Category: Regulation

  • FDA Grants IQOS Exposure Claim

    FDA Grants IQOS Exposure Claim

    Photo: PMI

    The U.S. Food and Drug Administration (FDA) on July 7 issued exposure modification orders to Philip Morris Products’ (PMP) IQOS heat-not-burn device system (holder and charger) and three Marlboro Heatstick variants.

    The FDA previously authorized the marketing of IQOS without modified risk information in April 2019 via the premarket tobacco application pathway.

    In its most recent ruling. the FDA determined that IQOS does not currently meet the standard for marketing with reduced-risk claims but can be marketed with a reduced-exposure claim.

    Specifically, the FDA is allowing the company to claim:

    • The IQOS system heats tobacco but does not burn it.
    • This significantly reduces the production of harmful and potentially harmful chemicals.
    • Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system significantly reduces your body’s exposure to harmful or potentially harmful chemicals.

    “Through the modified risk tobacco product application process, the FDA aims to ensure that information directed at consumers about reduced risk or reduced exposure from using a tobacco product is supported by scientific evidence and understandable,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products.

    “Data submitted by the company shows that marketing these particular products with the authorized information could help addicted adult smokers transition away from combusted cigarettes and reduce their exposure to harmful chemicals, but only if they completely switch.”

    In its announcement, the FDA stressed that is marketing authorization doesn’t mean the reviewed products are safe or “FDA approved.”

    The FDA’s marketing order requires PMP to conduct post-market surveillance and studies to determine the impact of these orders on consumer perception, behavior and health, and to enable the FDA to review the accuracy of the determinations upon which the orders were based.

    These post-market requirements include a rigorous toxicity study using computer models to help predict potential adverse effects in users. The orders also require the company to monitor youth awareness and use of the products to help ensure that the marketing of the MRTPs does not have unintended consequences for youth use.

    “The FDA’s decision is a historic public health milestone,” said Andre Calantzopoulos, CEO of Philip Morris International. “Many of the tens of millions of American men and women who smoke today will quit—but many won’t. Today’s decision makes it possible to inform these adults that switching completely to IQOS is a better choice than continuing to smoke. FDA determined that scientific studies show that switching completely from conventional cigarettes to IQOS reduces exposure to harmful or potentially harmful chemicals.”

    “The FDA’s decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to promote the public health.”

    “We’re delighted that the FDA authorized IQOS to be marketed as a modified-risk tobacco product,” said Billy Gifford, CEO of Philip Morris USA’s parent company, Altria Group, which will be marketing the product in the U.S. “This authorization gives PM USA an opportunity to communicate additional benefits of switching to IQOS and this decision is an important step for adult smokers.”

    In a note to investors, Morgan Stanley described the FDA’s order as a positive development because it provides greater flexibility for IQOS to be marketed as relatively less harmful than cigarettes.

    “The inability to make relative lower harm claims is a constraint to broader IQOS adoption in the U.S.,” wrote Morgan Stanley analyst Pamela Kaufman.

    “Over time, PM can continue to submit additional information towards a full MRTP approval. The modified exposure designation combined with pending PMTA approval for IQOS 3 should accelerate MO’s [Altria’s] U.S. expansion strategy for IQOS. The FDA’s recognition of IQOS’s benefits relative to cigarettes may also enhance IQOS’ perception with international health agencies, helping its growth prospects,” Kaufman said.

    Anti-smoking activists were less enthusiastic. In a joint statement, the Campaign for Tobacco-Free Kids, the American Cancer Society Cancer Action Network, the American Heart Association, the American Lung Association and the Truth Initiative, said the FDA marketing order would put consumers at risk.

    “With today’s action, the FDA has created a real danger that kids and adults will falsely believe IQOS has been proven to present a lower health risk and that kids will be exposed to marketing that portrays IQOS, a highly addictive tobacco product, as an appealing, cool alternative to cigarettes, in much the same way as e-cigarettes,” the anti-tobacco groups wrote in their statement.

    IQOS is the first tobacco product to receive exposure modification orders and the second to be authorized as a modified risk tobacco product. In October 2019, the FDA authorized Swedish Match U.S. division’s amended MRTP applications for eight varieties of General Snus, giving the company the right to market the product as a less harmful alternative to cigarettes.

