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September 14th, 2015:

Inquiry eyes tobacco-free generation

Tasmania’s top public health expert will give evidence to a parliamentary inquiry investigating the feasibility of laws that will create a tobacco-free generation.

Dr Mark Veitch is the state’s acting director of public health and on Monday he will address a hearing in Hobart.

The inquiry comes on the back of a proposal put to the Tasmanian parliament that the sale of tobacco products should be outlawed to anyone born in or after 2000, starting when they reach adulthood in 2018.

The idea has attracted international backing from anti-smoking groups, some of which believe the adoption of legislation in Tasmania could set a precedent for similar strategies elsewhere.

Tobacco Industry Indonesia Concerned about Looming Tax Hike

In order to generate more tax revenue in 2016 the Indonesian government plans to raise tobacco taxes by 23 percent (as mentioned in the draft of the 2016 State Budget). This plan resulted in concern among Indonesia’s cigarette producers as the country’s purchasing power has already been curtailed amid the nation’s economic slowdown and high inflation. Contrary to the global trend, the Asian region recorded solid tobacco sales growth in recent years but now these countries seem to join in on anti-tobacco measures such as higher excise taxes and large pictorial warnings on packages.

Indonesia is the world’s third-largest tobacco consumer (after China and India). Based on data from Basic Health Research (Riset Kesehatan Dasar) nearly 60 million Indonesians – aged over ten years – smoked in 2013, consuming around 225 billion cigarettes (figures that exclude passive smokers). Recently, the National Commission on Tobacco Control said that in the same year a total of 240,000 Indonesian people died due to smoking-related diseases. Nearly all of these casualties are men as less than five percent of Indonesian women consume tobacco products.

Widespread tobacco consumption in Indonesia is a problem for the economy as it jeopardizes enjoying the benefits of the country’s demographic bonus. Indonesia has a large and young population (about half of Indonesia’s population is below thirty years of age and thus potentially productive). However, this demographic bonus can turn into a burden if this young population cannot be absorbed by the labour market due to the lack of job availability or the lack of capable human resources due to physical illnesses (such as heart diseases brought about by tobacco consumption). Medical expenses, physical disability, and premature deaths also bring along economic costs for Southeast Asia’s largest economy.

Although Indonesia is one of the few countries, and reportedly the only one in Asia, that have not yet ratified the Framework Convention on Tobacco Control (FCTC), it did recently implement some measures to curb (directly or indirectly) the consumption of tobacco in Indonesia. In July 2014, the government introduced a regulation that requires domestic tobacco producers to place graphic warnings on cigarette packages. Then, in January 2015, Indonesian tobacco products became subject to an average tax hike of 8.7 percent in a bid to collect more tax income. And now, the government plans another tobacco tax hike in 2016. In the draft of the 2016 State Budget, the central government proposed a 23 percent tobacco excise revenues hike to IDR 148.85 trillion (approx. USD $10.4 billion).

Ismanu Sumiran, Chairman of the Association of Indonesian Cigarette Producers (Gappri), called the government’s plan to raise tobacco taxes by 23 percent ‘irrational’ due to the country’s current economic slowdown. “[…] a 6-8 percent hike would be enough, given that Indonesia’s cigarette production has fallen by 12 percent (y/y) per July 2015,” Sumiran added (quoted by Indonesian news portal Kontan).

Indonesian cigarette manufacturer Wismilak Inti Makmur responded to the looming 23 percent tax hike stating that it sees no other choice but to raise cigarette prices, hence adding inflationary pressure. In August 2015, Indonesian inflation stood at 7.18 percent (y/y). Indonesia’s largest cigarette manufacturer HM Sampoerna, currently planning a rights issue, is also expected to raise prices in order to safeguard solid profit margins.

Federal Register, Volume 80 Issue 177

[Federal Register Volume 80, Number 177 (Monday, September 14, 2015)]


[Pages 55124-55125]

From the Federal Register Online via the Government Publishing Office []

[FR Doc No: 2015-23001]



Food and Drug Administration

[Docket No. FDA-2013-D-1600]

Enforcement Policy for Certain (Provisional) Tobacco Products That the Food and Drug Administration Finds Not Substantially Equivalent; Guidance for Industry and Tobacco Retailers; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent.” This guidance provides information to tobacco retailers on FDA’s enforcement policy regarding certain so-called provisional tobacco products that become subject to not substantially equivalent (NSE) orders issued under the Federal Food, Drug, and Cosmetic Act (the FD&C Act).

DATES: Submit either electronic or written comments on Agency guidances at any time.

