Category: Regulation

  • Broughton: China Vapor Laws is Opportunity

    Broughton: China Vapor Laws is Opportunity

    Photo: Smoore

    Recent amendments to China’s Tobacco Monopoly Law present an opportunity for responsible companies to demonstrate how alternative high-quality products are an important and appropriate element of tobacco harm reduction, according to Broughton.

    Writing on the website of the contract research organization, Broughton’s head of regulatory affairs, Lloyd Smart, and regulatory consultant Xiangyin Wei summarize China’s tobacco monopoly law changes and explain what they means for electronic nicotine delivery systems (ENDS).

    On Nov. 26, 2021, China’s State Council amended the country’s tobacco law, giving the State Tobacco Monopoly Administration jurisdiction over e-cigarettes. Next-generation products will now be managed in the same way as combustible cigarettes.

    Among other things, this means that ENDS companies, including exporters, will need to apply for a license. A single transaction platform will be implemented for product distribution and all products must comply with a new national standard. Regulation of products likely to be introduced following an initial transition period of between three and five months, during which no new products may be brought to market. Products with synthetic nicotine will be banned in China.

    According to Broughton, the recently announced changes to e-cigarette regulation in China offer an excellent business opportunity for companies that want to build consumer trust by showcasing their product’s high quality and safety standards.

    “As with all regulatory requirements, the most important initial step is to understand fully what’s needed—to provide reassurance or identify gaps that need to be addressed. And to act quickly; seizing the opportunity while making sure you don’t get left behind as the market changes,” write Smart and Xiangyin.

  • Taiwan: Bill Approved to Raise Smoking Age

    Taiwan: Bill Approved to Raise Smoking Age

    Photo: toa555 | Adobe Stock

    The Taiwan Cabinet approved a draft amendment to the Tobacco Hazards Prevention Act, which would raise the legal smoking age to 20 from 18 as well as impose a ban on electronic cigarettes and flavored tobacco products, according to Focus Taiwan.

    The draft amendment will now go to the legislature for deliberation.

    If signed into law, those found in violation of the new age restrictions would face a fine ranging from TWD2,000 ($72) to TWD10,000.

    Those found violating the ban on manufacture, import, sale, supply, display, advertising and use of all tobacco-like products, including e-cigarettes, could face a fine ranging from TWD10 million to TWD50 million.

    The proposed bill would provide a legal basis for regulation of new tobacco products, such as heated-tobacco products, stating that suppliers of new tobacco products with unknown health risks should file an application for assessment of said products within a specific time period before suppliers are allowed to manufacture or import the products. Those caught violating this regulation could face a fine up to TWD50 million.

    The bill goes further, expanding the smoking ban to colleges and universities, kindergartens, baby care centers and in-home childcare locations. Smoking in bars and nightclubs would only be allowed in designated areas. Graphic warnings and text would also be increased to 85 percent from 35 percent of the total package surface.

  • Broad Support for Philippine Vape Bill

    Broad Support for Philippine Vape Bill

    Photo: Rawpixel.com

    Nine out of 10 smokers in the Philippines support the country’s proposed vaping bill, according to a study, reports the Manila Times. A majority of respondents said the government should enact policies to encourage adult smokers to switch to less harmful alternatives while also ensuring these products are not used by minors.

    In 2021, the Senate and House of Representatives approved their respective versions of the measure. The bills must be reconciled by a bicameral conference committee and ratified by the two chambers. If President Rodrigo Duterte then signs the bill into law, the Vaporized Nicotine Products Bill will regulate e-cigarettes, heated-tobacco products and other vaporized nicotine products while ensuring that they contribute to government revenues.

    The study was conducted by Acorn Marketing and Research Consultants and commissioned by consumer advocacy group Vapers PH in August 2021. The survey sampled 2,000 legal-age smokers.

  • Ukraine Enacts Tobacco Control Law

    Ukraine Enacts Tobacco Control Law

    Photo: Taco Tuinstra

    Ukraine’s President Volodymyr Zelensky on Jan. 6 signed a sweeping new tobacco control law after nearly two years of deliberations.

    The legislation prohibits smoking and e-cigarette in enclosed public spaces. Additionally, it bans the advertising, promotion and sponsorship of all tobacco products; increases the size of warning labels required on cigarettes, heated cigarettes and e-cigarettes; and bans flavored products.

    More than 40 percent of Ukrainian men smoke and approximately 130,000 Ukrainians die from tobacco-related diseases each year, according to the U.S.-based Campaign for Tobacco-Free Kids (CTFK).

