FDA FDA proposes banning more truthful claims about vaping, challenges Judge Leon's 2010 court ruling

[Bill Godshall]

Today, FDA proposed banning truthful claims about e-cigs and further challenged Judge Leon’s 2010 ruling that an e-cig is a “tobacco product” unless the manufacturer makes a “therapeutic claim”.
The agency has proposed redefining and regulating/banning any “tobacco product” as a “drug, device or combination product” if the agency believes it is “intended for use in the . . . prevention of disease” or “intended to affect the structure or any function of the body in any way that is different from effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.”
https://s3.amazonaws.com/public-inspection.federalregister.gov/2015-24313.pdf

Note that FDA’s proposal above follows warning letters FDA sent on 9/8/2010 to five e-cig companies and a trade group alleging that dozens of truthful marketing claims made by those companies (urging smokers to use their e-cig product) violated the FDCA despite Judge Leon’s ruling (since smoking isn’t a disease, and since just one of the dozens of marketing claims cited by FDA could be considered a “therapeutic claim”)
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm225224.htm

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm225206.htm (Johnson Creek)

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm225177.htm (Gamucci)

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm225178.htm (E-CigaretteDirect)

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm225181.htm (Ruyan America)

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2010/ucm225187.htm (E-Cig Technology Inc)

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/UCM225263.pdf (Electronic Cigarette Association)

Judge Leon’s 1/14/2010 ruling striking down FDA’s e-cig ban as unlawful, and stating that FDA could only regulate e-cigs as drugs or devices if a manufacturer made a “therapeutic claim”.
https://ecf.dcd.uscourts.gov/cgi-bin/show_public_doc?2009cv0771-54

 

[Bill Godshall]

This FDA proposal was cited by Smokey Joe in another post today at
https://www.e-cigarette-forum.com/f...coming-out-of-fda.703013/page-3#post-16577962

But I wanted to provide some details about FDA's actions. Unfortunately, the only way to stop FDA from redefining a "tobacco product" is if an injured e-cig company targeted by FDA (i.e. that FDA sends a warning letter and a subsequent cease-and-desist letter) sues the agency in federal court.

 

[Kent C]

further challenged Judge Leon’s 2010 ruling that an e-cig is a “tobacco product”

Exactly my first thought when I read SJ's post.

The "hint":
"Note that FDA’s proposal above follows warning letters FDA sent on 9/8/2010 to five e-cig companies and a trade group alleging that dozens of truthful marketing claims made by those companies (urging smokers to use their e-cig product) violated the FDCA..."

Thanks for posting Bill.

edit:
gamucci - one of the companies 'warned' by the FDA was the first company I found in a search after someone in another unrelated forum mentioned "ecigarettes". I hadn't hear of them before that. gamucci UK was formed in 2007. Pretty sure they made the first ecigarette I tried - a cigalike.

Here is their response to the warning:
http://www.prweb.com/releases/2010/09/prweb4488704.htm

 

[SeniorBoy]

Thanks Bill. The FDA page for this Proposed Rule with a comments link went live today.

 

[LaraC]

I see more to worry about in the FDA "clarification" that Smokey Joe posted, than just how marketing can/can't be done to stay on the non-medical side of FDA's fence. I see a big problem ahead with that little phrase the FDA uses: "affecting the structure or function of the body."

FDA's view of nicotine "affecting the structure or function of the body" does not bode well for e-cig users after the FDA deems electronic cigarettes to be a "tobacco product."

Ever since the FDA first proposed to deem electronic cigarettes to be "tobacco products", I've thought that once they get their claws on e-cigs, the effect will be catastrophic. The FDA will use "affect structure or function of the body" in every way they possibly can, to try to "protect" the population as a whole (and "youth" in particular) from ANY use of nicotine other than in FDA approved NRTs. Nicotine Replacement Therapy...gum, patch, etc. from the FDA's big funders...their pharmaceutical buddies.

E-cigs now (or as soon as the FDA can finally rope them in, via deeming.)

Nicotine next.

In FDA's warning letter to Gamucci America:

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm225177.htm

FDA says (bold red emphasis mine

The scientific and medical communities have determined that nicotine is a pharmacological agent,1 that nicotine addiction is a disease,2 and that nicotine withdrawal is itself a recognized medical condition.3 It is well understood that people smoke for the pharmacologically rewarding effects of nicotine, such as alleviation of stress and negative mood, enhancement of thinking, and increased alertness.4 For an addicted smoker, the body has adapted to nicotine, and abstinence produces withdrawal and craving.5 As a result, people also smoke to avoid the negative effects of nicotine withdrawal, such as anxiety, difficulty concentrating, negative mood, increased appetite, insomnia and irritability.6 Therefore, the claims noted above demonstrate that the Gamucci products are intended to affect the structure or function of the body and to mitigate, treat, or prevent disease.


