The company faces declining sales and thousands of lawsuits claiming it knowingly sold its trendy vaping products to minors. Soon the F.D.A. will decide whether it can keep selling them at all.Sales have plunged by $500 million. The work force has been cut by three-quarters. Operations in 14 countries have been abandoned. Many state and local lobbying campaigns have been shut down.Juul Labs, the once high-flying e-cigarette company that became a public health villain to many people over its role in the teenage vaping surge, has been operating as a shadow of its former self, spending the pandemic largely out of the public eye in what it calls ‘reset’ mode. Now its very survival is at stake as it mounts an all-out campaign to persuade the Food and Drug Administration to allow it to continue to sell its products in the United States.The agency is trying to meet a Sept. 9 deadline to decide whether Juul’s devices and nicotine pods have enough public health benefit as a safer alternative for smokers to stay on the market, despite their popularity with young people who never smoked but became addicted to nicotine after using Juul products.Major health organizations, including the American Heart Association, American Lung Association, American Academy of Pediatrics and the American Cancer Society’s Cancer Action Network, have asked the agency to reject Juul’s application.“The stakes are high,” said Eric Lindblom, a senior scholar at the O’Neill Institute for National and Global Health Law at Georgetown University, and a former F.D.A. adviser on tobacco. “If the F.D.A. blows it on this one, they will face public health lawsuits.”Juul is sparing no expense to push back. Last week, the company agreed to pay $40 million to settle just one lawsuit (with North Carolina) out of thousands lodged against it, avoiding a looming jury trial. The company had urgently sought the deal to avoid courtroom testimony from parents and teenagers while the F.D.A. is reviewing its vaping products.Juul has not made its 125,000-page application to the agency public. But it paid $51,000 to have the entire May/June issue of the American Journal of Health Behavior devoted to publishing 11 studies funded by the company offering evidence that Juul products help smokers quit. (A spokesman for Juul said the editors had rejected one of the company’s submissions.) That fee included an extra $6,500 to have the subscription journal open access to everyone. Three editorial board members of the journal resigned over the arrangement. And Juul’s federal lobbying has remained robust. It spent $3.9 million on federal lobbying in 2020, according to the Center for Responsive Politics, which tracks political spending. Altria, the big tobacco company that owns a chunk of Juul, spent nearly $11 million.Juul’s share of the vaping market has shrunk significantly, to 42 percent last year, according to analysts, from a high of 75 percent in 2018. But some public health experts say they are concerned that F.D.A. approval will lay the groundwork for the company to rise and expand its reach again.Juul has long denied that it knowingly sold its products to teenagers, and it has been pledging publicly for the last few years to do all it can to keep them away from minors. In its settlement with North Carolina, the company did not admit intentionally targeting youths.In an interview, Joe Murillo, Juul’s chief regulatory officer, said, “We have a bigger opportunity to convert smokers than ever before, but we will get that opportunity if and only if we continue to combat underage usage and continue to act like the highly regulated company that we are.”The company is seeking approval for its iconic vaping device, once dubbed the iPhone of e-cigarettes, with tobacco- and menthol-flavored pods in two nicotine strengths: five percent, which is equivalent to the nicotine in an average pack of cigarettes, and three percent.The decision is one of a number of critical issues the F.D.A. has been wrestling with — including the agency’s recent approval of a controversial Alzheimer’s drug and decisions on thousands of vaping products made by companies other than Juul — without a permanent commissioner in place. President Biden has yet to announce a nominee.Recently, a House panel questioned the acting commissioner, Dr. Janet Woodcock, about the agency’s plans for Juul. She said the agency would base its decision on sound science, and that she couldn’t prejudge the application, which is still under review.The decision will be based in large part on the answer to two questions: Will more smokers use Juul products as an off-ramp from traditional cigarettes than nonsmokers will use it as an on-ramp to nicotine? And can Juul really keep the products away from kids?K.C. Crosthwaite, Juul’s CEO, a former tobacco executive, testifies on Capitol Hill in February 2020.Ting Shen for The New York TimesThe bulk of Juul’s published research in the journal edition it bought tracks the 12-month experience of 55,000 adults who purchased a Juul starter kit. The researchers, all of whom were paid by Juul, concluded that 58 percent of the 17,000 smokers who stayed in the study had stopped smoking at 12 months. Twenty-two percent remained dual users of both traditional and e-cigarettes but cut their smoking by at least half. Elbert D. Glover, who was editor and publisher of the journal, but retired