FDA

The e-cigarette and cigar industries have enlisted high-profile lobbyists and influential congressional allies in an attempt to stop the Food and Drug Administration from retroactively examining their products for public health risks or banning them from the market.

The campaign targets a broad new rule that extends F.D.A. jurisdiction to include cigars, e-cigarettes and pipe and hookah tobacco.

The bipartisan effort has featured a former senator who did not register as a lobbyist before going to work for the cigar companies and a former Obama administration official, now a private consultant, who is trying to undo his earlier work reviewing the rule. In addition, one member of Congress introduced industry-written legislation without changing a word of it.

The battle shows how, nearly two decades after the $200 billion settlement between tobacco companies and state attorneys general to compensate the public for health consequences of smoking, the industry still wields extraordinary clout in Washington.

With its army of more than 75 lobbyists, tobacco-aligned companies have argued that the F.D.A.’s so-called Deeming Rule could hurt public health by forcing a large share of e-cigarette companies out of business.

“The F.D.A. has blatantly ignored evidence that our products improve people’s lives,” said Christian Berkey, chief executive of Johnson Creek Enterprises, one of the first companies to sell the e-liquid ingredient used in e-cigarettes and vaping products.

F.D.A. officials acknowledge that e-cigarettes, made out of tobacco-derived nicotine, are potentially less harmful than cigarettes. But they insist they must examine whether the electronic cigarettes or the liquid nicotine juices might contain toxic chemicals like diethylene glycol, an ingredient also used in antifreeze, or candy-like flavors contributing to the surge in the numbers of teenagers using e-cigarettes. They also want to examine the safety of the e-cig devices themselves after reports of battery-related burns.

“In the absence of science-based regulation of all tobacco products, the marketplace has been the wild, wild West,” said Mitch Zeller, the director of the F.D.A.’s Center for Tobacco Products, which is in charge of enforcing the new rule. “Companies were free to introduce any product they wanted, make any claim they wanted, and that is how we wound up with a 900 percent increase in high schoolers using e-cigarettes and as well as all these reports of exploding e-cigarette batteries and products that have caused burns and fires and disfigurement.”

The lobbying effort has been led by the Altria Group, the nation’s largest tobacco company, which has a growing e-cigarette unit.

Documents obtained by The New York Times show that Altria last year distributed draft legislation on Capitol Hill that would eliminate the new requirement that most e-cigarettes already on sale in the United States be evaluated retroactively to determine if they are “appropriate for the protection of public health.”

The proposal was endorsed by the R.J. Reynolds Tobacco Company, which has its own e-cigarette unit, as well as the National Tobacco Company, a major seller of loose tobacco, and trade associations representing the cigar industry and convenience stores, the documents show.

Altria delivered its proposal, entitled “F.D.A. Deeming Clarification Act of 2015,” to Representative Tom Cole of Oklahoma in April 2015, the documents show, even before the F.D.A. rule became final.

Just two weeks later, Mr. Cole, a Republican, introduced the bill — with the title and 245-word text pulled verbatim from the industry’s draft.

“Yes, we have shared our views with many policy makers, including Congressman Cole’s office,” David Sutton, a spokesman for Altria, said in a written statement, after being presented with a copy of its “legislative language” draft and Mr. Cole’s resulting bill, which has 71 co-sponsors and is still pending in the House.

Separately, former Senator Mary Landrieu, Democrat of Louisiana, spent part of her first year after losing re-election pressing officials from the White House, State Department and F.D.A. on behalf of the cigar industry — even though records show she had not registered as a lobbyist as required by federal law, which Ms. Landrieu said was an oversight.

Altria circulated suggested legislation, left, that Representative Tom Cole, Republican of Oklahoma, used verbatim for a House bill, center and right, rolling back regulation of e-cigarettes and other tobacco products.

“This is my fault,” she said. “I’m calling my lawyer now to get it corrected.”

The electronic vapor industry — representing smaller companies that sell e-cigarettes that can be refilled with vapor juice — also has a lobbying contingent, buttressed by a highly motivated community of consumers and vape shops.

Mr. Cole, and Representative Sanford D. Bishop Jr., Democrat of Georgia, who co-sponsored one of the tobacco-related measures originally drafted by Altria, said that the rule would bankrupt small businesses and curb the availability of e-cigarette options, which some use as a way to quit smoking.

“I don’t like regulating in the rearview mirror,” Mr. Cole said in an interview.

Mr. Bishop and Mr. Cole are also two of the top House recipients of tobacco industry campaign donations, with Mr. Bishop receiving $13,000 from Altria this election cycle and a total of at least $60,000 from the industry since 2004.

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Representative Nita M. Lowey of New York, the ranking Democrat on the House Appropriations Committee, said it was embarrassing that more than 70 lawmakers had signed on as co-sponsors of legislation that lobbyists from Altria and other industry groups originally wrote.

