Global Regulation - Tobacco Reporter

Malawi Approves Tobacco Law

Lawmakers in Malawi approved the Tobacco Industry Bill, which stipulates how stakeholders are supposed to operate, reports the Nyasa Times.

In addition to provisions on child labor and tenancy, the legislation includes clauses on traceability and the use of agrochemicals. Lawmakers hope the new rules will improve compliance and make it easier for Malawi to market its leaf around the world.

The Tobacco Industry Bill will also regulate contract and noncontract farming, tobacco production and delivery quota, and prices, along with disposal of tobacco stalks.

November 30, 2023

Accorto and Inter Scientific Team Up

Accorto Regulatory Solutions and Inter Scientific have entered into a strategic alliance agreement to provide single-point regulatory and testing solutions for customers in the nicotine industry and other sectors.

Based in the U.S., Accorto specializes in helping small- to mid-sized companies navigate the regulatory landscape to bring products that are regulated by the Food and Drug Administration to market. Inter Scientific is an ISO 17025/GMP-compliant testing laboratory and compliance firm based in the U.K.

The strategic alliance will offer customers in the U.S., Europe, the Middle East and Asia improved access to a Accorto’s regulatory strategy development expertise, FDA regulatory application development and submission services, and project management solutions combined with Inter Scientific’s testing and regulatory compliance expertise in the U.K., Europe and the Middle East.

The two companies aspire to use this alliance to streamline their clients’ regulatory application development processes, providing a turn-key solution for both regulatory support and associated analytical data development.

“We are thrilled to unveil our strategic alliance with Accorto,” said Inter Scientific co-founder David Lawson in a statement. “This collaboration represents a significant milestone, offering both new and existing clients a competitive advantage. By aligning with another industry-leading regulatory company that shares the same commitments to quality, urgency, and value, we are confident this will further elevate our standards and capacity.”

“We could not be more pleased to be entering into our first strategic alliance with a company like Inter Scientific that has such a fantastic team,” said Tom Beaudet, CEO of Accorto. “This not only provides our clients with the ability to collect data needed to prove the safety and efficacy of their products, but also allows us to shorten their regulatory application timelines, giving them a competitive advantage.”

November 28, 2023

BAT Urges Stricter Vape Rules

BAT is urging the U.K. to introduce new regulations that the company believes will help the country achieve its “smoke-free” ambitions.

England wants to reduce smoking prevalence to 5 percent of less by 2030, with Wales targeting a similar timeline and Scotland four years later.

Ahead of the consultation on the Tobacco and Vapes Bill that ends Dec. 6, BAT is now publishing proposals that seek to minimize the underage appeal of, and access to, vapor products, along with the environmental impact of single-use e-cigarettes.

In addition to a ban on dessert and soft drink flavors for vapes, the company is calling for an end to marketing slogans and imagery involving toys, cartoons and sweets.

“Vaping is the key to unlocking the U.K.’s smokefree target,” said Asli Ertonguc, BAT lead for the U.K., in a statement. “As the largest manufacturer of vaping products in the U.K., we are clear on our responsibilities and are urging the government to introduce more stringent vaping regulations. We believe that underage users should never vape, so we want confectionery, dessert and soft drink flavors to be banned and the introduction of a new regime for how and where vapes are sold.”

In practice, this would mean requiring vape sellers to have a retail license, similar to that in place with alcohol and cigarettes, and which would be revoked if they were found to be selling to anyone underage, according to BAT. Retailers would also have to demonstrate to Trading Standards that they observe either Challenge 25 protocols or new technologies at point-of-sale locations which verify age, such as facial recognition cameras.

In addition to tackling underage vaping, BAT also wants vapes to be made more environmentally responsible. BAT wants it to be mandatory for single use vapes to have removable batteries, to make recycling more straightforward.

Five million single use vapes are thrown away each week in the U.K. according to 2023 research from recycling campaign group Material Focus—a fourfold increase since 2022. But only 17 percent of vapers recycle in the correct recycling bins, according to the same data.

Finally, according to BAT, products shipped to the U.K. should be subject to a mandatory testing program to ensure products are compliant with U.K. regulations before they can be sold.

“We recognize that some want single use vapes banned altogether, but we are concerned such a move would lead to unregulated sales, and less options for adult smokers looking to switch,” said Ertonguc. “Governments should wield their enforcement powers to help re-build confidence in vaping by ensuring adult consumers can buy legitimate products, and suitably penalizing those who fail to comply.”

November 27, 2023

U.S. Crackdown on Youth Appealing Vapes Continues

The U.S. Food and Drug Administration issued warning letters to seven online retailers for selling and/or distributing unauthorized e-cigarettes packaged to look like youth-appealing toys and drink containers, including milk cartons, soft drink bottles and slushies, according to the FDA. The agency stated that the products’ designs may also help youth conceal the e-cigarettes from adults or be confused with an everyday object and the contents accidentally ingested by young children.

