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

[Silence]

ok then. If nicotine can naturally be found in other naturally occurring plants/veg then it would be absurd to claim that it is solely a tobacco product. Anyone know how to smoke a tomatoe and is it bad for me?

[Sun Vaporer]

What really gets me is e-cigs where banned because of a trace amount of Diethylene glycol. .

Bardic--A little clarification---the e-cig was not "banned" due to any findings by the FDA, rather the e-cig has and is unapproved according to the FDA as no manufacturer has yet to go though the requiste application and approval process that supplies the studies mandated.

SE and NJOY claim that the e-cig is not a drug subject to that level of regulation, but rather a tobacco product that can not be banned. The FDA's postion is that the E-cig is a drug delivery medical device and drug comination. Judge Leon will clarify the postition and the Appeals Courts will have the last word.

Sun

[just-a-nobody]

So if the argument comes down to the e-cig user determining their own dosage of juice, what's the difference between that, and a person applying multi nicotine patches or 10 pieces of nicotine gum?

[Sun Vaporer]

So if the argument comes down to the e-cig user determining their own dosage of juice, what's the difference betwee that and a parson applying multi nicotine patches or 10 pieces of nicotine gum?

Just--the patch and gum are FDA approved NRT's--the E-cig is not an NRT. It is meant to be used the same way tobacco is---big difference.


Sun

[bogiediver]

And this really has nothing to do with intended use, but with the fact that selling nicotinated non-tobacco products is prohibited under the new Tobacco Control Act.

I'm curious as to which "Tobacco Control Act" is being refered to.

The PACT Act of 2009 and The Family Smoking Prevention and Tobacco Control Act of 2009 do not address 'non-tobacco products'. The definitions in each of the acts are very specific - having read the full text of each, unless there is a definition change within the acts; and until, and if, the e-cig and/or juice are classified as tobacco products; these two acts do not apply.

The PACT Act hasn't even been voted on by the Senate yet so a definition change is possible, though not likely. The FSPTCA is in effect and would require amendment to change the definitions.

-bogie

[PhiHalcyon]

I'm curious as to which "Tobacco Control Act" is being refered to.

Section 201(rr)(4) of the FDCA (added via the FSPTCA) 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."

[Our House]

And, like it not, the FDA DOES have the responsibility to ensure that a drug product is safe for its intended use BEFORE that product should be permitted to be sold.

The burden of proving a drug product safe for its intended use should be on the manufacturer that seeks to sell it.

There is no such thing as a right to engage in the marketing of drug products that have not been proven generally safe for their intended use; but it is indeed unfortunate that nicotine replacement products - which are replacing the same nicotine being used by millions of tobacco users every day - must meet the same standards of safety that other drugs must meet; but this is, however, the current law of the land. Nonetheless, the FDA has no say in what we can consume; only in what we can sell.

So, yes, I agree that the ecig is as much a smoking replacement as it is a nicotine replacement product, but the current regulatory scheme leaves only the drug product classification available for it.

We can let the ecig go to the drug product dungeon without losing the benefits that it has brought us. It's just going to take a little bit of time.

Can you please stop asserting that the ecig is a drug/drug product and then building your argument on that when the very item in question for this case is whether or not the ecig is a drug/drug product? It's circular.

If it was such a no-brainer that the only thing an ecig could be was a "drug product" subject to FDA approval, then why wasn't this case over the same day it started?

[yvilla]

Vocal: I don't consider this a "drug product."

Phi: But the law does.

As Elaine (Vocalek) already pointed out, this is simply not true. The FDA is charged with interpreting and enforcing the law, but it by no means lays out the law. They have been proved wrong before (Brown, for one), and it can happen again.

We are currently still waiting for the “law” on this issue to be authoritatively pronounced.

The maximum allowable percentage of pg in an inhalation solution is 25%; and for glycerin, it is 7.3%. And these numbers are not arbitrary.

Also not true. I let you get away with this the first time you posted it, but I cannot let it pass without comment a second time.

You got those 25% and 7.3% figures from the FDA’s inactive ingredients database, but failed to fully understand their meaning, or the purpose of the database. They do NOT represent some fixed maximum allowable percentage at all. Here is what the FDA says the purpose of the database is:

The Inactive Ingredients Database provides information on inactive ingredients present in FDA-approved drug products. This information can be used by industry as an aid in developing drug products. For new drug development purposes, once an inactive ingredient has appeared in an approved drug product for a particular route of administration, the inactive ingredient is not considered new and may require a less extensive review the next time it is included in a new drug product. For example, if a particular inactive ingredient has been approved in a certain dosage form at a certain potency, a sponsor could consider it safe for use in a similar manner for a similar type of product.

http://www.fda.gov/Drugs/InformationOnDrugs/ucm080123.htm

Thus, the 25% figure for an inhalation solution you saw in the propylene glycol containing products database is nothing more than the maximum potency found in a currently approved inhalation product. So if a drug manufacturer wants its new inhalation product containing PG as an inactive ingredient to get approved with a “less extensive review”, it may well decide to go with 25%. However, if it has a reason why its new inhalation product should contain a higher percentage of PG, then it will have to be prepared to defend that decision through a more thorough review.

To illustrate my point further, you can see extremely similar types of products with wildly differing percentage concentrations of PG. For example, IM - IV; SOLUTION, INJECTION – 41.60% PG, and IM - IV; INJECTION – 82.04% PG. The same goes for glycerin – you can find one type of soft gelatin oral capsule with 75 mg. of glycerin, and another with only 25 mg; one IV infusion with 2.5%, and another with 22.5%.

[yvilla]

Section 201(rr)(4) of the FDCA (added via the FSPTCA) 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."

And you know darn well I have already presented very strong arguments earlier in this thread that your reading of this provision is simply incorrect as well.

[jadeninja]

I think a few people making the nicotine is tobacco claim, would also make the argument that milk should be classified as steak since they both come from a cow.

LMFAO