  • Mississippi Bill to Raise Vaping Age to 21 Awaits Signature

    Mississippi Bill to Raise Vaping Age to 21 Awaits Signature

    If the governor signs the legislation, Mississippi will increased the age to 21 to buy vapor products and penalties will increase for selling to minors.

    In addition to penalties for sellers, minors will face penalties for possessing and use of e-cigarettes and other vaping products. Senate Bill 2596 conforms Mississippi law to new federal law to purchase tobacco and vaping products, according to an article in the Clarion Ledger.

    If signed into law, several changes will also occur. For anyone selling or providing alternative nicotine products, the penalty increases from $250 for a first offense up to $1,000 for a third and subsequent offense.The maximum penalty is currently a $100 fine for a third or subsequent offense.

    The penalties triple if the alternative nicotine product contains any controlled substance prohibited by law, or any other substance that causes the recipient to require emergency medical care.

    If a person under 21 found by a court in possession of a tobacco or alternative nicotine product, the penalty will be $100 fine and a maximum 15 hours of community services for a first offense. For a second offense, a $300 fine and up to 25 hours of community service, and for a third and subsequent offense, a $500 fine and up to 40 hours of community service.

    In addition to fines and penalties, a business selling tobacco and vaping products to minors could face suspension up to revocation of permits to sell the products based on the number of violations in a 12 month period.

  • A Costly Failure: How The WHO Lost American Funding

    A Costly Failure: How The WHO Lost American Funding

    By Patrick Basham

    Amid the Covid-19 pandemic, imagine the top global health body instructing governments to shun a particular vaccine should it be found. An unimaginable scenario? Alarmingly, it did happen.

    The rationale for the World Health Organization’s (WHO) April 13 edict was the WHO’s disapproval of the specific industry—tobacco—working to develop the would-be vaccine. A loyal servant of the global anti-tobacco lobby, the WHO clearly abhors Big Tobacco more than it wants to save lives.

    The WHO told governments to have nothing to do with any tobacco-generated vaccine. Nonetheless, the tobacco plant remains a logical vaccine source as it is comprehensively researched and understood, cheaper to grow than animal-based vaccines and faster to scale up than traditional methods, which could yield a large amount of vaccine quickly.

    Consequently, Medicago, a biotech firm partly owned by Philip Morris International, and British American Tobacco are respectively developing potential vaccines grown in tobacco plants. Such a vaccine would enable several billion people to reap technology’s benefits.

    The WHO’s anti-tobacco industry prejudice, epitomized by its illogical Framework Convention on Tobacco Control, should be, but is not, among the reasons for America’s May 29 exit from the WHO. The Trump administration withdrew its $500 million yearly contribution for other interwoven, equally legitimate reasons, namely the WHO’s catastrophic failure on the Covid-19 file and the WHO’s pro-China bias.

    While China is culpable for the global pandemic, the WHO is complicit in the attendant public health debacle. Here is a synopsis of the WHO’s documented unpreparedness and the policy mistakes, factual errors and medical misstatements underlying the U.S. decision.

    On Dec. 31, the WHO was informed of China’s coronavirus outbreak. Absent WHO pressure to be transparent, China did not publicly report its first death until Jan. 11.

    Also, on Dec. 31, Taiwan told the WHO about human-to-human transmission of the virus. The WHO did not warn the world about this critical development. Instead, two weeks later, the WHO declared the virus was not contagious as there was “no clear evidence of human-to-human transmission.”

    On Jan. 20, the WHO acknowledged human-to-human transmission was occurring yet assured the world China would contain the virus. But Chinese cities had already exported coronavirus cases to America and Europe. Consequently, the pandemic was unpreventable.

    Chinese laboratories had sequenced the coronavirus genome by the end of last year, but Beijing ordered researchers not to publish their crucial findings. China did not share this data with the world until Jan. 12. Subsequently, the WHO Director General Tedros Adhanom Ghebreyesus publicly praised the speed with which China shared its genome research.

    The WHO endorsed China’s extremely draconian coronavirus response. Centered on a literally brutal quarantine regime, China’s heralded “defeat” of the coronavirus came at an incredibly high human and economic cost. Not having built herd immunity among its population, China was in the throes of a second wave of infections.

