FDA refuses to file 4 new tobacco product applications, falsely portrays FDA approved cigarettes as safer than unapproved smokeless & e-cigs

Status
Not open for further replies.

Bill Godshall

Executive Director<br/> Smokefree Pennsylvania
ECF Veteran
Apr 2, 2009
5,171
13,288
67
FDA announces its refusal to file 4 new tobacco product applications and other recent actions to protect cigarette cartel and Marlboro monopoly from market competition, falsely portrays FDA approved cigarettes as safer than far less hazardous (but unapproved) smokeless tobacco products and e-cigarettes (if/when FDA imposes “deeming” regulation).
http://www.fda.gov/downloads/TobaccoProducts/Labeling/MarketingandAdvertising/UCM389515.pdf
[URL="http://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm339928.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery"]
http://www.fda.gov/TobaccoProducts/Labeling/MarketingandAdvertising/ucm339928.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

[/URL]
If the FDA imposes the deeming regulation on e-cigs (as it continues to insist upon), the number of new tobacco product and SE applications rejected by the FDA (listed on webpage above) will rapidly increase.

Anyone who foolishly believes that imposing the FDA deeming regulation on e-cigs would benefit public health (or the e-cig industry), please explain how you would convince the FDA to approve a new tobacco product or SE application for any e-cig product.
 

Bill Godshall

Executive Director<br/> Smokefree Pennsylvania
ECF Veteran
Apr 2, 2009
5,171
13,288
67
While FDA has approved 17 SE applications for tobacco products, the agency has refused to file 4 new tobacco product applications, has rejected 17 SE applications, and has demanded so much info that 247 SE applicants withdrew their SE application.

In sum, FDA has so far approved 17 tobacco products (mostly cigarettes), and has banned 268 tobacco products.



Summary of Premarket Tobacco Application Final Actions

PMTA Final Actions February 2014 Total to Date
Refuse to File (RTF) submissions for PMTAs 4 4



Summary of Substantial Equivalence Final Actions

SE Final Actions Pre-June 2013 Jun Jul Aug Sep Oct Nov Dec Jan Feb Total to Date
SE Orders 0 2 0 0 4 3 8 0 0 0 17
NSE Orders 0 4 0 4 0 5 0 0 0 4 17
Report Withdrawals 132 7 6 10 13 31 4 1 26 17 247
 
Last edited:

Bill Godshall

Executive Director<br/> Smokefree Pennsylvania
ECF Veteran
Apr 2, 2009
5,171
13,288
67
Below is a letter I sent to many members of US Congress in 2004 urging them to oppose the recently introduced Family Smoking Prevention and Tobacco Control Act (because it protected existing cigarette markets from THR market competition by smokeless tobacco products).

If Obama's FDA imposes the deeming regulation on e-cigs, the TCA would give cigarettes far greater market protections from e-cigs than from smokeless tobacco products (because the TCA allowed smokeless tobacco companies to file SE applications to keep their products on the market, but won't let e-cig companies file SE applications).




Via FAX September 20, 2004

The Honorable Mitch McConnell
361-A Russell Senate Office Building
Washington, DC 20510
Attention: Michael Zehr

Dear Senator McConnell:

On behalf of Smokefree Pennsylvania, I write urging you to OPPOSE the DeWine-Kennedy Family Smoking Prevention and Tobacco Control Act (S.2461) for Food and Drug Administration (FDA) tobacco regulations that the Senate amended to the FSC/ETI legislation, and to also OPPOSE both House and Senate approved tobacco quota buyouts.

Since I founded Smokefree Pennsylvania in 1990, our nonprofit organization has advocated policies for smokefree air, reducing tobacco marketing to youth, increasing tobacco taxes, preserving civil justice remedies for injured tobacco victims, and increasing smoking cessation. We've also exposed many deceptive tobacco industry protection policies, programs, strategies, coalitions, front groups, lobbyists and politicians.

