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

[yvilla]

Then I was informed by LegalOne of the FDA's "all in" determination to regulate the ecig and its e-liquid as a drug/device combination product. Neither of these two facts seemed to square with the whole modified-risk-tobacco-product-approval conclusion I had come to. This forced me to re-examine the belief that e-liquid could be regulated as a tobacco product.

After taking a closer look at the definition of tobacco product, I recently stated that I had concluded that e-liquid is not a tobacco product. Then, in rather short order, LegalOne contested this conclusion with an 'active ingredient' argument. And, as much as I would have preferred to have been able to return to the more promising position of nicotine-containing e-liquid being a tobacco product, I have found the following to be far more persuasive:


Section 201(rr)(4) of the FDCA states that:
"A tobacco product shall not be marketed in combination with any other article or product regulated under this Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement."

According to the FDA's draft guidance of this prohibition, this includes a situation where:
"A tobacco product and a non-tobacco product regulated under the FDCA are physically, chemically, or otherwise combined or mixed to produce a single entity that is marketed as containing both products."

An example given is: Nicotine that is derived from tobacco is added to water, juice, or soda (which are regulated under the FDCA) and the water, juice, or soda is identified as containing a tobacco product.

Simply replace the words "water, juice, or soda (which are regulated under the FDCA)" with the words "propylene glycol and/or glycerine (which are regulated under the FDCA)", and it becomes clear that e-liquid is a prohibited combination product that cannot be regulated as a legal tobacco product. The only circumstance under which nicotine-containing e-liquid could be considered a legal product is if it were to be approved as a drug product subject to chapter V of the FDCA. Consequently, nicotine-containing e-liquid is an unapproved drug product; and the ecig, an unapproved drug delivery device.

Since nicotine-containing e-liquid cannot be regulated as a legal tobacco product, the equal protection argument that I have made in the past (regarding intended uses and classification) does not apply. As a result, the nicotine content of e-liquid is all that is needed to classify e-liquid as a drug - regardless of what claims are, or are not, made.

I disagree with your conclusion, Phi. It's all a matter of intended use and marketing. To take your example of water, juice or soda - that would be a prohibited combination because it would be marketed as water (or juice or soda) with nicotine. Ecigs are not marketed nor sought out as propylene glycol, with nicotine. They are marketed as a smoking alternative, and the PG is simply the carrier (or base if you will) for the nicotine

If you look at the rest of the examples provided in the FDA guidance document on this issue, you can see the point I'm making:


A tobacco product and a non-tobacco product regulated under the FDCA are physically, chemically, or otherwise combined or mixed to produce a single entity that is marketed as containing both products. For example:

• Mouthwash (which may be a drug or a cosmetic under the FDCA) is added to the ingredients of a cigarette and the cigarette is identified as containing mouthwash.
• Compressed or powdered tobacco is added to candy or gum (which are foods under the FDCA) and the candy or gum is identified as containing a tobacco product.
• Nicotine that is derived from tobacco is added to water, juice, or soda (which are foods under the FDCA) and the water, juice, or soda is identified as containing a tobacco product.

Taken from: Draft Guidance: The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act

The ecig is neither marketed or "identified" as a cigarette substitute "containing" PG (as a substance one would want to consume or receive the "benefits of" separately), nor is it marketed as PG (as a substance one would want to consume independently) "identified" or marketed as also containing nicotine.

That the PG (or glycerine) is simply the carrier for the wanted/marketed active ingredient - nicotine - makes all the difference as to this issue, I believe. And that's what LegalOne would say too, I think.

[PhiHalcyon]

I disagree with your conclusion, Phi. It's all a matter of intended use and marketing. To take your example of water, juice or soda - that would be a prohibited combination because it would be marketed as water (or juice or soda) with nicotine. Ecigs are not marketed nor sought out as propylene glycol, with nicotine. They are marketed as a smoking alternative, and the PG is simply the carrier (or base if you will) for the nicotine

If you look at the rest of the examples provided in the FDA guidance document on this issue, you can see the point I'm making:


A tobacco product and a non-tobacco product regulated under the FDCA are physically, chemically, or otherwise combined or mixed to produce a single entity that is marketed as containing both products. For example:

• Mouthwash (which may be a drug or a cosmetic under the FDCA) is added to the ingredients of a cigarette and the cigarette is identified as containing mouthwash.
• Compressed or powdered tobacco is added to candy or gum (which are foods under the FDCA) and the candy or gum is identified as containing a tobacco product.
• Nicotine that is derived from tobacco is added to water, juice, or soda (which are foods under the FDCA) and the water, juice, or soda is identified as containing a tobacco product.

Taken from: Draft Guidance: The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act

The ecig is neither marketed or "identified" as a cigarette substitute "containing" PG (as a substance one would want to consume or receive the "benefits of" separately), nor is it marketed as PG (as a substance one would want to consume independently) "identified" or marketed as also containing nicotine.

That the PG (or glycerine) is simply the carrier for the wanted/marketed active ingredient - nicotine - makes all the difference as to this issue, I believe. And that's what LegalOne would say too, I think.

