Tobacco Harm reduction and the FDA – the story behind the story.

Congress is working through the FDA bill which will ultimately regulate the Tobacco Industry. It’s likey to pass this year but even if it doesn’t most view it as only a matter of time – although we’ve been saying this for over ten years now.

What’s not encouraging is how little the bill has changed in this time. The bill has become a piece of history apparently frozen in time.

According to reports Congressamn Waxman had to ask what MSA stood for – which certainly conveys the impression he’s not entirely in the loop.

As written the bill favors the status quo. That’s great if you’re PM USA, but things change and there are other stake holders.

No word is included about tobacco harm reduction – in fact for cigarettes the bill almost precludes it by setting the bar so high as to be unattainable.

There’s no language differentiating or explaining relative risk for tobaco products. All will carry similar health warnings. The general public will not be informed and will not know that smokeless tobacco products can be greater than 90% less harmful than combustible products.

The bill needs serious amendment. Whether that will happen at this late stage is debatable.

Contact your congressman and ask him to amend the bill to include language on relative risk and at least the possibility to enable development of a lower risk cigarette at sometime in the future. Smokers deserve nothing less.


#1 Bill Godshall on 06.01.09 at 3:57 PM

Tomorrow (June 2) the US Senate is set to consider Philip Morris drafted and backed FDA tobacco regulatory legislation (S. 982). Please contact
your Senators (202-224-3121) and let them know your concerns about the legislation. Smokefree Pennsylvania wrote the following letter to
– – –

Smokefree Pennsylvania
1926 Monongahela Avenue
Pittsburgh, PA 15218
FAX 351-5881

June 1, 2009

Dear Senator

Unless Sen. Kennedy’s tobacco bill (S. 982) is amended with harm reduction provisions, Smokefree Pennsylvania urges you to OPPOSE this privately
negotiated deal (in 2004) between Philip Morris and the Campaign for Tobacco Free Kids to protect the deadliest tobacco product (Marlboro cigarettes) from market competition by the least hazardous tobacco/nicotine products (smokefree).

S. 982 poses an enormous threat to public health and the health of 45 million smokers because it:
– bans all new and recently introduced smokefree products while keeping cigarettes on the market,
– misleads consumers to believe that smokefree tobacco products are just as hazardous as cigarettes,
– bans companies from informing smokers that smokefree products are less harmful than cigarettes,
– requires the FDA to perpetuate the safer cigarette fraud by regulating cigarette smoke constituents,
– prohibits the FDA from ending tobacco marketing to 12th graders in high school (age 18), and
– authorizes an agency (FDA) to regulate tobacco that cannot reasonably regulate nicotine products.

Sound product regulations truthfully inform consumers about risks of different products and encourage industry to make lower risk products. Although cigarettes are 100 times deadlier than smokefree tobacco products, S. 982 requires misleading warnings on smokefree tobacco products that confuse consumers to believe they are as hazardous as cigarettes, bans new and recently introduced smokefree tobacco products (unless approved by
FDA), and violates the Constitutional rights of tobacco companies to truthfully inform consumers that cigarettes are more hazardous.

By switching to smokefree tobacco/nicotine products, smokers reduce their health risks by nearly as much as by quitting all tobacco/nicotine, and millions have already done so. The percentage of nicotine obtained from smokefree tobacco/nicotine products in the US has doubled (from 10% to 20%) during the past decade, but S. 982 will curtail that public health
progress. Smokers have a human right to truthful information about, and legal access to, far less hazardous alternatives. And public health agencies have an ethical duty to inform smokers about reduced risk alternatives.

S. 982 also requires the FDA to establish regulatory guidelines for cigarette companies to make claims that some cigarettes are “reduced exposure” compared to other cigarettes, and encourages the FDA to establish
limits for different constituents in tobacco smoke. This would be a disaster for public health because it perpetuates the safer cigarette myth/fraud that began with cigarette filters in the 1950’s and continues to
this day with low tar, light and ultralight cigarettes, which is why 85% of smokers inaccurately believe that the latter cigarettes are less hazardous than others.

