Smoking Everywhere V. FDA Daily Docket Sheet Update--APPEAL's COURT ISSUES STAY

[Bill Godshall]

It appears to me that Judge Leon ruled that the marketing of SE and NJOY e-cigarettes didn't meet the criteria necessary under the FDCA for the FDA to regulate them as drugs or devices, but that the FDA could (if it choses to) regulate them as tobacco products under the new FDA tobacco law (which is precisely what I've been urging the FDA to do, and what I urged Congress to stipulate in the FDA tobacco legislation).

But unless/until the FDA announces that it considers e-cigarettes to be tobacco products, the FDA cannot enforce provisions of the FDA tobacco law on e-cigarette companies.

I'm also not aware of anything in Judge Leon's ruling that precludes the FDA from regulating other e-cigarettes as drugs or devices if they are being marketed as "smoking cessation aids".

It appears that Judge Leon basically ruled that the legal/regulatory definition/category of e-cigarettes (and perhaps other smokefree tobacco/nicotine products) is determined by (or based upon) the marketing claims made by the product manufacturers/vendors.

It also appears that an e-cigarette company could begin marketing their e-cigarette brand as a smoking cessation aid (if/when their application to do so as a drug or device is approved by the FDA, which is likely to still require a clinical trial study) at the same time other e-cigarette brands can be marketed (and regulated by the FDA) as tobacco products.

Of course all of this presumes that that Judge Leon's ruling is not overturned by higher courts.

So the important question is whether or not the FDA will appeal Judge Leon's ruling or whether the agency will decide to go along with Judge Leon's ruling, and redefine and regulate e-cigarettes as tobacco products.

Regardless of the FDA decision (to appeal Judge Leon's ruling or to go along with it an redefine e-cigarettes as tobacco products), Judge Leon's ruling will give the e-cigarette market at least several additional months to expand without FDA interference. Since the e-cigarette market more than doubled in the past year (despite the FDA's actions), the e-cigarette market could easily double again within the next several months.

By then, it will be even more difficult for the FDA (or for those who urged the FDA to ban e-cigarettes by declaring them to be unapproved drug devices) to continue falsely claiming that there is no evidence that e-cigarettes can help smokers quit or reduce consumption. So e-cigarettes could have the best of both worlds, legally regulated by the FDA as tobacco products, while being obvious to the FDA and everyone else that they are also effective for smoking cessation (even though manufacturers/importers/marketers cannot say so).

But if/when the FDA declares/approves e-cigarettes to be tobacco products, then even a truthful claim (made by an e-cigarette manufacturer/vendor) that their e-cigarette is "far less hazardous than cigarettes" would be a violation of the "modified risk tobacco product" provision of the new FDA tobacco law (unless/until the FDA approves an application by the company to make the or a similar claim, which is likely to occur if the application is well argued and once the FDA approves similar applications by other companies).

Similarly, once the FDA declares/approves e-cigarettes to be tobacco products, e-cigarette companies would be required to apply to the FDA to make "reduced exposure" claims as campared to cigarettes. It would be even more difficult for the FDA to deny reasonable applications by e-cigarette companies to make those types of claims.

I agree with Phi that if/when the FDA redefines e-cigarettes as tobacco products, the FDA could attempt to stop some e-cigarette companies from marketing their "tobacco" products because they weren't on the market before 2/15/07 (by claiming that that are adulterated tobacco products), but the courts could overrule the FDA by citing that since other e-cigarette brands were on the market prior to 2/15/07, all of them are grandfathered in.

But if/when the FDA redefines e-cigarettes as tobacco products, Altria, Reynolds, Lorillard and others could (and are likely to) begin marketing Marlboro, Camel and Newport e-cigarettes as alternatives to cigarettes, and they probably apply to the FDA to make "reduced exposure" claims and "modified risk tobacco product claims".

But even without making "reduced exposure" or "modified risk tobacco product" claims, Altria, Reynolds, Lorillard, etc could quickly change the e-cigarette market (by putting them on the same shelves beside their cigarettes) at 500,000 retail stores throughout the country.

Within five to ten years, e-cigarettes could replace traditional cigarettes as the largest selling tobacco product, which would be a huge victory for public health.

[DC2]

Within five to ten years, e-cigarettes could replace traditional cigarettes as the largest selling tobacco product, which would be a huge victory for public health.

This will no doubt happen.

