E-cigarette makers rush new products to market ahead of U.S. rules

NEW YORK The e-cigarette market is suddenly getting more crowded. Makers of the "vaping" devices launched a flood of new products in the United States ahead of new federal regulations, taking effect on Monday, that require companies to submit e-cigarettes for government approval before marketing them, according to company officials and industry experts.The U.S. Food and Drug Administration, which announced the regulations in May, will allow e-cigarette devices introduced before the regulations came into force to be sold for up to three years while companies apply and await regulatory review.The regulations also ban the sale of e-cigarettes to anyone under age 18. The multibillion-dollar industry had sought to delay the new rules through lawsuits and proposed legislation in the U.S. Congress. At the same time, many of the smaller players hedged their bets by releasing new products during the three-month period between the announcement of the regulations and their effective date."I would be surprised if there was any other period when so many products were introduced," said Bryan Haynes, an attorney with the firm Troutman Sanders who represents several e-cigarette companies. Not of all the new products may be available immediately to consumers. Many companies beat the regulatory deadline with only limited shipments and product prototypes."There are scores of new products getting out ahead" of the deadline, said Oliver Kershaw, founder of the website e-cigarette-forum.com that tracks the industry. "They've been put quietly into the market. Some of them are just brand refreshers. Some are quite interesting products," Kershaw said, referring to such innovations as "pods" - capsules that can be inserted into the devices - that are prefilled with flavored nicotine.The FDA regulations for the first time bring regulation of e-cigarettes, cigars, pipe tobacco and hookah tobacco in line with existing rules for cigarettes, smokeless tobacco and roll-your-own tobacco. The rules require companies to submit these products for government approval, list their ingredients and place health warnings on packages and in advertisements.Cigar makers also rushed new products to the market to beat the regulations."We have attempted to do in 90 days what we usually do in three years," said Eric Newman, president of J.C. Newman Cigar Co, in business since 1895. "If it wasn't so serious, it would be comical to see the hoops we're going through."BIG COMPANIES MAY BENEFIT E-cigarettes are handheld electronic devices: metal tubes that heat liquids typically laced with nicotine and deliver vapor when inhaled. The liquids come in thousands of flavors, from cotton candy to pizza. Using them is called "vaping."Reynolds American Inc, Altria Group Inc and Fontem Ventures, a subsidiary of Imperial Brands Plc, are among the leading manufacturers of the devices. Their use has grown quickly in the past decade, with U.S. sales expected to reach $4.1 billion in 2016, according to Wells Fargo Securities.The healthcare community remains divided over the devices. Some experts are concerned about how little is known about their potential health risks and about growing use by teenagers, fearing that a new generation will become hooked on nicotine.Others support them as a safer alternative to tobacco for smokers unable to quit.The FDA regulations are expected to shutter many "vape shops" that make their own products and cannot afford undergoing the approval process. The rules may benefit the big manufacturers, especially tobacco companies like Reynolds and Altria, which have the checkbooks and experience to navigate regulatory agencies. Despite the new rules, France's leading manufacturer of "e-liquids" used in the devices started doing business in the United States last month. The company said it hoped the new market could help double its current sales of about $55 million."The vaping consumer is going to be drowned in a lot of new products," said Arnaud Dumas de Rauly, president of Gaïatrend USA, referring both to new devices and to types of liquids.Reynolds, which makes the top-selling VUSE, did not introduce any new products this summer. Altria launched new flavor varieties including Menthol Ice and Smooth Cream. Altria's Nu Mark e-cigarette company "has a robust pipeline of products and takes a disciplined approach to introducing those products to understand adult smoker and vaper acceptance," Altria spokesman Steve Callahan said.Callahan said the company was also mindful of the requirements of the new regulations and complying with the timelines the FDA established.Mistic E-Cigs had planned to introduce sometime this year a new product called the Mistic 2.0 POD-MOD personal vaporizer, which has pods prefilled with liquids, but said its staff worked 14-hour days to ensure it was ready before the regulations took effect."We got a little lucky but we had to work a little extra hard," said Justin Wiesehan, Mistic's vice president of regulatory affairs. (Reporting by Jilian Mincer; Editing by Michele Gershberg and Will Dunham)

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Florida travel warning issued for pregnant women after more Zika cases

