WVS NEWS: US FDA nicotine cap proposal: a plus for health and alternative nicotine products

Written by Freddie Dawson | ECigIntelligence

The US Food and Drug Administration (FDA) expects its new proposal for a very low nicotine cap on conventional cigarettes to be a net positive for alternative nicotine products.

The proposal still needs to go through a further consultation and review process. The comment period will extend to 15th September and include referring the proposal to the Tobacco Product Scientific Committee for a public meeting. The proposed rule will also have to survive a change in government leadership as well as civil service leadership to one that may prove less amenable to maintaining work on it.

The FDA declined to comment on whether the timeframe for implementing a final rule would lead to the rule being issued under the incoming Republican-led government under Donald Trump, which would generally oppose any and all actions undertaken by the outgoing Democrat-led government under Joe Biden. But soon-to-be retiring Democrat-affiliated leadership appeared optimistic.

Robert Califf, the current but soon-to-be-outgoing FDA commissioner, said: “As a political appointee, I’ll just say, if there is a goal to ‘make America healthy again’, I can’t imagine anything more important to get it done than [approving the nicotine cap rule].”

If the propsal does stay the course, it would become effective two years after the date of publication of the final rule. This means it would be in effect no sooner than 2027 – though in reality the further consultation and review period would almost certainly stretch for years rather than months.

The rule would also face myriad lawsuits that may have to be settled before it can come into effect.

“We are aware we will be sued,” said Brian King, director of the FDA’s Center for Tobacco Products (CTP). “So research has to be airtight to survive the challenges we will get in court. Keep in mind this is an industry that is still fighting us tooth and nail on graphic warnings on cigarette packages.”

Very low nicotine: how low is it?

The current proposal as it stands makes for short-term optimistic reading for nicotine alternatives. The FDA leaned significantly into the continuum of risk as part of the proposal. The agency said the proposal would not include “non-combustible nicotine products” because these products, for smokers transitioning to them from cigarettes, “would prevent severe adverse health consequences of long-term smoking at the individual level and result in public health benefits at the population level”.

King said models estimated that around 50% of current smokers would transition to e-cigarettes or other non-combustible products if the cap was introduced.

“For adults who smoke, switching completely to a lower-risk tobacco product such as FDA-authorised e-cigarettes would reduce exposure to the harmful chemicals present in cigarettes,” he said. “But it is important to note that no tobacco product is safe. So youth should not be using any tobacco products, and adults that do not use them should not start.”

The rule would set a maximum nicotine content level of 0.70 mg of nicotine per g of total tobacco. For comparison, the average nicotine content in the top 100 cigarette brands in 2017 was 17.2 mg of nicotine per g of total tobacco.

It would apply specifically to conventional cigarettes, cigarette tobacco, roll-your-own tobacco, cigars (including little cigars, cigarillos, and large cigars but excluding premium cigars) and pipe tobacco (other than waterpipe tobacco). It would also cover all “components, parts, and accessories of such products”, though accessories of deemed tobacco products such as cigars and pipe tobacco would be excluded.

The FDA warned that it intended to use its premarket review authority to ensure manufacturers do not re-engineer products in a way that would circumvent the proposed maximum nicotine level.

Smoking is still worse for human health than nicotine

The proposed rule will not include e-cigarettes, heated tobacco, nicotine pouches or other oral smokeless tobacco products like snus and chewing tobacco. As part of the notice of proposed rulemaking (NRPM) process, the FDA would now like to gather further public comments, data and research regarding the proposed scope of inclusion – including data that could justify otherwise. It had already gathered significant responses on the subject when it issued its advanced notice of proposed rulemaking (ANRPM) in 2018.

“Based on FDA’s experience with application review, certain non-combusted cigarettes produce fewer or lower levels of some toxicants than combusted cigarettes,” the agency said. “FDA recognises that tobacco products exist on a continuum of risk, with combusted cigarettes being the deadliest, and that certain non-combusted cigarettes pose less risk to individuals.”

The FDA fully believes the rule will lead to many current smokers looking to switch to a non-combustible product and that, while this may sustain their nicotine dependence, it will reduce their risk of tobacco-related death or disease.

The agency was sure to emphasise that while nicotine may be the addictive chemical in cigarettes, it was not the one likely to cause cancer or other typical smoking-related illnesses. It noted that harm perceptions around nicotine were often incorrect, with studies showing the general population widely believed nicotine to cause cancer.

The FDA added that it would not seek to reduce nicotine content to zero, as that would violate part of the Federal Food, Drug, and Cosmetic Act.

As part of its NPRM, the agency said it had considered feedback from its ANPRM on gradually easing down the maximum nicotine cap or undertaking it in one fell swoop. The FDA decided, upon reviewing the relevant information presented, that one single decrease would not only lead to better public health outcomes, it would also be easier for manufacturers, who would only have to reformulate and apply for market approval once (neatly ignoring the fact that if they do not have alternative non-combustible products in place, they will face much more significant declines in sales, which would definitely not make things much easier for them).

The FDA noted that the only current product to receive authorisation that would work under the proposed nicotine cap was 22nd Century Group’s VLN (very low nicotine) King and Menthol King cigarettes with 0.5 mg nicotine content. However, sales of these products amounted to less than 0.001% of total cigarette dollar sales in any four-week period for regular and for menthol cigarettes.

Illicit trade as a result of the rule not a big FDA concern

If the rule is approved, the FDA foresees manufacturers being able to utilise the Substantial Equivalence (SE) pathway to quickly get very-low-nicotine products approved and on the market.

“For example,” the FDA said, “for products modified to comply with this product standard, the applicant could demonstrate how the modification was made to the tobacco filler, provide test data to show that the modification reduced the nicotine content to meet the standard and did not cause the new product to raise any different questions of public health, and provide a certification that no other modifications were made to the new tobacco product other than those made to reduce the level of nicotine.”

The agency added that there was also limited scope for SE exemption pathways – where an applicant can say the new product is only making a minor modification to a legally marketed tobacco product. However, this option is limited as changes to tobacco itself are excluded, so only those employing an alternative method of lowering nicotine would be able to utilise this.

The FDA also attempted to forestall illicit market arguments. It said it did not anticipate a significant increase in illicit market sales because the rule would apply to the entirety of the US, and cross-international-border illicit sales at levels to maintain nicotine addiction were significantly more difficult than cross-state-border sales (which mainly take place due to taxation differences).

The agency added that, even in the worst-case illicit-market scenarios, implementing a nicotine cap on conventional cigarettes would still be a net benefit to public health as it would move significantly more smokers away from cigarettes at a quicker rate. “Lower-risk alternatives will also help combat illicit trade,” said the CTP’s King.

Similarly, although it had heard arguments about illicit cigarettes potentially being unhealthier as they do not necessarily have to conform to the same manufacturing and end-product standards, the FDA determined that the minimal differences in tar and toxicants would not significantly increase the health risk of an already dangerous product at the population level.

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