ADDRESSES: Submit written requests for single copies of this guidance to the Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-2000. Send one self-addressed adhesive label to assist that office in processing your request or include a fax number to which the guidance document may be sent. See the SUPPLEMENTARY

INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the guidance to Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Annette Marthaler, Center for Tobacco Products, Food and Drug Administration, Document Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-2000, email:


I. Background

FDA is announcing the availability of a guidance for industry entitled “Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent.” This guidance provides information to tobacco retailers on FDA’s enforcement policy regarding certain so-called provisional tobacco products that become subject to NSE orders issued under the FD&C Act. We received several comments to the draft guidance (79 FR 10534, February 25, 2014), and those comments were considered as the guidance was finalized.

II. Significance of Guidance

This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Enforcement Policy for Certain (Provisional) Tobacco Products that FDA Finds Not Substantially Equivalent.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.

III. Comments

A. General Information About Submitting Comments

Interested persons may submit either electronic comments regarding this document to or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document.

B. Public Availability of Comments

Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at As a matter of Agency practice, FDA generally does not post comments submitted by individuals in their individual capacity on This is determined by information indicating that the submission is written by an individual, for example, the comment is identified with the category “Individual Consumer” under the field titled “Category (Required),” on the “Your Information” page on For this docket, however, FDA will not be following this general practice.

Instead, FDA will post on comments to this docket that have been submitted by individuals in their individual capacity. If you wish to submit any information under a claim of confidentiality, please refer to 21 CFR 10.20.

C. Information Identifying the Person Submitting the Comment

Please note that your name, contact information, and other information identifying you will be posted on if you include that information in the body of your comments. For electronic comments submitted to, FDA will post the body of your comment on along with your State/province and country (if provided), the name of your representative (if any), and the category identifying you (e.g., individual, consumer, academic, industry). For written submissions submitted to the Division of Dockets Management, FDA will post the body of your comments on, but you can put your name and/or contact information on a separate cover sheet and not in the body of your comments.

IV. Electronic Access

Persons with access to the Internet may obtain an electronic version of the guidance at either or

Dated: September 9, 2015.

Leslie Kux,

Associate Commissioner for Policy.

[FR Doc. 2015-23001 Filed 9-11-15; 8:45 am]


New Regulations on Sale of E-Cigarettes to Take Effect

The California Department of Public Health released a report today that calls E-Cigarettes a health threat and suggests that they should be regulated like regular cigarettes and tobacco products. (Photo by Justin Sullivan/Getty Images)

Anyone under 18 years old will be barred from buying electronic cigarettes in Massachusetts and the liquid and gels used in the devices will have to be sold in child-resistant packaging under new regulations approved by the attorney general’s office.

The regulations also ban the promotional giveaway or free distribution of e-cigarettes and require that they be kept out of the reach of customers.

Attorney General Maura Healey said the regulations also ban most sales of e-cigarettes except through face-to-face purchases and not through vending machines except in adults-only establishments.

“The growth of the e-cigarette market has posed a serious public health risk to Massachusetts residents and calls for strict oversight to protect our young people,” Healey said.

The regulations were filed Friday and most take effect Sept. 25. The packaging requirement is effective March 15, 2016.

E-cigarettes are battery-powered devices that turn nicotine-containing liquid into vapor that is inhaled. Though nicotine can be addictive, e-cigarettes lack the chemicals and tars of burning tobacco.

The tougher packaging requirements are intended to prevent the accidental ingestion of the liquids or gels by children.

Jon Hurst, President of the Retailers Association of Massachusetts said shop owners prefer a single set of statewide regulations rather than a patchwork of regulations that vary by city and town.

Healey said while the statewide regulations set an age limit of 18 for purchasing e-cigarettes, the minimum sales age may be higher in cities or towns that have passed their own restrictions.

E-cigarettes haven’t been extensively studied and there’s no scientific consensus on any potential benefits or harms from “vaping,” including whether it leads kids to become regular smokers.

National data show e-cigarettes have become more popular among teens than regular cigarettes.

A recent government-funded study conducted at 10 Los Angeles high schools suggests that teens who use e-cigarettes are more likely than others to later smoke conventional cigarettes. Whether teens had tried just one e-cigarette or were habitual users isn’t known, nor is whether they became heavy smokers or just had a few puffs.

The study doesn’t prove that electronic cigarettes are a “gateway drug” but some doctors say it bolsters arguments that the devices should be strictly regulated as proposed by the Food and Drug Administration.

Despite its limitations, the study “is the strongest evidence to date that e-cigarettes might pose a health hazard by encouraging adolescents to start smoking conventional tobacco products,” according to Dr. Nancy Rigotti, director of a tobacco research and treatment center at Massachusetts General Hospital.

Rigotti’s comments and the study were published last month in the Journal of the American Medical Association.

The FDA in 2014 proposed rules that would ban the sale of electronic cigarettes to minors and would add the devices to the list of tobacco products it regulates.