FDA announces enforcement plan for some flavored e-cigs; local action remains key

The FDA has released its detailed “guidance” document that outlines what enforcement action it plans to take against flavored e-cigarettes.  It is important to understand that this is not a law or even a regulation, but rather a non-binding statement of how FDA plans to enforce the law.

This plan is based on the fact, stated several times (pages 3, 11, and 12) that all e-cigarettes currently on the market are there illegally. The FDA is simply going to stop giving all of them passes and is going to start enforcing the law against some e-cigarettes.  As FDA says on page 3, “This guidance does not in any way alter the fact that it is illegal to market any new tobacco product without premarket authorization.”

What the FDA says it is going to do is "prioritize enforcement" to stop the sale of:

1. Flavored, cartridge-based ENDS [electronic nicotine delivery systems, which includes e-cigarettes} products (except for tobacco or menthol flavored);
2. All other ENDS products for which the manufacturer has failed to take adequate measures to prevent minors' access; and
3. Any ENDS products targeted to, or whose marketing is likely to promote use by, minors.

As I (and others) said when the press reported that this plan was coming, overall it is a big win for industry.

Here are my comments on the details of the plan.

Some e-cigs popular with kids will probably get a pass

Here is how FDA defines “cartridge-based” e-cigarettes (on page 10):

Cartridge-based ENDS products are a type of ENDS product that consists of, includes, or involves a cartridge or pod that holds liquid that is to be aerosolized through product use. For purposes of this definition, a cartridge or pod is any small, enclosed unit (sealed or unsealed) designed to fit within or operate as part of an electronic nicotine delivery system.20

This raises the question of whether Suorin, an e-cigarette that is very popular with kids that it sold empty and has refillable pods, would be included.  I asked Matt Myers at Tobacco Free Kids.  He said that he asked the FDA, which didn’t answer his question.

I urge reporters to ask the FDA about Suorin, since lots of kids use it.

Footnote 20 to this definition adds a troubling exemption:  “An example of products that would not be captured by this definition include completely self-contained, disposable products.”

This means that popular disposable Puff Bar e-cigarette that is showing up around schools. 

In justifying going after the cartridge systems, FDA says (on page 16) that

Small products may allow youth to use the product in circumstances where use of tobacco products is prohibited, such as a school. Small size may also allow the user to quickly conceal the product in the palm of one’s hand or in a pocket. Small size may allow for product use in a social setting without others’ awareness, particularly in conjunction with vaping techniques that may be used to prevent or hide the vapor cloud.

On page 17, the FDA says

Other product features that facilitate ease of use include pre-filled cartridges, which are convenient because they do not require filling prior to use and are easy to dispose of and replace; a draw-activated battery that makes the devices much easier to use than other devices;

Both these statements are describing a Puff Bar (photo).

Will companies be able to keep mint flavor after all?

The guidance says that FDA will enforce against to mint, but not menthol.  Because FDA seems to be talking about characterizing flavors not ingredients, there is nothing to keep e-cig companies from simply relabeling mint flavored e-cigs “menthol.”  After all, menthol is derived from mint.  They could package them in green, just as the cigarette companies did in Canada when menthol cigarettes were banned (photo).  Or, they could put green leaves on the package.

FDA will allow products if the manufacturer takes “adequate” steps to avoid youth sales rather than making decisions on what kids are actually using

 On page 22, FDA spells out that they expect companies to do, including monitoring retailer compliance with age verification systems.  As the lawsuit by the California Attorney General documented in great detail, these systems are not reliable and the manufacturer can set the parameters for how strict hey are applied.

The FDA maintains the false choice of preventing youth initiation with protecting adults’ use of e-cigs for quitting

On page 19 (and elsewhere), FDA says its “intent was, to the extent possible consistent with protecting population health, to avoid foreclosing one potential means by which some adult smokers might seek to transition completely away from combusted tobacco products to potentially less harmful tobacco products.”  But then, in footnote 80 on page 24, the FDA admits that “no ENDS product has been approved by FDA as a drug for smoking cessation.”

FDA goes on to say, “However, the premarket review process for ENDS products will provide an opportunity for FDA to further examine the potential of an ENDS product to meet the tobacco product premarket authorization standard of ‘appropriate for the protection of public health,’ including adult decisions to completely transition away from use of combustible products to potentially less harmful ENDS products or other non-combustible forms of nicotine delivery.”

Thus, FDA is trading off the not-yet proven possibility that adults might quit smoking with e-cigs against the demonstrated impact on youth initiation.

This position ignores the fact that even under very favorable assumptions about the use of e-cigarettes for quitting smoking, for every adult that quits 80 kids will start.  And that is based on data from before the advent of Juul and the other nicotine salt e-cigarettes and the explosion of youth use.  It also ignores the fact that most population-level studies show that e-cigarette use is associated with less, not more, smoking cessation in adults.

FDA gives flavored little cigars a pass

That is what poor kids are using.

One hopeful note

On page 31, FDA says it “is continuously evaluating new information and adjusting its enforcement priorities in light of the best available data, and it will continue to do so with respect to these products.”

My suggestion: Health authorities need to watch how the industry and kids respond to these changes and keep the pressure on the FDA to act if we don’t see big drops in youth use immediately.

In addition, schools could send the e-cigs and other flavored products they collect from kids and find on the ground in parking lots to the FDA to show FDA how well things are going.

That would also mean that the FDA would have to figure out what to do with the toxic trash.

Local and state action remains key

As FDA said, the FDA is just changing how it applies “enforcement discretion” and this guidance does not have the force of law.  Localities and cities should keep passing laws to end the sale of all flavored tobacco products.