September 13, 2019

Stanton A. Glantz, PhD

What the FDA is and is not talking about doing now

The media has presented the anticipated FDA action on flavored e-cigarettes as a “ban” on flavors.  The FDA is not planning to issue a regulation (technically a product standard under Section 907 of the Tobacco Control Act) prohibiting the use of flavors.  Rather, it is planning to adjust and finalize the draft “compliance policy” it proposed in March 2019 by stopping to use its “enforcement discretion” to allow illegal e-cigarette products to remain on the market.

This is a good idea, at least in the short run, because, unlike a regulation, which could take years to finalize, the compliance policy will take effect 30 days after it is announced (unless the industry manages to block it in court).

To understand what this means, it is important to understand that after the August 2016 “deeming rule,” all e-cigarettes on the market became illegal because they were tobacco products under FDA jurisdiction that were being sold without a “marketing order” from the FDA, which is required to legally sell new tobacco products like e-cigarettes.

To be fair to manufacturers, the FDA deeming rule gave companies two years (until August 2018) to submit applications to the FDA, known as PMTA’s (premarket tobacco authorization), to make the case that allowing the products on the market would be “appropriate for protection of public health,” the standard in the law that the FDA is supposed to apply.  FDA committed to making decisions within a year, during which time products could remain on the market unless FDA declined to authorize marketing.

Had the original deeming rule been implemented, any e-cigarettes being sold today would have gone through that process, which would have been completed by August 2019.

But former FDA Commissioner Scott Gottlieb pushed the deadline out to August 2022 and, as of today (September 2019), not a single e-cigarette company has submitted a PMTA.

Health groups successfully sued the FDA, and the court has ordered the FDA to move the deadline for submitting PMTAs up to May 2020.

But, as I said, technically, all e-cigarettes on the market are illegal and subject to FDA enforcement action.

So, now, FDA is going to stop being so loose in applying its enforcement discretion.  In particular, media reports, FDA is going to stop allowing flavored e-cigarettes other than tobacco flavor (including menthol and mint, which is stronger than the draft compliance policy it released last March).  This decision, combined with FDA’s increased willingness to challenge e-cigarette claims that they are cessation products and reduced risk products integrates much of what we suggested they do in a public comment we submitted on the March 2019 draft.  This is better than what they proposed in March also because in March they were going to allow flavored products to be sold in “age restricted” locations.  This fully pulls them from the market for now.

Another way in which the announced plan is better than what they proposed in March is because in March FDA was going to allow flavored products to be sold in “age restricted” locations.  The FDA says they are going to fully pull all flavored e-cigarettes from the market for now.

The only thing in our public comment that the FDA has not addressed in our suggestion that internet sales be banned; it remains important for FDA to close this loophole in its final compliance plan.

In many ways, what FDA has said it was going to do is similar to the flavor policy that FDA tried to implement in the August 2016 deeming rule that the Obama White House blocked

As I said above, this is a good short-run solution.  It is not, however, a permanent ban on all flavors. A company can still submit a PMTA for a flavored e-cigarette, and if they can convince FDA that it is "appropriate for the protection of the public health," it could be authorized for sale.

Given FDA’s recent approval of PMI’s IQOS, a heated tobacco product, I remain very concerned that FDA will approve many e-cigarettes, perhaps even with menthol, as it did for IQOS.  As I pointed out in an earlier blog post, FDA set an exceptionally low bar in approving IQOS, only requiring PMI to demonstrate that IQOS was not worse than a cigarette and with the FDA taking on the burden of demonstrating that IQOS was not appropriate for the protection of public health” rather than requiring PMI to prove that it was. 

This is a very dangerous precedent that needs to be challenged not only on IQOS, but because. if it holds, FDA will approve a lot of dangerous e-cigarettes, maybe even with flavors.

In addition, FDA’s approval of IQOS may have created an alternative electronic product for kids.  A Morgan Stanley analyst observed

The inclusion of mint and menthol is an incremental negative for JUUL as these flavors represent >80% of its sales. Last year, JUUL pulled all of its flavors other than tobacco, mint, and menthol from brick-and-mortar retail distribution. However, essentially all of its flavor sales shifted to mint/menthol, which accounted for over 80% of JUUL’s sales in measured channels as of August 2019". Regarding the transaction, the analyst went on to state "this is an unfavorable development for JUUL, but cigarette volumes could improve and IQOS may be relatively better positioned. We would expect pulling flavors other than tobacco to have a negative impact on JUUL’s overall growth and financial performance, but it could be a benefit to cigarette volumes if vapers revert back to smoking cigarettes or if it slows the switch to vaping. Moreover, this could better position IQOS relative to e-cigs, given IQOS flavors are limited to tobacco and menthol.

Another concern is that the FDA prohibit the sale of flavored e-cigarettes, not just e-cigarettes with characterizing flavors, as is the case with cigarettes.  Because of this distinction, it is illegal to sell mango cigarettes but it is not illegal to sell cigarettes containing mango flavor, as long as they are not marketed as “mango cigarettes.”  FDA should not allow the e-cigarette companies to get away with this trick.

Why am I concerned?  This is exactly what is happening in Korea, according to my colleague Minji Kim.  In Korea JUUL sells five different pods: Classic (tobacco, Dark red color), Delight (Vanilla/cream, Light ivory color), Fresh (Mint or menthol, Teal color), Tropical (Mango, Orange color), and Crisp (Fruity, Apple green color).  (See picture at the bottom of this blog post.)

Here in America the cigarette companies use similar color coding trick to get around the prohibitions of “light” and “mild” claims for cigarettes (and the FDA and Department of Justice have let them get away with it for years).  In Ontario, Canada the companies started selling green packs of cigarettes when the government said they could no longer sell menthol cigarettes.  FDA has to be on the lookout for the companies playing such games and not give them a pass like it has on color-coded cigarette packs.  The compliance plan talks about flavors not characterizing flavors, which is a step in the right direction.  In the final policy, the FDA needs to explicitly prohibit this kind of color coding.

While a big step in the right direction for the FDA, we still don’t know how all this will play out at the federal level or what he courts will do.

 

That’s why states and localities should continue passing laws prohibiting the sale of all flavored tobacco products.

 

These comprehensive flavor bans are also important because all the FDA is talking about is e-cigarettes and poor kids still use the cheaper flavored little cigars.

 

And we need to get rid of menthol cigarettes, which the FDA has yet to address.  That is why local laws that comprehensively prohibit the sale of all flavored tobacco products are still important to pursue.

 

 

Here are the JUUL pods from Korea:

Comments

Comment: 

JUUL pods can be reloaded. I personally can reload them in less than 5 minutes. As long as re-loadable pods exist we will continue to have problems because kids and adults can vape anything they want. Also, using e-cigs with reservoirs, like the one I have, enables vapers to vape ANYTHING they want.

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