Sheila Kaplan

So are the grief-stricken woman, the man struggling to smoke despite a hole in his windpipe and the rotting teeth.

Nine years after the Food and Drug Administration first proposed graphic images as new warnings on cigarette packs but was thwarted by major tobacco companies in a successful court battle, the agency announced on Thursday that it is finally issuing a new set of images.

“The 13 proposed warnings, which feature text statements accompanied by photo-realistic color images depicting some of the lesser-known health risks of cigarette smoking, stand to represent the most significant change to cigarette labels in 35 years,” the FDA said in a release.

They feature photos involving lung and bladder cancers, diabetes, a chest incision scar from surgery, blackened lungs, a bulging tumor on a woman’s neck, an underweight infant and a man slumped on a bench who may be dealing with erectile dysfunction.

“While most people assume the public knows all they need to understand about the harms of cigarette smoking, there’s a surprising number of lesser-known risks that both youth and adult smokers and nonsmokers may simply not be aware of,” said Dr. Norman Sharpless, the acting FDA commissioner.

It was initially unclear whether the big tobacco companies would fight the latest proposals. R.J. Reynolds Tobacco, which led the earlier court fight, said it was studying the FDA’s suggestions, which will not become final until next year.

“We firmly support public awareness of the harms of smoking cigarettes, but the manner in which those messages are delivered to the public cannot run afoul of the First Amendment protections that apply to all speakers, including cigarette manufacturers,” said Neassa Hollon, a spokeswoman for the company.

The FDA’s warnings are required under the Tobacco Control Act, which Congress passed in 2009.

The agency unveiled its first choices in 2010, featuring colorful — and gruesome — pictures to wrap around the top half of cigarette packages and also on 20 percent of the surface area of advertisements.

A year later, the FDA whittled its final selection to nine images. Public health advocates loved them, but tobacco companies fiercely objected. A group sued the FDA, and in 2012 convinced an appeals court that these specific graphic images violated its First Amendment rights of free speech. Altria, the nation’s largest tobacco company, was not part of the lawsuit.

The court mandated that the warnings be purely informational, not aimed at scaring smokers, nudging them to quit or imposing an ideology.

The ruling was a huge setback for the FDA, which has spent the ensuing years trying to devise a set of warning labels that would be a strong deterrent. As the agency delayed doing anything, many other nations have imposed graphic images of smoking-related damage.

Eric Lindblom, a former FDA tobacco lawyer, said the agency hadn’t tried very hard.

“Once that ruling came through, the reason the FDA didn’t do another one is that the lawyers were scared to death,” said Lindblom, who is now director for tobacco control and food and drug law at the O’Neill Institute for National and Global Health Law at Georgetown University. “The FDA lawyers, the health and human services lawyers, the Department of Justice lawyers, they are all scared of any FDA issue that raises First Amendment issues because they lost big, and they don’t want to lose again.”

Although the rate of smoking declined from 21% in 2005 to 13.8% in 2018, there are still nearly 38 million smokers in the country and it remains the nation’s leading preventable cause of death. According to the Centers for Disease Control and Prevention, about 480,000 people die from smoking-related illnesses in the United States each year. Secondhand smoke can also be lethal, and is especially dangerous for children. A CDC report this week said that from 2013 through 2016, more than 35% of nonsmoking youths aged 3 to 17 were exposed to secondhand tobacco smoke.

The United States was the first nation to require warnings on cigarettes, but they have not been updated since 1985. Cigarette companies are permitted to rotate four warnings about lung and heart disease and cancers, and pregnancy complications. One says that cigarette smoke contains carbon monoxide, but does not explain why that is dangerous. The National Academy of Medicine has called the current warnings “woefully deficient.”

The 13 new warnings describe in greater detail how smoking damages the body. One notes that smoking causes cataracts, which can lead to blindness. Another says smoking can cause erectile dysfunction. Others note the possibility of getting diabetes or bladder cancer, and developing reduced blood flow to the limbs, which can require amputation.

In a 2019 report, the World Health Organization said warning labels “are most effective when they are pictorial, graphic, comprehensive, and strongly worded.” More than 91 countries have adopted what the organization considers strong labels, which cover at least half of the package. These include warnings about impotence — featuring sad-looking couples in bed — and magnified images of rotten teeth and cataract-covered eyeballs. Another 22 countries require graphic warnings that cover 30% of the pack, according to the organization.

Several published studies found mixed smoker reactions to the initial nine proposed labels. A February 2016 study published by University of Illinois researchers in the journal Communication Research suggests that graphic images could backfire, with smokers viewing the lurid images as “a threat to their freedom, choice or autonomy.”

Researchers at the University of North Carolina, Chapel Hill said in June 2016 that 40% of participants in their study said they were more likely to consider quitting after exposure to the graphic images, compared with 34% with the text warning. And a study led by Cornell University researchers found that graphic warnings reduced the appeal of cigarette brands among youth relative to social cue advertisements with the Surgeon General’s warnings. Neither graphic nor text warnings influenced people’s beliefs about the health risks of smoking.