“For Congress to consider going backward in how we regulate the public health hazard is simply mind-boggling,” she said. “It wasn’t that long ago that tobacco companies were telling the public that cigarettes were not addictive and denying clear evidence that they caused cancer.”

Matthew L. Myers, president of the Campaign for Tobacco Free Kids, who helped negotiate the 1998 tobacco settlement, said: “It is worse than spoiled kids who don’t get their way. It is bullies that don’t get their way and who are holding public health hostage.”

Industry executives and their allies on Capitol Hill dismiss such criticism, noting that they support provisions intended to prevent youths from buying and using e-cigarettes or cigars.

“The argument that it would make it more accessible to children is fallacious,” Mr. Bishop said.

The cigar industry lobbying pitch has gained the most traction in Congress.

Arguing that premium cigars are more of a recreational product with fewer health risks than cigarettes, the industry has been separately pushing members of Congress to enact legislation that would broadly exempt “premium cigars” from the new F.D.A. oversight. A bill to do so — also written in part by industry lobbyists — was introduced by Senator Bill Nelson, Democrat of Florida. It has 20 co-sponsors, while an identical bill in the House has another 165 co-sponsors.

The industry lobbyists, in addition to Ms. Landrieu, include Paul DiNino, a former finance director of the Democratic National Committee and onetime senior aide to Senator Harry Reid of Nevada, the Democratic leader. Mr. DiNino is assigned to enlist prominent Senate Democrats.

Mr. Reid, records show, contacted the White House on the industry’s behalf, with his spokeswoman explaining that cigar-oriented events are important to Las Vegas.

To target the House, the cigar industry hired former Representative James T. Walsh, Republican of New York, a former House Appropriations Committee member, who has implored lawmakers and their staffs to back the exemption for cigars.

Mr. Walsh and his lobbying partners from the firm K & L Gates drafted language that was inserted into a House Appropriations bill approved by the full committee in April that defines an exemption for a premium cigar and that would prohibit the F.D.A. from spending money in the 2017 fiscal year on enforcement provisions.

“My fingers are crossed,” Mr. Walsh said, about the prospects for getting the exemption.

Another critical assist came from Andrew Perraut, who until 2014 served as a desk officer at the Office of Management and Budget division that reviews major federal regulations, including the F.D.A.’s tobacco rule.

White House records show that he helped represent the Obama administration at more than a dozen meetings with outside parties, mostly pressing the government to ease the rule, before he was hired by a cigar-industry trade organization and by NJoy, a manufacturer of e-cigarettes.

Within less than a year, records show, Mr. Perraut was back at the Office of Management and Budget on the other side of the table.

Because Mr. Perraut was not a senior official and the regulation affects numerous industry players, federal revolving door rules did not apply, an agency spokeswoman said. Mr. Perraut said he was simply trying to help stop a “train wreck” that will be caused by the F.D.A. overreach.

Richard W. Painter, who served as the White House chief ethics lawyer during the George W. Bush administration, said Mr. Perraut’s quick turnabout violated the spirit of President Obama’s ethics pledge, intended to prevent former aides from lobbying the executive branch.

“Even if it is not prohibited, it is just not appropriate,” he said.

Interest groups attempting to shape the debate also have financial patrons with a clear stake in the outcome.

Americans for Tax Reform, a conservative group, and National Center for Public Policy Research, a pro-free market think tank, have come out against the F.D.A. rules, even as they receive funding from the e-cigarette and tobacco industry, including Altria and R.J. Reynolds, records show.

Jeff Stier, a scholar at the National Center for Public Policy Research, and Grover Norquist, from Americans for Tax Reform, both said they opposed the F.D.A. rule as bad policy.

The American Lung Association, which has spoken out in defense of the rule, accepts contributions from pharmaceutical companies like Pfizer and GlaxoSmithKline, which sell smoking-cessation products that could lose sales if e-cigarettes continue to gain market share, Mr. Stier added.

Erika Sward, an association lobbyist, while acknowledging the money her nonprofit group has received from companies that sell smoking-cessation treatments, said the criticism of her group is a diversionary tactic.

