A federal judge has agreed with a coalition of seven public health and medical groups that the Food and Drug Administration is unnecessarily delaying applying enhanced regulations on electronic cigarettes and cigars.
The FDA chose in August 2017 to allow certain flavored e-cigs and cigars to stay on the market for years without pursing FDA authorization or being reviewed by the agency, currently until 2022 for e-cigs and until 2021 for cigars.
Judge Paul Grimm for the District of Maryland ordered the FDA and the health groups to submit within 30 days their plans for speeding up the review process.
The lawsuit was filed in March 2018 by the American Academy of Pediatrics and its Maryland chapter, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids and Truth Initiative.
The FDA has said its plans are to finalize its draft guidance as quickly as possible after reviewing public comments submitted during a period that ended in April.
The coalition claims the FDA has “deliberately abdicated” its responsibilities under the 2009 Tobacco Control Act. It sued to force the FDA to shorten the deadline and accelerate putting tightened regulations into place.
The FDA announced plans in July 2017 for a sweeping regulatory “road map” on tobacco and nicotine products that included limiting or eliminating flavorings, such as menthol in traditional cigarettes and candy and fruits in e-cigs and vaporizers, that the agency says appeal to youths.
Grimm compared the trend of e-cig demand increasing as traditional cigarette demand decreases with the Internet supplanting libraries for researching information.
He said e-cig makers “have learned” their products appeal to youths “if they are fruit or dessert flavored, and marketed as cool and alluring.”
“Arguably, the five-year compliance safe-harbor has allowed the manufacturers enough time to attract new, young users and get them addicted to nicotine before any of their products, labels, or flavors are pulled from the market,” Grimm wrote.
“At which time, the youth is likely to switch to one of the other thousands of tobacco products that are approved — results entirely contrary to the express purpose of the Tobacco Control Act,”
Anti-tobacco advocates consider e-cigs — as well as smokeless tobacco and dissolvable tobacco products — as potential gateways to the use of traditional cigarettes.
Several studies, however, have demonstrated that there is no direct connection, particularly given that youth-smoking rates have declined throughout the decade even as e-cig usage among young people has increased.
Grimm wrote that Congress viewed tightening tobacco product regulations “as integral to address public health dangers that the (FDA) itself acknowledges are alarming for five or more years, while it tries to figure out how it will implement the statute.”
However, he said a continuing delay “affords those manufacturers responsible for the public harm a holiday from meeting the obligations of the law.”
The FDA said in a statement that it is reviewing Grimm’s decision.
“As Health and Human Services and FDA leadership have reiterated, the agency has and will continue to tackle the troubling epidemic of e-cigarette use among kids,” the FDA said.
“This includes preventing youth access to, and appeal of, flavored tobacco products, like e-cigarettes and cigars, taking action against manufacturers and retailers who illegally market or sell these products to minors, and educating youth about the dangers of e-cigarettes and other tobacco products.”
The Campaign for Tobacco-Free Kids called Grimm’s ruling “a major victory for America’s kids and public health.”
“It is now the FDA’s responsibility to take immediate action to protect our kids and require manufacturers to apply to the FDA if they want to keep their products on the market, including products like Juul that have fueled the youth e-cigarette epidemic,” the campaign said.
Grimm said that “manufacturers long have been on notice that they will have to file premarket approval applications, substantial equivalence reports, and exemption requests, and if they have chosen to delay their preparations to do so, then any hardship occasioned by their now having to comply is of their own making.”
Gregory Conley, president of American Vaping Association, said that “while we have long expressed concern about the FDA’s reliance on guidance documents rather than rulemaking, we believe that the FDA’s deadline extension was a proper and legal exercise of agency power.”
“Despite promises by the FDA, the agency has still yet to finalize critical documents that the industry needs to file pre-market applications.
“In order to protect adult access to less harmful alternatives to cigarettes and stop over 100,000 Americans from becoming unemployed, FDA and Justice Department must appeal this ruling.”