Global Regulation - Tobacco Reporter

Iceland Mulls New Restrictions on Nicotine

Iceland’s Office of Health Promotion and Science launched a consultation on a draft law on nicotine products, which, if passed, would introduce age limits for nicotine consumption, ban e-cigarette flavors perceived to appeal to children and stipulate a permissible maximum nicotine concentration.

Currently, the minimum purchase age for vapes in Iceland is 18, and the proposed bill would implement the same age limit for other nicotine products.

Iceland currently has an adult smoking rate of 7 percent, the lowest in Europe apart from Sweden.

According to Filter, the misinterpretation that nicotine consumption and smoking go hand-in-hand has distorted perceptions. “Nicotine is not the cause of death from smoking,” according to Yorkshire Cancer Research in England. “Nicotine is not a carcinogen; there is no evidence that sustained use of nicotine alone increases cancer risk. Of the three main causes of death from smoking (lung cancer, chronic obstructive pulmonary disease and cardiovascular disease), none are caused by nicotine. The harm from smoking comes from the thousands of other chemicals in tobacco smoke.”

March 21, 2022

PactAct POS Wants to Help Businesses

The Prevent All Cigarette Trafficking (PACT) Act has caused issues for some businesses trying to navigate the new regulatory landscape. PactAct POS is offering cloud-based software that includes integration with major e-commerce platforms like Shopify, BigCommerce and WooCommerce in hope of helping businesses remain in operation legally, according to a company press release.

“Pact Act vape compliance can be an overwhelming process for companies,” explained Terrence Johnathan, vice president of shipping and logistics for PactAct POS. “In some cases, the requirements are causing small businesses to shut down or stop shipping directly to consumers, which is hurting both consumers and manufacturers.”

PactAct POS provides registration, reporting, shipping and logistics, and government relations services.

PactAct POS is also releasing the PACT Act Survival Guide for 2022, a free e-book that focuses on PACT Act planning and strategies for 2022 and beyond.

“There are so many hoops to jump though,” said Johnathan. “We’ve worked with clients dealing with the vape mail ban [and] every kind of scenario, and we’ve been with them every step of the way. These companies don’t have to go at it alone. They just need to ask for help.”

PactAct POS is a cloud-based platform that automates PACT Act compliance for more than 250 businesses.

March 18, 2022

Denmark to Consider Sales Ban for Those Born After 2010

Denmark is considering a tobacco sales ban for anyone born after 2010, reports The Guardian and Geo News.

“Our hope is that all people born in 2010 and later will never start smoking or using nicotine-based products,” Health Minister Magnus Heunicke said. “If necessary, we are ready to ban the sale (of these products) to this generation by progressively raising the age limit.”

The current age of purchase is 18 years old. The health ministry stated that about 31 percent of 15-year-olds to 29-year-olds smoke.

A Danish Cancer Society poll showed that 64 percent of those surveyed were in favor of the proposed ban, with 67 percent being between the ages of 18 and 34.

Denmark’s proposed ban would be similar to that recently enacted in New Zealand, which will progressively raise the purchase age limit.

March 18, 2022

Sneak Peek at New Vapor Rules in China

Starting May 1, China will begin enforcing the licensing rules for e-cigarette production, wholesale and retail entities. The new rules, the draft of which was first announced in December 2021, apply to all hardware and e-liquid products, including all components and ingredients.

“The administrative department in charge of tobacco monopoly of the State Council takes charge of national supervision and management of electronic cigarettes, and is responsible for the formulation and organization of implementing electronic cigarette industry policies,” the regulations state. “The administrative department in charge of tobacco monopoly of the State Council shall organize professional institutions for technical review of electronic cigarette products based on inspection and testing reports and other application materials.

“Electronic cigarette products not sold in China and only used for export shall comply with the laws, regulations and standards of the destination country or region,” the rules state. “If the destination country or region does not have relevant laws, regulations and standards, they shall comply with China’s relevant laws, regulations and standards.”

Critically the new rules also ban nontobacco flavors and the sale of open systems. The importation of any vaping related products, such as pre-mixed e-liquids, must also be approved by Chinese authorities, according to the regulations.

Any company that produces e-cigarettes in China must now get a license. If a company wants to expand its production or product portfolio, the company must garner approval from the State Tobacco Monopoly Administration. All nicotine must be tobacco derived and purchased from approved sellers in China. Chinese regulators will also establish a comprehensive e-cigarette traceability system to keep track of vaping products.

“Electronic cigarette wholesale enterprises shall not provide electronic cigarette products to units or individuals that are not qualified to engage in electronic cigarette retail businesses,” the regulation states.

The rules also specify that “enterprises or individuals that have obtained the tobacco monopoly retail license … shall purchase electronic cigarette products from local … wholesale enterprises, and shall not exclusively operate the electronic cigarette products sold on the market.”

According to an industry expert, this means all retail outlets must sell multiple brands and not just a single brand. Traditionally, companies such as RELX only sold their own brands in their stores.

