Read this! Tuesday: Halo start first lawsuit against FDA, Debate in the UK House of Lords

[crxess]

Yes, nicotine is an active ingredient in a drug, just as penicillin is an active ingredient. The active ingredient is almost always provided for use in various forms, such as injectable penicillin, pills, or capsules. The active ingredient will be combined with a number of inactive ingredients for administration. So inactive binders may be used to create a tablet (or capsule, which have a different set of inactive ingredients such as the gelatin), or specific liquids may be mixed containing the active ingredient for injection.

The FDA began regulating nicotine (no matter how obtained, whether extracted from tobacco or synthetically manufactured) back when nicotine delivery systems first were approved for smoking cessation. Those were the now familiar Nicorette line of gum, patches, oral inhalers, and even a nasal spray. These all required a prescription from a healthcare provider to obtain. In time, gum and patches were allowed to be sold over the counter, not requiring a prescription. The nasal spray version still requires a prescription in the US. These products are also available as generic drugs as the original patents have expired.

Covington & Burling is a well regarded firm. I do hope Nicopure understands the fees a firm like Covington will charge. Firms such as this are far from your local legal firm that prepares wills and handles divorces.

The first three claims argued, which boil down to the agency overreaching their authority and acting in an arbitrary manner creating an undue burden on the plaintiff/Nicopure/the vaping industry will keep the courts busy for quite a while. The First Amendment argument though will likely fall flat.

While enlightening and interesting............Still does not answer the actual Question.

Is Nicotine Defined as an Addictive Drug(in and of itself) By the FDA?
Yes it is used in Pharmaceuticals
Yes it is in Tobacco Products
Yes it Has been used in Pesticides
and Yes, we use it in Vaping liquids
But is it an Active ingredient or a Classified Drug?

I Understand it is Regulated in inclusion in Pharmaceutical applications, and in Tobacco is Claimed to Be Highly Addictive, but it does not seem to Fall under Controlled Drug Classification and therefor would be a Questionable Active Ingredient, Not an Addictive Drug.

I would say the Addictive Potential of Nicotine is 90% Perception(Smokers are addicted arguments) and 10% Science(Nicotine without Tobacco)

Meanwhile - Thank you to Nicopure for not a moments Delay in taking action against the FDA!

 

[redrebel821]

Filling a tank with Belgian Cocoa to toast Halo!!!!

 

[UnclePsyko]

I just tried to place an order over at Halo but the site was far too slow for me... I hope that means they are seeing some increased business.
I'll try again later tonight.
Finally gonna try Tribeca after all these years!

 

[KY_Rob]

Glad to see NicoPure taking a stand!

Halo's SubZero has been my ADV for over 3 yrs now because their liquid really is high quality, consistent, and professional.

Looks like I need to order some more!

 

[wheezal]

Filling a tank with Belgian Cocoa to toast Halo!!!!

imma making a Peppermint Patty: 3 parts Belgian Cocoa to 1 part Kringle's Cruse. as delishus as bacon? no, of course not. but still awfully delishus!

 

[DC2]

Finally gonna try Tribeca after all these years!

Tribeca is the longest standing liquid in my rotation.
And it is still the best liquid in my rotation.

Having said that, you may not like it at all.

 

[rico942]

Three cheers for Halo/Nicopure !

I started vaping SubZero and Malibu over two years ago, for an odd reason. At that time they were located in Pompton Plains NJ, a few miles from my Dad's hometown of Wyckoff ...

Their consistent quality and fast delivery made me a loyal customer ...

I'm pleased to think that part of the proceeds from my last order will go toward a legal fund to fight the FDA demons ...

 

[redrebel821]

imma making a Peppermint Patty: 3 parts Belgian Cocoa to 1 part Kringle's Cruse. as delishus as bacon? no, of course not. but still awfully delishus!

Oh yes.....yumminess right there!

 

[UnclePsyko]

Tribeca is the longest standing liquid in my rotation.
And it is still the best liquid in my rotation.

Having said that, you may not like it at all.

Heh... Well if I don't dig it, at least I know who to PIF to.

 

[redrebel821]

Malibu is fantastic! I still have a few bottles of that in 6 mg I need to half down to 3mg....

 

[pianoguy]

Time to support them with a nice, big order - they've been a staple for me since 2010. I've always thought their quality, packaging and lot tracking were a great model.

 

[Eskie]

While enlightening and interesting............Still does not answer the actual Question.

Is Nicotine Defined as an Addictive Drug(in and of itself) By the FDA?
Yes it is used in Pharmaceuticals
Yes it is in Tobacco Products
Yes it Has been used in Pesticides
and Yes, we use it in Vaping liquids
But is it an Active ingredient or a Classified Drug?

I Understand it is Regulated in inclusion in Pharmaceutical applications, and in Tobacco is Claimed to Be Highly Addictive, but it does not seem to Fall under Controlled Drug Classification and therefor would be a Questionable Active Ingredient, Not an Addictive Drug.

I would say the Addictive Potential of Nicotine is 90% Perception(Smokers are addicted arguments) and 10% Science(Nicotine without Tobacco)

Meanwhile - Thank you to Nicopure for not a moments Delay in taking action against the FDA!

When you say classified as an addictive drug or classified drug by the FDA, do you mean is nicotine a Scheduled Drug as a Controlled Substance? No, it is not a scheduled drug however, it is recognized in product labeling as having dependence potential.