CHICAGO/NEW YORK U.S. health officials warned pregnant women to avoid traveling to a neighborhood in Miami on Monday after Florida said it had 10 more cases of Zika caused by the bite of local mosquitoes, bringing the total to 14.At the request of Gov. Rick Scott, the U.S. Centers for Disease Control and Prevention is sending in a special emergency response team of eight disease experts to assist Florida in its investigation.The state has been handling the investigation largely on its own since early July, when the first case of a possible Zika infection caused by local mosquitoes was suspected.CDC Director Dr. Thomas Frieden said in a conference call that local mosquito control efforts have not worked as well as hoped, but so far, the outbreak does not appear to have traveled very far."Nothing we have seen suggests widespread Zika virus transmission," Frieden said.The ongoing Zika outbreak was first detected last year in Brazil, where it has been linked to more than 1,700 cases of the birth defect microcephaly. Since that time the virus has spread rapidly through the Americas and its arrival in the continental United States had been widely anticipated.On Friday, Florida said the first four cases of Zika in the state likely were caused by mosquitoes, the first sign that the virus is circulating locally, although it has yet to identify mosquitoes carrying the disease. The 10 new cases announced on Monday bring the total to 14. Of these, 12 are men and 2 are women.Dr. William Schaffner, an infectious disease expert at Vanderbilt University School of Medicine, said there is concern that people infected in Florida will travel to other areas of the country where Zika could then be spread through local mosquitoes there.The CDC advised people returning from the affected area of Florida to use mosquito repellent for three weeks to protect their families and guard against further transmission at home. It also recommended that women avoid getting pregnant for up to eight weeks after returning from the affected area.The agency said that pregnant women who live in or traveled to the affected area after June 15 should be tested for Zika.A map of the neighborhood can be found here: hereFlorida health officials initially tested individuals in three locations in Miami-Dade and Broward counties, but ruled out two of those locations. Six of the 10 new cases are asymptomatic and were identified through a door-to-door campaign, which involved the collection of urine samples. Infectious disease experts expressed doubt that the outbreak was contained to such a small area of Miami. "To assume that it's just restricted to these few square blocks is presumptuous," said Dr. Peter Hotez, dean for the National School of Tropical Medicine at Baylor College of Medicine in Houston.Hotez believes there are other likely local outbreaks occurring and that more can be expected in the next six weeks in Florida and other Gulf Coast states where the mosquito that carries the virus is common.CONCERNS ABOUT SPREADINGFlorida said it began investigating a possible case of local Zika transmission on July 7. But the CDC was first informed of the case on July 18, a day before the state announced it had a possible case of non-travel related Zika, according to CDC spokeswoman Kathy Harben. CDC has been coordinating with Florida officials and sent Dr. Marc Fischer, a CDC epidemiologist, on July 22 at the state's request.Reuters was first to report that as of last Friday, Florida still had not activated a CDC Emergency Response Team (CERT) to help with its investigation, raising concerns from infectious disease experts that the state was not taking every step it could to contain the spread of Zika in the continental United States.Frieden said in a conference call there were signs of possible local transmission as early as mid-June.He said a full emergency response team - which include experts in epidemiology, vector control and logistics - will be on the ground in Florida on Tuesday.White House spokesman Eric Shultz told reporters on Air Force One that the president has been continually briefed on the situation in South Florida.Schultz said Florida will be redoubling its vector control efforts in the outbreak area, which involves a 1-square-mile (2.6 square km) area in the mixed-use area north of downtown Miami. CDC said pregnant women who live or work in the area and their partners should make every effort to avoid mosquito bites.Schaffner and Hotez said the government must come up with proper funding to fight Zika. "Local and state health department budgets are very tight," Schaffner said.President Barack Obama asked Congress for $1.9 billion to fund a Zika response last spring, but arguments over funding levels resulted in a stalemate, and Congress adjourned for the summer without authorizing any funding. (Reporting by Julie Steenhuysen and Bill Berkrot; additional reporting by Ayesha Rascoe in Washington; Editing by Bill Trott and Bernard Orr)

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U.S. health officials update Zika transmission and testing guidance

U.S. health officials issued updated recommendations for preventing and testing for Zika infection on Monday, warning that the virus can be transmitted through unprotected sex with an infected female partner.Previously, the U.S. Centers for Disease Control and Prevention, and other experts, believed that the virus could only be sexually transmitted by males because it can reside in semen potentially for several months.For that reason, the CDC had recommended that men who had been infected abstain from unprotected sexual contact for at least six months with a partner who is pregnant or hoping to become pregnant.But a recently reported case of female-to-male sexual transmission in New York City, and limited human and non-human primate data indicating that Zika virus RNA can be detected in vaginal secretions, led to the new warning, the agency said.CDC's expanded warnings on sexual exposure to Zika now caution against sex without a condom or other barrier method of protection with any person, male or female, who has traveled to or lives in an area with Zika, including female to female transmission with a pregnant partner. CDC also provided updated interim guidance for healthcare providers caring for pregnant women with possible exposure to the virus, expanding the window for Zika-specific blood testing from a week after the onset of symptoms, or believed exposure, to 14 days."New information has indicated that some infected pregnant women can have evidence of Zika virus in their blood for longer than the previously recommended seven-day window for testing after symptoms begin, and that even pregnant women without symptoms can have evidence of the virus in their blood and urine," the agency said. CDC also advises that pregnant women, with possible Zika exposure but no symptoms, receive testing as well."Expanding the use of the Zika-specific test could provide more women with Zika virus infection a definite diagnosis and help direct medical evaluation and care," CDC said. Zika has been proven to cause microcephaly, a birth defect marked by small head size that can lead to serious developmental problems, and has been linked to other severe fetal brain abnormalities. The connection between Zika and microcephaly came to light last fall in Brazil, which has now confirmed more than 1,600 cases of microcephaly that it considers related to Zika infections in the mothers.CDC has currently listed 400 pregnant women in the United States with evidence of Zika exposure on its registry. (Reporting by Bill Berkrot; Editing by Tom Brown)

