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FDA's tobacco stance faces test with Philip Morris iQOS device

FDA's tobacco stance faces test with Philip Morris iQOS device

Postby smix » Mon Jan 22, 2018 2:08 pm

FDA's tobacco stance faces test with Philip Morris iQOS device
Reuters

URL: https://www.reuters.com/article/us-heal ... SKBN1FB0J2
Category: Politics
Published: January 21, 2018

Description: WASHINGTON (Reuters) - In a decision expected to test the Trump administration’s approach to tobacco regulation, U.S. health advisers will vote this week on whether to allow Philip Morris International Inc to sell its novel iQOS tobacco device and claim it is less harmful than cigarettes.

iQOS.jpg

The sleekly packaged little tube would not look out of place in an Apple store. It is designed to heat tobacco but not burn it. Most of the harmful chemicals in tobacco are released when tobacco is burned. The advisers to the Food and Drug Administration will discuss the product on Wednesday and Thursday and recommend whether it should be cleared. The FDA is not obliged to follow the recommendations of its outside advisers but typically does. If cleared, iQOS would become the first product to carry a modified-risk claim and could help advance the FDA’s proposed new approach to reducing the dangers of smoking. For decades, U.S. health agencies have worked to help Americans quit cigarettes to avoid the risks of lung cancer and other disease. National smoking rates have declined to near historic lows of around 15 percent. But in July, newly appointed FDA Commissioner Scott Gottlieb proposed reducing nicotine levels in cigarettes to “non-addictive” levels while increasing development of lower-risk alternatives. The policy assumes that some percentage of the population will be unable or unwilling to give up nicotine. To make the new strategy succeed, the agency needs a stable of vetted, reduced-risk alternatives to cigarettes on the market. Philip Morris is one of the few companies that can finance such a long and expensive development process. It has spent close to $3 billion on reduced-risk products. “If this application fails, it will be clear that this is an expensive, wasteful, regulatory dead end,” said Clive Bates, a tobacco expert who runs the consulting firm Counterfactual and advocates for alternative nicotine products. Bates and others argue that if Philip Morris cannot win FDA clearance for a modified-risk product, no one will be able to. Other companies have submitted modified-risk products for FDA review. 22nd Century Group Inc, which genetically engineers tobacco plants to have lower nicotine levels, seeks clearance for its “Brand A” very low nicotine cigarettes. R.J. Reynolds Tobacco Co, owned by British American Tobacco Plc, is seeking clearance for six snus products - a moist smokeless tobacco pouch placed under the lip - under the Camel brand.
THE CLAIM
IQOS is used by nearly 4 million people in 30 markets outside the United States. It consists of a small pen-like holder containing a heated tobacco stick, and a charger. It looks similar to an e-cigarette, but uses real tobacco rather than nicotine-laced liquid. Philip Morris says that iQOS contains up to 95 percent fewer harmful or potentially harmful chemicals than the cigarette smoke produced from burning tobacco. If approved, the product would be marketed by U.S. partner Altria Group Inc. The hurdles for success are high. To sell a new tobacco product, a company must demonstrate that it significantly reduces the risk of disease and does not encourage more smoking or delay quitting. To date, the FDA has determined that only eight products meet that standard, all of them snus smokeless tobacco pouches made by Swedish Match AB. The agency has granted no company the right to specifically claim that their product is less risky than cigarettes. Tobacco control activists say companies like Philip Morris cannot be trusted to make reduced-risk claims. They point to the industry’s previous promotion of “light” and “low-tar” cigarettes as safer alternatives despite evidence showing they were not. Others argue that things have changed. Since 2009, the tobacco industry has had to answer to the FDA under federal law. New technology, including e-cigarettes and heat-not-burn products, may help smokers quit or shift those who cannot quit onto a less harmful substitute, they say. “Many of my friends in the tobacco control movement are still fighting the tobacco wars of the 1980s,” said Scott Ballin, an independent health policy consultant and long-time anti-tobacco activist. “We are beyond that now.” The FDA’s Gottlieb favors an approach to treating addiction that makes available less harmful versions of addictive substances, including nicotine and opioids. These products, he argues, can help minimize damage to those unable to quit. Mitch Zeller, head of the FDA’s tobacco division, refers frequently to a “continuum of risk” for nicotine products, with nicotine gums and lozenges on one end and cigarettes on the other. The FDA would like to shift smokers unable to quit nicotine from high-risk to low-risk products. “What we have developed is an offering on the continuum of risk,” said Ruth Dempsey, Philip Morris’ director of scientific engagement. “We believe it is better than cigarettes.”



