U.S. panel deals blow to Philip Morris tobacco device

[webfact]

U.S. panel deals blow to Philip Morris tobacco device

By Toni Clarke

 

A man uses an IQOS e-cigarette at an outlet in London, Britain, January 25, 2018. REUTERS/Peter Nicholls

 

WASHINGTON (Reuters) - Philip Morris International Inc <PM.N> should not be allowed to claim its iQOS electronic tobacco product is less risky than cigarettes, U.S. health advisers said on Thursday, dealing a blow to the company as it seeks to strengthen its portfolio of alternative nicotine devices.

 

The recommendation is not binding and the U.S. Food and Drug Administration could still allow Philip Morris to make such a claim, but some analysts think the agency might ask for additional data first.

 

"It's a process," said Bonnie Herzog, an analyst at Wells Fargo. The FDA will likely approve the request eventually, she said, "but timing is tough to predict."

 

Philip Morris, which has spent more than $3 billion to develop products that can counteract the decline in traditional cigarette sales, said it was encouraged by some of the committee members' comments that iQOS may have risk-reduction potential.

 

"We are confident in our ability to address the valid questions raised by the Committee with the FDA as the review process for our application continues," Corey Henry, a Philip Morris spokesman, said in a statement.

 

FDA Commissioner Scott Gottlieb recently proposed a broad tobacco policy shift that would reduce nicotine in cigarettes to "non-addictive" levels while increasing development of lower-risk alternatives for those unable to quit.

 

IQOS is a sleek, penlike device that heats tobacco but does not ignite it - an approach Philip Morris says produces far lower levels of carcinogens than regular cigarettes. It is used by nearly 4 million people in 30 markets outside the United States but needs FDA authorization to be marketed in America.

 

Last month, a Reuters investigation described irregularities in the clinical trials that supported Philip Morris' iQOS application to the FDA.

(https://www.reuters.com/investigates/special-report/tobacco-iqos-science/) and (http://www.reuters.com/investigates/section/pmi)

The company's shares fell 2.8 percent to close at $107.49 on Thursday, after falling as much as 6.8 percent.

 

Matthew Myers, president of the Campaign for Tobacco Free Kids, said panelists "identified that serious questions remain" about the company's application. He said it could amend the application and the panel's recommendation does not rule out an ultimate approval.

 

The panel said Philip Morris had not proven that iQOS reduced harm compared with cigarettes. It did conclude that the product exposes users to lower levels of harmful chemicals but said the company had not shown that lowering exposure to those chemicals is reasonably likely to translate into a measurable reduction in disease or death.

 

Philip Morris needs to show both in order to claim in its marketing materials that the product reduces a user's exposure to harmful chemicals.

Some panelists were concerned that not all the harmful or potentially harmful chemicals in iQOS were lower than in cigarettes. Philip Morris presented data showing an overall exposure reduction of about 95 percent.

 

"The negative recommendations did not come as a surprise," said Gregory Conley, president of the American Vaping Association. He said the panelists "disconnected themselves from the facts in favour of ideology."

 

The FDA is expected to decide whether Philip Morris can sell iQOS within the next few months. It will decide separately whether to authorise the modified-risk claims. There is no time frame for when that decision might come.

 

If cleared, iQOS would be sold in the United States by Philip Morris' partner Altria Group Inc <MO.N>. Altria shares closed 2.3 percent lower at $69.91.

 

(Reporting by Toni Clarke in Washington; Editing by Susan Thomas and Matthew Lewis)

 

-- © Copyright Reuters 2018-01-26

[darksidedog]

If and when the US FDA do give approval for e-cigs to be classified as less harmful than traditional cigarettes, I wonder how much longer they will be illegal here?

[Colborn]

It's not a true  e-cig as it uses tobacco, might aswell just smoke a real cig.

 

E-cigs are scientifically proven to be less harmful than cigarettes, even still back in the day when diacetyl was allowed in the liquids, still safer than cigarettes.

 

That device is a POS but the real issue is the government losing out on tax.

 

 

[Colborn]

If he had spent 3 billion on making decent eliquid he would be the world leader in eliquid.

 

Stats are skewed and nonsense

[AJBangkok]

True, but that 3 billion probably went into making it more addictive not less harmful. If they can do both then great as their customers will live longer to buy their products. If they can’t then addictive will trump less harmful for sure .

[Jonmarleesco]

On 1/26/2018 at 7:48 AM, darksidedog said:

If and when the US FDA do give approval for e-cigs to be classified as less harmful than traditional cigarettes, I wonder how much longer they will be illegal here?

Non-smokers still have to run the gauntlet of people using them, and those things produce almost as much smoke as a November 5th bonfire. In other words, they are as big a menace as cigarettes to those who don't want to participate.

[Jonmarleesco]

On 1/26/2018 at 8:09 AM, Colborn said:

E-cigs are scientifically proven to be less harmful than cigarettes

Then PM can presumably present the data to the US health watchdog?

[RuamRudy]

1 hour ago, Jonmarleesco said:

Non-smokers still have to run the gauntlet of people using them, and those things produce almost as much smoke as a November 5th bonfire. In other words, they are as big a menace as cigarettes to those who don't want to participate.

I actually wonder if e-cigs are more pernicious. The smell of a traditional cigarette can hardly be appealling to non-smokers, but the weird and fanciful varieties of flavours that e-cigs come in, and the voluminous clouds they create for passrs by to inhale must surely help to capture more of the youth market, especially with the healthy alternative tag?

[Orac]

1 hour ago, Jonmarleesco said:

Then PM can presumably present the data to the US health watchdog?

 

I would have thought tobacco companies have very little credibility now when it comes to asserting their products have some sort of health benefit, especially when it is in relation to one of their other products.