soon after the issue came out, said the journal followed its standard protocol for, scientists who vet studies before publication.The steady decline in Americans who smoke has been a public health success story. The rate has dropped from 42 percent in 1965 to 14 percent in 2019. Yet smoking remains the leading cause of preventable death, with some 480,000 people dying from smoking-related diseases each year, according to the Centers for Disease Control and Prevention. E-cigarettes, which emerged in the early 2000s, were designed to give smokers the nicotine fix they craved without the carcinogens that come from burning cigarettes. But until Juul launched in 2015, no e-cigarette had caught on widely with the public.Juul’s sleek design, and its novel use of nicotine salts in its pods created a high-nicotine, low- irritant experience in mango, mint and other flavors, that quickly became a fad, especially among high school and middle school students. Public health officials worried that rather than helping adults quit smoking, Juul was hooking a new generation on nicotine, with potentially harmful heath effects on their developing brains and posing other health risks.Juul’s rapid growth stayed under the F.D.A.’s radar until 2018, when the agency declared a youth vaping epidemic.“The F.D.A. left in place a wide open, Wild West marketplace around these vaping products and unfortunately Juul and others dove in and exploited it,” said Clifford E. Douglas, director of the University of Michigan Tobacco Research Network. “What took place then screwed up a genuine extraordinary public health opportunity for harm reduction. It’s our obligation to come back to that to serve the public health.”Mr. Douglas believes that Juul is marketing its vaping products more responsibly now, and that they could play a role in reducing harm to cigarette smokers.Mr. Lindblom, the former F.D.A. tobacco adviser, has been highly critical of Juul, but believes the F.D.A. cannot take past bad behavior into account.“The F.D.A. has to evaluate this in a forward-looking way and can’t really punish Juul, but it can certainly take into consideration how popular Juul is among youth,” he said. Many of Juul’s critics do not believe the company deserves another chance. They are wary of the company’s ‘reset,’ announced in September 2019 when K.C. Crosthwaite, a top executive of Altria, maker of Marlboro cigarettes, became Juul’s chief executive.The sleek design of Juul’s devices made them attractive for teenaged who never smoked as well as for adults trying to quit traditional cigarettes.Joshua Bright for The New York TimesMr. Crosthwaite pulled the plug on some of Juul’s controversial state and city lobbying campaigns. He closed shop in Juul’s foreign markets across the world, except for Britain and Canada, although Juul is still sold through distributors in Ukraine, Russia, Italy and the Philippines. Under public pressure, he took mint- flavored pods, which accounted for 70 percent of sales, off the market. And he suspended all U.S. advertising.“We must put earning trust at the center of everything we do,” he wrote in an email to company staff last summer.Critics contend that most of these changes were made at gunpoint — undertaken after the F.D.A. threatened to shut down the business if teenagers continued to have access to Juul. To these public health advocates, Altria’s purchase of a $12.8 billion stake in Juul in December 2018 makes them even more distrustful.“The Marlboro man road into Juul and now wants us to trust them,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids. The Federal Trade Commission is now trying to unravel the Altria-Juul deal, alleging that the two companies entered into a series of agreements that eliminated competition in violation of antitrust laws.The commission contends that Altria and Juul started as competitors in the e-cigarette markets, but that as Juul became more popular, Altria dealt with its competitive threat by discontinuing its Mark Ten e-cigarette in exchange for a share of Juul’s profits. Both companies have denied the charges. Even if the F.D.A. approved Juul products, perhaps with restrictions, the company would face considerable business hurdles.When Juul was forced to discontinue its fruity flavor pods, new competitors, sometimes nicknamed Juulalikes, flooded the vacuum with cheap, disposable e-cigarettes in flavors like Cherry Frost and Dinner Lady Lemon Tart. Altria now estimates Juul’s value at under $5 billion, a fraction of its $38 billion valuation when Altria bought 35 percent of the business in the 2018 deal.New York Attorney General Letitia James displays Juul ads that critics believe were aimed at young people, as she announces a lawsuit against the company in 2019.Spencer Platt/Getty ImagesIf Juul survives, the company will likely spend the next few years trying to settle thousands of lawsuits. Fourteen states and the District of Columbia, have sued Juul, seeking money to pay for combating the youth vaping crisis. . A criminal investigation of the company by the Justice Department is still underway.There is also multi-district litigation in a federal court in California, which has combined nearly 2,000 cases under the purview of one judge, similar to the treatment of opioid cases.Whether there would be any company left to collect from if plaintiffs prevail is up the F.D.A.