U.S. panel rejects most of Philip Morris' iQOS tobacco device claims
Reuters

URL: https://www.reuters.com/article/us-heal ... SKBN1FE2IQ
Category: Politics
Published: January 25, 2018

Description: WASHINGTON (Reuters) - Philip Morris International Inc should not be allowed to claim that its iQOS electronic tobacco device can reduce the risk of tobacco-related diseases, an advisory panel to the U.S. Food and Drug Administration concluded on Thursday. Philip Morris shares initially fell as much as 6.8 percent on the news but pared losses to trade down 2.7 percent at $107.59 in early afternoon. The panel concluded that Philip Morris had not proven that iQOS, which heats tobacco but does not burn it, reduces 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 lower exposure is reasonably likely to translate into a measurable reduction in disease or death. IQOS is a sleekly packaged electronic device that heats tobacco rather than burning it. The aerosol produced by iQOS contains roughly 95 percent fewer harmful chemicals than cigarettes according to data presented by the company at a two-day meeting that concluded with the vote. The FDA is expected to decide whether Philip Morris can sell iQOS within the next few months. It will decide separately whether to authorize the modified-risk claims. If cleared, iQOS would be sold in the United States by Philip Morris’ partner Altria Group Inc. Altria shares were down 2 percent at $70.12 in early afternoon. Last month, a Reuters investigation described irregularities in the clinical trials that supported Philip Morris' iQOS application to the FDA.



Lawmakers ask FDA to reject Philip Morris' iQOS application
Reuters

URL: https://www.reuters.com/article/us-heal ... SKBN1FR1WH
Category: Politics
Published: February 7, 2018

Description: WASHINGTON/NEW DELHI (Reuters) - Ten U.S. senators called on the Food and Drug Administration to reject Philip Morris International Inc’s application to market its iQOS smoking device as being less risky than cigarettes, according to a letter to the agency’s commissioner. The senators, all Democrats, cited remarks by an expert scientific panel that reviewed the application for the U.S. FDA and voted last month against granting Philip Morris permission to do so, according to the letter, a copy of which was seen by Reuters. They also referred to a Reuters report in December that identified shortcomings in the training and professionalism of some of the lead investigators in the clinical trials submitted to the FDA by the tobacco giant. Former Philip Morris employees and contractors also described irregularities in those experiments. The world’s largest publicly traded tobacco company by market value and maker of Marlboro cigarettes, Philip Morris International has applied to the FDA to be able to sell iQOS in America, and also for permission to market it as a modified-risk tobacco product. That designation could mean that Philip Morris is allowed to sell iQOS to consumers as presenting less harm or risk of disease to users than traditional tobacco. The senators’ letter, dated Feb. 7, asked FDA Commissioner Scott Gottlieb to “avoid rushing through new products, such as IQOS, to fit within this evolving FDA policy, without requiring strong evidence that any such product will reduce the risk of disease, result in a large number of smokers quitting, and not increase youth tobacco use.” It also said: “Such thorough review is especially critical given the tobacco industry’s deceitful history of marketing products under the guise of lower risk.” The signatories include Elizabeth Warren of Massachusetts, a prominent Democratic voice in the Senate, and five members of the Senate’s powerful appropriations committee, including Dick Durbin of Illinois and Jack Reed of Rhode Island. Two senators who signed, Durbin and Richard Blumenthal of Connecticut, released statements to Reuters at the end of last month expressing concern about the iQOS application to the FDA. Asked for comment at the time, an FDA official said the agency generally cannot comment on a pending product application. Philip Morris did not respond to the senators’ January remarks. A company spokesman at the time referred to a Jan. 29 statement in which Chief Executive Andre Calantzopoulos said, ”We look forward to working with the agency to clarify outstanding points so as to best assist in their ongoing decision-making process, which inherently entails a certain degree of scientific uncertainty pre-market.” By heating tobacco instead of burning it, the company says iQOS avoids subjecting smokers to the same levels of carcinogens and other toxic substances found in a regular cigarette. The device is part of a $3 billion-plus investment by Philip Morris in new-generation smoking platforms. Philip Morris is scheduled to release its fourth quarter and full-year earnings reports on Thursday. Since the first of two days of meetings by the FDA scientific advisory panel on Jan 24, which expressed doubts about Philip Morris’ application to the agency, the company’s stock had fallen about 9 percent as of close of markets on Tuesday. The panel said Philip Morris had not proven that iQOS reduced harm compared with cigarettes. It did conclude that iQOS 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. The recommendation is not binding.
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