Additionally, authorities will establish a “unified national electronic cigarette transaction management platform” that e-cigarette industry businesses that have obtained tobacco monopoly licenses must conduct all transactions through.

The rules also encourage stakeholders to report illegal activity. “Rewards will be given to units and individuals who have made meritorious deeds in reporting cases of illegal production and sales of electronic cigarette products, e-atomization material products and electronic cigarette nicotine,” the rules state.–T.S.D.

March 16, 2022

FDA Gets Authority Over Synthetic Nicotine

U.S. President Joe Biden on Tuesday signed into law a spending bill that gives the Food and Drug Administration authority over synthetic nicotine.

The language of the Tobacco Control Act will now change to define a tobacco product as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption.”

The amendment comes into effect 30 days after the bill’s enactment. Manufacturers of products made with synthetic nicotine will then have an additional 30 days to submit a premarket tobacco product application (PMTA) to the FDA. If FDA has not authorized the product within 90 days after the effective date, the product must be removed from the market.

According to Bryan Haynes, a partner with Troutman Pepper, the measure could amount to an effective ban on synthetic nicotine products. “FDA is highly unlikely to authorize a PMTA in 90 days when other PMTAs for electronic nicotine delivery systems have been pending for more than two years,” he wrote on the law firm’s blog.

April Meyers, board president for the Smoke-Free Alternatives Trade Association (SFATA) suspects the bill will have little effect on youth vaping, which is already down significantly since highs in 2015. “Although the sponsors of the bill claim the intent was to close the loophole on synthetic nicotine-derived products from large companies now popular among youth, the reality is that this bill—and others like it—aren’t likely to have the intended effect,” she said. “Instead, consumers using these products as a harm reduction option will suffer, as will licensed small businesses in full compliance with federal, state, and local laws.

“The FDA created a problem by overregulating a product used by millions of adults who find vaping a safer alternative to smoking. When a market in high demand is overregulated, grey and black markets emerge where there are no regulations requiring safe products or ID checks.”

The FDA appears keen to crack down on synthetic nicotine. During his Senate confirmation hearing, FDA Commissioner Robert Califf vowed to close what he described as the synthetic nicotine “loophole.”

March 16, 2022

Taiwan: Stakeholders Debate Policy Proposals

A demonstrative policy debate event on whether e-cigarettes should be regulated was held on March 8, 2022, in Taipei, showing how different public policy viewpoints can be rationally discussed, according to The Taipei Times. The debate was held by the Chinese Debate Promotion Association (CDPA) at the Taipei NGO House.

CDPA Chairman and Founder Chia Pei-te said that the Executive Yuan in January approved a draft amendment to the Tobacco Hazards Prevention Act proposed by the Ministry of Health and Welfare for legislative review. The proposed regulations on emerging tobacco products have sparked discussions, he said.

The amendment would classify emerging tobacco products as “tobacco-like products” and “designated tobacco products.” E-cigarettes would be classified as “tobacco-like products” and be fully banned while heated-tobacco products would be classified as “designated tobacco products” and be subject to regulation.

The reasoning behind banning e-cigarettes includes keeping curious teenagers away from the products, preventing consumers from adding nicotine to e-cigarette e-liquids and lowering the risk of teenage users turning to smoking.

The debate participants went back and forth discussing the pros and cons of regulating e-cigarettes versus banning them, bringing up subjects such as public health, tax revenue options and teenage use.

National Yang Ming Chiao Tung University (NYCU) College of Pharmaceutical Sciences Dean Kang Jaw-jou said that he was moved by opinions for and against e-cigarettes. He said the affirmative side proposed to directly manage e-cigarette use through regulations and an approval system while the opposing side stressed their attitude to life—banning a substance if the public consensus deems it harmful to society.

Many aspects of the topic can be argued, but e-cigarettes can cause negative health effects, and supporters and opponents must clearly present this fact to the public in further discussions, stated Wang Hsiang-tsui, NYCU Faculty of Pharmacy associate professor.

March 11, 2022

Smoore Launches TPD Compliance Lab

Smoore has established a vaping products risk assessment laboratory for European Union Tobacco Products Directive (TPD) compliance. The lab is part of the Smoore fundamental research center.

Operational since the first half of 2021, the laboratory has already completed 52 product tests for leading vape brands. As China’s first corporate TPD-compliant risk assessment laboratory, it can generate test reports within five working days. Its laboratory equipment is benchmarked against those in world-class analytical testing laboratories, such as Labstat and Enthalpy, according to Smoore.

As the industry’s harm reduction and quality benchmark, the company complies with its in-house Smoore 3.0 safety standards. Based on the risk assessment guidance of the U.S. Environmental Protection Agency and Food and Drug Administration, Smoore 3.0 covers all of the premarket tobacco product application (PMTA) vapor safety tests and FDA-listed harmful and potentially harmful constituents. In addition to vapor safety, Smoore 3.0 also involves extractable and leachable substances of medical-grade atomization materials.

