Tag: United States

FDA starts iQOS review
Philip Morris said yesterday that the US Food and Drug Administration’s Center for Tobacco Products had initiated a substantive scientific review process in respect of its electronically heated tobacco product (EHTP), iQOS.
On May 24, the FDA had published the executive summary and research summaries supporting PMI’s Modified Risk Tobacco Product (MRTP) application for its EHTP, the company said in a note posted on its website.
‘In doing so, the agency announced that it will publish a notice in the Federal Register establishing a formal docket for public comments on PMI’s application at a later date,’ it said.
‘PMI submitted the application to the FDA on December 5, 2016.
‘Publication of PMI’s summaries initiates a substantive scientific review process by the FDA’s Center for Tobacco Products.’
PMI said the FDA had made the application summaries publicly available and that the agency would publish additional modules of PMI’s MRTP application on a rolling basis.
The FDA had established a one-year timetable for reviewing MRTP applications, though that timing was non-binding.
“We welcome FDA and public review of the comprehensive scientific evidence package that we submitted to the agency through its MRTP application process,” said Dr. Moira Gilchrist, PMI vice president corporate affairs of reduced-risk products.
“PMI’s application demonstrates our commitment to develop innovative, smoke-free technologies that can ultimately replace combustible cigarettes to the benefit of smokers, public health and society at large.”
Meanwhile, the Altria Group said that it was pleased that the FDA had filed PMI’s MRTP application.
It said that upon regulatory authorization by the FDA of PMI’s Premarket Tobacco Product application (PMTA), Philip Morris USA, an Altria company, would have an exclusive license to sell the electronically-heated tobacco product in the US.
PMI submitted the PMTA to the agency on March 31, 2017.
“PM USA is actively working on commercialization plans and we look forward to bringing this electronically-heated product to the US market,” said Sarah Knakmuhs, vice president heated tobacco products, PM USA.
“We are excited about the opportunity to add this product to our portfolio for adult tobacco consumers who are looking for an alternative to conventional cigarettes.”
May 26, 2017
New line for Xcaliber
The US cigarette manufacturer, Xcaliber International, has invested in a new cigarette manufacturing line that will increase its capacity by about 30 percent.
The 10,000-cigarettes-per-minute line from Hauni Maschinenbau will sit alongside similar manufacturing lines housed in the company’s production facility at Pryor, Oklahoma.
It is expected to be operational by November.
“The decision to make an investment in a new manufacturing line underscores our confidence in Xcaliber’s growth strategy,” said COO Derrick Taylor.
“This investment will increase capacity by approximately 30 percent, will provide improved manufacturing flexibility, and further supports our mission to provide top value products in the Tier Four [discount/generic] category.”
In a press note published through PR Newswire, the company said that it was the leading Tier Four cigarette manufacturer in the US.
‘Xcaliber International is built on the foundation of providing the highest value products in the Tier Four category,’ the note said.
May 25, 2017
Flue-cured output to rise
The chairman, president, and CEO of Universal Corporation, George C. Freeman, III, has predicted that global flue-cured tobacco production outside China will increase by about nine percent in the fiscal year to the end of March 2018.
This increase would largely stem from the recovery of the Brazilian crop due to better weather conditions, he said.
At the same time, Burley production would decrease by about eight percent, primarily due to reductions in Africa.
In presenting Universal’s annual results to the end of March, Freeman said it was too early to determine whether additional purchases made by customers in fiscal year 2017 might impact their requirements in fiscal year 2018.
Net income for the fiscal year ended March 31 was $106.3 million, down from $109.0 million in fiscal year 2016, while operating income of $178.4 million was down $3.3 million.
Segment operating income, which excludes non-recurring items, was $188.5 million in fiscal year 2017, up $2.4 million from that of the previous year; a rise that was primarily attributable to improved results for the company’s North America segment, partly offset by a decline for the Other Tobacco Operations segment.
Revenues of $2.1 billion for fiscal year 2017 were said to have been ‘relatively flat’ as slightly higher volumes and a benefit from earlier receipt of distributions from unconsolidated subsidiaries were offset by lower green leaf costs and lower processing revenues.
