The Food and Drug Administration is recommending that a federal court judge extend the agency’s timeline for tobacco manufacturers to comply with planned enhanced regulations.
The FDA’s response Wednesday represents the latest step aimed at resolving a lawsuit filed in March 2018 by a coalition of seven public health and medical groups.
The FDA chose in August 2017 to allow certain flavored electronic cigarettes and cigars to stay on the market for years without pursing FDA authorization or being reviewed by the agency, currently until 2022 for e-cigarettes and until 2021 for cigars.
On May 16, 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 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 coalition has until Monday to respond to the FDA plan.
The coalition is requesting implementation of a 120-day deadline from Grimm’s final order for manufacturers to submit premarket applications for their innovative tobacco products. The FDA is recommending at least 10 months for such compliance.(tncms-asset)abd20ac6-8e19-11e9-b459-00163ec2aa770 —(/tncms-asset)
The FDA has asked Grimm to “remand the case back to the agency for further action.”
If Grimm declines that request, the FDA said, “We have committed to finalizing the March compliance policy to limit youth access to, and appeal of, flavored tobacco products, like e-cigarettes, as quickly as possible,” which could be as soon as October.
“Finalizing the compliance policy is one of the most critical public health steps that the FDA can take to curb youth vaping, and the agency expects to complete it within 120 days. The court should not go beyond vacating the August 2017 guidance.”
The FDA said that along with the 10-month period for manufacturers, it requests a one-year period to allow it to review a potentially large influx of applications.
“This timeline would help address the serious public health concern of migration from non-combustible to combustible forms of tobacco — if e-cigarettes were to abruptly exit the market — and would give manufacturers time to prepare higher quality applications,” the FDA said.
Matthew Myers, president of Campaign for Tobacco-Free Kids and coalition member, said the FDA’s “trust us approach is a recipe for even more delay in subjecting e-cigarette to public health review.”
“Further delays are not justified from a legal standpoint, and they are harmful to our nation’s children and public health,” Myers said.
In July 2017, the FDA announced plans 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.
In his May decision, 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.”
Stefanie Miller, an analyst with Sandhill Strategy, said Thursday it is possible that Grimm “is poised to announce a de facto ban on all e-cigarettes by the end of the year” by accelerating the deadline for submitting premarket applications.
“We see Congress careening toward new, comprehensive tobacco control policy that could ban nicotine altogether, ban menthol-flavored cigarettes, ban all flavors of e-cigarettes except tobacco-flavored products and ban all so-called ‘pod-like’ e-cigarette systems.”