Category: Regulation

FDA draft guidance issued
The US Food and Drug Administration yesterday issued a draft guidance on its enforcement policy for tobacco products that are the subject of a not-substantially-equivalent order.
The draft guidance, Enforcement Policy for Certain Marketed Tobacco Products, is said to explain the FDA’s enforcement policy for ‘manufacturers, importers, or distributors of certain marketed tobacco products that receive a not-substantially-equivalent (NSE) order.
It is said also to explain the sell-off time allowed, as well as the enforcement policy for retailers with such products in their inventory.
‘These certain marketed tobacco products include “provisional” tobacco products (those that were first introduced or delivered for introduction into interstate commerce after Feb. 15, 2007, and prior to March 22, 2011, and for which a substantial equivalence report was submitted no later than March 22, 2011) and to new tobacco products created by modifying the quantity of a provisional tobacco product in a pending substantial equivalence report,’ the FDA said in a note issued through its Center for Tobacco Products.
‘The Federal Food, Drug, and Cosmetic Act permits a provisional tobacco product to remain on the market pending FDA’s review of the substantial equivalence report for that product. Per the new draft guidance, FDA does not intend to take enforcement action against a manufacturer, importer, or distributor of a product that has received an NSE order for at least 30 calendar days from the date of the NSE order. The agency also does not intend to take enforcement action against a retailer for at least 30 calendar days from the date the NSE order is posted on FDA’s Misbranded and Adulterated NSE Tobacco Products webpage.’
The FDA is encouraging retailers to contact their supplier or manufacturer ‘to discuss possible options for the misbranded and adulterated product that they may have in their inventory’.
‘The new draft guidance also notes that should FDA receive a request for a supervisory review of an NSE order from the applicant within 30 calendar days from the issue date of the NSE order, FDA does not intend to take enforcement action against the manufacturer, importer, or distributor based on the order until the agency makes a decision on the request,’ the note said. ‘If the appeal results in FDA affirming the NSE order, the agency does not intend to take enforcement action for at least 30 calendar days from the date of FDA’s decision on the appeal.
‘When finalized, this guidance will supersede the “Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent” guidance issued in September 2015.’
Comments on the draft guidance may be submitted on Regulations.gov at “Docket No. FDA-2018-D-3244”.
The guidance is here.
March 1, 2019
BAT volume increased
British American Tobacco’s cigarette and tobacco-heating product (THP) volume during the 12 months to the end of December, at 708 billion sticks, was increased by about 3.3 percent on that of the 12 months to the end of December 2017, 686 billion.
On a representative basis – as if BAT had owned Reynolds American Inc and other acquisitions completed during 2017 from January 1, 2017 – volumes fell by about 3.5 percent. BAT said that in its key markets volume was down by 2.7 percent, outperforming industry volume, which was estimated to be down by about 3.4 percent, leading to an increase in market share of 0.4 of a percentage point.
Meanwhile, other tobacco volumes included that of oral pouches, up 93 percent (representative 10.5 percent) to 3.9 billion; that of other oral products, up 119 percent (-4.0 percent representative) to 14.6 million kg; that of vapor products, up 100 percent (35.5 percent representative) to 189 million pods; and that of other tobacco products (including roll-your-own and make-your-own tobaccos), down 6.6 percent (-7.5 percent representative) to 22 billion stick-equivalents.
BAT’s revenue during the year to the end of December, at £24,492 million, was said to have increased by 25.2 percent on that of 2017.
Profit from operations, at £9,313, was increased by 45.2 percent.
Earnings per share (EPS), at 264.0p, and diluted earnings per share, at 263.2p, were down each down by 85.6 percent.
The dividend per share was up by 4.0 percent to 203.0p.
“BAT performed well in 2018, exceeding our target of high single figure adjusted constant currency EPS growth, whilst continuing to invest in long-term sustainable returns,” chief executive Nicandro Durante (pictured) was quoted as saying as part of the company’s preliminary announcement. “The full year effect of the RAI acquisition and a translational foreign exchange headwind of approximately six percent (on revenue and profit from operations) and seven percent (on EPS) distorted the Group’s results…”
Durante said he recognised that “proposed potential regulatory changes” in the US had created some investor uncertainty. “We have a long experience of managing regulatory developments, a track record of delivering strong growth while investing for the future and an established multi-category approach,” he said. “I am confident that my successor, Jack Bowles, will continue to deliver a similar level of sustainable long-term returns as we accelerate our Transforming Tobacco agenda.
“Looking into 2019 we are confident of another year of high single figure adjusted constant currency earnings growth and this confidence is reflected in our Board’s proposal to increase the dividend by four percent.”