A federal judge in Texas has dismissed a lawsuit brought by employees of Houston Methodist Hospital who had challenged the hospital’s Covid vaccination requirement.U.S. District Judge Lynn N. Hughes, in the Southern District of Texas, issued a ruling on Saturday that upheld the hospital’s new policy, announced in April. The judge said the hospital’s decision to mandate inoculations for its employees was consistent with public policy.And he rejected the claim by Jennifer Bridges, a nurse and the lead plaintiff in the lawsuit, that the vaccines available for use in the United States were experimental and dangerous.“The hospital’s employees are not participants in a human trial,” Judge Hughes wrote. “Methodist is trying to do their business of saving lives without giving them the Covid-19 virus. It is a choice made to keep staff, patients and their families safer.”The judge’s decision appeared to be among the first to rule in favor of employer-mandated vaccinations for workers. Several major hospital systems have begun to require Covid shots, including in Washington, D.C., and Maryland.But many private employers and the federal government have not instituted mandatory immunization as they shift operations back to office settings. Earlier this year, the U.S. Equal Employment Opportunity Commission issued guidance allowing employers to require vaccines for on-site workers.In Houston, Ms. Bridges was among those who led a walkout on Monday, the hospital’s deadline for getting the vaccine. And on Tuesday, the hospital suspended 178 employees who refused to get a coronavirus shot.Ms. Bridgescited the lack of full Food and Drug Administration approval for the shot as justification for refusing to get vaccinated. But the F.D.A., which has granted emergency use authorizations for three vaccines, says clinical trials and post-market study shows they are safe, as does the Centers for Disease Control and Prevention.The judge also noted that Texas employment law only protects employees from termination for refusing to commit an act that carries criminal penalties.“Bridges can freely choose to accept or refuse a Covid-19 vaccine, however if she refuses, she will simply need to work somewhere else,” he said, also rejecting the argument that employees were being coerced.And the judge called “reprehensible” the lawsuit’s contention that a vaccination requirement was akin to medical experimentation during the Holocaust.In a statement late Saturday, Dr. Marc Boom, chief executive of Houston Methodist, said: “Our employees and physicians made their decisions for our patients, who are always at the center of everything we do.”Houston Methodist said it would begin proceedings to terminate employees who were suspended if they did not get vaccinated by June 21.Jared Woodfill, the employee plaintiffs’ lawyer, also issued a statement on Saturday, according to news reports, that indicated the workers would appeal the ruling.

Regulators OK’d a new antifungal treatment, but critics say it is unneeded and costs too much.The Food and Drug Administration on Tuesday approved a new drug to treat a vaginal yeast infection that is especially common in women who are pregnant, using birth control pills or taking antibiotics.The drug, Brexafemme (ibrexafungerp) made by SCYNEXIS, is a one-day oral treatment and the first of a new class of triterpenoid antifungal drugs. The company said the new drug kills candida — the yeast that can cause an infection.The standard oral medication, Diflucan (fluconazole), inhibits the growth of yeast but does not kill it.But the treatment most likely wouldn’t be prescribed widely at first for common vaginal yeast infections. Dr. David Angulo, the company’s chief medical officer, estimated that the list price of the drug would range from $350 to $450 for the four-tablet treatment. By comparison, GoodRx lists the average retail price of fluconazole as $29.81.He said Brexafemme was approved as a first-line treatment, but could also be prescribed for patients whose infections don’t clear up easily.“There has been nothing new that can be provided to patients who can’t tolerate it, don’t respond well or develop resistance,” Dr. Angulo said.Dr. Sumathi Nambiar, director of the F.D.A.’s division of anti-infectives said: “This approval for a new antifungal drug provides an additional treatment option for patients with vulvovaginal candidiasis, or vaginal or vulvar yeast infections, and represents another step forward in the F.D.A.’s overall efforts to ensure safe and effective antifungal drugs are available to patients.”Dr. Denise Jamieson, chair of gynecology and obstetrics at Emory University School of Medicine, said she wasn’t sure the new drug was needed.“I don’t see a tremendous amount of resistance,” she said. “I can’t really comment on whether this is going to be a large addition or not. It’s always helpful to have another option, and then you have to consider things like cost and tolerability.”According to Dr. Angulo, one clinical trial used to support the application showed 50 percent efficacy — meaning complete resolution of all signs and symptoms — at 10 days after treatment and 60 percent 25 days after treatment. The other trial showed 64 percent efficacy at day 10 and 73 percent at day 25.Dr. Michael Carome, director of Public Citizen’s Health Research Group, was not impressed by the F.D.A.’s approval of Brexafemme.“This drug is not necessary and few women should need it,” Dr. Carome said. “Fluconazole is available at very low cost and in general is very effective. The cost of this is just outrageous.”The F.D.A. is requiring SCYNEXIS to conduct several post-market studies, including one to assess the risks to pregnant women, the developing fetus and newborns; and another to study how much of the product goes into the breast milk of lactating women.The drug will go on sale later this year.