S. 982 would do very little to reduce smoking or protect youth (as promoters of the bill continue to falsely assert). The Congressional Budget Office recently estimated that H.R. 1256 (Rep. Waxman’s nearly
identical bill) would reduce youth smoking by only 11%, and adult smoking by just 2% over the next DECADE. In contrast, youth tobacco use declined
by 50% to 65% (depending upon product and age group) in the past decade, while overall cigarette consumption declined by 26% in the past decade. A
key reason S. 982 does little to reduce youth tobacco use is because it prohibits the FDA from banning the sale and marketing of tobacco products to virtually all 12th graders, ensuring easy access to all high school

Finally, the FDA should not be given authority to regulate tobacco products unless and until the agency can reasonably regulate the least hazardous nicotine products (e.g. NRT products including gums/lozenges/skin patches, and electronic cigarettes). The FDA still hasn’t acted on a petition filed
by the New York State Health Commissioner more than 14 months ago to require the FDA to allow the sale of NRT in daily dose packages, allow their sale at all stores that sell cigarettes, and to improve the misleading and scary warning labels on NRT. And during the past several months, the FDA has blocked imports of electronic cigarettes and proposed banning the products, which would result in tens of thousands of product users going back to smoking lethal cigarettes.

Once again, please support harm reduction amendments to S. 982, and reject the legislation unless harm reduction amendments are approved. Smokefree
Pennsylvania supports the following list of amendments that have been filed to S. 982.

Since 1990, Smokefree Pennsylvania has advocated policies to reduce indoor tobacco smoke pollution, increase cigarette taxes, reduce tobacco marketing
to youth, preserve civil justice remedies for tobacco victims, expand smoking cessation services, and inform smokers that smokefree tobacco/nicotine products are less hazardous alternatives to cigarettes.


William T. Godshall, MPH
Executive Director
– – –

Amendments to S. 982 endorsed by Smokefree Pennsylvania

Burr #2 Change “public health” standard to “reduce youth tobacco use” standard
Burr #3 Smokeless tobacco carveout
Burr #4 Require reductions in tobacco illness and death
Coburn #1 Internet sales
Coburn #3 Including Native American retailers and manufacturers
Coburn #4 7 year hard sunset
Coburn #7 GAO study on metrics
Coburn #9 PACT Act
Enzi #2 Higher civil penalties for tobacco companies
Enzi #4 Imminent hazard authority
Enzi #5 Strike adverse event reporting and require DSMB
Enzi #8 Indexing user fees in outyears
Hagan #1 To ensure that performance standards are based on achievable technology
Hatch #7 Standard for reduced risk products
Hatch #10 Performance and financial reports
Hatch #11 Report on impact of program on SCHIP
Murkowski #1 Track and trace for tobacco

#2 fedup on 06.04.09 at 12:23 AM

Any update on what is taking place at the senate level with the proposed FDA regulation. Any hope for harm reduction or is PM going to sleep nicely at night with it’s friends at ctfk and acs

#3 OTP Kid on 07.23.09 at 6:33 PM

OK Bill, now that you’ve been proven wrong on e-cigs (as I told you that you would be ), I think it’s time to shut down the lecturous tone. The only thing you’re providing on this site is blather.

#4 Jean on 12.02.15 at 3:33 PM

These graphic cianamgps get through to people on a level that words alone cannot! And the potential savings in health care costs (to say nothing of lost work productivity) for just one person’s cancer would be tens of thousands of dollars. These public health interests, which include helping protect people from the physical and emotional impacts of cancer (as well as the financial ones) certainly seem to me worth far more that $1,080 per person (if 50,000) quit. Many dangerous activities are legal, because we credit people with the ability to make informed choices. But that assumption suggests that the people are well informed, and repeatedly so, in the context of a powerful craving!

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