    Mid-January found the WHO playing down the rising coronavirus caseload outside China. Hence, at a Jan. 22 emergency committee meeting, the WHO refused to declare the coronavirus—all available evidence to the contrary—a formal public health emergency, which would have better prepared the world in all facets of its response.

    Following the meeting, Tedros visited China. He praised China’s response even as Beijing was persecuting medical whistleblowers, destroying virus samples, expelling foreign journalists and spreading anti-American disinformation about the virus’ origins.

    The next day, the WHO confidently predicted the coronavirus would be less deadly than SARS in 2002–2003, which caused 774 deaths. At the time of writing, Covid-19 had killed 464,000 people.

    On Jan. 30, Tedros advised (and influenced some) governments against introducing travel bans. The next day, the WHO condemned the Trump administration’s new Chinese travel ban, which public health experts credit with saving tens of thousands of American lives. On Feb. 4, the WHO declared that asymptomatic individuals cannot transmit the virus. Again, the world received incorrect information about a crucial medical element.

    In mid-February, the WHO stated that China’s response had bought the rest of the world valuable time to prepare. According to a University of Southampton study, if China had informed the world three weeks sooner, 95 percent of global cases would have been prevented.

    On Feb. 27, the WHO said the virus was “controlled easily” and therefore community spread was not a serious issue. Adding insult to injury, a March 2 WHO publication claimed the stigma emanating from attaching a geographic label (say, “Chinese” or “Wuhan”) to the virus was more dangerous than the virus itself.

    On March 8, after the WHO refused, at China’s behest, to declare the coronavirus a formal pandemic, the Chinese government gifted the WHO $20 million. The WHO finally declared a pandemic on March 11. Without shame, on April 9 the WHO asked member states for an additional billion dollars (the WHO’s annual budget is $2.3 billion) to help fund its Covid-19 campaign.

    Of all global institutions, the WHO should be the least political yet it continues to act as Beijing’s global public health spokesperson. Revealingly, the WHO Goodwill Ambassador Peng Liyuan is Chinese dictator Xi Jinping’s wife.

    The WHO should be renamed the Chinese Health Organization, quipped Japanese Deputy Prime Minister Taro Aso in late March. The WHO’s illogical treatment of Taiwan is Exhibit A.

    From the onset of the pandemic, Taiwan stood out as a model of successful public health policy. Taiwan’s experienced a comparatively low number of Covid-19 cases and suffered few deaths. The island nation’s success is based upon a travel quarantine, massive testing and contact tracing and the mandatory isolation of potential carriers. As such, Taiwan is an important case study for other governments.

    Taiwan is not a U.N. member therefore it cannot be a WHO member. Since 2017, China has blocked Taiwan from receiving observer status at the World Health Assembly (WHA), the WHO’s annual decision-making meeting, a status it previously enjoyed.

    The Trump administration petitioned the WHO to allow Taiwan to gain entry to the WHA held May 18–19 so that the rest of the world could benefit from Taipei’s real-time knowledge and expertise. The brave souls ensconced within the WHO’s Geneva headquarters declined to take a position on whether Taiwan’s participation may be beneficial.

    The WHO’s tragic Covid-19 performance is unsurprising. The WHO’s awful track record on SARS, Ebola and the H1N1 flu is well documented. The rot at the WHO extends beyond and predates an unsavory relationship with Beijing. It involves both mission creep and the misallocation of precious funds.

    In 1948, the WHA inaugurated the WHO with a mandate to control and prevent the spread of epidemic disease and to coordinate the global response to pandemics. This required a “vertical” focus upon specific diseases, which found success in the WHO’s battle against malaria, for example.

    Over time, the WHO’s vertical approach evolved into a “horizontal” approach that attempts to deal with all aspects of health. In 1979, for example, the formal mandate was expanded to “primary care” and “health for all.”

    In a 2009 report, the American Enterprise Institute’s Roger Bate and Karen Porter explained that, “[the] WHO would now promote health ‘development’ more broadly by improving health systems, building infrastructure and fighting chronic diseases. The WHO expanded into many highly political areas where it had less technical ability, managerial competence, or experience, duplicating the efforts of other organizations.”

