahue)
Despite a seven-year old ban on e-cigarettes, the number of vapers has steadily increased in Thailand, according to the ECST. While the National Statistical Office estimates there are 78,742 vapers in the country, ECST representative Maris Kranyawath believes there are almost a million, based on the number of people following social media pages that sell vape products.
Maris said legalizing vapor products would allow state agencies to set product standards. “Thailand has had a ban on vaping for seven years, but the number of vapers has continued to increase despite it,” said Maris. “This means the policy has not been effective. If vape products were legal, they could be examined and standardized by state agencies.”
To protect young people, the ECST has proposed regulations to ban minors from buying and using vape products. “A salesperson must provide vape products that are appropriate for each user,” said Maris. “Moreover, each vaper should register for a vape card at a district office first. When a vaper purchases products, he/she must show the card. Also, vape stores must have a machine to scan cards to identify the customer who has a daily limit of no more than 200ml of e-liquid per day.”
The push for permitting vapor products has been gaining momentum in Thailand. Recently, Digital Economy and Society Minister Chaiwut Thanakamanusorn said he would explore ways to legalize the sale of e-cigarettes, citing their comparatively low health risk and the impact of black market sales on tax revenues.
South Africa’s National Treasury has outlined a proposal on the taxation of electronic nicotine delivery systems (ENDS), reports BusinessTech.
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Among other measures, the agency is considering taxes on hardware and e-liquids, with higher-nicotine products attracting higher levies than low nicotine varieties.
While the market for ENDS is still in its infancy in South Africa, the National Treasury expects it to grow. The agency says it wants to learn from the experience of other countries where growth of ENDS has raised concerns about underage consumption. The agency said it is also aware of concerns about the potential of ENDS to undermine global tobacco control efforts and public health.
Vaping products are covered neither by South Africa’s Tobacco Products Control Act nor by the country’s Medicines Act. The government has proposed the Control of Tobacco Products and Electronic Nicotine Delivery Systems Bill in which it hopes to regulate vapor products in a similar way as cigarettes.
The bill was introduced for public comment in 2018, but remains in a draft form.
According to 2021 study commissioned by the Vapor Products Association of SA, the vapor industry in 2019 contributed ZAR2.49 billion to South Africa’s GDP while paying ZAR710 million in taxes. More than 350,000 South Africans use vapor products.
New Jersey Congresswoman Mikie Sherrill, on Dec. 15, introduced the Clarifying Authority Over Nicotine Act of 2021 — a bipartisan bill designed to give the U.S. Food and Drug Administration (FDA) the authority to regulate synthetic nicotine products just as it regulates nicotine products made or derived from tobacco. In a press release, Rep. Sherrill stated, “This bill will ensure all tobacco products, including products made with synthetic nicotine, are regulated by the FDA in order to protect kids in our communities and those who may seek to use these products.”
Credit: DedMityay
In a blog post, Bryan Haynes and Michael Jordan, attorneys with Troutman Pepper, state that, as it stands, the Federal Food, Drug, and Cosmetic Act (FDCA) defines “tobacco product” as “any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.” 21 U.S.C. § 321(rr)(1) (emphasis added). As the FDA concedes on its website, “it’s possible that a disposable, closed system device that contains an e-liquid with truly zero nicotine (or synthetic nicotine) would not be regulated by the FDA as a tobacco product.”
That said, there are other ways FDA might try to regulate synthetic nicotine, whether under its authority to regulate a “component” of a tobacco product or as a “drug.” In November, FDA Center for Tobacco Products Director Mitch Zeller discussed the “component” aspect of the FDCA’s definition of “tobacco product” and suggested “that components and parts could include everything from coils and batteries to all the ingredients comprised in producing e-liquids (such as flavorings and vegetable glycerin) even if the product does not contain nicotine.” He added, “That’s an assessment that we need to make on a case-by-case basis based upon the totality of all the information that we have.”