The reason I didn't dig deeper into addressing this issue you have raised is because it doesn't matter whether or not e-liquid is a prohibited combination product. All that matters is that e-liquid is not a tobacco product, but a pharmaceutical grade fog juice that contains a tobacco product. Therefore, it is not a true statement to say that e-liquid is "made or derived from tobacco."

[yvilla]

And a further thought, Phi: If an ecig were to be marketed specifically as containing PG - as a "germ-killer", for instance, and nicotine - as a smoking alternative, for consumers to get the benefits of those two purposes at once, then and only then would it run afoul of the "cannot be marketed in combination" rule.

[yvilla]

The reason I didn't dig deeper into addressing this issue you have raised is because it doesn't matter whether or not e-liquid is a prohibited combination product. All that matters is that e-liquid is not a tobacco product, but a pharmaceutical grade fog juice that contains a tobacco product. Therefore, it is not a true statement to say that e-liquid is "made or derived from tobacco."

I still disagree.

[PhiHalcyon]

I still disagree.

You're allowed.

[PhiHalcyon]

I'd disagree with myself if I could. But, if you put me in a lie-detecting electric chair that would activate if I were to lie, and were to ask me point blank: "Is e-liquid made or derived from tobacco?", I can guarantee that one answer that would NOT come out of my mouth would be "yes".

[yvilla]

But we cannot forget that even the FDA agrees that ecigs meet the statutory defintion of a tobacco product - as seen in its (by now should be infamous) supplemental brief:

"There appears to be no dispute among the parties that SE’s E-cigarettes satisfy the first prong of the definition of “tobacco products,” in that they are “made or derived from tobacco [and] intended for human consumption.” FSPTCA, Sec. 101(1)."

http://www.fda.gov/downloads/NewsEve.../UCM173193.pdf

(Of course, then they go on to argue but no, they can't be a tobacco product because we already decided they were a "drug" or "drug device or combination" product. But I've already argued exhaustively about why that's such a circular argument, so I'm not going to repeat myself here).

[JerryRM]

I think you have more initiative than consultation. There is a reason why the legal issues get discussed in this thread, and that is because this is the thread that members turn to for this sort of information. At least that is why I post here. Just because the conclusions have been becoming more and more grim is no reason to hide the word in some low-traffic corner of the legal section. People need to know.

I believe you have misjudged my intention. I am not attempting to move lengthy comments to "some low-traffic corner of the legal section". Personally, I enjoy reading all the comments here, but I have noticed that some members feel that we have gone off topic. That may cause some to hesitate to post their remarks on this thread. My intention is to link my thread with this one, therefore giving everyone the option of posting there if they feel hesitant to post here and nothing more.

[PhiHalcyon]

But we cannot forget that even the FDA agrees that ecigs meet the statutory defintion of a tobacco product - as seen in its (by now should be infamous) supplemental brief:

"There appears to be no dispute among the parties that SE’s E-cigarettes satisfy the first prong of the definition of “tobacco products,” in that they are “made or derived from tobacco [and] intended for human consumption.” FSPTCA, Sec. 101(1)."

It was the FDA not disputing that e-liquid was a tobacco product that helped keep me anchored in the same belief for so long. It nevertheless remains to be seen as to whether or not it will change this position. But, even if my assessment of the matter is incorrect, and e-liquid remains considered a tobacco product, all the e-liquid on the market today is technically misbranded and/or adulterated. Which means that an FDA approval as a new tobacco product, or a modified risk tobacco product, would still be required in order for a manufacturer's e-liquid to be a legal product. Nonetheless, something tells me that if the FDA loses its bid to regulate e-liquid as a drug product, then it is not going to all of a sudden become eager to issue approvals.

[yvilla]

It was the FDA not disputing that e-liquid was a tobacco product that helped keep me anchored in the same belief for so long. It nevertheless remains to be seen as to whether or not it will change this position. But, even if my assessment of the matter is incorrect, and e-liquid remains considered a tobacco product, all the e-liquid on the market today is technically misbranded and/or adulterated. Which means that an FDA approval as a new tobacco product, or a modified risk tobacco product, would still be required in order for a manufacturer's e-liquid to be a legal product. Nonetheless, something tells me that if the FDA loses its bid to regulate e-liquid as a drug product, then it is not going to all of a sudden become eager to issue approvals.

Now here I do agree with you, especially the bit about the FDA's likely "eagerness" (or lack thereof) to issue approvals of ecigs as modified risk tobacco products, even if they are forced by Judge Leon to concede they are not drug products.

However, there is one tiny spark of hope in me that some ecig vendor may be able to prove that their ecigs were marketed in the US prior to the critical February, 2007 date. To my knowledge, no one has definitively proved or disproved that as of yet.

And even if that small hope of being grandfathered in is ultimately smashed, I still think and hope that despite the FDA's reluctance, if the legal ruling comes down on the side of ecigs being tobacco products, then with sufficient pressure being brought they will at some point obtain the necessary approvals to be sold as modified risk tobacco products. On the other hand, if they are ruled as drug products - then I fear that's their death knell.