FDA's comment claiming IQOS wasn't "FDA approved" traces its roots to my 2004 letter to members of US Congress (below) urging them to reject the Tobacco Control Act legislation (that was negotiated and agreed to in 2003/04 by Philip Morris lawyer Mark Berlind, RWJF financed CTFK's Matt Myers and then GlaxoSmithKline lobbyist Mitch Zeller).
One of the reasons cited in my letter was that the TCA legislation would
"- allow manufacturers to promote cigarettes as FDA approved,"
When Henry Waxman and Ted Kennedy introduced the Tobacco Control Act bills in 2005 they included a clause that specifically prohibited all tobacco companies from claiming that any of their products were "FDA approved" (even if FDA approved a marketing order for Substantial Equivalence, or a PMTA). That clause is in the TCA, the FDA has already approved marketing orders for hundreds of different cigarette brands via SE, but none of the companies are allowed to say so).
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