The move has been long sought by public health and civil rights groups, after decades of marketing aimed at Black smokers.The Biden administration is planning to propose a ban on menthol cigarettes, a long-sought public health goal of civil rights and anti-tobacco groups that has been beaten back by the tobacco industry for years, according to a federal health official.For decades, menthol cigarettes have been marketed aggressively to Black people in the United States. About 85 percent of Black smokers use menthol brands, including Newport and Kool, according to the Food and Drug Administration. Research shows menthol cigarettes are easier to become addicted to and harder to quit than plain tobacco products.The F.D.A. is being forced to act by a court deadline — a federal district judge in Northern California had ordered the agency to respond by April 29 to a citizens’ petition to ban menthol. But the odds are unlikely that a ban would take effect anytime soon, because any proposal is likely to wind up in a protracted court battle. The proposal would also include a ban on all mass-produced flavored cigars, including cigarillos, which have become popular with teenagers. The ban would not, however, apply to e-cigarettes, which are being considered as a means to help smokers of regular menthol cigarettes quit. Most e-cigarette brands, including Juul, are undergoing an F.D.A. review that will determine whether they are sufficiently beneficial to public health to be allowed to stay on the market. Details of the proposal were first reported by The Washington Post. Delmonte Jefferson, executive director of the Center for Black Health and Equity, one of the organizations behind the petition, called the decision a victory for African Americans and all people of color.“This has been a long time coming,” said Mr. Jefferson. “We’ve been fighting this fight, since back in the 1980s. We told the industry then, we didn’t want those cigarettes in our communities.”Steven Callahan, a spokesman for Altria, which owns Philip Morris, U.S.A. said the company remained opposed to a menthol ban.“We share the common goal of moving adult smokers from cigarettes to potentially less harmful alternatives, but prohibition does not work,” Mr. Callahan said. “A far better approach is to support the establishment of a marketplace of F.D.A.-authorized non-combustible alternatives that are attractive to adult smokers.”Three years ago, the F.D.A., under Dr. Scott Gottlieb, President Trump’s first F.D.A. commissioner, proposed a similar menthol ban. But the Trump administration backed down after intense resistance from tobacco state lawmakers, led by Senator Richard Burr, Republican of North Carolina.Pressure to resurrect a ban had been building since President Biden’s election, and as the coronavirus pandemic and the Black Lives Matter movement further exposed sharp racial disparities in the country’s public health and medical systems.While Black smokers smoke less, they die of heart attacks, strokes and other causes linked to tobacco use at higher rates than white smokers do, according to federal health statistics.Matthew L. Myers, president of Campaign for Tobacco-Free Kids, which was part of the citizens’ petition, also noted that menthol and other flavors appeal widely to teenagers.“Menthol cigarettes are the No. 1 cause of youth smoking in the United States,” he said. “Eliminating menthol cigarettes and flavored cigars used by so many kids will do more in the long run to reduce tobacco-related disease than any action the federal government has ever taken.”Menthol is a substance found in mint plants, and it can also be synthesized in a lab. It creates a cooling sensation in tobacco products and masks the harshness of the smoke, making it more tolerable. Decades ago, marketing research showed it was more appealing to Black smokers than white smokers and cigarette companies began to focus their marketing on Black consumers.Support has also been growing in Congress to enact a ban through legislation. Several states and municipalities, including Massachusetts and California, have instituted their own menthol bans, but many of those are tied up in litigation too.The F.D.A. has not yet announced details of the proposal, which will have to go through a formal federal rule-making process, that can take several years and is likely to face stiff tobacco industry challenges.