While some health groups have endorsed S.2461, upon detailed analysis,
Smokefree Pennsylvania opposes this FDA legislation because it would:

- protect cigarettes from market competition by lower risk tobacco,
- increase Philip Morris cigarette sales and huge 50% market share,
- perpetuate manufacturer safer cigarette frauds via FDA oversight,
- misrepresent health risks of noncombustible (smokeless) tobacco,
- ban harm reduction marketing of lower risk products to smokers,
- severely limit FDA authority to issue effective product regulations,
- do very little if anything to reduce cigarette use, diseases or deaths,
- allow manufacturers to promote cigarettes as FDA approved,
- fool people into believing FDA is resolving the cigarette pandemic,
- reduce manufacturer liability as cigarettes kill 500,000 annually.

Sound regulations discourage or eliminate the most hazardous products, and encourage the development of and transition to lower risk products. But S.2461 protects the most hazardous tobacco product (cigarette) from competition by prohibiting truthful marketing of lower risk noncombustible (smokeless) tobacco products to addicted smokers.

Cigarettes kill 50% of addicted smokers, and up to 63,000 American nonsmokers annually (from secondhand smoke and fires). In contrast, smokeless tobacco kills about 1% of addicted users, but ZERO nonusers. Swedish smokeless (snus) and other new low nitrosamine noncombustible tobacco products pose even fewer risks. Smokers who
switch to smokeless products sharply reduce disease and death risks.

But S.2461 perpetuates the myth/fraud that noncombustible tobacco is as hazardous as cigarettes by requiring larger labels on smokeless packs and ads stating: "This product is not a safe alternative to cigarettes," and by not informing smokers (e.g. labels on cigarette
packs and ads) that smokeless tobacco poses fewer mortality risks.

Sound product regulations protect consumers from health frauds. But S.2461 perpetuates the deadliest consumer fraud (safer cigarettes) by allowing 'light' cigarettes to remain on the market in their easily recognized pack designs and colors (minus the word 'light'). Marlboro Lights largest market share would increase (at expense of competitor brands) while current customers continue smoking the brand, which Philip Morris would call Marlboro Gold. Yet, S.2461 does nothing to warn smokers that 'lights' are just as hazardous as other cigarettes.

Any S.2461 authorized FDA performance standards for cigarettes almost certainly would be incorrectly perceived by the public as making cigarettes safer, which would discourage many smokers from quitting and could encourage youth and exsmokers to smoke. Just as filters, low tar, lights and ultralights never reduced cigarette's health hazards, neither would removing a few chemicals or carcinogens from cigarettes or from the smoke, but the public (especially smokers) would be fooled.

Section 911(g)(2) would allow a cigarette manufacturer to apply for and receive FDA approval for "an explicit or implicit representation that such tobacco product or its smoke contains or is free of a substance or contains a reduced level of a substance, or presents
a reduced exposure to a substance in tobacco smoke."

Philip Morris has stated it will market a so-called 'reduced exposure' cigarette this year, and it appears that Section (g)(2) was drafted by the company in order to obtain FDA approval for its new marketing campaign. The FDA shouldn't perpetuate, initiate or allow safer cigarette frauds.

Although Philip Morris desires the benefits it receives from S.2461, the company is contemplating legal challenges to other provisions. Mary Shaffrey of the Winston-Salem Journal (upon interviewing Mark Berlind of Philip Morris about the legislation) recently reported: "However, because of a 2001 Supreme Court ruling that dealt with tobacco advertising, Berlind said he is confident that the FDA provisions in the Senate bill would eventually be changed."

Sound regulations also allow regulatory agencies unfettered authority to issue regulations that reduce access to hazardous products. But S.2461 prohibits the FDA from issuing many of the potentially most effective cigarette access reduction regulations, including:

- increasing the minimum age to purchase cigarettes beyond 18 years,
- eliminating cigarette sales from any type of retail outlet (about 500,000
retail outlets sell cigarettes in America),
- requiring prescriptions to buy cigarettes (as FDA does with other drugs),
- removing nicotine from cigarettes,
- eventually removing cigarettes from the market.

More comprehensive public health analyses of this FDA legislation is available at: www.notobaccobailout.org.

Smokefree Pennsylvania supports fair and effective federal regulations for tobacco products, and we acknowledge that S.2461 contains some improvements over the status quo. But overall, this FDA legislation gives the cigarette and Philip Morris significant unwarranted protection and benefits, at the expense of public health.