“As we continue into the school year, it’s critical that parents, teachers and other adults are aware of illegal e-cigarettes deceptively packaged to look like everyday items,” said Brian King, director of the FDA’s Center for Tobacco Products. “These types of products can be easily concealed and contain nicotine, which is highly addictive and can harm the developing adolescent brain.”

The seven retailers that were issued warning letters were given 15 working days to respond with the steps they will take to correct any violations and to prevent future violations. Failure to promptly correct the violations can result in additional FDA actions such as an injunction, seizure and/or civil money penalties.

November 17, 2023

Ghana’s Tobacco Control Strategy

Ghana’s government has developed a five-year National Tobacco Control Strategy (NTCS) with a goal of decreasing the consumption rate of tobacco in the country, reports The Ghanaian Times. The end goal of the NTCS is to eradicate all tobacco usage.

The Ministry of Health, the Food and Drugs Authority (FDA), the World Health Organization and the United Nations Development Program put the strategy plan together along with advocate policymakers on tobacco control.

According to Baffour Awuah, acting director of the Technical Coordination Directorate of the Ministry of Health, cardiovascular disease rates due to increased smoking are rising.

“The strategy we are launching today is the climax of extensive collaboration, research and commitment by various stakeholders, experts and civil society,” Awuah said. “Its purpose is to guide us in combatting the devastating effects of tobacco use, both in terms of health and the economy.

“It aims to ensure effective coordination among agencies involved in tobacco control, setting clear goals and adopting strategic timelines.”

Awuah encouraged stakeholders to actively engage in discussions to help transform the document into tangible action.

Olivia Boateng, director in charge of tobacco and substance abuse at the FDA, stated that illicit trade in tobacco products has made them more accessible at lower prices. The country has made progress in tobacco control policies, but the illicit trade has “amplified the tobacco epidemic,” according to Boateng.

Stakeholders will be trained on the protocol to eliminate illicit trade in tobacco products in the country once the NTCS is implemented, according to Boateng.

November 16, 2023

Malaysia Scraps Endgame Clause

The government of Malaysia has eliminated the generational endgame (GEG) clause from its Control of Smoking Products for Public Health Bill 2023, reports CodeBlue.

The move follows an opinion issued by Attorney-General Ahmad Terrirudin Mohd Salleh’s that the proposed age-based prohibition—which seeks to ban tobacco and vape products for anyone born from Jan. 1, 2007—is unconstitutional because it would create two sets of laws for two different groups of citizens based on age.

Enacting the GEG would require a change to Malaysia’s constitution, according to the attorney general, and the government was reportedly not confident it would be able to secure the required two-thirds majority in Parliament.

Anti-smoking activists were outraged, saying that the cabinet’s decision to drop the generational provision from the bill violates the Convention of the Rights of the Child, which Malaysia ratified in 1995.

“We believe that this is a backward step that will lead the people of Malaysia, especially children and adolescents, into the realms of nicotine addiction and drug dependence,” said Family Medicine Specialists’ Association (FMSA) President Nor Hazlin Talib.

The FMSA urged the government to reinsert the GEG clause into the bill. “The government needs to prioritize public health over political and economic interests,” Talib said.

In addition to the now removed GEG clause, the bill includes provisions on registration of tobacco products, advertisement, packaging and smoke-free places, among other items.

November 14, 2023

Slovenia Bans Flavors and Smoking Rooms

The government of Slovenia has banned most flavorings in electronic nicotine delivery systems such as e-cigarettes and tobacco-heating products, reports Euractiv. The only flavors still permitted are tobacco and mint.

“There is mounting research showing that among adolescents who otherwise do not smoke, the use of electronic cigarettes raises the likelihood of them starting to smoke regular cigarettes by up to four times,” Health Minister spokesperson Valentina Prevolnik Rupel was quoted as saying.

The government has also prohibited smoking rooms in public places such as bars and airports, as ventilation, filtration and other technologies have proven ineffective against exposure to tobacco smoke, according to Rupel.

To discourage black market sales of flavored products, the government intends to introduce new rules prohibiting individuals from selling or importing tobacco products in bulk.

Every year, 3,100 people die from smoking in Slovenia, according to Health Ministry data.

November 13, 2023

FDA Sends More Warnings

The U.S. Food and Drug Administration sent warning letters to seven online retailers for selling unauthorized e-cigarette products. The warning letters cite the sale of popular and youth-appealing disposable e-cigarette products marketed under the brand names Elf Bar, EB Design, Bang, Cali Bars and Lava.