    “Ukraine’s new law is a significant step in curbing this deadly toll and will also align the country’s tobacco control measures with member states of the European Union. These measures include regulations on nicotine content and emission levels from tobacco products,” said CTFK Regional Director for Eurasia Joshua Abrams in a statement.

    “For decades, tobacco companies have used strategies like youth-oriented marketing and flavors to lure young people into a lifetime of addiction. Ukraine’s new measures send a strong message to Big Tobacco that Ukraine will not allow its youth to face this fate.”

  • Thailand Urged to Allow E-Cigarette Sales

    Thailand Urged to Allow E-Cigarette Sales

    Photo: Thanagon

    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.

    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.

    Kranyawath 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 Kranyawath. “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 Kranyawath. “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 200 mL 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.

  • Who D’Ya Think You Are?

    Who D’Ya Think You Are?

    Photo: EwaStudio

    Your business from the regulators’ perspectives

    Willie McKinney and Cheryl K. Olson

    Let’s do a thought experiment. Imagine—some of this may sound familiar—that you’re one of two brilliant young graduate students attending a university in the middle of Silicon Valley. You come up with a jewel of an idea for a product that could help cigarette smokers reduce their mortality and morbidity by delivering nicotine with far fewer health-destroying byproducts of combustion than traditional cigarettes.

    The business environment around you is laced with artificial intelligence, self-driving cars and apps that brashly take on entire industries. The ethos of your fellow entrepreneurs is to challenge everything, smash things when they get in your way and loudly proclaim that you’re changing the world for the better. You can always correct your mistakes later.

    What business are you in? To your eyes, you’re in the smoking cessation business. That is, after all, your stated goal and the purpose of the device you’ve designed. It’s a noble cause that could save millions of lives while making your investors and you a fortune. You’ve hit that ideal of doing good while doing well. What could possibly go wrong?

    A lot, it turns out. Predicting those potential disasters requires that you know whether you perceive the fundamentals of your business the way that others—especially government regulators—perceive it. In our not-really-hypothetical example, the protagonists saw themselves as fighting Big Tobacco. They approached marketing their product as if it were a kind of ride share or housing share offering, industries in which regulations are both few and local. They were making consumer goods, so they mostly hired executives from packaged goods industries little acquainted with addictive ingredients or tobacco industry history. 

    The U.S. Food and Drug Administration viewed your imagined company through a different lens. To the government (and soon the press and the general public), you were simply an extension of Big Tobacco. Your Silicon Valley brashness backfired, triggering memories of industry lies about the addictiveness of nicotine and cynical attempts at youth smoking prevention by tobacco companies. A hero’s journey became a cautionary tale.

    Can this still happen today? Can the lens through which you view your company be dramatically different from the perspective taken by government regulators? Unfortunately, we see it all the time.

    A Tale of Two Companies

    Josh Israel started Hale Therapeutics with a co-founder who lost a family member to smoking combustible cigarettes. His device is programmed to deliver and taper off heated, aerosolized nicotine as a way of ending the addiction.

    “It minimizes the discomfort of nicotine withdrawal while you learn to live a smoke-free life,” said Israel.

    Hale approached the FDA’s Center for Drug Evaluation and Research (CDER) to open discussions toward approval of what Israel viewed as an innovative pharmaceutical delivery system for a much-studied drug. That may sound like a strange approach to take. Why not pursue a marketing authorization from the FDA’s Center for Tobacco Products (CTP)? That would be faster and likely to succeed. CTP had already authorized VUSE, calling that ENDS device’s aerosol “significantly less toxic than combusted cigarettes.”

    “We’re not a tobacco product. So we don’t want to be licensed as a tobacco product, and we don’t want to be looked at as a tobacco product,” Israel continued. “It’s a smoking cessation product. Why would we be classified as anything else?”

    The FDA saw things differently. New CDER guidance on testing “inhaled nicotine-containing drug products” focuses on the word “heated,” and the “novel chemicals” that heat might generate. CDER may have viewed Hale’s device as akin to an e-cigarette because it heats. This difference in perceptions led CDER to point Hale toward spending a substantial chunk of time and money on animal studies that would not have been required had Hale gone down the CTP path for permission to market the same device. (And run counter to FDA pledges and initiatives to reduce use of animals in research.)

    Meanwhile, Brian Quigley, the COO of Respira Technologies, was preparing to meet with CDER about his product, a nebulizer for use as a nicotine-replacement therapy. It creates and controls an unheated nicotine aerosol.

    “It’s kind of shocking to think that in 2021, the number one way that smokers try to quit is cold turkey,” said Quigley.

