The Senate’s Committee on Health, Education, Labor & Pensions heard testimony from leaders at the U.S. Food and Drug Administration and Centers for Disease Control and Prevention on the lung illness epidemic, as well as what is being done to keep kids away from e-cigarettes.
To date, more than 2,000 Americans have been diagnosed with lung illness related to vaping, and 39 have died. Most of these cases have been linked to the use of e-cigarettes containing THC, many of which contain vitamin E acetate, a compound in cosmetics that is poisonous when inhaled.
The hearing was held less than 24 hours after the Henry Ford Health System in Detroit announced that a 17-year-old had undergone a double lung transplant in October after being diagnosed with “irreparable” lung damage from vaping.
Committee Chair Lamar Alexander, R-Tenn., initiated Wednesday’s hearing to gauge what the agencies have learned about e-cigarettes in the wake of the outbreak and why there are still no standards to regulate the e-cigarette and vapor industries.
“When you go to the store to buy one of these products, you probably assume somebody said it was okay to do so,” Alexander said. “But you’d be wrong. Not a single e-cigarette product has been reviewed and approved for sale by the FDA.”
Democratic members of the committee grilled Mitch Zeller, director of the FDA’s Center for Tobacco Products, on why the agency has yet to develop a formal regulatory policy on e-cigarettes, particularly in light of the Trump administration’s announcement in September that it plans to ban flavored vaping products.
At present, the agency does not perform pre-marketing reviews of any e-cigarette products for safety.
Zeller responded by referring policy questions “to the White House,” adding that the FDA was still in the middle of a “deliberative process” on any new regulatory standards for the manufacture and sale of these products.
“I urge you to move through your deliberative process,” said Sen. Maggie C. Hassan, D-N.H., echoing the sentiments of several of her Democratic colleagues. “You’ve had plenty of time already.”
Anne Schuchat, the CDC’s Principal Deputy Director, cited recently released data indicating that roughly one in four high school-age teens are using e-cigarettes, and that they prefer certain flavored products.
Faced with the troubling statistics, including those on teen use, JUUL announced last Thursday that it has suspended sales of mint-flavored vaping devices. Mint was the most popular flavor among teens, according to CDC data. The company’s legal e-cigarette products do not contain THC or vitamin E acetate.
Currently, Schuchat said, the CDC strongly advises consumers to not use e-cigarettes containing THC and recommends that they refrain from the use of all vaping products until more is learned about their possible health effects.
From a regulatory perspective, Zeller noted that the FDA has had enforcement authority over tobacco products since Congressional passage of the Family Smoking Prevention and Tobacco Control Act in 2009.
The agency took up regulatory authority over e-cigarette products in August 2016, crafting a policy on the industry after its earlier regulatory efforts had been challenged in court.
The FDA already requires legal e-cigarette manufacturers to include warning labels on product packaging highlighting the risks associated with their use. And, Zeller said, the FDA has issued nearly 10,000 warning letters to retailers — both online and in brick-and-mortar retail stores — for sales of vaping products and their components to minors.
In September 2018, in the largest coordinated enforcement effort in the agency’s history, the agency issued more than 1,100 warning letters and initiated 131 civil money penalty complaints to retailers who sold e-cigarettes to minors.
Alexander also wanted to know how much of the $5.5 billion the Center for Tobacco Products has collected from industry in the form of “user fees” has been used to address regulation of vaping products and public education on the risks associated with their use.
Zeller said that since late 2017 the FDA has allocated $150 million toward a media campaign targeting teens on the dangers of vaping, and that the agency has budgeted $85 million for it in 2020.
Under questioning from Senator Richard Burr, R-N.C., it was revealed that the FDA’s budget for inspections of tobacco shops — which included enforcement of restrictions on selling all tobacco products, like e-cigarettes, to minors — actually declined from 2017 to 2018, and that the agency inspected 22,000 fewer retailers last year.