SE, NJoy vs FDA -- Discussion

[MoonRose]

Here's the official FDA posting on their site.

Regulation of E-Cigarettes and Other Tobacco Products

 

[yvilla]

This email just in:

April 25, 2011

Dear Stakeholder:

The purpose of this letter is to provide stakeholders and the public with information, in light of a recent court decision, regarding the regulation of products made or derived from tobacco.
The Family Smoking Prevention and tobacco Control Act of 2009 (Tobacco Control Act), which amends the Federal Food, Drug, and Cosmetic Act (FD&C Act), was enacted on June 22, 2009, and it provides the Food and Drug Administration (FDA) with authority to regulate “tobacco products.” The FD&C Act, as amended by the Tobacco Control Act, defines the term “tobacco product,” in part, as any product “made or derived from tobacco” that is not a “drug,” “device,” or combination product under the FD&C Act.
Under the FD&C Act, the definition of “drug” includes articles intended: (1) for use in the diagnosis, cure, mitigation, treatment or prevention of disease, or (2) to affect the structure or any function of the body. Similarly, “device” is defined to include articles intended: (1) for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or (2) to affect the structure or any function of the body.
Between 2008 and 2010, the FDA determined that certain electronic cigarettes (e-cigarettes) were unapproved drug/device combination products and detained and/or refused admission to those offered for import by Sottera, Inc. and other manufacturers. Sottera, Inc. challenged that determination in court.
The U.S. Court of Appeals for the D.C. Circuit, in Sottera, Inc. v. Food & Drug Administration, 627 F.3d 891 (D.C. Cir. 2010), recently issued a decision with regard to e-cigarettes and other products “made or derived from tobacco” and the jurisdictional line that should be drawn between “tobacco products” and “drugs,” “devices,” and combination products, as those terms are defined in the FD&C Act. The court held that e-cigarettes and other products made or derived from tobacco can be regulated as “tobacco products” under the Act and are not drugs/devices unless they are marketed for therapeutic purposes.
The government has decided not to seek further review of this decision, and FDA will comply with the jurisdictional lines established by Sottera.
Under the Tobacco Control Act, “tobacco products” are subject to a number of controls. Section 201(rr)(4), for example, prohibits the marketing of a “tobacco product” in combination with any other article or product regulated under the FD&C Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement). FDA has already issued a draft guidance that addresses the status of such products.
Moreover, Chapter IX of the FD&C Act subjects “tobacco products” to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and adulteration and misbranding provisions. Chapter IX also subjects “new tobacco products” (i.e., products that are first marketed or modified after February 15, 2007) and “modified risk tobacco products” (i.e., products that are “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products”) to premarket review. Although the statute places certain “tobacco products” immediately under the general controls and premarket review requirements in Chapter IX (i.e., cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco), it also permits FDA, by regulation, to extend those controls to other categories of “tobacco products.”
FDA plans to take the following steps to ensure that appropriate regulatory mechanisms govern all “tobacco products” and all other products made or derived from tobacco after the Sottera decision:
• The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act. The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”
• The Sottera decision states that products made or derived from tobacco can be regulated under the Tobacco Control Act unless they are “marketed for therapeutic purposes,” in which case they are regulated as drugs and/or devices. The Agency is considering whether to issue a guidance and/or a regulation on “therapeutic” claims.
• Section 201(rr)(4) of the Tobacco Control Act prohibits the marketing of “tobacco products” in combination with other FDA-regulated products. As mentioned, FDA has already issued a draft guidance on this provision, which it intends to finalize.
• “Tobacco products” marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.” A “tobacco product” that is not “grandfathered” is considered a “new” tobacco product, and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action, unless it has received premarket authorization or been found substantially equivalent. FDA has already developed draft guidance explaining how manufacturers can request a determination from FDA that a “tobacco product” is “grandfathered.”
We look forward to working with all stakeholders to ensure that the existing authorities granted the Agency are harnessed to best protect and promote the public health.
Sincerely,


Lawrence R. Deyton, M.S.P.H., M.D.
Director
Center for Tobacco Products


Janet Woodcock, M.D.
Director
Center for Drug Evaluation and Research

 

[StormFinch]

Here's the official FDA posting on their site.

Regulation of E-Cigarettes and Other Tobacco Products

Thanks MoonRose. I can already see the "grandfathering" thing causing a problem, but at least we won't be buying pre-filled 4 mg cartridges from Johnson and Johnson for $10.00 a piece.