February 28, 2019
Usual suspects support ban
Sixty-nine percent of Germans are in favor of a ban on tobacco advertising, according to a Xinhua News Agency story citing the results of a survey conducted by the German opinion research institute Forsa and published yesterday.
Out of 1,003 respondents, 27 percent were opposed to a ban on tobacco advertisements.
Banning alcohol advertising was supported by 58 percent of respondents and opposed by 36 percent.
Tobacco advertising has been banned from radio, television, newspapers and magazines since 2016.
But politicians from the governing conservative CDU/CSU alliance and those from its coalition partner, the Social Democratic Party, are planning to extend the ban.
Opposition to banning tobacco advertisements has come from some German politicians and the tobacco industry.
Several politicians, such as former CDU/CSU parliamentary group leader Volker Kauder wants to limit the scope of the ban.
In November, the German Cigarette Association (DZV) argued that tobacco advertising would not ‘lead to more people starting smoking or fewer consumers give up smoking’.
But it warned that a ban on tobacco advertising would have a ‘significant signal effect and would cause domino effects’ in other sectors, such as alcohol, spirits or food. ‘Commercial communication for a legally manufactured and distributed product would be switched off’ for the first time in Germany, it added.
Official 2017 figures from the German Federal Statistical Office (Destatis) showed that 22.4 percent of German citizens smoked regularly or occasionally, while 77.6 percent had never smoked or had quit.
February 26, 2019
Olympic effort on smoking
The Tokyo Organizing Committee of the 2020 Olympic and Paralympic games intends to impose a tobacco smoking ban at all indoor and outdoor games venues, according to a story in The Japan Times citing The Yomiuri Shimbun.
Quoting unnamed sources, the Times said it would be the first time that such a measure had been taken at a Summer Olympic Games.
In 2017, the committee announced plans to ban smoking within buildings used for the games. However, at that time, it was still studying a ban on smoking outside the buildings because there had been smoking areas on the premises of the 2012 London Olympics and the 2016 Rio de Janeiro Olympics.
According to the sources, the Tokyo committee’s move not to allow smoking areas within the sites of the two games would be line with the wishes of the International Olympic Committee, which promotes smoke-free games.
At the PyeongChang Winter Olympics in 2018, a total smoking ban was imposed on venue sites, but cigarette butts ended up being scattered around entrances. So the Tokyo committee will discuss with local governments, including the Tokyo metropolitan government, what measures will have to be taken.
February 25, 2019
Quitting made easier
Electronic cigarettes will not be offered as an aid to help UAE smokers quit their habit until the full health impact of these devices is determined, according to a story in thenational.ae.
This week the Government’s product regulator said that vaping products could be sold legally from mid-April, overturning the current ban.
New regulations are being introduced to ensure product standards are maintained and to help the authorities stamp out the black market in these devices.
But government doctors said the country would not go as far as some nations in promoting the devices to smokers who wanted to quit but who had failed to do so using other methods.
Dr. Mohammad El Disouky, who is in charge of Dubai Health Authority’s smoking cessation clinic, said more long-term research was needed.
“Consumers will now have full details of the chemicals contained in the products and information on how to use them,” he said.
“From a public health perspective, this is a good move as people who are using these products will know they have been legally distributed under supervision from the authorities.
“That will guarantee their content and will restrict what materials some companies are using.
“But legalising and regulating e-cigarettes does not mean they can be offered as a quitting aid for tobacco smokers.”
February 22, 2019
Banning multi-tasking
Smoking tobacco while walking in public places will be banned in South Korea if a proposed bill passes into law, according to a story in The Korea Times.
The bill, which was proposed early this month by Rep. Hwang Ju-hong of the Liberal Party for Democracy and Peace, is aimed at banning smoking on virtually all public roads and walkways.
“Non-smokers are often exposed to tobacco smoke because of some inconsiderate smokers,” Hwang was quoted as saying. “Public opinion is in favor of banning smoking while walking.”
If the National Assembly passes the bill, violators would be liable to a fine of 100,000 won ($90).
South Korea has already banned smoking in most restaurants, offices and public venues such as parks.
The Times said that smokers opposed to the bill complained that there were not enough smoking rooms.
According to a study by the Seoul Institute in 2017, there were 10,000 public smoking rooms in the city, which has a population of 10 million people.
February 21, 2019
Questions without answers
A Finnish member of the EU Parliament has asked the Commission what member states intend to do to reduce the use of snus by young people.
In a preamble to two questions that the Commission is due to answer in writing, Merja Kyllönen said Directive 2014/40/EU required member states to prohibit the placing on the market of tobacco products, such as snus, with characterising flavors.
‘The purpose of banning characterising flavours and aromas (Directives 89/622/EEC and 92/41/EEC) is to make products less tempting, particularly to young people,’ she said.