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Trump forces quash attempted revolt at Republican convention

CLEVELAND The Republican National Convention briefly erupted in chaos on Monday when opponents of presumptive U.S. presidential nominee Donald Trump stormed out of the room and others chanted in a failed attempt to force a vote opposing his candidacy.The turmoil threatened efforts by the Trump campaign to show the party had united behind the businessman-turned-politician and distracted from the day's theme of "Make America Safe Again," meant to depict Trump as a strong leader capable of shielding the country from violence and Islamist militancy.Trump's son and adviser, Donald Trump Jr., threatened the leaders of the attempted revolt, saying: "Your careers are finished" in a message posted on Twitter.The anti-Trump forces wanted to change the party's nominating rules to allow delegates to support alternative Republican candidates over Trump.Party leaders held a voice vote, then declared the opponents lacked enough votes, triggering pandemonium on the floor of the Cleveland basketball arena where Trump is due to be formally nominated this week for the Nov. 8 election.Many delegates began chanting: "Roll Call. Roll Call," effectively calling for a lengthy process that would allow every state to weigh in. Some, including the Colorado delegation, walked off the convention floor saying they had to assess their next steps."This entire system is rigged to force the vote for Donald Trump," said Kendal Unruh, one of the Colorado delegates. Ken Cuccinelli, a delegate from Virginia who also favored a roll-call vote, called the situation "appalling". "This is the party of law and order. ... If you won't obey your own rules there is no reason to think you'll obey any others," Cuccinelli, the state's former attorney general, told MSNBC.While delivering a jolt to the highly scripted program, the anti-Trump forces failed, their rebellion quashed.The convention then approved the party policy platform and took a scheduled break before a lineup of evening speakers due to include Trump's wife, Melania, and former New York Mayor Rudy Giuliani.But the furor, an embarrassment to Trump, put a spotlight on the deep divisions within the party that have emerged over his candidacy. A string of senior Republicans, worried about Trump's temperament and policies, were already avoiding the convention. KILLINGS OVERSHADOW CONVENTIONThe gathering opened on Monday afternoon in the shadow of racially tinged killings of police officers and black men, and as protesters for and against Trump faced off in a plaza a few blocks from the convention, shouting slogans at each other, separated by a wall of police.Trump allies planned to promote what he has billed as a tough line on law and order and national security in speeches on Monday night. Sunday's shooting of three policemen in Baton Rouge, Louisiana - a targeted attack that may have been in retaliation for a series of police killings of black Americans - hung over the gathering.Trump has sought to position himself as the law-and-order candidate in an echo of Richard Nixon's successful presidential campaign of 1968. Speakers were likely to promise that Trump will crack down on Islamic State abroad and toughen up on crime at home if he wins the election.Iowa's Republican Party chairman, Jeff Kaufmann, said the top issue a month ago for voters in the state was the economy. Now, he said, he was hearing concerns about security."Rightly or wrongly, the shootings that we've had have vaulted, not just national security in terms of external terrorism but also the knowledge that terrorism is occurring within our country," Kaufmann said.Such concerns might lead voters to choose Trump over Democratic candidate Hillary Clinton in November, he said. (Additional reporting by Emily Stephenson, Amy Tennery, Michelle Conlin, Scott Malone, Daniel Trotta and Jonathan Allen; Writing by Richard Valdmanis; Editing by Howard Goller and Peter Cooney)

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Exxon Mobil says no attacks at its facilities despite Nigerian militants' claim

LAGOS Exxon Mobil Corp said on Tuesday no attacks had taken place at its facilities after Nigerian militant group Niger Delta Avengers said it had blown up the Qua Iboe 48" crude oil export pipeline operated by the company. "There were no attacks on our facilities," said Exxon Mobil spokesman Todd Spitler. Late on Monday Nigerian militant group Niger Delta Avengers said on its website that it had blown up an Exxon Mobil Corp facility. The group has claimed responsibility for a series of attacks in Nigeria's southern oil hub. The militants, whose attacks briefly pushed Nigeria's crude production to 30-year lows in spring, have said they want a greater share of the OPEC member's energy wealth to go to the impoverished southern Niger Delta, the source of most of the country's oil.Qua Iboe is Nigeria's largest crude oil stream and exports usually amount to more than 300,000 barrels per day. Nigeria is typically Africa's biggest oil producer, although attacks in the last few months have pushed it behind Angola. The West African country relies on crude oil sales for around 70 percent of government revenues. (This version of the story was refiled to correct company name in headline to Mobil instead of Mobile) (Reporting by Bhanu Pratap in Bengaluru and Alexis Akwagyiram in Lagos; Editing by Richard Chang, Toni Reinhold)

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