Advocates are hoping that President Biden will soon come out in favor of banning mint-flavored cigarettes and other tobacco products.The banning of menthol cigarettes, the mint-flavored products that have been aggressively marketed to Black Americans, has long been an elusive goal for public health regulators.But Covid-19 and the Black Lives Matter movement have put new pressure on Congress and the White House to reduce racial health disparities. And there are few starker examples than this: Black smokers smoke less but die of heart attacks, strokes and other causes linked to tobacco use at higher rates than white smokers do, according to the Centers for Disease Control and Prevention. And 85 percent of Black smokers use Newport, Kool and other menthol brands that are easier to become addicted to and harder to quit than plain tobacco, according to the Food and Drug Administration.“Covid-19 exposed the discriminatory treatment that Black people have been facing for hundreds of years,” said Dr. Phillip Gardiner, a co-chairman of the African American Tobacco Control Leadership Council, which has been pushing for menthol bans in communities across the country. Calling menthol cigarettes and cigarillos “main vectors” of disease and death among Black Americans, he added, “It’s precisely at this time that we need strong public health measures.”There is now growing momentum in Congress to enact a ban. In states and municipalities across the country, Black public health activists have been organizing support and getting new laws passed at the state and local level. Public opposition among white parents to all flavored e-cigarettes, including menthol, has brought new resources to the issue. And the F.D.A. is under a court order to respond to a citizens’ petition to ban menthol by April 29.Advocates are hoping that President Biden, whose campaign had strong support from Black voters and who has put addressing health inequities front and center among his goals, will soon come out in favor of a ban.“I have no doubt that it’s time for a ban on menthol,” said Representative Karen Bass, of California, who led the Congressional Black Caucus during the last Congress. “We should never allow a chemical that is specifically targeted to a population, that increases death, no matter who it is. In this case, it’s menthol and the Black population. I’m so excited that we have an administration that puts racial equity and health disparities at top of its agenda.”Kevin Munoz, a spokesman for the White House, declined to say whether Mr. Biden supported a menthol ban, but he noted the president’s past support for tobacco control measures.“We are thinking about all of our options that could help reduce tobacco use and address persistent disparities,” Mr. Munoz said.Dr. Gardiner and other public health advocates are particularly concerned about the growing popularity of menthol cigars and cigarillos among Black teenagers. The 2020 National Youth Tobacco Survey, conducted by the federal government, found that 6.5 percent of Black students in high school and middle school, smoked cigars and cigarillos compared with 2.5 percent who smoked traditional cigarettes. The F.D.A. says that menthol is the preferred flavor for the cigarillos, which are cheap and mass-produced, unlike premium cigars.Dr. Phillip Gardiner has been pushing for menthol bans in communities across the country. “It’s precisely at this time that we need strong public health measures,” he said.Jim Wilson/The New York TimesMenthol is a substance found in mint plants, and it can also be synthesized in a lab. It creates a cooling sensation in tobacco products and masks the harshness of the smoke, making it more tolerable. Some studies have shown that menthol also acts as a mild anesthetic. Back in 1953, when menthol was not widely used, a Philip Morris Co. survey revealed that 2 percent of white smokers preferred a menthol brand, while 5 percent of Black smokers did, according to a review of tobacco industry documents by Dr. Gardiner that was published in 2004 by the medical journal Nicotine & Tobacco Research.“The industry looked at that and said, ‘We’re missing an opportunity,’ and consciously targeted the African-American community,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, which has long lobbied for a menthol ban and also helps fund the African American Tobacco Leadership Council.What followed has been well-documented in records made public from numerous lawsuits, that tobacco companies have targeted Black communities with menthol cigarettes for decades. They distributed free samples, offered discounts and sponsored countless concerts and special events, among them the famous Kool Jazz Festival. Tobacco companies also gained good will by advertising in newspapers and magazines geared to a Black readership — and by donating money to civil rights organizations.The companies have also been frequent donors to Black political candidates, and they have been generous supporters of the Congressional Black Caucus and the Congressional Black Caucus Foundation. Officials with Juul and Altria, which owns Philip Morris and also has a 35 percent stake in Juul, serve on the foundation’s corporate advisory board.The Biden administration still lacks a permanent F.D.A. commissioner, and Dr. Janet Woodcock, the acting commissioner, has not been vocal on tobacco issues. But public health advocates were heartened by the confirmation on Thursday of Xavier Becerra, the former attorney general of California, as the secretary of health and human services. In California, Mr. Becerra took aggressive action against tobacco and e-cigarette companies. In August, California became the second state — after Massachusetts’ lead — to ban the sale of all flavored tobacco products. (The law is on hold, pending an industry-sponsored referendum to repeal it, which will be on the ballot in November 2022.)The tobacco industry is in a tricky spot. For several years, the largest companies, Altria and R.J. Reynolds Tobacco, now owned by British American Tobacco, have sought to position themselves as transforming their companies into responsible businesses being eager to to preventing young people from smoking and to developing less harmful products. For critics, the industry’s lobbying to protect its menthol brands contradicts that assertion.