    The WHO was desperately unprepared for this pandemic. One reason for such inexcusable incompetence is the financial ramification of mission creep. According to the Heritage Foundation’s Brett Schaefer, only 15 percent of the WHO’s $2.3 billion annual budget goes to pandemic response. An Associated Press investigation found that, in 2018, the WHO spent more money on high-end staff travel and personnel junkets than on programs combatting disease.

    The WHO consistently prescribes statist, top-down, anti-market solutions, from government-run healthcare to an ever-expanding menu of politicized “problems,” which now include tobacco, nicotine, obesity, sex education, mental health and domestic violence. Yet, persuasion and policymaking on these topics is the purview of national governments rather than an elitist bureaucratic body.

    This year, the WHO faced its most serious challenge—a once-in-a-century pandemic—and failed miserably. The WHO has been worse than useless; the WHO literally has been a deadly failure. Surely, there must be consequences for its poor performance, argued the Trump administration.

    Cost-benefit analysis informs us that, by allocating its WHO funding to other health organizations, America will receive a better rate of return on its public health investment.

    The WHO needs root-and-branch reform not merely technocratic tweaks. The Wall Street Journal recently concluded, “One way to ensure future pandemics are less deadly: reform or defund the WHO.” Can the WHO be reformed? There are few grounds for optimism that this option can succeed.

    China’s organized and concerted influence over the WHO is paramount. As Beijing holds tremendous sway over many African, Asian and Latin American members, Chinese funding clearly trumps the will to reform.

    On April 14, President Trump placed American funding on a 60 day to 90 day hold dependent upon the WHO’s willingness to reform itself. The WHO chose to ignore the threat, with last month’s WHA enacting no reform measures. The U.S. concluded that, as reform would not occur, America should stop hitting its head against this bureaucratic wall.

    Financial threats do not work because the WHO possesses a Bank of China ATM card. American funds will be replaced by a commensurate increase in China’s contribution.

    The WHO resembles too many peer organizations: anachronistic, complacent and incompetent. The WHO’s predicament is part of a pattern of decline among international institutions from the United Nations to the European Union to the World Trade Organization.

    National governments need to choose between supporting public health or politicized institutions. Defunding the WHO is a down payment on the public health side of the ledger.

  • Chicago Flavor Ban Stalls in City Council Committee

    Chicago Flavor Ban Stalls in City Council Committee

    Credit: Lance Anderson

    A proposal  to ban the sale of flavored e-cigarettes and other tobacco products in Chicago stalled in a City Council committee after running into an avalanche of opposition.

    Owners of gas stations, convenience stores and tobacco stores — and trade groups representing them — showed up in force at the virtual meeting to accuse the City Council’s Committee on Health and Human Relations of “kicking them when they’re down,” according to an article in the Sun-Times.

    They argued small businesses are fighting for survival after a double-whammy: first, the coronavirus pandemic; then, damage during civil unrest, which came when many were “woefully under-insured.”

    The last thing they need is “legislative over-reach” that would cost them even more business, they said, noting that tobacco products account for 40% of revenue for a typical Chicago gas station — and that 52% of that tobacco revenue comes from flavored tobacco products.

    “This is the equivalent to kicking this industry while they’re down. You not only lose out on flavored tobacco sales to adults. You lose a significant driver of other business. When people buy tobacco, they buy other things. So the business loses out on all of those sales. The city loses out on all of the revenue,” said Tanya Triche Dawood, vice president and general counsel for the Illinois Retail Merchants Association, the article states.

    Dawood acknowledged there is “absolutely … an issue with teen vaping,” but it can be solved by “identifying products that are attractive to teens” and banning those — not by “taking products away from adults” like “tobacco- and menthol-flavored vapes,” she said.

    “I’m not aware of any data that shows that pipe tobacco is gaining in popularity with teens. Neither is chew. Or even menthol cigarettes. But all of these products are included in this proposal,” Dawood said.