Finally, we urge you to oppose both the $9.6 billion House approved and $12 billion Senate approved tobacco quota buyouts because the overwhelming majority of beneficiaries don't even grow tobacco.

Thank you for your consideration, and feel fee to contact me for additional information about these important policy matters.

Sincerely,


William T. Godshall, MPH
Executive Director
 

Vocalek

CASAA Activist
Supporting Member
ECF Veteran
Seems to me that they are putting the cart before the horse. Your New Product Application is supposed to tell them precisely how you are manufacturing a product that you are not allowed to sell yet.... If you can't sell the product yet, why would you be manufacturing it?
 

Bill Godshall

Executive Director<br/> Smokefree Pennsylvania
ECF Veteran
Apr 2, 2009
5,171
13,288
67
It's one thing for the FDA to reject a New Tobacco Product application, which hasn't occurred yet.

But in these four cases, the FDA refused to even accept (i.e. file) New Tobacco Product applications.

If the FDA refuses to accept New Tobacco Product applications, it is impossible for the FDA to approve a New Tobacco Product application (which seems like a convenient way for the FDA to reject New Tobacco Product applications without actually doing so).
 

Sundodger

Super Member
ECF Veteran
Sep 22, 2013
351
964
All 57 States
It's one thing for the FDA to reject a New Tobacco Product application, which hasn't occurred yet.

But in these four cases, the FDA refused to even accept (i.e. file) New Tobacco Product applications.

If the FDA refuses to accept New Tobacco Product applications, it is impossible for the FDA to approve a New Tobacco Product application (which seems like a convenient way for the FDA to reject New Tobacco Product applications without actually doing so).

So in other words ecig manufacturers will be dealing with the Office of Repetitive Redundancy?
 

aikanae1

Vaping Master
ECF Veteran
Verified Member
Feb 2, 2013
8,423
26,259
az
Did you get a response to your letter?

Below is a letter I sent to many members of US Congress in 2004 urging them to oppose the recently introduced Family Smoking Prevention and Tobacco Control Act (because it protected existing cigarette markets from THR market competition by smokeless tobacco products).

If Obama's FDA imposes the deeming regulation on e-cigs, the TCA would give cigarettes far greater market protections from e-cigs than from smokeless tobacco products (because the TCA allowed smokeless tobacco companies to file SE applications to keep their products on the market, but won't let e-cig companies file SE applications).




Via FAX September 20, 2004

The Honorable Mitch McConnell
361-A Russell Senate Office Building
Washington, DC 20510
Attention: Michael Zehr

Dear Senator McConnell:

On behalf of Smokefree Pennsylvania, I write urging you to OPPOSE the DeWine-Kennedy Family Smoking Prevention and Tobacco Control Act (S.2461) for Food and Drug Administration (FDA) tobacco regulations that the Senate amended to the FSC/ETI legislation, and to also OPPOSE both House and Senate approved tobacco quota buyouts.

Since I founded Smokefree Pennsylvania in 1990, our nonprofit organization has advocated policies for smokefree air, reducing tobacco marketing to youth, increasing tobacco taxes, preserving civil justice remedies for injured tobacco victims, and increasing smoking cessation. We've also exposed many deceptive tobacco industry protection policies, programs, strategies, coalitions, front groups, lobbyists and politicians.

While some health groups have endorsed S.2461, upon detailed analysis,
Smokefree Pennsylvania opposes this FDA legislation because it would:

- protect cigarettes from market competition by lower risk tobacco,
- increase Philip Morris cigarette sales and huge 50% market share,
- perpetuate manufacturer safer cigarette frauds via FDA oversight,
- misrepresent health risks of noncombustible (smokeless) tobacco,
- ban harm reduction marketing of lower risk products to smokers,
- severely limit FDA authority to issue effective product regulations,
- do very little if anything to reduce cigarette use, diseases or deaths,
- allow manufacturers to promote cigarettes as FDA approved,
- fool people into believing FDA is resolving the cigarette pandemic,
- reduce manufacturer liability as cigarettes kill 500,000 annually.