“It doesn’t seem very transformative if you’ve taken zero steps to address a particular product that has so disproportionately and detrimentally harmed Black Americans,” said Maura Healey, the attorney general of Massachusetts, which enacted a ban on flavors, including menthol, in June. “It’s time for the F.D.A. to act on the scientific evidence that is out there.”A 2008 issue of Essence magazine. Tobacco companies gained good will by advertising in newspapers and magazines geared to a Black readership — and by donating money to civil rights organizations.Tony Cenicola/The New York TimesThe number of Americans who smoke cigarettes has declined to 14 percent in 2019 from a peak of 40 percent in the mid-1960s, according to the F.D.A. That translates to an estimated 34.1 million adult smokers in the United States, nearly 20 million of whom smoke menthol cigarettes. Roughly 480,000 Americans die each year from tobacco-related illnesses and more than 16 million Americans live with a smoking-related disease. In 2009, Congress gave the F.D.A. the authority to regulate the tobacco industry. That year, the Family Smoking Prevention and Tobacco Control Act banned all intentionally flavored cigarettes except menthol, which it referred to the F.D.A. for further study. The F.D.A. came close to a ban under the Obama administration but did not have sufficient White House support.In 2018, Dr. Scott Gottlieb, the first F.D.A. commissioner of the Trump administration, announced the agency would ban menthol cigarettes. He was immediately opposed by Senator Richard Burr, Republican of North Carolina, one of the few unapologetically pro-tobacco lawmakers left in Congress.Mr. Burr often promotes the jobs that the industry provides in his home state. His sons have two of those jobs: Tyler Burr works in state governmental affairs at R.J. Reynolds Tobacco Co., and William Burr works in regulatory affairs at Altria, which owns Philip Morris.After the announcement, Mr. Burr started dispatching oversight letters to the F.D.A. every Friday from mid-November 2018 through early January 2019, with the exception of the week of Thanksgiving. Emails obtained under the Freedom of Information Act show the hundreds of minute questions from Mr. Burr that tied up staff for weeks. He also demanded personal travel records for the agency’s seven center directors and accused the F.D.A. of leaks.The F.D.A. did not back down, but Mr. Burr helped to persuade the Trump administration to kill the plan in early 2019, according to former White House officials. Mr. Burr’s office declined to comment. David Sutton, a spokesman for Altria, which makes Marlboro and other brands that come in menthol, defended keeping menthol cigarettes on the market.“Prohibition and criminalization of adult behavior does not work for products intended for adults 21-plus,” Mr. Sutton said.Kaelan Hollon, a spokeswoman for R.J. Reynolds, whose Newport brand is the biggest menthol seller in the United States, said a menthol ban would infringe on the rights of adults who preferred it to plain tobacco.But such arguments ignore the fact that most smokers start the habit and become addicted to nicotine when they are young, and are most likely to seek flavored products, according to the F.D.A.At this point, the F.D.A. could again propose a federal ban, which would then have to be approved by the White House. Alternatively, Congress could adopt legislation expanding the current restrictions on sales of flavored cigarettes to include menthol — effectively undoing the current exemption.More than 120 localities have already enacted bans of flavored tobacco products, including menthol cigarettes, according to the Campaign for Tobacco-Free Kids. The African American Tobacco Control Leadership Council is running an anti-menthol campaign with Delta Sigma Theta, a historically Black sorority, and others. The council is also a plaintiff, along with the Action on Smoking and Health, in the citizens’ petition that forced the April 29 deadline for the F.D.A. to say whether or not it will ban menthol.Advocates hope President Biden, whose campaign had strong support from Black voters and who has put addressing health inequities front and center, will come out in favor of a ban.Bryan Thomas for The New York TimesThe Center for Black Health and Equity, a nonprofit organization in North Carolina, has also pushed hard on the issue, enlisting churches to sponsor “No Menthol Sundays.”In recent years, the tobacco industry has joined forces with certain civil rights activists, among them the Rev. Al Sharpton, who according to the California Department of Public Health, visited Black communities in the state, raising fear that a menthol ban would give the police an excuse to stop and frisk more Black individuals. Mr. Sharpton also helped to defeat a ban in New York.Ms. Bass has lost patience with that argument, saying a ban would prohibit selling menthol cigarettes, not possessing them.Ms. Bass said that a majority of lawmakers, including those in the Congressional Black Caucus, favor banning all tobacco flavors, including menthol. Eighty percent of the Congressional Black Caucus members voted last year for legislation that would have banned menthol cigarettes.Marc Scheineson, a lawyer with Alston and Bird, who represents small tobacco companies, believes that Representative James Clyburn, Democrat of South Carolina, may be the decisive vote. Mr. Clyburn was instrumental in developing support for Mr. Biden among Black Americans during his presidential campaign.“He can get whatever he wants,” Mr. Scheineson said. “I’m sure he’s got a wish list, but I’m sure all the African-American groups are coming to him and he’s got to prioritize.”Last year, Mr. Clyburn was absent for the House vote on legislation that would have banned menthol cigarettes. He has kept a low profile on the issue, not lobbying for tobacco companies but not standing in the way, either. Mr. Clyburn did not return requests seeking comment.Dr. Gottlieb believes the Biden administration will finally ban menthol cigarettes.“We opened the door on this in a Republican administration,” he said. “You don’t think a Democratic administration will finish the business? Of course they will.”