[Sun Vaporer]

I agree with Phi that if/when the FDA redefines e-cigarettes as tobacco products, the FDA could attempt to stop some e-cigarette companies from marketing their "tobacco" products because they weren't on the market before 2/15/07 (by claiming that that are adulterated tobacco products), but the courts could overrule the FDA by citing that since other e-cigarette brands were on the market prior to 2/15/07, all of them are grandfathered in.

I would take exception with your concusion here Bill as IMO, the FDA would have argued that as an "even arguendo" and they failed to. If you take a hard read of the decision, Judge Leon did not leave the door open to find them as a "adulterated tobacco product". That is my take on it.


Sun

[tvujec]

I would take exception with your concusion here Bill as IMO, the FDA would have argued that as an "even arguendo" and they failed to. If you take a hard read of the decision, Judge Leon did not leave the door open to find them as a "adulterated tobacco product". That is my take on it.

I agree, and I don't see them being able to argue that on the appeal. However, would they be able to bring it in as evidence during the regular trial?

[Sun Vaporer]

I agree, and I don't see them being able to argue that on the appeal. However, would they be able to bring it in as evidence during the regular trial?

Tvujec--this case is what we call a "Case Stated". Basically like a Motion For Summary Judgment as there are no genuine issues of material facts in dispute, rather just an interperation of the law to the facts in the instant case.

Here, none of the parties disputes, what an e-cig is, or how it works, and now, after the ruling, what it is intended for.

So there really is no evidence, per se, that can change Judge Leon's ruling that the e-cig is an adulterated tobacco product or nicotine is a "drug" for the purposes of the statutory scheme.

Rather, Judge Leon found the e-cig was for recreational use, and that nicotine was being used consistat with that use. So the adulterated tobacco argument really has no merit.

If you look over all the FDA pleadings, at no point in time did they advance this argument. They can try to now, but are up against the ruling the Judge already made that they are a tobacco like product used for recreational purposes with no theraputic endpoint.

Sun

[Sinless1]

We will not link to sites, or allow suppliers to post on ECF whose sites contain the following:
Health claims of any sort whatsoever, including:
quotes from medical professionals
comparisons to tobacco
words such as "safe" "healthier" "cleaner" "toxin-free" "no-carcinogens" etc.
Claims for smoking cessation, such as:
"give up tobacco" "quit smoking" etc
The above claims are misleading to potential consumers and may create problems with the regulatory agencies. Claims of this type are unsubstantiated since there is no recognised research data to confirm them, and this means that there are also legal issues if such claims are made.

So since the ruling was won per the arguments of SE "healthier alternative" and such.
Is the e-cigarette-forum gonna relax the rules here now?
and face the facts that the e-cigarette works very well because a very high percentage really do "quit Smoking"
and the fact it takes very little common sense to know the ecig is in fact "a Healthier Alternative"

Can people finally stand up for what they believe uncensored on this forum now?

[Sun Vaporer]

So since the ruling was won per the arguments of SE "healthier alternative" and such.
Is the e-cigarette-forum gonna relax the rules here now?
and face the facts that the e-cigarette works very well because a very high percentage really do "quit Smoking"
and the fact it takes very little common sense to know the ecig is in fact "a Healthier Alternative"

Can people finally stand up for what they believe uncensored on this forum now?

Not until the ruling is final and we have a fully adjudicated Judgment.


Sun

[Sun Vaporer]

Due to the Holiday, the Court is closed today, but I will be looking for the FDA's filing of its Notice of Appeal.

On another note, I do not know if it was posted that on Friday, the Docket showed that Judge Leon entered into the Record and Docketed the Amicus curiae Briefs filed by ASH and Alliance.


Sun

[TheIllustratedMan]

Due to the Holiday, the Court is closed today, but I will be looking for the FDA's filing of its Notice of Appeal.

On another note, I do not know if it was posted that on Friday, the Docket showed that Judge Leon entered into the Record and Docketed the Amicus curiae Briefs filed by ASH and Alliance.


Sun

I was wondering what happened with those. Thanks for that nugget.

[mpetva]

Due to the Holiday, the Court is closed today, but I will be looking for the FDA's filing of its Notice of Appeal.

On another note, I do not know if it was posted that on Friday, the Docket showed that Judge Leon entered into the Record and Docketed the Amicus curiae Briefs filed by ASH and Alliance.
Sun

what does that mean for the e-cig?