 

[DC2]

No more NHaler lung juice?

Under the Tobacco Control Act, “tobacco products” are subject to a number of controls. Section 201(rr)(4), for example, prohibits the marketing of a “tobacco product” in combination with any other article or product regulated under the FD&C Act (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement). FDA has already issued a draft guidance that addresses the status of such products.

 

[Our House]

I can't tell if this is good or bad.

 

[DC2]

This....

The Agency intends to propose a regulation that would extend the Agency’s “tobacco product” authorities in Chapter IX of the FD&C Act, which currently only apply to certain specifically enumerated “tobacco products,” to other categories of tobacco products that meet the statutory definition of “tobacco product” in Section 201(rr) of the Act. The additional tobacco product categories would be subject to general controls, such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, and the adulteration and misbranding provisions, as well as to the premarket review requirements for “new tobacco products” and “modified risk tobacco products.”

And this...

“Tobacco products” marketed as of February 15, 2007, which have not been modified since then are considered “grandfathered” and are not subject to premarket review as “new tobacco products.” A “tobacco product” that is not “grandfathered” is considered a “new” tobacco product, and it is adulterated and misbranded under the FD&C Act, and therefore, subject to enforcement action, unless it has received premarket authorization or been found substantially equivalent. FDA has already developed draft guidance explaining how manufacturers can request a determination from FDA that a “tobacco product” is “grandfathered.”

 

[kai kane]

I can't tell if this is good or bad.

this is GOOD. The FDA will no longer ban the import of ecigs as marketed prior to 2007.

Now we need to hear from our other legal eagles as to implementation and timelines ... is Mr. Godshall in the house ???

And thanks Yvilla for posting the letter !!!

A hui ho!

 

[Bill Godshall]

For immediate release:
contact: Bill Godshall 412-351-5880

E-cigarettes, e-liquid and other nicotine containing products are now tobacco products

Today's annoucement by the FDA Regulation of E-Cigarettes and Other Tobacco Products to not appeal Judge Richard Leon's ruling in NJOY v FDA https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54 to the US Supreme Court means that e-cigarettes, e-liquid, nicotine gums, lozenges, patches, skin creams and nasal sprays are now unregulate tobacco products according to federal law (as long as no therapeutic claim is made by the manufacturer/importer).

These nicotine products now join cigars and pipe tobacco as unregulated tobacco products under the Family Smoking Prevention Tobacco Control Act. Currently regulated tobacco products include cigarettes, roll-your-own and smokeless tobacco.

Bill Godshall, executive director of Smokefree Pennsylvania, welcomes this sea change in the federal legal definintion and regulation of tobacco/nicotine products, stating: "Smokers will have greater access to many different less expensive smokefree alternatives, and manufacturers can now truthfully market these new smokefree tobacco products to smokers as far less hazardous alternatives to cigarettes."

Sales of e-clgarettes are likely to continue skyrocketing with this decision, and many more stores will begin selling them.
There is no evidence that e-cigarettes have harmed any of the estimated million smokers who have switched in the past several years. "This decision will boost e-cigarette sales at the expense of tobacco cigarettes, and many more smokers will switch," said Godshall.

The change is also likely to decimate drug industry sales of nicotine gums, lozenges and patches. "Not many smokers will pay $.75 for a nicotine lozenge if they can buy a virtually identical tobacco lozenge for $.20," added Godshall.

The FDA has indicated that it plans to propose regulations for these smokefree nicotine alternatives as tobacco products.

 

[cozzicon]

For immediate release:
contact: Bill Godshall 412-351-5880

E-cigarettes, e-liquid and other nicotine containing products are now tobacco products

Today's annoucement by the FDA Regulation of E-Cigarettes and Other Tobacco Products to not appeal Judge Richard Leon's ruling in NJOY v FDA https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54 to the US Supreme Court means that e-cigarettes, e-liquid, nicotine gums, lozenges, patches, skin creams and nasal sprays are now unregulate tobacco products according to federal law (as long as no therapeutic claim is made by the manufacturer/importer).

These nicotine products now join cigars and pipe tobacco as unregulated tobacco products under the Family Smoking Prevention Tobacco Control Act. Currently regulated tobacco products include cigarettes, roll-your-own and smokeless tobacco.

