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For years, the FDA has moved in slow motion on tobacco rules. Now, a dramatic acceleration on new restrictions.

For years, the FDA has moved in slow motion on tobacco rules. Now, a dramatic acceleration on new restrictions.


When Donald Trump was elected president in November 2016, an era of federal deregulation was projected for many industry sectors, particularly tobacco.

The Trump administration Food and Drug Administration was expected to shift into lower gear, if not halt, its already slow-walking of asserting the regulatory authority given to it by a Democratic Congress in the 2009 Tobacco Control Act.

Instead, in a stunning 13-day turn of events, the FDA accomplished two once-improbable goals sought by public-health and anti-tobacco advocacy groups:

  • Getting Congress and Trump to approve raising the federal minimum age for buying and consuming tobacco products from 18 to 21. Trump signed the new minimum age language into law Dec. 20 as part of a federal spending bill.
  • Establishing a ban — potentially temporarily — on flavored closed/cartridge electronic-cigarette products outside menthol and tobacco. Thursday’s ban is set to go into effect in early February.

The FDA also determined that makers of nicotine liquids are manufacturers, and thus required to submit a premarket application by a federal court-mandated May 12 deadline in order to be included in a 12-month FDA review process.

The premarket standard requires the FDA to consider products’ existing risks and benefits to the population as a whole, including users and non-users, particularly as it compares with traditional cigarettes.

If e-liquid manufacturers don’t apply, their products would be deemed as illegal to sell. However, being in the process allows their product to stay in the marketplace.

Analysts, industry officials and advocates have said for years it could cost millions of dollars for each product to go through the premarket regulatory pipeline.

The FDA, meanwhile, has estimated it would cost about $500,000 per product. FDA officials said Thursday they would offer application assistance to small manufacturers of vaping liquids.

Finding a balance

For a Trump administration trying to revive so-called “clean coal,” lower automobile emission standards, and rescind, if not eliminate, Affordable Care Act health regulations, the willingness to expand tobacco restrictions appears out of character.

But analysts say the national outcry, or some would say histrionics, over the vaping crisis in 2019 may have forced Trump and the FDA’s hands with the public.

The FDA was given the authority in June 2009 to: remove ingredients considered as hazardous; restrict the marketing and distribution of cigarettes and smokeless tobacco; focus on limiting the impact of advertising on youth; expand warning labels; and stop the use of such characterizations as “light” or “low tar.”

At that time, e-cigarettes were in their infancy, mostly made in China with little popularity with smokers.

The FDA’s dilemma has been that there are no safe-for-consumers tobacco products, even with the potential for reduced risk with e-cigarettes and snus.

The risk with an FDA “seal of approval” for tobacco products is that it would be perceived as a symbol that they are appropriate to consume, rather than just less harmful than traditional-cigarette products that contribute annually to more than 400,000 premature deaths in the U.S. alone.

There have been only four tobacco products to have gained a form of FDA authorization: iQOS heat-not-burn traditional cigarette by Philip Morris USA; the very-low-nicotine traditional cigarettes Moonlight and Moonlight Menthol by 22nd Century Group Inc.; and the General Snus style of Swedish Match.

They all carry the caveat that it does not mean “these products are safe or FDA approved.”

R.J. Reynolds Tobacco Co. said in July 2018 that its heat-not-burn traditional cigarette, Eclipse and Eclipse Menthol, had received market authorization from the FDA. Reynolds has not announced a test market for the Eclipse styles after initially projecting it would begin such an effort by July 2019.

Thom Golab, president of the American Council of Science and Health, a health-care think tank, said the FDA’s challenge remains “finding a balance on tobacco and public health to eliminate as much exposure to underage users as possible, while also expanding the potential for electronic cigarettes to be a public-health benefit for those trying to stop smoking.”

“Flavors are necessary for enticing people to buy your product, whether it’s candy, soft drinks, fast food or tobacco.”

That’s why Golab said he is hopeful the FDA will accelerate its review process of innovative tobacco products, particularly the premarket application process, so that flavored e-cigarettes can be returned to retail outlets if determined to have an overall public-health benefit.