FDA could also seek to regulate synthetic nicotine as a drug. The FDCA defines drug, among other things, as “articles (other than food) intended to affect the structure or any function of the body.” 21 U.S.C. § 321(g)(1). To the extent synthetic nicotine is intended to affect a consumer’s body, FDA could attempt to assert jurisdiction. Indeed, in the 1990s, FDA tried to regulate nicotine as a “drug” and cigarettes and smokeless tobacco as “drug delivery devices.” The Supreme Court in FDA v. Brown & Williamson Tobacco Corp. found FDA lacked such authority, but one of the Court’s key findings was that Congress had passed “tobacco-specific legislation [that] effectively ratified the FDA’s previous position that it lacks jurisdiction to regulate tobacco.” Today, things are different. The 2009 Family Smoking Prevention and Tobacco Control Act gave FDA the authority to regulate tobacco products. Should FDA regulate synthetic nicotine as a drug today, it could point to recent legislation from Congress giving FDA a role in this space more broadly. So far, however, FDA has not taken this approach.
With FDA having ordered more than five million tobacco-derived, e-cigarette products off the market, several manufacturers appear to have turned to synthetic nicotine to avoid FDA’s rigorous (and costly) premarket review process. In general, that process requires those who seek to market new tobacco products to demonstrate that their sale is “appropriate for the protection of public health” with the support of scientific evidence. 21 U.S.C. §387j(c)(4), (5). After receiving a denial from FDA of his premarket review applications, one vaping company owner took to Facebook to announce the company’s switch to synthetic nicotine, adding: “We never wanted to switch to [synthetic nicotine], but the FDA forced us to make that decision as we have so many adults relying on us [for alternatives to cigarettes].”
Lawmakers have taken notice. In November, a flurry of investigations and calls to regulate synthetic nicotine products reached a new high. On November 16, nine senators sent a letter to the FDA imploring the agency to regulate synthetic nicotine products. The authors expressed concerns that e-cigarette manufacturers like Puff Bar are switching to synthetic nicotine to skirt FDA oversight and pre-market review requirements to continue selling their products — including flavored products — that they assert appeal to youth. That same day, the North Carolina attorney general launched an investigation into Puff Bar for similar reasons. And, on November 8, the House Oversight Committer’s Subcommittee on Economic and Consumer Policy sent letters to e-cigarette manufacturers Puff Bar and Next Generation Labs LLC, requesting extensive records pertaining to the production and marketing of the companies’ synthetic nicotine products.
Time will tell if Congress will pass Rep. Sherrill’s Clarifying Authority Over Nicotine Act of 2021. Given the uptick in scrutiny of synthetic nicotine products, however, there is a strong chance Congress could give FDA a clear mandate to regulate synthetic nicotine in 2022.
Smokers in England continue to be encouraged to quit by being offered free vaping devices. The action will now bring the borough of Kirklees in West Yorkshire, one step closer to fulfilling the UK government’s ambition for England to be smoke free by 2030, a move which could save local National Health Service (NHS) trusts millions of pounds.
The devices are now available from Kirklees Council’s stop smoking services and the charity Yorkshire Cancer Research alongside more traditional forms of Nicotine Replacement Therapies such as patches or gum. The devices are being offered as part of the Kirklees Wellness Service, a council funded initiative that supports over-18 youth in Kirklees to live healthier lives.
Stuart Griffiths, director of research, services and policy at Yorkshire Cancer Research, said his organization is committed to saving lives by helping more people quit smoking for good. “Yorkshire has the highest smoking rate in England, and this causes thousands of smoking-related cancers and needless deaths in our region each year,” he told Yorkshire Live. “When it comes to helping people quit for good, being able to offer vaping products is essential. They are an incredibly effective aid in helping people give up cigarettes.”