“I am pleased to announce that Universal delivered solid results again this year despite supply headwinds, most notably from the weather-reduced crop sizes in Brazil and ongoing challenging market conditions in Tanzania,” said Freeman.
“Although we had anticipated ending the year with slightly lower volumes, earlier shipment timing as well as attractive green prices in some origins resulting in some additional purchases by our customers boosted shipments later in our fiscal year, allowing us to improve our market share and achieve lamina sales volumes that were slightly above those of the prior fiscal year.”
May 24, 2017
Ventilation in a hole
An article in the Journal of the National Cancer Institute has suggested that the US Food and Drug Administration should consider regulating cigarette filter ventilation, up to and including a ban.
It further suggests a research agenda to support such an effort.
A short background to the article says that Filter ventilation was adopted in the mid-1960s and was initially equated with making cigarettes safer. But since then, lung adenocarcinoma rates had paradoxically increased relative to other lung cancer subtypes.
Filter ventilation is said to alter tobacco consumption in such a way as to increase smoke toxicants. It is said to allow for elasticity of use so that smokers inhale more smoke to maintain their nicotine intake. And it is said to cause a false perception of lower health risk from ‘lighter’ smoke.
Little of this seems particularly new. The problems caused by changes in smoking behavior with the advent of low-delivery cigarettes were identified long ago, though the emphasis on filter ventilation is more recent.
The background says that the 2014 Surgeon General’s Report on smoking and health concluded that changing cigarette designs had caused an increase in lung adenocarcinomas, implicating cigarette filter ventilation that lowers smoking machine tar yields.
The lead author of a recent study has said that research data suggests a clear relationship between the addition of ventilation holes to cigarettes and increasing rates of lung adenocarcinoma seen over the past 20 years.
The study, by researchers at the Ohio State University Comprehensive Cancer Center’s Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, and five other universities/cancer centers, was the subject of a story in EurekAlert! relayed by the TMA.
The lead author, Professor Peter Shields said that what was especially concerning was that these ventilation holes were still added to virtually all cigarettes smoked today.
Shields said the FDA had a public health obligation to take immediate regulatory action to eliminate the use of ventilation holes on cigarettes.
He said it was a complicated process to enact such regulations, but that there was more than enough data to start the process.
“Such an action would drive down the use and toxicity of conventional cigarettes, and drive smokers to either quit or use less harmful products,” he said.
May 23, 2017
Ray of hope for e-cigs
In his first remarks to staff at the US’ Food and Drug Administration, the new commissioner, Scott Gottlieb, signaled an openness to electronic cigarettes that might hint at a future weakening of the Obama-era rule that clamped down on the industry driving the development of these products, according to a story by Dan Diamond for Politico.
“We need to have the science base to explore the potential to move current smokers — unable or unwilling to quit — to less harmful products, if they can’t quit altogether,” Gottlieb was reported to have said on Monday.
Gottlieb did not mention electronic cigarettes directly, but his comments echoed proponents’ arguments that such products can be a stepdown from traditional tobacco cigarettes.
However, Diamond said that critics were saying that the reality was less rosy, without explaining why they thought this way.
The FDA announced last week that it was delaying aspects of a rule that aimed to regulate electronic cigarettes as traditional cigarettes.
May 17, 2017
Altria to webcast AGM
The Altria Group is due to host a live audio webcast of its 2017 Annual Meeting of Shareholders from 09.00 Eastern Time on May 18.
Accessing the webcast, which will be in listen-only mode, will require pre-event registration at www.altria.com/webcasts.
An archived copy of the webcast will be available on altria.com or through the Altria Investor App. The free app is available for download at www.altria.com/irapp or through the Apple App Store or Google Play.
May 12, 2017
Results due May 23
Universal Corporation is due to webcast a conference call after market close on May 23 following the release of its results for fiscal year 2017.
The conference call will begin at 17.00 Eastern Time and will be hosted by Candace C. Formacek, vice president and treasurer.
A live webcast of the conference call will be available online on a listen-only basis at www.universalcorp.com.
A replay of the webcast conference call will be available at that site until August 3, and a taped replay of the call will be available from 20.30 on May 23 through June 5 at (855) 859-2056. The telephone replay identification number is 22767546.
