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Senate Tobacco Bill Would Alter FDA's Mission

WhyQuit's Statement for the Senate Hearing on FDA Regulation of Tobacco
Senate Committee on Health, Education, Labor and Pensions

John R. Polito

February 27, 2007

Dear Chairman Kennedy:

WhyQuit is the Internet's oldest and largest quit smoking forum devoted exclusively to abrupt nicotine cessation, the quitting method employed by 80 to 90% of all long-term successful ex-smokers. As an all volunteer forum we dream of the day when the need for our free education, counseling and support services is at an end and the team can turn their energies and passions to new causes. But, sadly, the bill before you would better be titled "The Nicotine Addiction Industry Protection Act."

It seeks to grant the Food and Drug Administration (FDA) limited authority to regulate cigarettes and tobacco. At first blush the idea sounds great. In fact, an initial reading of the full bill will likely reinforce that opinion. But don't we want America's 9,000 FDA food and medicine watchdogs ringing alarms when any product is found responsible for even a single death? How can we not pollute their mission and minds by commanding them to accept regulatory oversight and thus some degree of responsibility for hundreds of thousands of smoking related deaths annually?

The FDA's full mission statement reads as follows:

"The FDA is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable; and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health."

Key Congressional "findings" from the bill assert that "tobacco products are inherently dangerous and cause cancer, heart disease, and other serious adverse health effects," "nicotine is an addictive drug," "virtually all new users of tobacco products are under the minimum legal age to purchase such products," and "tobacco use is the foremost preventable cause of premature death in America. It causes over 400,000 deaths in the United States each year and approximately 8,600,000 Americans have chronic illnesses related to smoking."

Clearly, America's leading cause of preventable death isn't a medicine or food but by the bill's own findings an inherently dangerous and highly addictive killer. Isn't it obvious that the Federal Trade Commission (FTC), pursuant to the Federal Cigarette Labeling and Advertising Act of 1966 (15 U.S.C. §§ 1331-1340, as amended) is the proper federal agency for addressing what are primarily tobacco advertising, marketing and sales oversight responsibilities.

But instead, the bill's language, which clearly had strong input from Philip Morris USA, is loaded with provisions that tie the FDA's hands. It prohibits the FDA from removing all nicotine from cigarettes, from banning their sale, from requiring that tobacco be removed from neighborhood convenience stores (what to youth is the neighborhood candy, chip, ice cream and soda store), and from raising the age of purchase above age 18.

Philip Morris USA's website notes the February 15, 2007 introduction of the bill and states, "PM USA strongly supports this bipartisan legislation and urges Congress to take quick action" on the bills. Philip Morris asserts that the bill will bring "predictability" to the tobacco industry in the United States. Predictability?

This bill is a tobacco industry dream come true - an official government birth certificate that guarantees the right to sell a chemical that the Surgeon General claims is at least as addictive as heroin to eighteen year-old high school students across the nation, eighteen year-olds who want to be liked. Try to find any convenience store without a buy 1 get 1 free or buy 1 get 2 free deal. They make captivating gifts that all but guarantee that underage recipients will become new friends who'll soon return begging for more.

Although the bill is well intended, it plays smack dab into the tobacco industry's hand. The industry always seems two moves ahead of health policymakers but considering that its economic survival is at stake it must stay ahead. When the 1998 Master Settlement agreement with the states ended tobacco product advertising in high youth readership magazines they simply shifted those dollars into neighborhood convenience stores - into what is now "nicotine addiction central."

Think like a tobacco company. Imagine watching in horror as smoke-free workplace laws sweep the nation and nearly all states raise cigarette taxes in an attempt to price nicotine products beyond the disposable income of most youth. But what's now just starting to sweep the tobacco control community is a realization that cigarettes, by far the dirtiest drug delivery device ever devised, are no longer needed.

In November 2003 GlaxoSmithKline consultants reported that nearly 37% of all nicotine gum users were engaged in chronic long-term use of at least 6 months. We have no reason to believe that nicotine lozenges, releasing 25% more nicotine than gum, won't be just as high. Although nicotine replacement therapy products have shown 1.5 to 2 fold efficacy over placebo in randomized clinical trials, once outside the door and going head-to-head against cold turkey they fall flat on their face. But replacement nicotine's true value to society isn't in cessation but as an ongoing daily dependency alternative to cigarettes.