But public health organizations have been pushing for them. In 2016, with the FDA lagging on its revised labels, a coalition of public health groups, including the American Academy of Pediatrics, the American Cancer Society, the American Lung Association and others, sued the agency for taking too long.

In March, a federal court ruled in the groups’ favor, noting that the FDA had “unlawfully withheld,” and “unreasonably delayed” action to require the graphic warnings. Judge Indira Talwani set a deadline of Thursday, Aug. 15 for the agency to issue a draft, and March 15, 2020, for the final rule.

This article originally appeared in <a href="https://www.nytimes.com/2019/08/15/health/cigarettes-warnings-fda.html" id="cb1b8a74-500d-3ee6-a547-da25b119a750">The New York Times</a>.

FDA Issues New Images to Add to Warnings on Cigarette Packages

WASHINGTON — The corpse is gone.

But here in Columbia, the South Carolina capital, and in statehouses and city halls across the country, a vast, new army of Juul lobbyists is aggressively pushing measures that undermine that pledge.

The company’s 80-plus lobbyists in 50 states are fighting proposals to ban flavored e-cigarette pods, which are big draws for teenagers; pushing legislation that includes provisions denying local governments the right to adopt strict vaping controls; and working to make sure that bills to discourage youth vaping do not have stringent enforcement measures.

Though Juul supports numerous state bills that would raise the legal age for buying vaping and tobacco products to 21, some of those bills contain minimal sanctions for retailers. Others fine only the clerks and not the owners for violations.

“Juul is attempting to rehabilitate its public image by posing as a public health advocate while working behind the scenes to weaken or defeat tobacco control proposals and prevent communities from even considering policies to curb tobacco use,” said Nancy Brown, chief executive of the American Heart Association, whose network of lobbyists has parried with e-cigarette and tobacco industries in many states this year.

In a statement, Juul said, “We are as committed as ever to combating youth usage but don’t take our word for it — look at our actions.”

The company cited its action plan, unveiled in November, which included shutting down its social media accounts, discontinuing sales of many flavored pods in retail stores and strengthening its online age verification systems.

E-cigarettes allow smokers to inhale the nicotine they crave without the toxins that come from burning tobacco. But Juul’s sleek devices, which resemble a flashdrive, became immensely popular with teenagers, stoking worries that the devices were creating a new generation of nicotine addicts among people who have never smoked.

Juul denies marketing to young people, and it has revamped its website to focus on adult smokers. But as it faces serious regulatory threats from the Trump Administration, as well as targeting by state and city lawmakers, the company has quickly built an enormous lobbying machine to protect its turf as best it can. With the recent departure of Scott Gottlieb, a vociferous critic of Juul, from the post of FDA commissioner, the company’s more urgent battles, for now, are in the states.

Most of Juul’s state lobbyists work for well-connected firms run by ex-governors, former state lawmakers and big political donors, public records show. Some are in-house, based in the growing number of offices the company is opening around the country. The company’s latest star hire is Martha Coakley, the former attorney general of Massachusetts. (The state’s current attorney general, Maura Healey, is investigating whether Juul intentionally targeted its vaping products to minors.)

In a series of interviews, Lindsay Andrews, a spokeswoman for Juul, said the lobbyists were primarily focused on raising the minimum age for buying e-cigarette and traditional tobacco products to 21 from 18, or in a few states, 19. More than 400 local governments and 14 states have already done so, eight of the states this year.

But in numerous states, the proposals that Juul publicly supports, known as Tobacco 21, or T21, contain measures that public health experts consider poison pills.

Juul says it prefers that T21 legislation does not have added provisions. But it worked to help pass a T21 law in the Arkansas Legislature, for example, that would also block local governments from enacting new rules regarding the manufacture, sale, storage or distribution of tobacco and vaping products — including restrictions on flavored products.

For related reasons, public health advocates have opposed Juul-backed T21 bills in Arizona, Florida, Iowa, Louisiana, Pennsylvania, Utah, Virginia and West Virginia. The tobacco industry supported the T21 bills.

In some states Juul’s advocacy is public, and in others the company is barely visible, working only through the Vapor Technology Association, or by relying on Altria, the tobacco company that late last year paid Juul $12.8 billion for a 35 percent stake.

In South Carolina, for example, Juul has not taken a public position on a contentious proposal to pre-empt local governments from banning flavored e-cigarettes or otherwise regulating any tobacco product. But at a hearing on the bill last month, Brian Flynn, one of Juul’s three lobbyists with McGuireWoods Consulting, a firm run by former Gov. James H. Hodges, testified in favor of the pre-emption plan.

At the hearing, Flynn introduced himself as a lobbyist for both Juul and the South Carolina Association of Convenience Stores. He noted that on the matter of pre-emption, he spoke only for the retailers. Critics did not see much of a distinction.

“This is too cute by half,” said Pamela Gilbert, a lawyer and a former executive director of the Consumer Product Safety Commission. “Juul must know their lobbyist is lobbying for the pre-emption bill, and Juul must have approved that. If Juul really didn’t want to be connected to the support for that bill, Juul should hire another lobbyist.”