  • U.S. Senate Passes Bill to End Online Sales to Minors

    U.S. Senate Passes Bill to End Online Sales to Minors

    Ded Mityay I Dreamstime.com

    The vote was unanimous. On July 1, the U.S. Senate passed the Preventing Online Sales of E-Cigarettes to Children Act (S.1253) by unanimous consent. The legislation aims end online e-cigarette sales to minors by applying the same measures that are required when traditional cigarettes are purchased online. The House passed its version of the bill last year.

    The National Association of Convenience Stores (NACS) said it strongly supports S. 1253, which “ensures responsible retailing of e-cigarettes and age verification across all channels. The legislation would require online sellers of e-cigarettes to ensure the delivery carrier verifies the age of the recipient upon delivery. It would also require online sellers to collect and remit the appropriate state and local taxes,” according to a story on the NACS website.

    These rules are already in place for cigarettes and smokeless tobacco products purchased over the internet after Congress passes the Prevent All Cigarette Trafficking (PACT) Act, in 2010. Language for vapor products was not included in the law.

    “It’s been long in coming, but finally the Senate has now passed legislation that requires the same proof of age requirement that is needed for tobacco products for e-cigarettes and vaping products, particularly those that are sold over the internet,” stated Senator John Cornyn in his speech on the Senate floor.

    After Wednesday’s vote, the legislation is one step closer to becoming law. Last October, the House passed its version of the bill (H.R. 3942) on suspension. Given that the Senate bill is slightly different than the House version, the House will need to pass the Senate’s version before it can become law, according to NACS.

  • Boulder, Colorado: 40% Vapor Tax Begins Today

    Boulder, Colorado: 40% Vapor Tax Begins Today

    Credit: Alexander Mills

    All vaping products sold in the U.S. city of Boulder, Colorado will be subject to an additional city sales and use tax of 40 percent. City leaders say its part of an effort to curb use among young people.

    Nearly 80 percent of voters approved the additional tax last November. It applies to any refill, cartridge and component of an electronic smoking device, according to a story by CBS4 in Denver.

    Additional measures to curb youth tobacco use were passed by City Council in 2019, including:

    • Raising the age to purchase to 21 for vaping and tobacco products
    • Limiting any one retailer from selling more than two electronic cigarettes or four associated products including refills to any one person in any 24-hour period
    • Banning the sale of flavored vaping products (with a temporary exception for menthol-flavored products)
    • Restricting the ability to sell menthol-flavored vaping products only to businesses that have 21 and over age restrictions for entry until Dec. 31, 2019. After Jan. 1, 2020, the sale of menthol flavored electronic cigarettes in the city of Boulder is completely prohibited.
  • Last Day: New York State Vapor Ban Starts July 1

    Last Day: New York State Vapor Ban Starts July 1

    A Billion Lives
    Credit: A Billion Lives

    Tomorrow, July 1st, a ban on the sale of flavored vapor products, other than tobacco and menthol, goes into effect for the State of New York. Pharmacies will also no longer be permitted to sell any tobacco or nicotine product that isn’t an approved smoking cessation therapy.

    Online sales of any e-liquids–regardless of flavor–are banned (vapor products are folded into the same provision that bans shipment of cigarettes to consumers). This does not include components or devices. The penalty for selling or shipping a vapor product to a consumer in NY is a Class A misdemeanor and carries a fine of $5000 or $100 per vapor product, according to the Consumer Advocates for Smoke-free Alternatives Association (CASAA), a non-profit, grassroots organization.

    A person other than a common or contract carrier can still transport vapor products, but there is now a limit of 500 milliliters or 3 grams of nicotine. Additionally, coupons or “price reduction instruments” for tobacco products are banned.

    “Vapor manufacturers must post a detailed ingredient list including a disclosure of ‘the nature and extent of investigations and research performed by or for the manufacturer concerning the effects on human health of such product or its ingredients.’” writes Casaa. “Manufacturers are also required to list ‘each byproduct that may be introduced into vapor produced during the normal use of such e-cigarette.’ (this requirement does not apply to any other tobacco product).”

    In April, New York became the fourth state in the U.S. to restrict the sale of flavored vaping products. The New York Assembly reluctantly passed S. 7506-B, a budget bill, which banned the sale of vapor products in flavors other than tobacco. The budget bill was heavily criticized because it debated and passed under cover of darkness, according to CASAA. “There were no opportunities for the public to weigh in on the bill unless you diligently followed the constantly changing bill numbers and language,” the organization wrote at the time.