‘The use of snus is increasing, especially among young people. Experts are of the opinion that banning the use of flavorings in snus would reduce its use.
‘In addition, young people and new users are drawn to snus by its attractive retail packaging.
‘Prolonged use of snus results in various types of damage to the mouth area. It particularly affects the biting surfaces of teeth and the gums. The damage caused by snus can be greater for young people than for adults, because young people’s gums are more sensitive. Nicotine in snus has similar effects to nicotine in tobacco, including insomnia, headaches and changes to the nervous system. Using snus brings about a significant increase in the risk of cancers of the mouth, throat and pancreas and is also linked to cardiovascular disease.’
Kyllönen asked:
1. ‘What do member states intend to do to reduce the use of snus by young people?
2. ‘Are there any plans for reducing the attractiveness of snus to young people and new users by taking measures with regard to the appearance of retail packaging so as to add appropriate health warnings in the form of a combination of pictures and text?’
[The EU bans the sale of snus in all member states except Sweden.]
February 20, 2019
Preparing IQOS launch
Philip Morris International is preparing to introduce its heat-not-burn products to the Philippines after the creation of regulations governing such products, according to a story in The Manila Standard.
PMI Asia’s director for regulatory strategy and engagement James Arnold was quoted as saying that while some countries had no regulations covering these new tobacco products, consumers were nevertheless ready to embrace the new technology.
“What we are doing is for those people who cannot and won’t quit smoking,” said Arnold.
“Based on a study, there are millions of Filipinos who are still smoking and there [are] more than a billion smokers across the world. Twenty years after, there will still be a billion smokers globally. What do we want to do with them? At least provide them with better alternatives,” he said.
Despite the absence of laws covering these products, a few people are using them, having acquired them from other countries or from the black market in Manila.
“What is the most important here is the minimum age law,” Arnold said. “We don’t want children dipping their hands into something that should be regulated.”
Quality and safety standards and health warning labels, though not as graphic as those seen on combustible-cigarette packs, were also seen as being critical.
Another measure that would help improve the regulatory scheme was the scientific substantiation of the product and regular monitoring and surveillance.
“Products that don’t burn should be regulated differently than cigarettes,” Arnold said. “This is totally a different category that should be regulated differently than cigarettes, although the same principles will apply.”
February 19, 2019
New take on old problem
Italy is mulling a ban on tobacco smoking in private automobiles, according to a Xinhua News Agency story.
The country already bans smoking in vehicles for hire, such as taxis, and in private vehicles when a pregnant woman or a person under the age of 12 is present.
But people are divided on the latest measure to be proposed.
Advocates of the ban claim it would help avoid health problems related to smoking, while also decreasing traffic risks associated with drivers being distracted while smoking.
Fabio Galli, a road- and traffic-issues analyst with the consumer organization Codacons, was said to have told Xinhua that the issue presented a new take on a very old problem, which is how to balance the rights of an individual’s freedom to make personal choices and the desire to make changes that benefit the public at large.
Galli said the proposal was in the “earliest stages” of passage, and that it had several apparent flaws. “The first question I have is how it would be enforced,” Galli said. “There’s also the question of whether this is the kind of issue where the government should be involved.”
Oliviero Fiorini, a political affairs consultant with ABS Securities, said a law limiting smoking in vehicles would probably be treated as government overreach if questioned by courts. “We see a few examples of the government trying to incentivize a kind of moral code,” he said in an interview.
Fiorini said that if the goal was to reduce smoking, it would be more efficient to raise taxes on cigarettes or to outlaw them altogether. If the goal was to remove distractions from drivers, then rules should be introduced also in respect of mobile-phone use in vehicles.
February 18, 2019
E-cig ban to be lifted
A ban on the sale of electronic cigarettes and heat-not-burn (HNB) devices is due to be lifted in the UAE by mid-April, according to a story in The Khaleej Times.
The lifting of the ban had been expected following an announcement on February 16 that the Emirates Authority for Standardization and Metrology (ESMA) had approved new standards for electronic cigarettes and HNB devices.
And the intention to lift the ban was confirmed the next day by Abdullah Al Maeeni, director general of the ESMA. “We issued the regulation to legalize it, and it will be enforced by mid of April 2019, as the Authority is working hard through the development of technical standards and regulations,” he said.
UAE residents readily smoke electronic cigarettes in public though their sale has been illegal.
The new standards set by ESMA will reportedly regulate a range of matters, including nicotine components, technical specifications, packaging, and labeling.
They will apply to e-cigarettes and HNB devices, and to their associated products such as e-liquids and tobacco sticks.
The story said that the new ESMA standards were in line with the Government’s efforts to curb smoking and put a stop to the illegal sale of electronic cigarettes.
February 18, 2019