Sound regulations discourage or eliminate the most hazardous products, and encourage the development of and transition to lower risk products. But S.2461 protects the most hazardous tobacco product (cigarette) from competition by prohibiting truthful marketing of lower risk noncombustible (smokeless) tobacco products to addicted smokers.

Cigarettes kill 50% of addicted smokers, and up to 63,000 American nonsmokers annually (from secondhand smoke and fires). In contrast, smokeless tobacco kills about 1% of addicted users, but ZERO nonusers. Swedish smokeless (snus) and other new low nitrosamine noncombustible tobacco products pose even fewer risks. Smokers who
switch to smokeless products sharply reduce disease and death risks.

But S.2461 perpetuates the myth/fraud that noncombustible tobacco is as hazardous as cigarettes by requiring larger labels on smokeless packs and ads stating: "This product is not a safe alternative to cigarettes," and by not informing smokers (e.g. labels on cigarette
packs and ads) that smokeless tobacco poses fewer mortality risks.

Sound product regulations protect consumers from health frauds. But S.2461 perpetuates the deadliest consumer fraud (safer cigarettes) by allowing 'light' cigarettes to remain on the market in their easily recognized pack designs and colors (minus the word 'light'). Marlboro Lights largest market share would increase (at expense of competitor brands) while current customers continue smoking the brand, which Philip Morris would call Marlboro Gold. Yet, S.2461 does nothing to warn smokers that 'lights' are just as hazardous as other cigarettes.

Any S.2461 authorized FDA performance standards for cigarettes almost certainly would be incorrectly perceived by the public as making cigarettes safer, which would discourage many smokers from quitting and could encourage youth and exsmokers to smoke. Just as filters, low tar, lights and ultralights never reduced cigarette's health hazards, neither would removing a few chemicals or carcinogens from cigarettes or from the smoke, but the public (especially smokers) would be fooled.

Section 911(g)(2) would allow a cigarette manufacturer to apply for and receive FDA approval for "an explicit or implicit representation that such tobacco product or its smoke contains or is free of a substance or contains a reduced level of a substance, or presents
a reduced exposure to a substance in tobacco smoke."

Philip Morris has stated it will market a so-called 'reduced exposure' cigarette this year, and it appears that Section (g)(2) was drafted by the company in order to obtain FDA approval for its new marketing campaign. The FDA shouldn't perpetuate, initiate or allow safer cigarette frauds.

Although Philip Morris desires the benefits it receives from S.2461, the company is contemplating legal challenges to other provisions. Mary Shaffrey of the Winston-Salem Journal (upon interviewing Mark Berlind of Philip Morris about the legislation) recently reported: "However, because of a 2001 Supreme Court ruling that dealt with tobacco advertising, Berlind said he is confident that the FDA provisions in the Senate bill would eventually be changed."

Sound regulations also allow regulatory agencies unfettered authority to issue regulations that reduce access to hazardous products. But S.2461 prohibits the FDA from issuing many of the potentially most effective cigarette access reduction regulations, including:

- increasing the minimum age to purchase cigarettes beyond 18 years,
- eliminating cigarette sales from any type of retail outlet (about 500,000
retail outlets sell cigarettes in America),
- requiring prescriptions to buy cigarettes (as FDA does with other drugs),
- removing nicotine from cigarettes,
- eventually removing cigarettes from the market.

More comprehensive public health analyses of this FDA legislation is available at: www.notobaccobailout.org.

Smokefree Pennsylvania supports fair and effective federal regulations for tobacco products, and we acknowledge that S.2461 contains some improvements over the status quo. But overall, this FDA legislation gives the cigarette and Philip Morris significant unwarranted protection and benefits, at the expense of public health.

Finally, we urge you to oppose both the $9.6 billion House approved and $12 billion Senate approved tobacco quota buyouts because the overwhelming majority of beneficiaries don't even grow tobacco.

Thank you for your consideration, and feel fee to contact me for additional information about these important policy matters.

Sincerely,


William T. Godshall, MPH
Executive Director
 
Status
Not open for further replies.

Users who are viewing this thread