Some of the so-called pre-emption measures around the country were written using model language from the Vapor Technology Association, according to Kinn Elliott, a VTA lobbyist who recently joined the association from Juul. Other pre-emption bills, in whole or in part, have been drafted with language from lobbyists for Altria and R.J. Reynolds Tobacco Co.

Altria, maker of Marlboro cigarettes, has a potent lobbying network in Washington and around the country. Asked if Altria was advising Juul’s state lobbying efforts, or if the two related businesses were working together, an Altria spokesman, David Sutton, replied that there was no contractual service agreement by which Altria would assist Juul’s government affairs. He added that he did not know what informal conversations on state lobbying issues might have taken place.

“I just don’t know, I’m not on the ground,” Sutton said. “Is there a conversation between the Altria government affairs people and the Juul government affairs people on the ground? I don’t know.”

He declined to provide access to Altria employees who could answer the question. Juul also declined to answer the question.

But Vince Willmore, a spokesman for the Campaign for Tobacco-Free Kids, which has been involved in many of these state battles, said, “It’s hard to say where Altria ends and Juul begins.”

So far, Juul’s state and local efforts have had mixed success. In Sacramento, Juul tried to head off a proposal to ban the sale of all flavored e-cigarettes and tobacco products in the city, as San Francisco did last year.

Steve Hansen, the councilman who wrote the bill, met with two Juul lobbyists in early March to hear their alternative plan. They were pushing a plan that would ban only flavors that are “knowingly attractive to minors.” The City Council rejected Juul’s proposal and on April 16 passed Hansen’s plan.

Hansen said he was surprised by the intensity of the lobbying effort. “In my six years on the City Council I’ve never seen the number of money, lobbyists and Astroturfing we’ve seen here on anything else,” he said.

Andrews, the Juul spokeswoman, said the effort was important because flavored e-cigarette pods were critical to help smokers switch to vaping.

“In our studies of thousands of Juul users, people who exclusively used nontobacco flavors were 30 percent more likely to switch than those who use tobacco flavors,” she said. “While we do not and will not sell flavors which are clearly targeted to youth, we also understand that flavors that drive adults from cigarettes have the potential to appeal to youth.”

One afternoon last month, Flynn and another Juul lobbyist, Darrell Campbell, milled about under the South Carolina Statehouse dome, awaiting the fate of a bill that would restrict youths’ access to vape shops.

That legislation, written by state Rep. Beth Bernstein, a Democrat, bars anyone under age 18 from going into vape shops without an adult. It also prohibits vaping on school property. But at Juul’s request, Bernstein took out a provision that would have required an adult to sign for online deliveries of any e-cigarette products ordered online.

In an interview, Bernstein said that Flynn and Campbell were helpful in providing input for the bill, as was Juul’s in-house lobbyist, Jennifer Cunningham.

“They had a little heartburn with it because they felt they were already employing a robust process for verification,” she said. “Juul came to me and said, ‘We already employ a very robust measure to make sure the person purchasing online is over 18.’”

The bill passed, and Gov. Henry McMaster, a Republican, is expected to sign it.

The American Cancer Society Cancer Action Network opposed the legislation, saying it did not go far enough.

“This bill is like putting lipstick on a pig,” said Cathy Callaway, state and local campaign director for the American Cancer Society Cancer Action Network. “We don’t need cosmetic fixes; we need proven policies and strong tobacco retailer enforcement to prevent illegal sales to kids.”

Katrina F. Shealy, a Republican senator who supported the bill, said: “I have talked to the people from Juul. They want this.”

Shealy also said that Juul had spoken to her about bringing a manufacturing plant to her district. “They are looking at locations and one of them is in my district; 825 jobs,” she said. “That’s a lot of jobs.”

This article originally appeared in <a href="https://www.nytimes.com/2019/04/28/health/juul-lobbying-states-ecigarettes.html" id="f608fecb-9585-3452-a654-c5fb3fa6d6a2">The New York Times</a>.

COLUMBIA, S.C. — For months, Juul Labs has had a clear, unwavering message for officials in Washington: The e-cigarette giant is committed to doing all it can to keep its hugely popular vaping products away from teenagers.

Juul's Pledge to Combat Youth Vaping Is Undermined by Its Army of Lobbyists

McConnell, the Republican Senate majority leader whose home state, Kentucky, is the nation’s second-largest tobacco producer, said he was motivated by the increasing rate of vaping among teenagers and young adults.

Public health agencies have cracked down on e-cigarette companies and distributors in an effort to curb access to the products.

“For some time, I’ve been hearing from the parents who are seeing an unprecedented spike in vaping among their teenage children,” McConnell said at a news conference Thursday in Louisville, Kentucky. “In addition, we all know people who started smoking at a young age and who struggled to quit as adults.”

McConnell, who is seeking re-election to a seventh term, said he believed the proposal would have bipartisan support. He did not release specifics, but said he planned to introduce a bill in May.

Proposals called “Tobacco 21” that would raise the minimum age required to buy cigarettes to 21 from 18 have been gaining more support in recent years.

Tobacco and vaping companies have gotten on board, too, partly in an apparent effort to distance themselves from accusations that they have deliberately marketed their products to youth to hook a new generation. Altria, Juul and R.J. Reynolds Tobacco Co. all have said they back raising the minimum age.

