An independent review of the Food and Drug Administration’s tobacco regulators described them as overwhelmed, reactive and fatigued by an oppressive workload involving e-cigarettes and called for a major effort, by several parts of the Biden administration, to remove millions of illegal vaping products from the market.
The review said there are millions of illegal vaping products on the market — involving companies that should have applied for FDA authorization and never did, or others that had their applications rejected — and that a major effort is needed to remove them.
While the review faulted the FDA for enforcement shortfalls, it also acknowledged that the agency does not have the authority to clear millions of illegal products from the marketplace on its own — much of that power rests with the Justice Department.
The review group, headed by Lauren Silvis, chief of staff to former FDA commissioner Scott Gottlieb, called on the Biden administration to establish “an interagency task force to make enforcement of the tobacco laws a government-wide priority, particularly to address the marketing of illegal products and the risks of youth use.”
In addition, the panel said the FDA should lay out a road map of priorities and explain how it will implement them, including the standard used for authorizing e-cigarettes. The group suggested that people with varying views were dissatisfied.
FDA Commissioner Robert M. Califf, who authorized the review following sharp criticism from Congress and advocates of the agency’s handling of e-cigarette issues, said the agency would review the report and provide an update on future action steps by early February.
“We’ve made important progress and reached science-based regulatory decisions across a broad array of products in the 13 years since Congress tasked the FDA with regulating tobacco products,” Califf said. But, he added, even greater challenges are ahead.
The report won praise from both sides in the vaping battle, but for different reasons. Anti-tobacco groups liked the emphasis on enforcement and compliance, while pro-vaping groups said the report validated their view that the center was not working effectively.
“The most important thing that could come out of this is if it results in a government-wide commitment to effectively enforcing the law clearing the market of products that the FDA has not authorized,” said Matthew L. Myers, president of Campaign for Tobacco-Free Kids, a leading anti-tobacco group. He also said the FDA should move to prohibit the marketing of vaping products that have not gone through agency review.
Products with applications submitted by fall 2020 are allowed to stay on the market while their items are under review.
Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, an industry trade group, said: “Over and over again, the policy flaws that we have repeatedly laid at FDA’s doorstep were validated by [the report] yet the problem is that in the report there doesn’t seem to be any mechanism for forcing these problems to be corrected other than a new presidential administration.”
Califf requested the review of the FDA’s tobacco activities in July, not long after the agency ordered vaping products from Juul Labs off the shelves in the U.S. market and then suspended the order, saying it needed more time to examine “scientific issues unique to the Juul application.” The reversal was seen as an embarrassment for the agency.
The Reagan-Udall Foundation, which works closely with the agency, receives funding from the FDA, industry, nonprofit groups and private donors.
Mitch Zeller, longtime director of the tobacco center until he retired in April, said the report was accurate in saying that “one of the challenges the FDA and the center faces, at the end of the day, is that it does not call the shots.” While the FDA can take some enforcement steps on its own, such as sending warning letters to companies, “the decision-makers when it comes to using tools such as seizure and injunctions, are not the lawyers at FDA or HHS but lawyers at the Justice Department,” he said.
Califf, in asking for the tobacco review, also requested one on the agency’s food-safety regulation, a response to the furor over the infant-formula shortage this year. Earlier this month, the Reagan-Udall Foundation offered a scathing indictment of the agency’s food-safety structure and culture, and it recommended major restructuring. It faulted the agency for inadequate oversight of foodborne illness and persistently slow decision-making. Califf said in a statement that he was forming a group of agency leaders to advise him on how to implement the findings and would unveil those efforts to the public early next year.
The FDA has been under intense pressure from members of Congress and tobacco-control advocates to be more aggressive in removing flavored tobacco products, including e-cigarettes, from the market. Congress this year gave the agency additional regulatory authority so that it could go after flavored products made with synthetic nicotine.
But the FDA received millions of applications and now says it will take until next year to finish the reviews. The agency has completed its review of the vast majority of applications, rejecting millions while approving some applications for tobacco-flavored vapes, but it has not finished reviewing the ones from companies that make up the biggest part of market share.
Zeller noted that the time frame set by the agency in 2017 had been collapsed from four years to 10 months when it lost a lawsuit. That gave the agency much less time to prepare for a deluge of applications, he said.
On enforcement, the FDA stepped up activity this fall. In October, the agency announced that the Justice Department, on behalf of the FDA, was seeking permanent injunctions in federal district courts against six e-cigarette manufacturers. The government accused the companies of selling new tobacco products without first obtaining marketing authorization from the FDA. It was the first time the FDA has initiated such proceedings to enforce the law’s premarket review requirements for new tobacco products.
This month, the Supreme Court refused to block a California law banning flavored tobacco. Voters overwhelmingly supported the ban on the sale of all flavored tobacco products, including e-cigarettes and menthol cigarettes, in a ballot measure on Nov. 8. The law was enacted in 2020, but its implementation was delayed as opponents, led by tobacco companies, collected enough signatures to put it on the ballot.
Juul Labs, the e-cigarette manufacturer, announced this month that it has reached settlements covering more than 5,000 cases with nearly 10,000 plaintiffs. The sweeping resolutions, which litigators say will address youth e-cigarette usage, come after more than three years of legal battles. The company did not release the amount but the Wall Street Journal reported that Juul agreed to pay $1.7 billion in the broad legal settlement.
