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[단독외신] FDA Authorizes Marketing of IQOS as a Modified Risk Tobacco Product
- [단독외신] FDA Authorizes Marketing of IQOS as a Modified Risk Tobacco Product The U.S. Food and Drug Administration (FDA) today authorized the marketing of IQOS, Philip Morris International’s (PMI) electrically heated tobacco system, as a modified risk tobacco product (MRTP). In doing so, the agency found that an IQOS exposure modification order is appropriate to promote the public health. - Today’s decision demonstrates that IQOS is a fundamentally different tobacco product and a better choice for adults who would otherwise continue smoking - IQOS is the first and only electronic nicotine product to be granted marketing orders through the FDA’s MRTP process - The FDA authorized the marketing of IQOS with the following information: - The IQOS System heats tobacco but does not burn it - This significantly reduces the production of harmful and potentially harmful chemicals - Scientific studies have shown that switching completely from conventional cigarettes to the IQOS system reduces your body’s exposure to harmful or potentially harmful chemicals. - The agency concluded that the available scientific evidence demonstrates that IQOS is expected to benefit the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products - The FDA’s decision further builds on the emerging independent international scientific consensus that IQOS is a better choice than continuing to smoke, and follows the FDA’s April 2019 decision authorizing the commercialization of IQOS in the U.S. - The FDA’s decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to protect and promote the public health This decision follows a review of the extensive scientific evidence package PMI submitted to the FDA in December 2016 to support its MRTP applications. Commenting on the FDA’s announcement, André Calantzopoulos, PMI’s Chief Executive Officer, said: “The FDA’s decision is a historic public health milestone. Many of the tens of millions of American men and women who smoke today will quit—but many won’t. Today’s decision makes it possible to inform these adults that switching completely to IQOS is a better choice than continuing to smoke. FDA determined that scientific studies show that switching completely from conventional cigarettes to IQOS reduces exposure to harmful or potentially harmful chemicals. IQOS is a fundamentally different product than combustible cigarettes and must be regulated differently, as the FDA has recognized. Now—more than ever—there is an urgent need for a fundamentally different conversation on a cooperative approach to achieve a smoke-free future. The FDA’s decision provides an important example of how governments and public health organizations can regulate smoke-free alternatives to differentiate them from cigarettes in order to promote the public health. We are excited that this important decision will help guide the choices of adult smokers in the U.S. The best choice for health is to never start smoking or to quit altogether. For those who don’t quit, the best thing they can do is switch to a scientifically substantiated smoke-free product. As of March 31, 2020, PMI estimates that approximately 10.6 million adult smokers around the world have already stopped smoking and switched to IQOS. We believe that this decision can help to further accelerate the transition of U.S. adults away from cigarettes. We, along with our licensee Altria, are committed to guarding against unintended use and fully support FDA’s focus on protecting youth. Today’s decision is a result of our ongoing commitment to put science at the forefront as we continue on our quest to replace cigarettes with smoke-free alternatives as quickly as possible. We look forward to working with the FDA to provide any additional information they may require in order to market IQOS with reduced risk claims. Harnessing innovations like IQOS to dramatically speed-up the decline in cigarette smoking is the opportunity of this century. Comprehensive, science-based regulation can help to rapidly shift adult smokers who would otherwise continue smoking to better options, while simultaneously guarding against unintended consequences.”