“We commend Sen. McConnell for announcing this legislation as we strongly support raising the purchasing age for all tobacco products, including vapor products, to 21,” said Kevin Burns, chief executive of Juul. “Tobacco 21 laws fight one of the largest contributors to this problem — sharing by legal-age peers — and they have been shown to dramatically reduce youth usage rates.”

Altria and R.J. Reynolds also praised the senator and noted that they had also supported state Tobacco 21 efforts. David Sutton, an Altria spokesman, said that this year eight states had passed such legislation, which brings the number of states with Tobacco 21 laws to 14 as well as the District of Columbia; two of the measures await signing.

Public health advocates were more cautious, reserving judgment until they see the details of the plans.

“While we strongly support raising the tobacco age to 21,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, “it is critical that Congress enact strong Tobacco 21 legislation that is free of special interest provisions that benefit the industry.”

Some provisions that Altria, Juul, R.J. Reynolds and the Vapor Technology Association, a trade group, have sought to include in state proposals treat the industry more favorably on other issues. A few measures would prevent local governments from banning flavors or otherwise regulating e-cigarettes and tobacco products. Others would make enforcement difficult, or penalize youths for buying them, rather than fining stores for selling the products to those under the age limit.

In the House, lawmakers have sponsored two T21 proposals. This month, Rep. Robert Aderholt, R- Ala., introduced the Stopping Consumption of Tobacco by Teens Act. The bill’s acronym is a tribute to Dr. Scott Gottlieb, who stepped down as commissioner of the Food and Drug Administration this month and was known for his efforts to curb vaping.

Brian Rell, Aderholt’s chief of staff, said Juul opposed his bill because it included a requirement that someone over age 21 must sign for delivery of the product.

The Campaign for Tobacco-Free Kids has also raised concerns about aspects of the legislation. It and some other public health organizations prefer a proposal introduced this week by Reps. Frank Pallone, D- N.J., chairman of the Energy and Commerce Committee, and Donna Shalala, D-Fla., a former secretary of the Department of Health and Human Services.

The bill would not only raise the minimum age to buy the products, but it would also order the FDA to speed up work on other measures, including putting graphic health warnings on cigarette packages.

McConnell’s bill is a question mark for many tobacco industry watchers. Eric Lindblom, a former FDA tobacco official who is now at the O’Neill Institute at Georgetown Law, wondered how committed McConnell was to protecting the tobacco control law passed in 2009.

Lindblom suggested that Congress could pass a free-standing bill that would raise the minimum age for purchase of tobacco products to 21. Or, he said, McConnell could start a new debate over provisions of the landmark act and add measures that would undo important restrictions.

“Raising the age to 21 by itself is terrific,” Lindblom said. “If that’s all the act said, it would be terrific. There’s no reason for the bill to say anything more than that.”

This article originally appeared in <a href="https://www.nytimes.com/2019/04/18/health/mcconnell-tobacco-vaping-21.html" id="117b6cdc-a7df-3819-a86e-25dc03d6297e">The New York Times</a>.

WASHINGTON — Sen. Mitch McConnell, long one of the tobacco industry’s loyal allies, said Thursday that he would sponsor legislation to raise the minimum age to 21 for the purchase of tobacco and e-cigarettes.

Kentucky's Senator McConnell Supports Bill to Raise Minimum Age to Buy Tobacco to 21

His last day at the FDA is Friday. In an interview, Gottlieb said he was not yet sure what other work he would pursue beyond the half-dozen or so days he’d spend each month at the conservative think tank. Although AEI, where Gottlieb once worked, opposed some regulations of vaping, it did not take part in the vituperative public attacks on Gottlieb for his work to end the youth vaping epidemic like much of the rest of the Washington conservative establishment.

Gottlieb took office in May 2017, and was best known for his aggressive drive to regulate the tobacco and e-cigarette industries. But he also ventured beyond the typical regulatory boundaries for an FDA chief, frequently criticizing the prescription drug industry for high prices and accusing some pharmaceutical businesses of gaming the system to avoid the competition that would lower them.

A prolific writer of op-eds, Gottlieb said he would focus on some of the structures in the Medicare program that inhibit competition.

“We have product competition in the market, but we don’t have price competition because of the way the payments are structured, in part because the drug industry has lobbied for rules that are in some cases an impediment to true competition,” he said.

He also expects to continue working on the issue of brand-name drug companies blocking generic competitors from entering the market, and related problems.

Gottlieb said he plans to spend the summer relaxing with his family before working full time. Before coming to the FDA, he had a varied career; he has been a practicing physician, a venture capitalist and entrepreneur and also served as a drug company adviser and board member.

Gottlieb’s announcement that he would step down as commissioner came as a surprise to the industries his agency regulates and to Congress. The reason he gave was weariness with his weekly commute to see his wife and three children, who have remained in their Westport, Connecticut, home since he started the job. If he had it to do over, Gottlieb said, he would have moved them to Washington right away.

Some of the agency’s highest profile work during Gottlieb’s tenure, other than tobacco control, was the speeding up of drug and medical device approvals, measures that won industry praise but also heavy criticism from public health advocates who feared for public safety.