AdvertisementContinue reading the main storySupported byContinue reading the main storyPandemic Forces F.D.A. to Sharply Curtail Drug Company InspectionsThe steep decline in oversight has stalled a number of new drug applications. The agency says it is trying to protect its employees but critics say inspectors should be considered essential workers and do their jobs.The F.D.A. conducted more than 1,671 inspections of foreign and domestic drug manufacturing facilities in 2019. Last year, that number dropped by more than half, to 742. Credit…Ariana Lindquist/BloombergMarch 9, 2021, 5:00 a.m. ETThe Covid-19 pandemic has forced the Food and Drug Administration to postpone hundreds of drug company inspections, creating an enormous backlog that is delaying new drug approvals and leading the industry to warn of impending shortages of existing medicines.Pandemic-related travel restrictions and safety concerns have also hampered the F.D.A.’s ability to ensure the safety of the ever-increasing number of imported medicines, which make up more than 60 percent of the drugs sold in the United States.“Regardless of where drugs are manufactured, domestically or overseas, the F.D.A. has the responsibility to ensure they are effective and safe,” said Mary Denigan-Macauley, director of health care, public health and private markets for the Government Accountability Office, a congressional watchdog agency. “Any drop in inspections, or backlog, is concerning.”The numbers show a steep decline. The F.D.A. conducted 52 inspections of domestic pharmaceutical plants between March 2020, when the pandemic took hold in the U.S., and Oct. 1, compared with 400 during the same months in 2019, according to the G.A.O. Inspections of foreign manufacturing facilities have been at a virtual standstill for months.In an interview, F.D.A. officials said they sharply curtailed the inspections to protect their investigators, following guidelines from the Centers for Disease Control and Prevention, which discouraged federal employees from travel during the pandemic.But some people in both industry and public health communities say that federal drug inspections are essential, and that the agency should bypass travel restrictions by taking precautions, including wearing proper personal protective equipment.“I think they can and they should,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group, a nonprofit advocacy organization. “They should be considered essential workers and they should be vaccinated as soon as possible. And they should be provided with N95s masks, gowns and gloves to ensure their own safety during travel and during the inspection.”Dr. Denigan-Macauley said that the F.D.A. has postponed more than 1,000 surveillance inspections — the routine visits that the agency conducts to check for adherence to good manufacturing practices. “Drugs that are waiting for pre-approval inspections will also have a backlog,” she said.In interviews, F.D.A. officials denied that the dramatic drop in inspections has slowed drug approvals. But a number of drug companies, including Spectrum Pharmaceuticals, Biocon Biologics and Bristol Myers Squibb, has issued statements noting deferred F.D.A. action because of the agency’s inability to conduct inspections.In October, Spectrum announced that the F.D.A. had deferred action on its application for Rolontis, a treatment for cancer patients who have a very low number of certain white blood cells, because it could not inspect the manufacturing plant the company uses in South Korea.In late December, Biocon Biologics notified shareholders that the F.D.A. deferred action on its joint application with Mylan for a proposed biosimilar to Avastin, a cancer drug.Bristol Meyers Squibb announced in November that the F.D.A. would miss its November deadline for taking action on a lymphoma treatment, lisocabtagene maraleucel because it could not inspect a third-party Texas manufacturing plant. The agency eventually did complete its inspection and approved the drug last month.In addition, Nivagen, a pharmaceutical company specializing in generic versions of injectable medications, filed an application in January 2019 for an expedited review of a generic version of a drug used in cardiac therapy and for other problems. In March 2019, the F.D.A. granted its request for what is known as a competitive generic therapy designation, for products that the F.D.A. believes should get high priority for consideration. Then the pandemic hit, and the F.D.A. pushed the company’s inspection back twice, according to Jay Shukla, Nivagen’s chief executive officer. He said he does not know when one will be scheduled.Dr. Erin Fox, who tracks drug shortages for the American Society of Health System Pharmacists, says shortages of the brand name version of the drug, which is made by only one company in its injectable form, have occurred on and off since 2006. That’s why Mr. Shukla said he decided it would be a good product for his new business.“For me, a small start-up company, our growth depends on this product for the manufacturing I want to build in the U.S.,” said Mr. Shukla. “It all depends on this approval. The review is done, it’s only pending the facility inspection. We appreciate the hard work the F.D.A. is doing, but we are suffering too.”Mr. Shukla has proposed an alternative — a virtual inspection using remote video technology to permit the F.D.A. inspector to view inside the facility. The pharmaceutical industry has been pressing the F.D.A. to adopt remote inspections, but the agency said that it is still evaluating the idea, as it has been doing for months. So far, it has conducted virtual sessions sparingly, generally more for viewing a company’s documents than for actual remote viewing of a manufacturing plant.Donald D. Ashley, director of compliance for the agency’s Center for Drug Evaluation and Research, said he was wary of relying heavily on remote viewing, especially for inspections at facilities that had had past violations.