    Unlike Hale’s experience, CDER apparently viewed Respira’s product much as the company did. The fact that the nicotine was unheated worked to Respira’s advantage. CDER was more comfortable allowing the data to guide what preclinical studies Respira’s product will need. Quigley expects to submit an Investigational New Drug application to CDER in 2022.

    Hale Therapeutics, however, faced a potentially costly choice. It could fight CDER. It could devote time and capital to research that it contends is unnecessary. It could switch paths, reluctantly accept the perception that it was making a tobacco product, and apply to CTP. After much deliberation, Josh Israel decided to … do something different. Hale would keep talking with the FDA about reducing the testing burden but would take action to forward its mission elsewhere.

    Hale went to the U.K. and applied for a license from its Medicines and Healthcare products Regulatory Agency (MHRA) as a smoking cessation device.

    “The goal for any public health agency should be to get people off combustible cigarettes, full stop,” said Israel. “We were embraced by the MHRA. And it’s unfortunate that the FDA is not taking the same approach.”

    What is that approach? The MHRA is developing a licensing process by which e-cigarettes could be prescribed by the National Health Service in England as a medical product for smokers who wish to quit smoking. It would be the first country in the world to do so.

    There are about 6.1 million smokers in England, with rates of smoking roughly inversely correlated with socioeconomic status. That means that smokers generally are at greater risk for a variety of other health and social problems, making smoking cessation especially impactful. For several years, e-cigarettes have been promoted by the governmental to combustible cigarette smokers as an effective way of both reducing immediate harm and putting those smokers on a path to quitting nicotine completely.

    “The MHRA evaluation program for e-cigarettes is focused on nicotine delivery—not cessation per se—as a measure of efficacy, and with as few harmful and potentially harmful constituents as possible,” said Ian Fearon, a U.K.-based clinical research scientist who consults on nicotine and tobacco product studies. “It appears easier to obtain a medical license with MHRA than a market authorization from the Center for Tobacco Products, given the volumes of data required to support a PMTA.”

    A Difference in Politics and Philosophies

    One reason why there may be such a difference is that regulators reflect and illuminate the values and experiences of the countries they regulate. When CDER issued its guidance for inhaled nicotine-containing drugs in October 2020, the public perception of vaping in the U.S. had hit new lows.

    San Francisco had recently banned the sale of all e-cigarettes within the city limits, ironically using a supposedly pro-health agenda to push an unknown number of former smokers who were using vaping to quit back to using combustible cigarettes. E-cigarette or vaping use-associated lung injury, which had been falsely associated with commercial vaping products, was still in the headlines.

    Not surprisingly, the CDER guidance focuses on what could go wrong. It recommends hunting for potentially toxic “novel chemicals” through years of rodent inhalation studies before testing heated nicotine products in humans.

    The U.K. has never experienced an American-style moral panic over e-cigarettes and youth. This takes a political thumb off the scale in their pragmatic weighing of the science.

    It’s also not surprising that the two FDA centers that regulate nicotine products can be fractious. CDER has been part of the FDA since the 1980s. Its pathways to approval are well entrenched and clearly marked. Its mission is “making sure that safe and effective drugs are available to improve the health of the people of the United States.”

    By contrast, the FDA’s Center for Tobacco Products is a newbie, born from the Tobacco Control Act of 2009. It’s about balancing health risks among different segments of the public. CTP plays by different rules, proclaiming on its website that the “FDA’s traditional ‘safe and effective’ standard for evaluating medical products does not apply to tobacco.” It doesn’t approve products; it permits them to be marketed. Because of its youth, CTP procedures are still forming and solidifying. 

    So, let’s go back to our mind experiment for a moment. Now how do you view the business your company is in?

    Willie McKinney is the founder of McKinney Regulatory Science Advisors. He’s held senior regulatory roles at major tobacco product companies and served for three years as the industry representative on the FDA’s Tobacco Products Scientific Advisory Committee.
    Cheryl K. Olson is a California-based public health researcher who specializes in behavioral health issues and consults on tobacco product behaviors. She spent 15 years on the faculty of Harvard Medical School.
  • Forest Condemns Anti-Smoking Plan

    Forest Condemns Anti-Smoking Plan

    Photo: sezerozger

    Smokers’ rights group Forest has condemned plans by Ireland’s Health Service Executive (HSE) to consider a complete ban on the sale of tobacco.

    HSE is reportedly contemplating a sharp reduction in the number of outlets allowed to sell tobacco products and a ban on selling tobacco products near schools and universities, along with an annual tobacco tax increase of 20 percent. Other measures to be considered include reducing the nicotine content of tobacco products, banning filters and adding health warnings to individual cigarettes.