But tobacco is what Gottlieb will be remembered for, and the question of whether his successors will continue his mission with the same fervor is still up in the air. Much of the FDA’s tobacco control plan is years from being formally adopted, if ever. It includes measures to ban menthol cigarettes, curb youth vaping and reduce nicotine to non-additive levels in traditional cigarettes.

Gottlieb will be replaced, at least temporarily, by Dr. Norman “Ned” Sharpless, currently director of the National Cancer Institute, who will become acting FDA commissioner.

This article originally appeared in <a href="https://www.nytimes.com/2019/04/04/health/scott-gottlieb-fda-drug-prices.html" id="d808baf6-c913-39df-ab4f-f205da858055">The New York Times</a>.

Dr. Scott Gottlieb plans to work on drug prices and other health policy issues as a part-time fellow at the American Enterprise Institute, after he leaves his post as commissioner of the Food and Drug Administration.

Scott Gottlieb Says He Will Return to Conservative Think Tank After Leaving FDA

The agency issued a proposal requiring that stores sequester flavored e-cigarettes to areas off limits to anyone younger than 18. Retailers, including convenience stores and gas stations, will be expected to verify the age of their customers.

“Evidence shows that youth are especially attracted to flavored e-cigarette products,” Gottlieb said in a statement, “and that minors are able to access these products from both brick-and-mortar retailers as well as online, despite federal restrictions on sales to anyone under 18.”

The rate of teenage vaping has risen sharply in the past few years, with 3.6 million middle and high school students reporting that they had vaped last year, according to a study by the Centers for Disease Control and Prevention. But teenage smoking continues to be at record lows, alongside the general decline in smoking rates, a pattern that public health experts warn could be reversed if nicotine addiction spurred by vaping leads young people to traditional tobacco products.

Last fall, the FDA began a crackdown on teenage vaping, threatening to ban most flavored e-cigarettes and warning retailers to stop selling the products to minors. It stopped short of prohibiting the flavors.

But the proposal issued Wednesday outlines details for how retailers must wall off the areas where the products can be sold. For stores that are open to consumers of all ages, the guidelines call for a physically separated room, a spokesman said, adding that stores cannot simply hang a curtain to create a space where flavored e-cigarettes could be sold.

Retailers, including convenience store and gas station owners, are on Capitol Hill this week, lobbying against the FDA’s proposals. Some have threatened to fight the restrictions in court.

Lyle Beckwith, a senior vice president for the National Association of Convenience Stores representing thousands of retailers, said the group did not believe the FDA had the authority to impose the new requirements. “The Tobacco Control Act clearly indicates they cannot discriminate against a specific channel of distribution, which is exactly what they are doing.”

Conservative groups and vaping trade associations also have come out in opposition, saying that the agency’s efforts to regulate the e-cigarette industry amount to government overreach.

The new restrictions do not apply to menthol, mint or tobacco flavors, which the FDA wants to keep available for adults who are using e-cigarettes to quit smoking combustible cigarettes.

The FDA will also track youth use of menthol and mint e-cigarettes, Gottlieb said. If they become too popular, he added, the FDA will reconsider the exemption. Such a move would be especially harmful to Juul Labs. The vaping giant, under FDA pressure, has already moved sales of its flavored e-cigarettes online, except for menthol, mint and tobacco, which it sells in stores.

But some public health advocates say the moves are too late.

“While this announcement sounds big and bold, it isn’t really,” said Micah Berman, an associate professor at The Ohio State University College of Public Health and Moritz College of Law. “The FDA’s announcement exempts mint/menthol, which is the most popular flavor with kids and one that makes it easier to initiate use. And in any event, most kids are getting these products online or through older friends, not buying them in convenience stores.”

The proposal also calls for banning the sale of many flavored cigars.

“The data also indicate that eliminating flavors from cigars would likely help prevent cigar initiation by young people,” Gottlieb said. Under the new rule, cigar companies would have 30 days to remove the products from the market and would have to apply for FDA approval to go back on the shelves.

In addition, all e-cigarettes, cigars and related products not on the market by Feb. 15, 2007, must seek FDA approval to sell them by August 2021. As part of their application, manufacturers must prove that their products are beneficial to public health. The agency’s original deadline for these products to comply with new, tougher regulations was extended by Gottlieb from August 2018 to 2022. Wednesday’s action chops one year off that extension.

The plan issued Wednesday is still a draft, and must undergo a 30-day comment period before it can be finalized. It’s an unusual regulatory approach, neither a new rule, nor a voluntary guideline. Instead, the FDA is telling e-cigarette makers that if their products are sold in violation of this request, they can be taken off the market, and forced to apply for agency approval. The FDA can do this under its discretionary enforcement authority.

Gottlieb is scheduled to have stepped down by that time, and Norman E. (Ned) Sharpless, director of the National Cancer Institute, was named this week to replace him as acting commissioner.

Sharpless has expressed support for the e-cigarette crackdown to reduce teenage use. In his comments, Gottlieb stressed that the Trump administration has backed the plan.