“For so many years the focus in fighting tobacco wars has been on the cigarette industry,” she said. “With historic declines in cigarette use, which is wonderful, what we are seeing is a surge in use in other tobacco products. And their push on Capitol Hill reflects this new clout.”

http://www.nytimes.com/interactive/2016/08/26/us/politics/document-tobacco-lobbying-documents.html#document/p1/a315064

The e-cigarette and cigar industries, backed up by dozens of lobbyists, are engaged in an intense fight on Capitol Hill to roll back a new rule that for the first time subjects them to regulation by the Food and Drug Administration. Here is a inside look at this fight, with lobbying documents that rarely become public.

https://news.vice.com/article/big-tobacco-really-doesnt-want-the-feds-to-regulate-e-cigs

Now that e-cigarettes have turned into a multi-billion dollar a year industry, Big Tobacco lobbyists are again flexing their muscles in Washington to make sure they’re not regulated. The New York Times reported Friday that the tobacco industry has assembled a team of over 75 lobbyists—including a former Obama administration official and former Democratic Senator Mary Landrieu—to fight a new FDA rule to extend its regulatory control to include e-cigarettes, cigars, hookah tobacco, pipe tobacco, and more.

Republican Congressman Tom Cole recently introduced legislation to curtail the FDA. The Times found that the bill’s title and 245-word text were taken word-for-word from the proposal written by the tobacco industry. Cole has already attracted 71 cosponsors from both parties in an effort to pass the bill.

The new FDA rules and the industry pushback come in response to the rapid growth of e-cigarettes over the past 6 years, especially among teenagers. A recent survey by the FDA and Centers for Disease control found that 16 percent of high school students use e-cigarettes, a 900 percent increase since 2011.

Makers of the vaping devices have already taken precautions in case they lose the regulatory battle. Before the FDA rules took effect in August, e-cigarette makers released a dizzying array of new products. All of these devices will be immune from the new FDA rule for the next three years. A lot of vaping and lobbying can be done in three years.

Manufacturers will have to guess which circumstances those are, because the FDA won’t say.

http://reason.com/blog/2016/08/19/fda-will-regulate-nicotine-free-e-liquid

Smoke NVThis week, responding to one of the lawsuits challenging its e-cigarette regulations, the Food and Drug Administration (FDA) further muddied the question of whether those regulations apply to products that do not contain tobacco-derived nicotine. The lawsuit, which was brought by Nicopure, a manufacturer of e-liquids and vaping systems, argues that such a result would be unfair, illogical, and illegal. In response, the FDA says Nicopure has failed to show that any of its nicotine-free liquids are actually covered by the regulations and therefore has no standing to challenge that aspect of the rules. At the same time, the FDA concedes that “e-liquids marketed as ‘nicotine-free’ may properly be considered tobacco products—or components or parts thereof—under certain circumstances.”

What circumstances are those? “Some e-liquids ‘claiming to be nicotine-free actually contain[] high levels of nicotine,” the FDA says, quoting its regulations. “Others are tobacco flavored, and are thus ‘made or derived from tobacco’ regardless of their nicotine content.”

Does that mean e-liquids are not subject to the FDA’s burdensome, prohibitively expensive regulations as long as they do not contain nicotine or any other tobacco derivative? No, because the FDA’s definition of “tobacco product” does not require nicotine or any other tobacco derivative.

The Family Smoking Prevention and Tobacco Control Act, the statute that gave the FDA authority over tobacco products, defines them as products “made or derived from tobacco that [are] intended for human consumption, including any component, part, or accessory of a tobacco product.” In deeming e-cigarettes to be tobacco products, the FDA defined “component or part” as “any software or assembly of materials intended or reasonably expected…to alter or affect the tobacco product’s performance, composition, constituents, or characteristics” or “to be used with or for the human consumption of a tobacco product.” Hence vaping equipment, whether a closed, disposable e-cigarette or an open system with a refillable tank and parts that can be switched out, is a “component or part” of a tobacco product, which means it is also a tobacco product.

Does that mean a nicotine-free e-liquid is a “component or part” of a tobacco product—i.e., the vaporizer? The FDA can’t or won’t give a straight answer to that question.

“The only nicotine-free e-liquids that the rule brings under the FDA’s regulatory authority are those that are made or derived from tobacco (such as tobacco-flavored varieties) or that otherwise meet the definition of a ‘component’ or ‘part,'” it says. “Thus, nicotine-free e-liquids not made or derived from tobacco are subject to the deeming rule only where they meet the definition of a ‘component or part.’…Whether nicotine-free e-liquids meet this definition ‘will be evaluated on a case-by-case basis.'”

That means a company like Nicopure cannot know ahead of time which of its products are covered by the regulations. It can only find out by asking the FDA about each one, a process that will carry its own costs, even if they do not rise to the hundreds of thousands or millions of dollars that each “premarket tobacco product application” is expected to cost. The FDA’s position is that Nicopure can’t challenge the potential regulation of its nicotine-free e-liquids because it does not know whether they will actually be regulated. Never mind that it doesn’t know because the FDA won’t say.

http://www.dailymail.co.uk/wires/reuters/article-3729301/E-cigarette-makers-rush-new-products-market-ahead-U-S-rules.html

NEW YORK, Aug 8 (Reuters) – 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)