All eyes on the FDA: upcoming regulations on Juul e-cigarettes


For years, the FDA has allowed the vast majority of e-cigarettes to stay on the market, even though none of them have the pre-market tobacco product application orders (PMTAs) they need to be. legally sold. But all of that is changing. Following a court ruling, the FDA must issue PMTA orders by September 9, for or against, for each brand or variant of e-cigarette that has requested to remain on the market and withdraw any orders from the market. not allowed.

So the big questions are whether the FDA will issue PMTA orders to allow the continued marketing of all e-cigarettes and, if so, what restrictions and requirements the FDA might place on permitted e-cigarettes, their flavors and their use. marketing.

Juul in the spotlight

One of the first PMTA orders issued by the FDA will likely be for Juul’s e-cigarettes. Juul has focused on marketing electronic cigarettes in just two flavors, tobacco and menthol, and with two different nicotine strengths. Juul says its app includes data-driven ways for the company to address the possible use of its e-cigarettes by minors – but it has not been made public.

Many blame Juul’s aggressive marketing of the multi-flavor versions of its particularly addictive e-cigarettes for the sharp rise in e-cigarette use among young people. North Carolina recently settled its lawsuit against Juul for $ 40 million, and a number of other lawsuits against Juul are ongoing. Prior to that, following bad publicity and pressure from the FDA, Juul stopped all TV, print and digital advertising of its e-cigarettes, and then stopped selling flavors other than tobacco or menthol. Largely because of the increase in consumption among young people, in January 2020, the FDA launched an enforcement action to remove all Juul-type cartridge electronic cigarettes from the U.S. market if they had flavors other than tobacco or menthol.

Likewise, the FDA decision on Juul will set a framework for the FDA’s PMTA decisions for all other electronic cigarettes.

What factors play in the PMTA?

The FDA can only allow an electronic cigarette to be marketed if it believes it is “appropriate for the protection of public health” – that is, it will reduce the overall harms associated with tobacco. While using e-cigarettes is less harmful than smoking, the only safe way for e-cigarettes to reduce harm and health risks is for smokers to who wouldn’t have quit smoking otherwise switch entirely to the use of electronic cigarettes. Or if the young who otherwise would have become addicted smokers instead become regular users of electronic cigarettes.

Any other regular use of electronic cigarettes will increase the health risks. More clearly, any use by young people or adults who would not otherwise use any tobacco product will increase the overall harms (especially if it later progresses to smoking). And any use of e-cigarettes by smokers that stops or delays their smoking cessation or stops all tobacco and nicotine use will also increase the damage to overall health.

Thus, to allow e-cigarettes to remain on the market, the FDA must determine that the harm reductions from their future use as a complete substitute for traditional smoking by those who would otherwise smoke will be greater than the potentially new health harms. caused by electronic cigarettes.

So far, the use of e-cigarettes among young people who would not otherwise smoke appears to be much more common than smokers who only use e-cigarettes. It remains unclear whether the use of electronic cigarettes by smokers will end up accelerating and increasing smoking cessation or reducing or delaying it. As a result, it may seem rather difficult for the FDA to conclude that it is “appropriate for the protection of public health” to allow any electronic cigarette to remain on the market.

However, in any PMTA order authorizing the marketing of electronic cigarettes, the FDA has the authority to include any restrictions and requirements regarding their labeling, packaging, marketing and sale that would increase their harm reduction potential or reduce collateral risks or damage. For example, in the PMTA order allowing Philip Morris’ IQOS “not to burn” cigarette on the market, the FDA stated that it cannot be advertised or sold through any electronic media without strict verification of the age and identity to prevent exposure or purchases of young people. . The FDA will likely impose the same requirement on all e-cigarettes it allows for sale, but the FDA could include much more to protect public health.

For example, the FDA could ban all electronic cigarettes with added flavors other than tobacco and menthol (the only flavors now allowed for cigarettes). Or could allow only tobacco and unflavored versions, and use other measures, instead of flavors, to encourage smokers to change. The FDA could further prevent youth use by allowing e-cigarettes to be sold only in stores that do not allow youth, such as adult-only vape shops or tobacconists. The FDA could also allow e-cigarette advertising only through direct communications with pre-verified adult smokers and ban the sale of cheaper disposable e-cigarettes, which tend to be used more by young people than by smokers trying to smoke. change.

To try to ensure that e-cigarettes are only used in a risk-reducing manner, the FDA may require e-cigarette labeling, package inserts, and advertisements to explain how to use them to reduce health risks. and how all other uses increase the risks and risks to health. .

Put such restrictions and requirements in all PMTA orders of electronic cigarettes. But electronic cigarettes would still be readily available to adult smokers as a likely less harmful alternative. And the FDA could impose parallel restrictions on cigarettes and other smoked tobacco products to further reduce smoking.

In the few PMTA orders already issued by the FDA to allow the marketing of other types of tobacco products, the FDA has not included many measures that would have better protected public health. However, the public health risks associated with the marketing and sale of e-cigarettes are clearly much greater, which may prompt the FDA to act more responsibly this time around. Additionally, the FDA’s failure to adhere to applicable laws to more effectively protect public health in its previous PMTA orders is now a matter of common knowledge, leaving the FDA vulnerable to remedial legal action. This should make continued FDA PMTA failures less likely. It is also possible that some e-cigarette manufacturers have proposed certain product and marketing restrictions and requirements in their applications in order to increase their chances that the FDA deems it appropriate, for the protection of public health, to issue. orders authorizing their marketing.

Is it really a public health issue?

What the FDA ends up doing could, unfortunately, largely depend on a range of political and bureaucratic factors, rather than what is best for public health. Since the Tobacco Control Act of 2009 gave the FDA sweeping powers to regulate tobacco products, the FDA has never received the support from the White House it needs to take strong and effective action to reduce the many deaths and damages caused by smoking. With luck, the Biden administration will support the FDA more than the Trump or Obama administrations. A key indicator for whether this is happening is whether the PMTA orders that the FDA’s questions for Juul and other electronic cigarettes be clearly designed to effectively protect and promote public health, and are also supplemented by new rules. strict FDA regulations to directly prevent and reduce smoking.

Eric N. Lindblom, JD, a former official with the Center for Tobacco Products at the FDA, is now an independent legal and policy consultant on tobacco control and other public health issues, and a senior researcher at the O’Neill Institute in Georgetown Law for national and global health. Right.

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