Bill Godshall, executive director of Smokefree Pennsylvania, welcomes this sea change in the federal legal definintion and regulation of tobacco/nicotine products, stating: "Smokers will have greater access to many different less expensive smokefree alternatives, and manufacturers can now truthfully market these new smokefree tobacco products to smokers as far less hazardous alternatives to cigarettes."

Sales of e-clgarettes are likely to continue skyrocketing with this decision, and many more stores will begin selling them.
There is no evidence that e-cigarettes have harmed any of the estimated million smokers who have switched in the past several years. "This decision will boost e-cigarette sales at the expense of tobacco cigarettes, and many more smokers will switch," said Godshall.

The change is also likely to decimate drug industry sales of nicotine gums, lozenges and patches. "Not many smokers will pay $.75 for a nicotine lozenge if they can buy a virtually identical tobacco lozenge for $.20," added Godshall.

The FDA has indicated that it plans to propose regulations for these smokefree nicotine alternatives as tobacco products.

Bill,

If your reading of the statement is accurate- this is exceptionally good news.

 

[mwa102464]

It was either that or they made it a drug delivery device and handed to the drug companies, complete with bow. With this decision we can now push to have vaping labeled as reduced harm, a classification that congress mandated but the FDA has yet to do anything about.

I guess, I see big tobacco being all over this and now they will be getting into the ecig game and probably taking control as they are with all the rest of it, they probably have had R&D working for a long time and have been waiting for this decision. Well we shall see, a little time will tell if Big Tobacco becomes a player now in the e-cig world with this latest decision and if so I cant wait to see if and how the tax rate goes on eliquids and a few other things with liquids too.

 

[melloyello]

big tobacco have known the thumb screws will get tighter and tighter for decades. they have diversified and invested in other things long long ago and they had to be prepared for this result, make no mistake. for allwe know, they were the ones starting operations of e-cigs in china....

 

[kai kane]

The change is also likely to decimate drug industry sales of nicotine gums, lozenges and patches. "Not many smokers will pay $.75 for a nicotine lozenge if they can buy a virtually identical tobacco lozenge for $.20," added Godshall.

Mahalos Bill. Please keep us posted as things progress, and thanks also for keeping up the 'good fight'!

Aloha

 

[cruz_msl]

YouTube - E-Cig legislation on CNN

 

[JerryRM]

I assume that you will be retiring from the daily docket updates, Julie. It's been a long and interesting journey.

I want to thank SunVaporer and Julie for keeping us informed all these many months.

 

[Big Daddy]

I assume that you will be retiring from the daily docket updates, Julie. It's been a long and interesting journey.

I want to thank SunVaporer and Julie for keeping us informed all these many months.

+++++11111

 

[JustJulie]

I assume that you will be retiring from the daily docket updates, Julie. It's been a long and interesting journey.

I want to thank SunVaporer and Julie for keeping us informed all these many months.

Thanks so much, Jerry.

I'll still be checking the docket until the cases are officially resolved. i won't, however, be posting here every day . . . I'll pop in and update when something gets filed.

Thanks everyone for keeping me company on the docket watch.

 

[Rosco]

But Julie......I still have to let ya know when the bad storms have left KC heading your way....even if the bad storms aren't fda bs.

 

[Vaporologist]

Thanks for everything, Julie!!!!!!!!!!!!

 

[CES]

I assume that you will be retiring from the daily docket updates, Julie. It's been a long and interesting journey.

I want to thank SunVaporer and Julie for keeping us informed all these many months.

but...the docket watch is over? it's been part of my entire vaping experience

Thanks so much, Jerry.

I'll still be checking the docket until the cases are officially resolved. i won't, however, be posting here every day . . . I'll pop in and update when something gets filed.

Thanks everyone for keeping me company on the docket watch.

Thank you Julie and Sun!!!


I know that the war isn't over- but I'm glad this case is pretty much close to being complete

 

[The Wiz]

Thanks so much, Jerry.

I'll still be checking the docket until the cases are officially resolved. i won't, however, be posting here every day . . . I'll pop in and update when something gets filed.

Thanks everyone for keeping me company on the docket watch.

Julie.....I too want to thank you for all of the info you have passed on to us here. Now if someone can please explain to me what has happed the past few days while I have been away I will appreciate it. Either that or it seems I have alot of catching up to do.

Sounds like we have a partial victory here in any case.

Wiz!