    “Any form of prohibition would drive consumers underground and into the arms of criminal gangs. Ireland already has a huge problem with illicit trade,” said John Mallon, spokesman for the smokers’ group Forest Ireland, in a statement. “This would make it far worse.”

    “The government has no right to intervene to this extent. Tobacco is a legal product, and many adults enjoy smoking.

    “Future generations of adults should have an equal right to choose to smoke, just as many adults will choose to drink alcohol, and that choice must be respected.

    “Governments have a duty to inform consumers about the health risks of smoking or drinking, but beyond that, it’s a matter for the individual.

    “Any attempt to impose further restrictions on tobacco will be fiercely resisted.”

  • FDA Releases Draft Guidance on Validation of Test Methods

    FDA Releases Draft Guidance on Validation of Test Methods

    Photo: PMI

    The U.S. Food and Drug Administration on Dec. 21 announced the availability of a draft guidance for the industry titled “Validation and Verification of Analytical Testing Methods Used for Tobacco Products” and is requesting comments, including scientific and other information, concerning the recommendations set forth in the draft guidance. The comment period will continue through Feb. 22, 2022.

    The draft guidance, when finalized, would provide information and recommendations related to the validation and verification of analytical test methods, including analytical testing of tobacco product constituents, ingredients and additives as well as stability testing of tobacco products. This draft guidance would help the industry produce more consistent and reliable analytical data used to support regulatory submissions for finished tobacco products.

  • Group Calls for Risk-Proportionate Rules

    Group Calls for Risk-Proportionate Rules

    Photo: Balint Radu

    The Malaysian Vape Chamber of Commerce (MVCC) has urged to government to introduce risk-proportionate taxes and regulations for e-cigarettes and combustible cigarettes, reports The New Straits Times.

    Recently, the government of Malaysia announced a 200 percent tax hike for vape products, to be implemented at MYR1.20 per ml for nicotine e-liquids and non-nicotine e-liquids.

    Industry players feel that the taxation rate is too high and will negatively impact the industry. They are likely to pass on the cost to consumers.

    “Manufacturers have no choice but to increase the price of their products as the tax rate imposed is equivalent to the current retail price of vape products,” said MVCC Head of Information Ashraf Rozali. “For example, each 30ml bottle of e-liquid will be taxed at MYR36.”

    “With this rate, the estimated retail price of vape e-liquids will reach twice the current price per 30ml bottle. Therefore, the new tax rate will not only affect one party but will impact the entire ecosystem, including adding burden on consumers,” Ashraf said.

     At the same time, the government has also announced recently that a regulatory framework for tobacco and vape products will be tabled next year.

    Any regulations introduced must include elements that can encourage smokers to switch to less harmful products such as e-cigarettes, said Ashraf. He called on the public to sign a petition calling for risk proportionate regulation.

  • Philippines Senate Passes Vaping Bill

    Philippines Senate Passes Vaping Bill

    Photo: Oleksii

    The Philippine Senate on Dec. 16 approved the proposed Vaporized Nicotine Products Regulation Act, reports The Philippine Inquirer.

    Senate Bill 2239 transfers regulatory authority over vapor products from the Philippines Food and Drug Administration’s authority to the Department of Trade and Industry.

    According to Vaping360, the move was prompted partly by outrage over news that groups supported by Bloomberg Philanthropies had funded the FDA in an effort to influence the agency to impose harsh vaping restrictions.

    The legislation prohibits the sale of vapor products to people below the age of 18 and bans e-cigarette sales within 100 meters from “any point of the perimeter of” a school, playground, or other facilities frequented by minors.

    The bill also prohibits celebrities or social media influencers from endorsing vapor products.

    Physical and online retailers or distributors must register with the Department of Trade and Industry and the Securities and Exchange Commission.

    Senate President Pro Tempore Ralph Recto, the sponsor of the bill, said shifting to vaporized nicotine products “is a good public policy.”

    “There will be less death and less expense on the part of society in treating patients. And that is the direction where many countries, more developed economies are moving toward,” Recto added.

    The Philippines House of Representatives overwhelmingly passed a similar bill in May. The two bills will now go to a conference committee where they will be reconciled, and both houses will vote on the final version. Then the unified bill will go to President Rodrigo Duterte to sign into law or veto.

    Tobacco control groups are lobbying the president to veto the bill when it reaches his desk. A veto can be overridden with a two-thirds vote of both houses.