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- Animal Rights
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[단독외신] FDA Authorizes Marketing of IQOS as a Modified Risk Tobacco Product
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MAXST Launches Official Industrial AR Service ‘MAXWORK’
- MAXST Launches Official Industrial AR Service ‘MAXWORK’
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- Animal Rights
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MAXST Launches Official Industrial AR Service ‘MAXWORK’
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속보[단독-속보] 트럼프, WHO 탈퇴서 제출… 1년 뒤 탈퇴 완료
- 트럼프, WHO 탈퇴서 제출… 1년 뒤 탈퇴 완료 도널드 트럼프 미국 대통령이 세계보건기구(WHO) 탈퇴서를 제출하며 미국을 WHO에서 공식적으로 탈퇴시키는 절차를 시작했다. 앞서 트럼프 대통령은 지난 5월 WHO의 신종 코로나바이러스 감염증(코로나19) 대응을 비판하며 탈퇴 의사를 밝혔다. 유럽연합(EU) 국가 등의 만류에도 불구하고 트럼프 대통령은 WHO에 내고 있는 지원금을 다른 곳에 쓸 것이라고 말했다. 트럼프 대통령은 유엔(UN)과 의회에 탈퇴서를 제출했으며, 탈퇴 절차는 최대 1년까지 걸릴 수 있다. 유엔 사무총장의 대변인 스테판 두자릭은 미국이 탈퇴서를 제출했고, 탈퇴는 2021년 7월 6일부로 유효하다고 확인했다. 미 의회 상원 외교위원회 민주당 대표인 로버트 메넨데즈 의원 역시 트위터에 "의회는 팬데믹이 한창인 가운데 대통령이 미국을 WHO에서 공식적으로 탈퇴시켰다고 통보받았다"며 "이는 미국을 아프게 놔둘 것이며 미국은 혼자가 됐다"고 덧붙였다. 미국 정부 고위관계자는 CBS 뉴스에 미국은 WHO가 받아들였으면 하는 변화를 구체적으로 열거했으며 WHO와 직접 해결하려고 했지만, WHO가 이를 거부했다고 말했다. 이 관계자는 "우리가 요청한, 그리고 현시점에서 매우 절실히 필요한 변화를 WHO가 받아들이지 않았기 때문에 우리는 오늘 WHO와의 관계를 종료한다"고 설명했다. 한편 민주당 대선 후보인 조 바이든 전 부통령은 "내가 대통령이 된다면 첫날 WHO에 재가입하고 국제무대에서 미국의 리더십을 회복할 것"이라고 트위터를 통해 공언했다. 미국은 WHO의 최대 지원국으로 지난해 기준 WHO 총예산의 15% 정도인 4억달러 이상을 지원해 왔다. 미 의회가 1948년 WHO 가입을 승인하면서 통과시킨 공동결의안엔 '미국이 WHO에서 탈퇴하려면 서면으로 1년 전에 통지하고 WHO에 남은 부채를 해결해야 한다'는 내용이 담겨있다. 트럼프 대통령은 부채 해결에 관해 입장을 아직 내놓지 않은 상태이지만, 두자릭 유엔 대변인은 결의안을 따라야 한다는 입장이다. 미국의 탈퇴가 가시화하면 WHO의 재정과 질병 관리 및 의료서비스 분야 등 다양한 프로그램의 지속가능성이 문제가 될 수 있다.
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- NEWS & ISSUE
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속보[단독-속보] 트럼프, WHO 탈퇴서 제출… 1년 뒤 탈퇴 완료
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[속보]- 단독외신 - Trump administration gives formal notice of withdrawal from WHO
- [속보]- 단독외신 - Trump administration gives formal notice of withdrawal from WHO The World Health Organization headquarters in Geneva.Fabrice Coffrini / AFP - Getty Images The United States officially notified the United Nations on Tuesday of its withdrawal from the World Health Organization, a White House official said. The notice, which comes as the coronavirus pandemic continues to spread around the globe, was submitted to the U.N. secretary-general and to Congress. The withdrawal is expected to take effect July 6, 2021. A spokesperson told NBC News that the WHO was aware of reports but declined to comment further. Lawmakers from both parties, including Sen. Lamar Alexander, R-Tenn., swiftly criticized the move. "I disagree with the president's decision," Alexander, chairman of the Health, Education, Labor and Pensions Committee, said in a statement. "Certainly there needs to be a good, hard look at mistakes the World Health Organization might have made in connection with coronavirus, but the time to do that is after the crisis has been dealt with, not in the middle of it. "Withdrawing U.S. membership could, among other things, interfere with clinical trials that are essential to the development of vaccines, which citizens of the United States as well as others in the world need," he added. "And withdrawing could make it harder to work with other countries to stop viruses before they get to the United States." The top-ranking Democrat on the committee, Patty Murray of Washington, called the withdrawal "an abdication of America's role as a global leader and it is the opposite of putting America first— it will put America at risk." "Refusing to work with our partners across the world to fight this pandemic will only prolong the crisis, further undermine our international standing, and leave us less prepared for future crises," she said in a statement. "President Trump needs to realize this crisis doesn't recognize borders and hiding from it or passing the blame won't make it go away or make him any less responsible." Trump said at the White House in late May that the U.S. would be "terminating" its relationship with the WHO over its response to the COVID-19 pandemic. "Because they have failed to make the requested and greatly needed reforms, we will be today terminating our relationship with the World Health Organization and redirecting those funds to other worldwide and deserving urgent public health needs," Trump said. "The world needs answers from China on the virus. We must have transparency." That followed an announcement by Trump in April that the U.S. was halting funding to the organization pending a review. In 2019, the U.S. contribution was about 15 percent of the WHO's budget. move.
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- NEWS & ISSUE
- Politics
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[속보]- 단독외신 - Trump administration gives formal notice of withdrawal from WHO