Smoore’s fundamental research center has developed a comprehensive analytical testing and risk assessment system, covering PMTA nonclinical testing and health risk assessment. Accredited by the China National Accreditation Service for Conformity Assessment (CNAS) in 2019, the system is now capable of up to 149 CNAS tests involving the chemical analysis of e-liquids and aerosols, electrical safety, material safety and battery safety.

Smoore entered the EU market in 2018 with its FEELM atomization brand.

March 11, 2022

Synthetic Nicotine Rule Clears Senate

Synthetic nicotine products will soon require U.S. Food and Drug Administration marketing approval. The U.S. Senate approved a $1.5 trillion spending bill that includes language that changes the definition of a tobacco product to include synthetic nicotine. The legislation now heads to President Joe Biden, who looks forward to signing it into law, according to White House spokesperson Jen Psaki.

Synthetic nicotine—nicotine that is made in a lab rather than derived from tobacco—has long existed in a legal gray area, and many companies started using it after their natural nicotine products were denied market access by the FDA. Public health groups have been warning that synthetic nicotine e-cigarettes, such as Puff Bar, have grown in popularity among teens while skirting FDA oversight.

The Food, Drug and Cosmetic Act, which includes the 2009 Tobacco Control Act, defines a 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 (except for raw materials other than tobacco used in manufacturing a component, part or accessory of a tobacco product).”

At a time when FDA is under scrutiny from multiple federal courts for unlawful regulatory overreach on nicotine, handing the agency even more powers to prevent Americans from switching to vaping is like handing car keys and a bottle opener to your drunk uncle.

Amanda Wheeler, president of the American Vapor Manufacturers Association

Proponents of the policy change refer to it as closing a loophole. “By using synthetic nicotine, e-cig companies are avoiding public health protections for flavored tobacco products and still hooking teens,” tweeted billionaire philanthropist Michael Bloomberg. “With millions of kids still using e-cigs, we must get synthetic nicotine products off the market.”

Critics contend that, given the flaws and deficiencies in the FDA approval process, the new rules will likely result in the prohibition of products that smokers have been using to quit cigarettes.

Amanda Wheeler, president of the American Vapor Manufacturers Association, said banning synthetic products will drive millions back to combustible cigarettes.

“At a time when FDA is under scrutiny from multiple federal courts for unlawful regulatory overreach on nicotine, handing the agency even more powers to prevent Americans from switching to vaping is like handing car keys and a bottle opener to your drunk uncle,” she said.

March 11, 2022

U.S. States Target Synthetic Nicotine

Georgia, Maryland and Mississippi legislators recently introduced bills in their respective states that would only allow the sale of vapor products that are authorized by or pending authorization from the U.S. Food and Drug Administration, according to a Filter article.

The pieces of legislation would also establish directories to inventory authorized vapor products, which would eventually be made public. On the surface, these bills look like they are reiterating what the FDA is already doing through its premarket tobacco product application (PMTA) process, through which the FDA has denied millions of products. However, many have noted that the bills serve as a roundabout way to ban synthetic nicotine.

Many manufacturers have turned to synthetic nicotine as a way to continue selling their products since synthetic nicotine is not currently regulated.

“The elected officials sponsoring these bills may be under the mistaken impression that their proposals are only targeted at illicit and counterfeit dealers,” Greg Conley, president of the American Vaping Association, told Filter. “The reality is that these bills would shut down licensed small businesses that are operating in full compliance with federal, state and local laws.”

The Republican lawmakers who introduced the bills—Maryland State Senator JB Jennings, Georgia State Senator Jeff Mullis and Mississippi Representative Nick Bain—have all received campaign funds ranging from $500 to $4,800 from Juul Labs, according to Filter. Some feel that Juul and other large companies want to see synthetic nicotine (and competition) diminished.

“To preserve the harm reduction opportunity for adult smokers, Juul Labs supports a fully regulated, science-based marketplace,” a Juul spokesperson said. “Illegally marketed and illicit products and products designed to evade federal and state oversight undermine harm reduction and a responsible e-vapor category.”

March 4, 2022

Sweden Wants to Prohibit Flavored Vapes

The Swedish government has proposed a ban on nontobacco-flavored vapes, including menthol, according to Vaping360.

The proposed law includes nicotine and non-nicotine e-liquid and regulates all synthetic nicotine products, setting the purchase age to 18. If the law is passed, the sale of flavored vape products will be banned effective Jan. 1, 2023.

The bill is currently being reviewed by the Council on Legislation, which considers the legal validity of proposed bills before they are considered by legislators. Parliament will vote on the bill as early as March 22.

If the bill is passed, Sweden will be the eighth European country to prohibit flavors, following Estonia, Finland, Hungary, Ukraine, Denmark, Lithuania and the Netherlands.

March 4, 2022

Category: Global Regulation