Also drawing opposition is the agency’s request in the president’s budget released Monday to collect an estimated $100 million in user fees from e-cigarette makers, similar to the fees imposed on tobacco companies and other manufacturers, to help enforce regulations aimed at teenage vaping.

Liz Mair, a Republican political consultant who founded Vapers United, a group that supports tools to stop smoking, said the user fee was equivalent to a tax on the industry and would raise prices on alternatives to traditional smoking.

“If your concern is improving public health, either as a matter of altruism and ethics or pure concern for taxpayers’ pocketbooks,” she said, “your policy should generally be to keep vapor taxes lower than cigarette taxes to incentivize people to try to quit smoking using them.”

This article originally appeared in <a href="https://www.nytimes.com/2019/03/13/health/e-cigarettes-teenage-vaping.html" id="0983c836-d9a2-3f69-ab3a-e2c6d86f959d">The New York Times</a>.

FDA Moves to Restrict Flavored E-Cigarette Sales to Teenagers

WASHINGTON — With a few weeks left in his tenure as commissioner of the Food and Drug Administration, Dr. Scott Gottlieb on Wednesday moved to restrict sales of flavored e-cigarettes to try to reduce the soaring rate of teenage vaping.

“The data also indicate that eliminating flavors from cigars would likely help prevent cigar initiation by young people,” Gottlieb said.

Under the new rule, cigar companies would have 30 days to remove the products from the market and would have to apply for FDA approval to go back on the shelves.

Sharpless has expressed support for the e-cigarette crackdown. In his comments, Gottlieb stressed that the Trump administration has backed the plan.

The agency issued a proposal requiring stores to sequester flavored e-cigarettes to areas off limits to anyone younger than 18. Retailers, including convenience stores and gas stations, will be expected to verify the age of their customers.

But the proposal issued Wednesday outlines details for how retailers must wall off the areas where the products can be sold. It calls for a physically separated room, a spokesman said, adding that stores cannot simply hang a curtain to create a space where flavored e-cigarettes could be sold.

Lyle Beckwith, a senior vice president for the National Association of Convenience Stores representing thousands of retailers, said the group did not believe the FDA had the authority to impose the new requirements.

“The Tobacco Control Act clearly indicates they cannot discriminate against a specific channel of distribution, which is exactly what they are doing," Beckwith said.

The plan issued Wednesday is still a draft and must undergo a 30-day comment period before it can be finalized. Gottlieb is scheduled to have stepped down by that time, and Dr. Norman E. (Ned) Sharpless, director of the National Cancer Institute, was named this week to replace him as acting commissioner.

Gottlieb, whose wife and three children have remained in their Westport, Connecticut, home since he took office, said he was weary of the commute and missed his family.

Gottlieb had been subject to increasing pressure from some Republicans in Congress and his former associates in the conservative movement, for his tough stance against youth vaping and traditional cigarettes. A coalition of influential conservative groups recently asked the White House to block some of the key parts of the FDA’s strategy to prevent youths from vaping; and Republican Sen. Richard Burr of North Carolina blasted the commissioner on the Senate floor for his proposal to ban menthol cigarettes.

Gottlieb said these protests had no role in his departure.

“There’s no intrigue here,” he said, adding that he planned to advance the agency’s pending tobacco regulations before he leaves, in about one month.

A senior White House official said Gottlieb was not pressured to leave and that President Donald Trump was “very fond” of him.

Under Gottlieb’s leadership, the FDA approved a record number of generic medicines, new drugs and medical devices. The agency also waded into unusual territory for an FDA chief, calling for lower drug prices and often speaking about the opioid crisis.

This article originally appeared in <a href="https://www.nytimes.com/2019/03/05/health/scott-gottlieb-resigns-fda.html" id="fddd31ab-e087-3be7-ae9e-d0bfab189f7d">The New York Times</a>.

WASHINGTON — Scott Gottlieb, the commissioner of the Food and Drug Administration, known for his aggressive efforts to regulate the tobacco and e-cigarette industries, resigned Tuesday.

FDA Commissioner Scott Gottlieb Resigns

Gottlieb, whose wife and three children have remained in their Westport, Connecticut, home since he took office, said recently that he was weary of the commute and missed his family. But he has also been subject to increasing pressure from Republicans in Congress and his former associates in the conservative movement for his tough stance against youth vaping and traditional cigarettes.

Scott Gottlieb Resigns as Commissioner of the FDA

At the same time, Dr. Scott Gottlieb, the agency’s commissioner, suggested Congress strengthen the FDA’s authority over an estimated $40 billion industry, which sells as many as 80,000 kinds of powders and pills with little federal scrutiny.

These products range from benign substances like vitamin C or fish oil, to more risky mineral, herbal and botanical concoctions that can be fatal.

“People haven’t wanted to touch this framework or address this space in, really, decades, and I think it’s time we do it,” Gottlieb said. He is particularly concerned about supplements that purport to cure diseases for which consumers should seek medical attention.

“We know there are effective therapies that can help patients with Alzheimer’s,” he said. “But unproven supplements that claim to treat the disease but offer no benefits can prevent patients from seeking otherwise effective care.”