 

[lulu836]

Hooray for Halo. I usually make my own ejuice but I think I need to find something that Halo makes and order some of it hoping that a lot of others do the same. And, where are the other vendors? Haven't seen anyone else step up to the plate yet.

 

[Robino1]

I hope more do step up to the plate.

 

[p51mustang23]

Yes, nicotine is an active ingredient in a drug, just as penicillin is an active ingredient. The active ingredient is almost always provided for use in various forms, such as injectable penicillin, pills, or capsules. The active ingredient will be combined with a number of inactive ingredients for administration. So inactive binders may be used to create a tablet (or capsule, which have a different set of inactive ingredients such as the gelatin), or specific liquids may be mixed containing the active ingredient for injection.

The FDA began regulating nicotine (no matter how obtained, whether extracted from tobacco or synthetically manufactured) back when nicotine delivery systems first were approved for smoking cessation. Those were the now familiar Nicorette line of gum, patches, oral inhalers, and even a nasal spray. These all required a prescription from a healthcare provider to obtain. In time, gum and patches were allowed to be sold over the counter, not requiring a prescription. The nasal spray version still requires a prescription in the US. These products are also available as generic drugs as the original patents have expired.

Covington & Burling is a well regarded firm. I do hope Nicopure understands the fees a firm like Covington will charge. Firms such as this are far from your local legal firm that prepares wills and handles divorces.

The first three claims argued, which boil down to the agency overreaching their authority and acting in an arbitrary manner creating an undue burden on the plaintiff/Nicopure/the vaping industry will keep the courts busy for quite a while. The First Amendment argument though will likely fall flat.

While the the first 3 arguments are clearly very strong, I actually think they have a good chance on that first amendment argument. In the case of cigarettes, the facts clearly show that the information on the warning label is truthful. In the case of ecigs that same warning label may be partially or wholly inaccurate. Depending on who they get as a judge it could be wholly removed, or the court could require that the FDA reword the warning label in such a way that it does not make any claims that are yet to be strongly and clearly proven.

On the other hand, the standard for free speech for commercial activity is lower than the standard for personal/political/religious speech, so I guess it could go either way.

Either way, the case is well written. Worst case scenario I expect them to get that injunction and hold off the effective date of the deeming.

If the law firm feels good about winning the case, they may be working for a contingency fee, with Halo paying for some costs out of pocket, and the firm taking the money awarded from the court if they win.

 

[bnrkwest]

Good job Halo!!! I quit smoking with a G6 and Tribeca Go Halo!

 

[p51mustang23]

Good job Halo!!! I quit smoking with a G6 and Tribeca Go Halo!

Same here. I've graduated to better hardware (although they sell some proper mods now), but still love their liquid. Got 1 or 2 others off cigarettes by recommending Halo.

For anyone considering trying their Tribeca, it's a pretty bold, sugary tobacco flavor. I think it may be a love / hate type flavor. Either you love it or you find it overbearing. Kringles curse and Malibu are awesome non-tobacco flavors.

 

[LittleBird]

Checked lawyers. Looking good:
Covington & Burling LLP is an international law firm with offices in Beijing, Brussels, London, New York, San Francisco, Seoul, Shanghai,Silicon Valley, San Diego, and Washington, DC. The firm advises multinational corporations on significant transactional, litigation, regulatory, and public policy matters. Covington & Burling LLP consistently ranks among the top 20 on The American Lawyer’s "A-List", based on financial performance, pro bono activity, associate satisfaction, and diversity.[2] As of 2015, it is the largest law firm in Washington, DC.

Covington is the premiere firm in DC. I've worked with them as outside counsel on a number of occasions. Top notch. Nicopure is in great hands. Nice to have a little good news...

 

[bnrkwest]

Covington is the premiere firm in DC. I've worked with them as outside counsel on a number of occasions. Top notch. Nicopure is in great hands. Nice to have a little good news...

That is such good news! Glad they are in good hands

 

[Steamix]

I've never tried Halo but that's about to change...
I just hope they didn't jump too soon.

No such thing as too soon on that one.

PMTA is - the way it's currently set up and they way the FDA expects it- not something you copy-paste together from some websites.
Labs aren't fast food joints. They haven't got a drive-in window for one PMTA to go.
So anyone serious about having his products put through the hoop, would need to get cranking right away.
Read somewhere that FDA would review reply within 180 days. Leaves you precious little time to get your ton of paperwork together. If you're inclined to do so in the first place.

Some are big enough to foot the bills of some high-class law firm, but not big enough to to pay for all that what the FDA wants.

So they have no choice but to go against the deeming rule. And court dates aren't available at the snap of a finger either...

Let alone the mom'n pop stores. PMTA unattainable. And the legal battle is in a different league. This is not about arguing a speeding ticket. So they may or may not chip in to fund some concerted effort. Apart from that, sell what you can for two years and then pull the plug.

FDA has been singing BT's tune, so that legal action would come forth is expected.

And intended.

A major player, a product portfolio that might not be a product portfolio anymore two years hence, exorbitant bills from my lawyer...

Then I get a phone call from a BT CEO making me an offer....

Not what the company's truly worth what with all that stormy sailing in legal waters, but...

Be thou on yer guard , there be tygers