May 12, 2017
FDA deadlines guidance
The US Food and Drug Administration has issued its guidance on the Three-Month Extension of Certain Tobacco Product Compliance Deadlines Related to the Final Deeming Rule. The extension applies only to dates set for May 10 or later.
In a press note, the FDA’s Center for Tobacco Products said the extension was first communicated in legal filings in federal court on May 1, and was then shared with stakeholders. It was announced also that the FDA intended to issue the latest guidance document.
‘As announced, and under the guidance being released today, all provisions with compliance dates that have already occurred – such as mandatory age and photo-ID checks to prevent illegal sales to minors – will remain in effect,’ the note said. ‘The FDA will continue to enforce such requirements.
‘For all future compliance dates related to the final deeming rule, the FDA is deferring its enforcement for an additional three months. Provisions for which this extension will apply include, but are not limited to:
- Submission of cigar rotational warning plans
- Registration and listing
- Ingredient listing
- Health documents
- Substantial Equivalence (SE) exemption requests
- Substantial Equivalence (SE) applications
- Premarket tobacco product applications (PMTAs)
- Harmful and potentially harmful constituent (HPHC) reports.’
The guidance is at https://www.fda.gov/TobaccoProducts/Labeling/RulesRegulationsGuidance/ucm557714.htm?source=govdelivery&utm_campaign=ctp-compliancedeadlines&utm_content=guidance&utm_medium=email&utm_source=govdelivery.
May 11, 2017
Senate confirms FDA head
The US Senate voted 57 to 42 yesterday to confirm Dr. Scott Gottlieb as commissioner of the Food and Drug Administration, where he will be responsible for regulating drug companies to which he has had close ties in recent years, according to a story by Katie Thomasmay.
Gottlieb has promised to divest himself from several health care companies and recuse himself for one year from decisions involving those businesses, but that was not enough for many Democratic senators, including Patty Murray of Washington.
“He has not convinced me he can withstand political pressure from this administration, or that he will be truly committed to putting our families’ health first,” Murray said during the debate before Tuesday’s vote. “I’ve grown increasingly concerned about whether he can lead the FDA in an unbiased way, given his unprecedented industry ties.”
In a statement, Tom Price, the health and human services secretary, said Dr. Gottlieb’s “background will be crucial” for maintaining the FDA’s high standards for safe treatments “while advancing new, innovative solutions” to the nation’s public health challenges.
For Gottlieb, this is a return to the agency where, during the administration of President George W. Bush, he held various jobs, including that of deputy commissioner.
He will take over a sprawling agency that regulates everything from food to drugs, medical devices and tobacco products, which include, according the FDA’s deeming regulations, products such as electronic cigarettes.
Unless the regulations on vapor products are changed, many observers believe that most of these products will disappear from the market along with the hopes of many people trying to quit smoking.
The full story is at: https://www.nytimes.com/2017/05/09/health/scott-gottlieb-senate-fda-commissioner.html?emc=edit_tnt_20170509&nlid=60534081&tntemail0=y&_r=1.
May 10, 2017
Life-expectancy gap
A county-by-county survey of US life expectancy reports a 20-year gap between the lows and the highs, according to a story by Alan Boyle for Yahoo!
The gap between the highs and lows is said to correlate with socioeconomic factors, race and ethnicity, the availability of health care, and preventable risk factors such as obesity and smoking.
The study, conducted by researchers at the University of Washington’s Institute for Health Metrics and Evaluation and published in JAMA Internal Medicine, suggests that the gap is widening.
“This is way worse than any of us had assumed,” University of Washington professor Ali Mokdad, who leads US county health research at the institute, was said to have told The Guardian newspaper.
A cluster of counties in Colorado showed the highest life expectancy in 2014, with Summit County topping the list with 86.8 years.
South Dakota’s Oglala Lakota County reported the lowest average of 66.8 years, a figure that is comparable to life expectancies in Sudan and Iraq.
The good news was said to be that nearly all counties registered gains in life expectancy between 1980 and 2014.
The bad news was said to be that the high-low gap had widened over those 34 years, and that 13 counties had registered declines in expected lifespans.
Cigarette smoking in the US has been on a downward trend for many years.
The full story is at: https://finance.yahoo.com/news/uw-researchers-map-widening-gap-193011156.html.
May 9, 2017