Dramatically lowering nicotine levels in traditional cigarettes appears to no longer be a priority of the Trump administration.
The U.S. Department of Health and Human Services disclosed the policy reversal in a regulatory filing Wednesday.
The decision comes amid advocate and analyst speculation that the current Food and Drug Administration commissioner nominee, Dr. Stephen Hahn, does not favor heightened federal tobacco regulations.
In July, the FDA said it would review the public-health benefits of making cigarettes with very low levels of nicotine available to smokers.
That included studying two modified-risk tobacco product applications from 22nd Century Group Inc., which has its production plant and most of its workers in Mocksville.
A modified-risk tobacco product application seeks authorization to advertise products as reduced harm or reduced risk compared with cigarettes.
Cliff Fleet, 22nd Century's chief executive, said in a statement Friday that the company "is disappointed that FDA appears to have delayed its efforts to enact a product standard rule to lower the amount of nicotine in all cigarettes sold in the United States to non-addictive levels."
“We are encouraged, however, that FDA publicly stated that the agency continues to work on the nicotine-reduction rule. Furthermore, we remain optimistic about the approval of our MRTP application for very-low nicotine content cigarettes.
"We believe this application is moving quickly through the agency’s scientific review process, and we plan to launch this product in the U.S. after we receive an MRTP marketing order for this application," Fleet said.
Anti-smoking advocates have expressed concern that reducing nicotine levels too much could lead smokers to consume more cigarettes to get the same amount of nicotine, thereby increasing their exposure to carcinogens from the burning of the tobacco leaves.
“We have long thought FDA was unlikely to issue a proposed rule to cap the amount of allowable nicotine in combustible cigarettes this year,” said Stefanie Miller, an analyst with Sandhill Strategy.
“Removing it from the fall 2019 Unified Agenda signals to us that the nicotine-cap rule is unlikely to move until after next year’s election,” Miller
FDA spokesman Michael Felberbaum said the Unified Agenda reflects the agency’s “most immediate priorities.”
“That does not mean the agency does not consider them (nicotine levels in combustible cigarettes) a priority or will not continue to work on their development. FDA is focused on implementing a science-based, comprehensive approach to tobacco and nicotine regulation,” Felberbaum said.
“As part of this effort, FDA continues to gather evidence and data on an on-going basis regarding all tobacco products.”
Miller said that if the FDA does release the notice for its nicotine-cap rule, “we think that will start a two- to three-year clock before they announce the final regulation.”
“Once that happens, we expect the real fun to begin, as tobacco companies are highly likely to sue FDA immediately following the release of the final rule,” she said.
The DHHS decision had anti-tobacco advocates further questioning the Trump administration’s tobacco-control policies, particularly as it appears to be backing away from President Donald Trump’s pledge in September to support banning most flavored tobacco products.
“If the FDA abandons its plan to limit nicotine levels in cigarettes, it will miss an unprecedented opportunity to improve health and save lives in our country,” said Matthew Myers, the president of the Campaign for Tobacco-Free Kids.
“The cost of inaction can literally be measured in lives as the FDA has estimated that this plan would prevent more than 33 million young people from becoming regular smokers and save more than 8 million lives by the end of this century,” Myers said.
Gregory Conley, the president of American Vaping Association, said it’s not surprising that the Trump administration is putting a lower priority on making low-nicotine traditional cigarettes available.
“Moving towards very-low-nicotine cigarettes clearly would require a wide range of acceptable smoke-free alternatives to be on the market,” Conley said.
“With the FDA regulatory system being so broken, that is not guaranteed to be the case 18 months from now.
“Additionally, FDA may be worried about data showing that many adult smokers, particularly African Americans, believe very-low-nicotine cigarettes are less dangerous than regular cigarettes,” Conley said.
Trump’s election was considered by advocates on both sides of the issue to have been a boon for tobacco manufacturers, given his stance on reducing, not expanding, federal regulations.
However, Trump’s FDA commissioner, Dr. Scott Gottlieb, was known foremost nationally for how aggressively he tried to reduce youth exposure to traditional and electronic cigarettes by calling it an epidemic.
Gottlieb’s recommendations in November 2018 for resolving the epidemic included removing most e-cigarette flavors, banning menthol traditional cigarettes and drastically reducing nicotine levels in tobacco products.
As the FDA moved slowly toward putting that goal into action, Gottlieb unexpectedly announced his resignation in March, effective in April.
Gottlieb denied that he was encouraged to step down, or that there were any policy disputes.
However, he acknowledged he couldn’t predict the fate of his initiatives.
Interim FDA commissioners have not moved forward with Gottlieb’s agenda.
22nd Century claims
22nd Century filed FDA applications in December 2018 for its “Brand A” product, which has been the subject of more than 50 global studies. Some of those studies have been financed in all or in part by the FDA and the National Institutes of Health.
The products initially would go by the brand VLNTM King and VLNTM Menthol King. The FDA has authority over product names.
According to 22nd Century, studies have shown that its low-nicotine cigarettes lessen exposure to toxins across time; contribute to smokers consuming fewer cigarettes a day; create a greater reduction in nicotine dependence; and lead to more cigarette-free days.
22nd Century also filed in December 2018 a premarket tobacco application for the Brand A product. The premarket standard requires the FDA to consider products’ risks and benefits to the population as a whole, including users and non-users.
“Together, these important applications seek the FDA’s authorization to commercialize the company’s VLNTM cigarettes and to advertise that the VLNTM cigarettes contain 95% less nicotine as compared to the 100 leading cigarette brands in the United States,” 22nd Century said in December.
The company bases the claim of 95% less nicotine on its VLNTM products containing just 0.5 milligrams of nicotine per gram of tobacco, compared with an average of 20 milligrams, or 0.71 ounces, for many of the top-selling traditional cigarette brands.
British American Tobacco Plc, the parent company of Reynolds American Inc., has stated its opposition — and staked its reputation — on calling enhanced FDA oversight of tobacco products “not justified or workable.”
The global manufacturer strongly voiced its opinion in a March analyst presentation, saying it “believes the FDA does not have the (congressional) authority to ban a category of product (in traditional markets) ... or reduce nicotine (levels) in tobacco products to zero.”