Which city in America would have been the first to ban the sale of all cigarettes and have a city-wide transfer campaign to help smokers adapt to cleaner forms of nicotine delivery? What would have happened to youth and adult smoking rates in that community? Like smoke-free workplace air, could such a movement quickly sweep the entire nation? Under this bill we'll never know.

Section 907(b)(3) of the bill, entitled "POWER RESERVED TO CONGRESS," "expressly reserves" to Congress the power to ban all cigarettes. If we were thinking ahead, instead of another aspect of federal preemption why couldn't this reservation have expressly shared such power with the states or their political subdivisions?

As for tasking the FDA with determining which of 4,000 cigarette smoke constituents are the most deadly and then battling the industry to have one or more removed, picture for a moment the marketing representations that would be made in association with selling this reduced risk product that's still extremely deadly. In fact, as soon as this bill is passed all cigarette advertisements will instantly be able to honestly proclaim that they are in full accord with all Food and Drug Administration safety requirements. Imagine how that message will play inside a fifteen year-old's mind.

We encourage the Committee to amend the bill to task all sales, marketing and advertising provisions to the FTC while including a strong preemption disclaimer that makes it clear that the states are free to regulate all aspects of advertising, marketing and sales, including the power to ban any or all forms of nicotine delivery, with the exception of altering required tobacco product health warnings if tobacco products are sold.

If the Committee insists on going forward with this ill-advised bill it should be amended to:

  1. Make it clear that, as with alcohol, the states and their political subdivisions have full authority to ban the sale of any or all classes of nicotine delivery devices, including all forms of nicotine replacement therapy.
  2. Authorize the FDA to raise the smoking age to 21.
  3. Authorize the FDA authority to limit the sale of any class of nicotine delivery device to stores to which those who are underage are denied access. Responsible stores need to make a choice. They either want to market and sell what many consider earth's most captivating chemical or cater to children but they cannot do both.
  4. Authorize the FDA to both remove all nicotine from tobacco products and ban the sale of any class of nicotine delivery device.
  5. Include an express provision that any reference to FDA regulation of tobacco during any products liability jury trial will result in a mistrial and a statutory penalty of $100,000.
  6. Amend the warnings to require that alternating nicotine addiction warnings appear on one side of each cigarette pack sold, with a health warning appearing on the other side. For example, Canada's 2000 addiction warning reads, "Warning Cigarettes are Highly Addictive - Studies have shown that tobacco can be harder to quit than heroin or cocaine." Canadian youth smoking rates have fallen dramatically since the warning first appeared in 2000. Relative risk information is critical if youth are to make informed decisions. Youth also need to know how quickly dependency can occur, the warning signs, and the truth about how ineffective over-the-counter quitting aids such as the nicotine patch and gum actually are with a 93% six-month smoking relapse rate as determined by GlaxoSmithKline consultants. Otherwise we provide them a false belief that quitting is easy when in fact 50% of adult U.S. smokers are losing 13 to 14 years of life. As for giving dependency warnings equal weight with health warnings, it is nearly impossible to experience most health risks unless the user first becomes dependent, the greatest risk of all.
  7. Provide clearer language that the Secretary is not only free to amend existing warnings but to create new warnings.

If this were any other consumer product the FDA would instantly battle to have it removed from the market. The bill attempts to pound a square peg into roundness. It cannot be done. Although all sponsoring this bill are well intended they should put themselves in the shoes of the average FDA employee and reflect upon how this bill will fundamentally alter their mission and thinking in regard to product risk analysis. Is that really what's best for America? We're making great strides. Give the states full authority to regulate sales and then, like smoke-free workplace laws, watch the magic unfold.

Respectfully submitted,

John R. Polito
Editor WhyQuit.com (843) 797-3234

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Written 02/27/07 and page reformatted 08/05/18 by John R. Polito