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February, 2007:

Regulation of Tobacco Products – Henningfield Oral Testimony

ORAL STATEMENT of Jack E. Henningfield, Ph.D.

Vice President, Research and Health Policy
Pinney Associates, Bethesda, Maryland and
Professor of Behavioral Biology, Adjunct, and
Director of the Innovators Awards Program
Department of Psychiatry and Behavioral Science
The Johns Hopkins University School of Medicine

Before the The Health Education, Labor and Pension (Help) Committee
United States Senate Hearing on Senate Bill S.625
February 27, 2007

Mr. Chairman and Members of the Committee, thank you for the opportunity to testify and serve. I have studied drug addiction and health
for three decades at Johns Hopkins Medical School, the National Institute on Drug Abuse, and through my consulting at Pinney Associates to
GlaxoSmithKline on smoking cessation medications.

Many people think of tobacco products as relatively simple concoctions of tobacco and flavorings that people smoke for simple pleasure, and with full awareness of the dangers; and, that smoking is a completely free choice. Nothing could be further from the truth.

Tobacco products are sophisticated drug delivery systems – They are engineered and manufactured to increase addiction risk, and without any regulatory oversight to draw the line on practices that unnecessarily increase harmful and addictive effects. FDA authority could lead to less addictive and less harmful products and regulation of marketing to reduce deception.

Existing AND future products need to be regulated. Existing products are used by more than 50 million Americans, killing more than 1000 every day. Setting standards for chemicals that can heighten addictiveness such as ammonia and acetaldehyde, and flavorings such as menthol and chocolate, could be steps towards less addictive, less attractive tobacco products.

Developing performance standards for toxicants such as pesticide residues, tobacco specific nitrosamines, carbon monoxide, and formaldehyde could reduce exposure in those who continue to use tobacco.

Regulation is needed to prevent deceptive designs that are killing Americans. Today, more than two thirds of cigarette smokers smoke light
cigarettes. My sister was one of them. As she told me: “You can tell Marlboro Reds are worse: they felt stronger and left my throat raw
compared to Lights.”

Let me tell you a few things she didn’t know. She assumed there were government standards for light cigarettes and that the FTC test method for tar and nicotine reflected health effects or at least actual intake as is the case for food labeling. She assumed that cooler, smoother smoke meant that it was weaker and less harmful. She couldn’t believe “the government” would allow such a scam.

[SHOW CIGARETTE & VENT HOLES]

Cigarette ventilation is one deadly scam you can see for yourself. If you tear the paper from a cigarette filter and hold it to a light, you can see bands of tiny vent holes about 3/8 to 1/2 inch out from the end. This is right where they can be easily covered with lips or fingers. Unbeknownst to most smokers, blocking some of the holes can easily double or triple delivered tar and nicotine. I did this demonstration a few years ago for my son’s third grade class and his classmates reacted with clarity and passion. Their comments included: “that’s cheating!” and “they can’t do that”.

Well Senators, that is cheating, and there is a means of stopping and preventing such deception – for food products, but not for tobacco – not until tobacco is regulated by the FDA.

Light cigarettes may just be the tip of the iceberg. New generations of products appear to be following the commercially effective model of light cigarettes, which is to develop highly addictive products with designs and marketing efforts to assuage fears about tobacco so as to hook more people and keep them using. These products will need their own standards so their potential effects are understood BEFORE they are allowed to be marketed, and to make sure that marketing does not inappropriately promote use.

FDA is the right agency and the only agency with appropriate experience to develop and enforce product performance standards. I have heard the entire range of arguments about why FDA should not be granted regulatory authority, including that FDA was not designed to evaluate cigarettes or inherently dangerous products. The fact is FDA was designed to assess safety, ingredients, and resultant toxicant exposures for a broad range of products. Furthermore, tobacco products are drug delivery systems at heart. Even the tobacco industry admits this in their documents. Moreover, tobacco products are designed and marketed to deceive and heighten addiction risk.

Finally, let me emphasize that FDA authority will not make tobacco products safe, and should not be seen as a substitute for comprehensive
tobacco control efforts to reduce all forms of tobacco use and disease. In fact, FDA regulation should be viewed as a partner in tobacco – the Bill will bring the most powerful health regulatory body to the world to the table in partnership with tobacco control experts. It will then be positioned to serve these efforts because it will restrict the ability of the industry to modify products and descriptors that undermine prevention and cessation.

I therefore urge expeditious passage and implementation of the Bill.

Regulation of Tobacco Products – Henningfield Testimony

Statement of Jack E. Henningfield, Ph.D.

Vice President, Research and Health Policy
Pinney Associates, Bethesda, Maryland and
Professor of Behavioral Biology, Adjunct, and
Director of the Innovators Awards Program
Department of Psychiatry and Behavioral Science
The Johns Hopkins University School of Medicine

Before the The Health Education, Labor and Pension (Help) Committee
United States Senate Hearing on Senate Bill S.625

February 27, 2007

Thank you for the opportunity to testify on S.625, the Family Smoking Prevention and Tobacco Control Act, that would provide “the Food and Drug Administration with effective authority to regulate tobacco products.” FDA regulation is not only the right thing to do, it is urgent. More than 4 million Americans have died prematurely since FDA asserted jurisdiction and issued its Final Rule to regulate cigarettes and smokeless tobacco in 1996. Although we have made modest progress in reducing tobacco use, I believe FDA regulation would have made the progress significantly greater. Furthermore, the tobacco industry is unleashing new products, new claims, and clandestinely modifying conventional products at a terrifying rate, with no plausibly-effective regulatory mechanism in sight, except for the approach embodied in the Senate Bill. Even the FTC has thrown in the towel and apparently given up on its own widely criticized and deeply flawed method of cigarette testing.

You can find the entire Henningfield Testimony here.