These warning letters were informed by the FDA’s ongoing monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal, according to the agency. Findings released last week from the 2023 National Youth Tobacco Survey found that more than half of current youth e-cigarette users reported using the disposable e-cigarette brand Elf Bar; earlier this year, the manufacturer of Elf Bar began marketing the product under the name EB Design. In addition, the brands Bang, Cali Bars and Lava were identified as popular or youth appealing by the agency following review of retail sales data and emerging internal data from a survey among youth.

“FDA’s robust surveillance of the e-cigarette landscape helps us to identify youth-appealing products and to act quickly to protect public health,” said Brian King, director of FDA’s Center for Tobacco Products. “The goal is to identify, prevent and reduce these risks to our nation’s youth before they escalate further.”

The retailers receiving warning letters sold or distributed e-cigarette products in the United States that lack authorization from the FDA in violation of the Federal Food, Drug and Cosmetic Act. Warning letter recipients are given 15 working days to respond with the steps they’ll take to correct the violation and to prevent future violations. Failure to promptly correct the violations can result in additional FDA actions, such as an injunction, seizure and/or civil money penalties.

To date, the FDA has authorized 23 tobacco-flavored e-cigarette products and devices. The distribution or sale of unlawfully marketed products is subject to compliance and enforcement action. For retailers looking for information on which e-cigarettes are legal to sell, the FDA created a printable, one-page flyer of these authorized products. This information is also available on the FDA’s website.

November 10, 2023

FDA Warns Nic Nac ‘Nicotine Mints’

The U.S. Food and Drug Administration issued a warning letter to Nic Nac Naturals for the marketing of their unauthorized dissolvable nicotine products, which the company describes as “nicotine mints” and which resemble a pack of mints. These products are of particular concern because of their resemblance to popular candies and the potential to cause severe nicotine toxicity or even death if accidentally ingested by young children, according to the FDA.

“FDA remains steadfast in our commitment to actively monitor the marketplace and to crack down on companies selling unlawful products, particularly those that can appeal to youth,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “Our goal is to identify and prevent these emerging threats to our nation’s youth before they become mainstream.”

The manufacturer markets these tobacco products in a variety of mint and fruit flavors, all of which come in two nicotine strengths (3 mg or 6 mg). The packaging states the products contain nontobacco nicotine. The FDA regulates tobacco products containing nicotine from any source, including nontobacco nicotine. Nic Nac Naturals does not have a marketing authorization order from the agency to sell or distribute these products in the U.S.

One container of 15 of these mints can have as much as 90 mg of nicotine total. According to research, the FDA stated, ingesting 1 mg to 4 mg of nicotine could be toxic or severely toxic to a child under 6 years old, depending on body weight. This means ingesting one mint could be severely toxic to a child under 6 years old. Nicotine toxicity among youth of any age can lead to nausea, vomiting, abdominal pain, increased blood pressure and heart rate, seizures, respiratory failure, coma and even death. The FDA also stated that nicotine is highly addictive and exposure during adolescence can harm the developing brain.

“Today’s action is another example of our ongoing efforts against illegal nontobacco nicotine products,” said Ann Simoneau, director of the CTP’s Office of Compliance and Enforcement. “We remain unwavering in our use of compliance and enforcement resources to curb unlawful marketing of tobacco products, particularly those that youth could easily confuse with something that they consume regularly—like candy.”

The company has 15 working days to respond to the FDA with steps they will take to correct and prevent future violations. Failure to respond and correct violations may result in addition FDA action, such as an injunction, seizure and/or civil money penalties.

November 7, 2023

Cigar Group Wants Better Justification for U.S. Flavor Rule

The Premium Cigar Association (PCA) testified before the White House Office of Management and Budget’s Office of Information and Regulatory Affairs (OIRA) as part of the administration’s review of the U.S. Food and Drug Administration’s draft Final Rule “Tobacco Product Standard for Characterizing Flavors in Cigars.”

PCA President Scott Regina provided several examples of the impact that the rule would have on specialty tobacco retail, emphasizing that the FDA had not conducted a proper small business impact analysis. The PCA also outlined how the rule would directly affect regulatory matters outside of the FDA’s jurisdiction, including law enforcement, international trade and foreign policy.

“It’s questionable whether FDA has the authority to issue standards that result in a product ban, especially when they are acknowledging that the regulation does not address a specific risk,” said Regina in a statement.

“Ultimately, we asked OIRA to consult with a host of affected federal agencies and to remit the draft Final Rule back to FDA for better justification of authority, cost-benefit analysis and small business impact,” said Scott Pearce, executive director of the PCA.

The OIRA has scheduled meetings with additional stakeholders throughout the month as well as proponents of the characterizing flavor product standard for cigars.

The PCA published a full list of recommendations on the draft Final Rule.

November 7, 2023

Category: Global Regulation