The companies included TEK Naturals, Pure Nootropics and Sovereign Laboratories. In their letter to TEK Naturals, the FDA and the Federal Trade Commission chastised the company for marketing “Mind Ignite” as a product “clinically shown to help diseases of the brain such as Alzheimer’s and even dementia.”

TEK Naturals said in an email it was reviewing the letter and was committed to complying with requirements.

Gottlieb said the FDA would create an online watch list of specific ingredients the agency is concerned about.

The FDA’s oversight is based on a 1994 federal law, which imposed minimal reporting and labeling requirements on the makers of vitamins, minerals and herbs — a fledgling industry at the time. To prevent a company from selling a product, the law requires the FDA to prove it is unsafe. The agency says it is difficult to track the myriad products, many of which are sold on the internet.

The law has drawn increasing criticism as the sector has grown. There are now between 50,000 and 80,000 dietary supplements on the market, according to the FDA. The agency also says 3 of every 4 American consumers now take a dietary supplement regularly.

This article originally appeared in <a href="https://www.nytimes.com/2019/02/11/health/fda-dietary-supplements.html" id="1450aedd-a1f7-384a-ae20-4741409e8988">The New York Times</a>.

The Food and Drug Administration on Monday warned 12 sellers of dietary supplements to stop claiming their products can cure diseases ranging from Alzheimer’s to cancer to diabetes.

Supplement Makers Touting Cures for Alzheimer's and Other Diseases Get FDA Warning

At the same time, Dr. Scott Gottlieb, the agency’s commissioner, suggested that Congress strengthen the FDA’s authority over an estimated $40 billion industry, which sells as many as 80,000 kinds of powders and pills with little federal scrutiny.

“People haven’t wanted to touch this framework or address this space in, really, decades, and I think it’s time we do it,” Gottlieb said in an interview. He is particularly concerned about supplements that purport to cure diseases for which consumers should seek medical attention.

In response to a request for comment, TEK Naturals said in an email that it was reviewing the agency’s letter and was committed to complying with legal requirements.

Dr. Peter Lurie, president of the Center for Science in the Public Interest, a nonprofit advocacy organization, said that the FDA’s warning letters call attention to the lack of regulation.

“Each time they issue a new one, it hopefully acts as a shot across the bow for that segment of the industry,” said Lurie, a former associate commissioner with the agency.

He also expressed frustration that the FDA has spent years debating policy that would encourage manufacturers to notify the agency of new dietary ingredients but has not yet released it.

The FDA’s oversight is based on a 1994 federal law, which imposed minimal reporting and labeling requirements on the makers of vitamins, minerals and herbs — a fledgling industry at the time. To prevent a company from selling a product, the law requires the FDA to prove that it is unsafe. The agency says that it is difficult to track the myriad products, many of which are sold on the internet.

The law also requires businesses to notify the FDA that they are making a dietary supplement, but not to say what’s in it.

“That just makes it impossible for the agency to police the market,” Lurie said.

The 25-year-old law has drawn increasing criticism as the sector has grown. There are now between 50,000 and 80,000 dietary supplements on the market, according to the FDA. The agency also says that 3 of every 4 American consumers now take a dietary supplement regularly. For older Americans, the rate is 4 out of 5.

In recent years, the FDA has cracked down on several sectors of the industry, including dietary supplements sold for weight loss, sexual function and energy enhancement. More recently, one of the biggest targets has been kratom, a botanical substance that is marketed as a safe alternative for opioids or to help opioid users’ withdrawal symptoms. The FDA has ordered that kratom imports be seized and told companies not to use it in supplements. The agency has linked several deaths to kratom.

Steve Mister, chief executive of the Council for Responsible Nutrition, which represents the dietary supplement business, said he believed the dietary supplements industry is “remarkably safe." He also said the current law strikes the right balance between ensuring safety and giving consumers access to affordable products.

“These products are not drugs and should not be regulated like drugs,” he said. Mister also said his group supports the FDA’s enforcement actions and has been working with Congress to increase the program’s budget.

On TEK Naturals’ website, a statement notes, “We draw the line when it comes to disingenuous marketing. We don’t make stupid claims.”

The law also requires businesses to notify the FDA they are making a dietary supplement, but not to say what’s in it.

The Food and Drug Administration on Monday warned 12 sellers of dietary supplements to stop claiming their products can cure Alzheimer’s disease.

FDA Warns Supplement Makers to Stop Touting Cures for Diseases Like Alzheimer's

The companies were not immediately available for comment, but on TEK Naturals’ website, a statement notes, “We draw the line when it comes to disingenuous marketing. We don’t make stupid claims.”

Food inspections — about 160 of which are conducted a week — have been halted since the federal government shut down and about 40 percent of the FDA’s workforce was furloughed.

But Dr. Scott Gottlieb, the agency’s commissioner, said he was asking employees to return from furlough to conduct some of the inspections and other agency functions involving surveillance of certain drugs, devices and potential outbreaks of food-borne illnesses.

About one-third of all food safety inspections are for high-risk foods, he said. It was unclear when more routine inspections would resume.