The citations below (also from their warning letter to Gamucci America, and to other E-cig companies) are a big part of what the FDA will rely upon in their future attack on nicotine:

1 E.g., P. Taylor, Agents Acting at the Neuromuscular Junction and Autonomic Ganglia, in GOODMAN & GILMAN’S THE PHARMACOLOGICAL BASIS OF THERAPEUTICS 193, 193-218 (J.G. Hardman, L.E. Limbird & A.G. Gilman eds., 2001).


2 WORLD HEALTH ORGANIZATION, ICD-10 INTERNATIONAL STATISTICAL CLASSIFICATION OF DISEASES, 10TH REVISION (2nd ed. 2007).


3 AMERICAN PSYCHIATRIC ASSOCIATION, DIAGNOSTIC AND STATISTICAL MANUAL -- TEXT REVISION 192 (2000).


4 E.g., N.L. Benowitz, Drug Therapy. Pharmacologic Aspects of Cigarette Smoking and Nicotine, 319 NEW ENG. J. MED. 1318 (1988)


5 See WORLD HEALTH ORGANIZATION, supra note 2.


6 E.g. T.B. Baker, T.H. Brandon & L. Chassin, Motivational Influences on Cigarette Smoking, 55 ANN. REV. PSYCHOL. 463 (2004).

 

[skoony]

One wonders if these people have ever bothered to read any pertinent literature at all
concerning nicotine.
http://www.sciencedirect.com/science/article/pii/0024320596001002
or
http://www.formindep.org/The-myth-of-nicotine-addiction.html
This is what the Surgeon Generals 1964 report had to say about nicotine.
From chapter 4.

"The habitual use of tobacco is related primarily to psychological and social drives, reinforced and perpetuated by the pharmacological actions of nicotine. Social stimulation appears to play a major role in a young person’s early and first experiments with smoking. No scientific evidence supports the popular hypothesis that smoking among adolescents is an expression rebellion against authority. Individual stress appears to be associated more with fluctuations in the amount of smoking than with the prevalence of smoking. The overwhelming evidence indicates that smoking-its beginning, habituation, and occasional discontinuation-is to a very large extent psychologically and socially determined. Nicotine is rapidly changed in the body to relatively inactive substances with low toxicity. The chronic toxicity of small doses of nicotine is low in experimental animals. These two facts, when taken in conjunction with the low mortality ratios of pipe and cigar smokers, indicate that the chronic toxicity of nicotine in quantities absorbed from smoking and other methods of tobacco use is very low and probably does not represent an important health hazard."

http://profiles.nlm.nih.gov/ps/access/nnbbmq.pdf

Regards
Mike

 

[bigdancehawk]

You quote the FDA as saying, "The scientific and medical communities have determined that nicotine is a pharmacological agent,1 that nicotine addiction is a disease"

That seems somewhat inconsistent with the FDA's position on its approved NRT products. When they announced that those scary warnings they used to required weren't needed, they said, "The changes that FDA is allowing to these labels reflect the fact that although any nicotine-containing product is potentially addictive, decades of research and use have shown that NRT products sold OTC do not appear to have significant potential for abuse or dependence."

Furthermore, how can e-cigarettes be called a cure for nicotine addiction and/or nicotine withdrawal if they contain nicotine?

 

[Kent C]

I see a big problem ahead with that little phrase the FDA uses: "affecting the structure or function of the body."

I agree - good 'hunting' as well But with the above, esp. if they get into the 'childrens' brain' thing - it could be a problem, regardless of whether it's considered a disease or cure....

 

[DrMA]

"affecting the structure or function of the body."

We're talking about water, right?

 

[Bill Godshall]

So much for FDA's April 25, 2011 claim (below) when the agency conceded to abide by Judge Leon's ruling at
http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm252360.htm

"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."

 

[DC2]

"affecting the structure or function of the body."

We're talking about water, right?

No, I believe we are talking about oxygen.

 

[snork]

Thanks Bill. The FDA page for this Proposed Rule with a comments link went live today.

That page contains 10,629 words.
We need JMan8 on the case.