Warning labels

When the Tobacco Control Act was enacted in June 2009, the FDA provided a guideline for implementing new restrictions expected to be fully in place by 2012.

For example, traditional cigarette flavorings outside menthol were to be banned by September 2009 — not a major task given most manufacturers already had abandoned candy and fruit flavors.

The law required FDA premarket approval for new products, those introduced after Feb. 15, 2007. There was an exemption for new products if they were substantially equivalent health-wise to existing products.

Camel Snus, the top-selling snus in the U.S., was introduced by Reynolds before February 2007, and there were similar snus products in existence as well.

Litigation from U.S. tobacco manufacturers successfully bogged down some of the FDA’s roll-out initiatives.

One example is the FDA’s efforts to put new graphic warnings labels still have not reached cigarette packaging.

The FDA said in August 2019 that it has released a new set of 13 graphic warning labels for traditional cigarettes that are toned down considerably from its first attempt in 2012. They include images of diseased lungs, a man with surgical stitches from heart or lung surgery and a child with an oxygen mask.

The warnings have been mandated by a federal judge to be in place by March 2020 for cigarette packaging and marketing. The ruling does not affect other tobacco products, such as electronic cigarettes.

By July 2021, the labels would be required to cover the top 50% of the front and rear panels of cigarette packages, as well as at least 20% of the top of cigarette advertisements.

“The FDA needs to stop focusing on the flavorings and for once, focus on the nicotine, which is the problem,” said Michael Siegel, a professor in the Boston University School of Public Health.

“The epidemic we have is not one of youth flavor use, but of youth addiction to the Juul device ... because Juul has more than 50 milligrams/milliliters of nicotine salts.”

“If policy makers were interested in protecting the health of Americans, the first thing they would do is to get the nicotine out of combustible cigarettes and restrict their sale to tobacco shops that are only open to adults.

“The second thing they would do is limit the level of nicotine salts in electronic cigarettes, especially Juul.”


Four months after the Trump administration took office, it chose in May 2017 to give federal health officials more time to evaluate Obama administration-era guidelines on e-cigarettes, vaporizers and other innovative nicotine and tobacco products.

As a result, rules that were supposed to go into effect were put on hold, supposedly for just three months.

Those guidelines include: manufacturer submission of cigar warning label plans; registration and listing; ingredient listing; health documents; substantial equivalence exemption requests; substantial equivalence applications; premarket tobacco product applications; and harmful and potentially harmful constituent reports.

Meanwhile, Sen. Ron Johnson, R-Wis., sent a letter to the FDA commissioner warning that a Republican-controlled Congress and White House would take aim at the August 2016 regulations.

Johnson said part of his motivation is that the costs of adhering to the new regulations “are so needlessly high that the very existence of the vapor products industry is being threatened.”

For example, a bill sponsored by Rep. Duncan Hunter, R-Calif., would require that e-cigs no longer be classified as tobacco products.

Gregory Conley, president of the American Vaping Association, said the fact that President Trump “is also a teetotaler who has never drank or smoked” likely influenced his decision in September to support a more extensive banning of flavored tobacco products.

“The only voices President Trump was hearing from the morning he announced the ban were pro-ban advocates like HHS Secretary Alex Azar and Kellyanne Conway,” Conley said.

David Sweanor, an adjunct law professor at the University of Ottawa and the author of several e-cig studies, said that “since the time of initial regulation of nicotine-replacement therapy products, there has been the seemingly absurd position that the least hazardous nicotine products are subject to the greatest regulatory constraints.”

Some studies, including one by the Royal College of Physicians, have claimed e-cigs and vaporizers are up to 95% less harmful than traditional cigarettes. The Royal College’s study on traditional cigarettes played a key role in the landmark 1964 surgeon general’s determination.

“The public positioning on vaping has been overwhelming focused on risks rather than benefits,” Sweanor said.

“To the extent that the use of a low-risk form of nicotine is now widely seen as a bigger problem than the 500,000 annual U.S. deaths from cigarette smoking.

“Fears often outweigh facts, and politicians are responding to the public mood,” Sweanor said.



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