  • Vapers in Georgia to pay 7% Excise Tax

    Vapers in Georgia to pay 7% Excise Tax

    Credit: Dawid Cedler

    Georgia’s General Assembly passed a measure Friday to authorize the taxation of vapor products. The bill also contained language that raises the U.S. state’s minimum age to vape or smoke cigarettes from 18 to 21.

    The measure slaps a 7% excise tax on vaping products sold in Georgia like e-cigarettes, vape pens, refillable cartridges and electric hookahs, according to an article in the Athens Banner-Herald.

    The vaping tax was added to a separate bill that raises the minimum age to use tobacco and vape products to 21. The bill passed by a 45-8 vote in the Senate Friday after the state House passed it by a 123-33 vote on Thursday. It now heads to Gov. Brian Kemp for his signature.

    Vaping manufacturers and store owners had opposed the excise tax and new licensing rules in Rich’s proposal, arguing higher prices on vaping could drive smokers back to cigarettes after using the tobacco-less products to kick the habit.

  • L.A. Moving to Make Changes to Its Legal Marijuana Market

    L.A. Moving to Make Changes to Its Legal Marijuana Market

    Los Angeles City Council voted unanimously Wednesday to make numerous changes to its once-flourishing marijuana market. The legislative body gave its initial approval to expand licensing and get more assistance to operators who endured the consequences of the nation’s war on drugs.

    Broad legal sales kicked off in California in 2018, and at that time Los Angeles was expected to quickly establish itself as a world-leading cannabis economy, according to an article from the Associated Press. “But that never happened. Instead, robust illegal sales continue to outpace the up-and-down legal market, while businesses complain that hefty taxes and a cumbersome bureaucracy have slowed, rather than encouraged, growth,” the article states.

    The new revisions are designed to provide a jump in licenses for so-called “social-equity” applicants. These include individuals, many of color, who were arrested or convicted of a marijuana-related offense, and lower-income residents who live, or have lived, in neighborhoods marked by high marijuana arrest rates.

    Only applicants meeting those criteria would be eligible for new retail and delivery licenses through 2025.

    The council also seeks to help businesses wanting licenses to quickly get temporary approval to begin operating once certain benchmarks are met. The rules would permit businesses to relocate while being licensed and streamline the application process, according to the article.

    Credit: Manish Panghal

    If the plan gets final approval by the council, Mayor Eric Garcetti is expected to sign it.

    “This is a great opportunity for the city to focus on the expansion of the cannabis industry,” said dispensary owner Jerred Kiloh, who heads the United Cannabis Business Association, a Los Angeles-based industry group, according to the AP article.

    Kiloh said the city is on target to eventually double the number of retail businesses, up from 187 now operating. In time, rules allow for as many as 537 dispensaries, he added, though there are also restrictions that limit the number of businesses that can operate in neighborhoods, according to the article.

    More legal shops, linked with tougher enforcement, would help in the long-running fight to shut down illicit operators and delivery services that run in plain sight in the city, he added.

    But the plan has also been criticized within the industry, with some saying the legal market remains flawed and could get worse.

  • FDA Will Not Request Extension to Sept. 9 PMTA Deadline

    FDA Will Not Request Extension to Sept. 9 PMTA Deadline

    Credit: Succo

    The U.S. Food & Drug Administration (FDA) does not intend to delay the current Sept. 9, 2020 deadline for the vapor industry to submit applications for marketing authorization before a hearing is scheduled for the plaintiffs in the case.

    In a status report filed Wednesday to the U.S. District Court for the District of Columbia, the regulatory agency told the court that it does “not currently plan to seek an extension of the September 9, 2020 premarket application deadline.”

    Any extension requested by the plaintiffs could be complicated because the request would have to be approved by the Maryland-based federal court that forced the agency to move the deadline to May 12, 2020 due to a separate lawsuit.

    The FDA has already delayed the PMTA deadline due to the Covid-19 pandemic. The deadline was previously scheduled for May 12, 2020 but was moved to Sept. 9. According to the FDA’s status report, the plaintiffs in the case are expected to file a status report requesting their preferred argument date for a further extension.