“When we go back to reassess whether they have corrected their ways, we want to use our most robust tool, and that’s an on site inspection,” Mr. Ashley said.F.D.A. inspectors at a mail facility in New York in 2018. The agency cited pandemic-related restrictions and safety concerns for hampering its  ability to conduct on-site reviews of the increasing number of imported medicines.Credit…Michael J. Ermarthh/U.S. Food and Drug AdministrationDuring most drug company inspections, investigators review the company’s internal records and scrutinize the building, checking how supplies are handled, reviewing quality controls and determining whether the company complies with good manufacturing practices. The F.D.A. conducts three types of inspections: pre-approval inspections when companies have filed applications for new drugs; routine surveillance inspections, which it tries to do at least once every five years; and those following up on a problem.Proponents of remote audits say they can do the same thing virtually. Peter Miller, president of Dynamic Compliance Solutions, of New Jersey, which helps life science companies comply with F.D.A. regulations, says his remote audit kit can do a great inspection. The kit features a tiny 360-degree camera, which an on-site host carries on a tripod while the investigator watches on a computer screen.“The inspector can say, ‘I see a stack of boxes there. Can we move a little closer? I’d like to see if they have proper stickers,’ ” he said. “I believe the auditor should be in control of what they are looking at. We do a livestream, unrecorded broadcast.”Industry lawyers believe the F.D.A. is being too fussy in rejecting remote inspections, given the current backlog. Mark I. Schwartz, a former F.D.A. deputy director who had oversight of inspections conducted by the agency’s Center for Biologics Evaluation and Research, thinks wider use of remote inspections is way overdue. Mr. Schwartz believes that when done properly, remote inspections will yield similar results to in-person visits — which he said more than a dozen of his clients are desperate to have done.“The suggestion that being on-site makes a whole hell of a difference in finding things is a fallacy,” said Mr. Schwartz, now a director at Hyman, Phelps & McNamara, a law firm with a large pharmaceutical industry practice. At best, Mr. Schwartz said, investigators on-site see only about 15 percent of a company even when they are there in person.The issue has drawn congressional attention. Dr. Denigan-Macauley is scheduled to testify on Tuesday before the House appropriations subcommittee that oversees the F.D.A. Representative Sanford Bishop, a Georgia Democrat who is chairman of the panel, said, “The pressure to ensure F.D.A. is still able to assess the safety and efficacy of the drug supply grows every day. ”While public health experts are troubled by the big drop in inspections, most believe that virtual inspections would be a poor substitute for in-person reviews.“Remote inspections just aren’t going to cut it,” Dr. Carome said. “Often the F.D.A. identifies serious problems and if you aren’t on-site, those will go undetected.”“There have been examples where F.D.A. have found filthy conditions in the manufacturing facility or they found rodents or insects that could contaminate products,” Dr. Carome said. “The facility isn’t going to show you that.”The F.D.A. has increasingly relied on electronic submission of manufacturing records during the pandemic, but prefers to view them in person to confirm accuracy. Mr. Ashley of the F.D.A. recalled a 2019 inspection of an over-the-counter drug manufacturer in China, where an investigator found falsification of records that would not have been detected by simply studying them on line.“The front management presented these to our investigator, who noticed that the documents were dated a long time ago, but the ink was still wet,” Mr. Ashley said. “We asked them to recall all their drug products.”The F.D.A. was already behind on inspections before the pandemic, according to congressional investigators, particularly those overseas. The G.A.O. placed part of the blame on the lack of investigators qualified to conduct the inspections.But the watchdog also questioned the wisdom of the F.D.A.’s practice of giving foreign manufacturers up to 12 weeks notice before the inspection, potentially enabling them to fix or hide problems. The pandemic has also prompted the F.D.A. to provide domestic facilities advance notice of its visits, the G.A.O. noted. Another problem is the F.D.A.’s reliance on translators chosen by the company being inspected.Dr. Denigan-Macauley of the G.A.O. said that from March to October 2020, the F.D.A. conducted only three foreign inspections that it considered “mission critical,” compared to more than 600 during the same time period in 2019 and 2018. The G.A.O. also said that the F.D.A. was able to put 54 overseas manufacturers on what are called “import alerts” by sampling their products, rather than doing an inspection. An import alert permits the F.D.A. to block that company’s products from entering the United States.The F.D.A. confirmed that the vast majority of foreign inspections continue to be postponed.“If this continues,” Dr. Denigan-Macauley said, “they are going to be very challenged.”AdvertisementContinue reading the main story