In an interview, Gottlieb said he hoped several hundred workers — not just food inspectors but also other employees — would return despite being unpaid. “I can’t tell you that they are not feeling personal hardship, but they are dedicated and want to come back,” he said.

The Agriculture Department oversees meat and poultry, and its workers have continued inspections without pay. The FDA oversees about 80 percent of the nation’s food supply, as well as imports of foods shipped to the United States.

In a series of tweets, Gottlieb said the agency began sampling some high-risk imported produce in the Northeast on Monday. He said workers would begin inspections as early as Tuesday at sites with food considered “high risk” soft cheeses, seafood, custard-filled bakery products, some fruits and vegetables or baby formula.

While there are an estimated 80,000 food plants in the United States, the FDA inspects about one-tenth of those in a year, according to various reports.

Gottlieb said few inspections had been conducted since the shutdown began Dec. 22 because of the holidays, and only a handful had been scheduled for last week so the shutdown had not affected that many visits by inspectors.

But as the shutdown wore on, he sought and received permission late last week from the Department of Health and Human Services and the White House to call the furloughed workers back.

Other monitoring — including of high-risk medical products like compound drugs and problem devices — may resume next week, Gottlieb said.

This article originally appeared in <a href="https://www.nytimes.com/2019/01/14/health/shutdown-fda-food-safety.html" id="2691e4fe-fd65-33f9-a921-e3cba9db76f9">The New York Times</a>.

Food safety inspectors furloughed during the federal government shutdown will be returning to work beginning Tuesday — but still without pay — so the Food and Drug Administration can begin to resume inspections of some high-risk foods at manufacturing and other processing plants, the agency’s commissioner said Monday.

FDA Says It Will Resume Inspecting Some High-Risk Foods

FDA inspectors normally examine operations at about 160 domestic manufacturing and food processing plants each week. Nearly one-third of them are considered to be at high risk of causing food-borne illnesses. Food-borne diseases in the United States send about 128,000 people to the hospital each year, and kill 3,000, according to the Centers for Disease Control and Prevention.

Domestic meat and poultry are still being inspected by staff at the Agriculture Department, but they are going without pay. The FDA oversees about 80 percent of the nation’s food supply, as well as most overseas imports.

In a series of tweets, Gottlieb said he was taking steps to restore food safety surveillance inspections and to cover more of the high-risk sites as the shutdown continued. He said he hoped to bring back about 150 inspectors who had been furloughed during the shutdown, perhaps as early as next week.

Food safety advocates said they were worried that outbreaks would not be prevented without inspections, or would not be caught at the earliest warning signs.

The agency, part of the Department of Health and Human Services, is not dependent on federal funding for all of its activities. It receives much of its support from user fees imposed on the pharmaceutical, medical device, generic drug and other industries it regulates.

Although about 41 percent of the staff is now furloughed because the agency had not received its federal appropriations before the shutdown, those in jobs supported by user fees have remained at work. But even those departments have taken a hit, as the FDA has had to shift priorities for some duties.

In the pharmaceutical section, for example, some officials who generally consider pending drug applications are now working on post-market surveillance, checking for adverse events, like unexpected side effects of drugs or other problems.

This article originally appeared in <a href="https://www.nytimes.com/2019/01/09/health/shutdown-fda-food-inspections.html" id="db4fff2d-1eb8-358a-a603-c199ccc1e188">The New York Times</a>.

WASHINGTON — The Food and Drug Administration has stopped routine food safety inspections of seafood, fruits, vegetables and many other foods at high risk of contamination because of the federal government’s shutdown, Dr. Scott Gottlieb, the agency’s commissioner, said Wednesday.

FDA Suspends Most Safety Inspections of Food

“It’s not good news at all,” said Dr. Nora Volkow, director of the National Institute on Drug Abuse, which decided to release the new vaping numbers from an annual survey conducted by University of Michigan researchers three months earlier than scheduled. “There has to be a policy that would make it much harder for teenagers to be introduced to vaping.”

Vaping prevalence more than doubled in the grades surveyed — eighth, 10th and 12th — from 2017 through this year.

One in 4 students in the 12th grade reported that they had vaped within the previous 30 days this year, 1 in 5 in the 10th grade; and 1 in 11 in the 8th grade.

Students who had vaped nicotine during the previous 12 months and those who had ever vaped nicotine also significantly increased in each grade this year over last year, the survey found.

The results were issued at a time when the number of mysterious vaping-related illnesses — after patients reporting using e-cigarettes, THC-products or both — has continued to increase. Nearly 400 cases of vaping-related sicknesses have been documented in nearly three dozen states, with some patients suffering acute lung illnesses. And a seventh death linked to vaping was reported in California this week.

The startling popularity of teenage vaping and the sicknesses have alarmed public officials. After presenting similar numbers on teenage vaping to President Donald Trump, Alex Azar, secretary of health and human services, and other officials said they would draft a ban on most flavored e-cigarettes, including mint and menthol.

WASHINGTON — The rate of vaping among teenagers continued to rise sharply this year, federal health officials said, suggesting that campaigns to curb e-cigarette use among minors are not working.

Sheila Kaplan

Articles written by the author

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