A recent review of evidence by global researchers Cochrane has shown that vaping devices are more effective than Nicotine Replacement Therapy (NRT) when supporting smokers to quit. More than 500 people in Kirklees lose their lives to smoking related illnesses every year, yet smoking remains one of the biggest causes of preventable death in the region, according to the story.
Several consumer and harm reduction advocacy groups claiming to represent 16 million Filipino smokers and 1 million vapers, praised the country’s Congress for the passage of the Vaporized Nicotine Products Bill, and appealed to President Rodrigo Duterte to sign the bill into law.
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Vapers PH, Vaper Ako, Smoke Free Conversation PH, Nicotine Consumers Union of the Philippines, Philippine E-cigarette Industry Association, Quit For Good, Heated Equipment as Alternative to Traditional Smoking Philippines, PROVAPE, Philippine Tobacco Harm Reduction Advocates Inc. and Consumer Choice Philippines, stated in a letter to the Duterte that, “with the growing positive scientific evidence coupled with our life-changing experiences, our resolve is stronger that vaping saves lives.”
“We earnestly hope you would consider our humble plea Mr. President and sign the Vape Bill into law,” the groups wrote, according to the Manilla Standard.
The Vape Bill bans the sale to and use by minors of vape products, and the sale, advertising and promotion of vape products within 100 meters of school perimeter and playground. Use of flavor descriptors that unduly appeal to minors in vape products and the display of vape products immediately next to products of particular interest to minors are prohibited. Persons who violate the provisions will be penalized with a fine or imprisonment.
Congress is expected to hold a bicameral conference committee this month to unify the Senate and the House of Representatives’ versions of the bill. The version approved by the committee will be sent to the president for his approval and signature.
Several court cases challenging the U.S. Food and Drug Administration’s issuing of marketing denial orders (MDOs) in response to its review of premarket tobacco product applications are still pending. Last week, three high profile tobacco harm reduction advocates filed their fourth amicus brief in support of companies that are challenging the FDA.
Credit: Sang Hyun Cho
Clive Bates, director of Counterfactual Consulting, David Abrams, a professor of social and behavioral sciences at the NYU College of Global Public Health, and David Sweanor, adjunct professor of law at the University of Ottawa, filed the latest brief in support of Chicago-based Gripum LLC, which has had its MDO temporarily stayed by the court while the FDA’s actions are reviewed.
“The PMTA process and [appropriate for the protection of public health] APPH test do not apply to combustible cigarettes, which have a much less onerous path to market; accordingly, the most dangerous products are easily accessible throughout the United States, and their manufacturers do not face the threat of financial ruin from FDA’s regulatory burdens and determinations,” the brief states. “FDA’s regime for evaluating ENDS amounts to a major barrier to entry for less harmful products than cigarettes and unjustified regulatory protection of the incumbent combustible cigarette trade. The harms arising from adult and adolescent cigarette smoking far outweigh the harms arising from youth use of ENDS.”
The group also addressed the FDA’s having established an onerous new standard of evidence in PMTAs. The FDA has admitted to using a “fatal flaw” checklist to deny over one million PMTAs without further consideration because they do not provide randomized controlled trials, cohort studies, or other types of (unspecified) evidence that FDA had retrospectively deemed necessary. They also state that the APPH test doesn’t differentiate between adults and youth.
“The APPH test applies to the ‘population as a whole.’ There is no distinction drawn between adolescents and adults in the Act. In some circumstances, ENDS use can be beneficial to adolescents who would otherwise smoke,” the brief states. “As a matter of policy, FDA chooses to take no account of such benefits to youth, but that approach is incompatible with the APPH test in either the PMTA pre-market review process TCA §910(c)(4) or in rulemaking for setting product standards §907(a)(3).”
The group filed similar briefs in three other cases: Triton v FDA – Fifth Circuit (17 Nov 2021), My Vape Order v FDA – Ninth Circuit (24 Nov) and Bidi Vapor v FDA – Eleventh Circuit (24 Nov).
