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FDA approves 44 new cigarette brands

FDA approves 44 cigarette brands but still intends to ban >99% of far less hazardous smokefree e-cigarette vapor products and give the e-cig industry to Big Tobacco companies "to protect the children and public health".

Instead of a press release announcing FDA's approval to market 44 cigarette brands, the agency tried burying this important news story (highlighting how the FSPTCA, the FDA and its proposed deeming regulation protect cigarettes at the expense of public health) on its website and by sending out the following non-announcement e-mail yesterday afternoon (July 3) just before the national holiday.

"This Week in CTP - Updates from the Center for Tobacco Products
FDA continues to review tobacco product marketing applications and issue decisions on those submissions. In June, FDA issued 50 Substantial Equivalent (SE) orders and 6 Refuse to Accept (RTA) letters. Additionally, companies withdrew 19 SE reports from the review process.
More information on these actions, and a summary of all the actions FDA has taken, can be found on our Tobacco Product Marketing Orders webpage."

Specifically, FDA issued SE orders for 44 Riverside and Valu Time cigarettes made by S&M Brands (6/2014)

Previously, FDA issued SE orders for 2 Lorillard Newport cigarettes made by Lorillard (6/2013)

2 Elements Aficionado cigarette rolling papers made by HBI International (9/2013)

5 brands of RYI cigarette papers/tubes made by Republic Tobacco LP (9-10/2013)

8 Timber Wolf and Renegade smokeless tobacco products made by Swedish Match NA (11/2013)

5 Oliver Twist Chewing Tobacco Bits made by House of Oliver Twist A/S (5-6/2014)

5 FasFil Cigarette Tubes (RYI) made by Silverfoiltubes International, Inc. (6/2014)

Historical protection of cigarette sales

Nearly a decade ago, Smokefree Pennsylvania sent the following letter to US Congress Conference Committee members urging them to reject the proposed FSPTCA legislation (which they did until 2009) because it protected cigarettes and threatened public health and tobacco harm reduction.

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:

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.


William T. Godshall, MPH
Executive Director