FDA Regulation – good or bad?

This week, The house passed by a large bipartisan majority, the Bill regulating tobacco under the control of the FDA.

What are your thoughts – will it pass, and if so when?

If you don’t think it will pass – do you think this is good?


#1 Bill Godshall on 08.04.08 at 2:50 PM

US Senate consideration of either S 625 or HR 1108 continues appearing less likely this session. Harry Reid is unlikely to let the full Senate waste a week debating the legislation (as Burr and McConnell have indicated they’ll filibuster) unless there are 60 supportive votes. A recent NY Times article by Stephie Saul indicated there were just 57 Senate votes in support of the legislation.

If the Senate considers either FDA bill, Mike Enzi still has several amendments to be considered (including a menthol cigarette ban, and a tobacco tax hike to fund FDA) that could create interesting debate and contraversy.

Even if the Senate were to pass S 625 (with or without additional amendments), the House and Senate would also still have to reconcile the differences between the bills (as S 625 requires color graphic warnings on all cigarette packs). Meanwhile, HR 1108 was amended with a 4 year moratorium for compliance by small tobacco companies, an allowance for the FDA to lower or eliminate penalties against retailers caught selling tobacco to minors, and a sampling exemption for smokeless products in limited adult-only locations.

But even if the House and Senate enact the same language, Bush is very likely to veto the legislation for various reasons (including several reasons I’ve been criticizing the bill for since 2004).

Unfortunately, the key reason (for public health and for tobacco companies) why the legislation should be rejected is because it protects the most hazardous tobacco products (cigarettes) from harm reduction market competion by far less hazardous smokefree tobacco products.

#2 John Rolfe on 08.07.08 at 9:48 AM

Bill is right on in my judgment and the fact that Sen. Kennedy is around more in spirit than body doesn’t help either when push comes to shove. The only conceivable angle here would be for the Democrats to want to further embarrass the Republicans in time for November by seeking the Bush veto and the Republican defense of tobacco, much like they did on SCHIP.

#3 CIG GUY on 08.12.08 at 1:37 AM

I think that folks should write to their senators that the truth must be proclaimed! Too many just sit back and do NOTHING AT ALL!

#4 Troubadour on 08.16.08 at 6:18 PM

Seems like no body cares which is really a shame. Slowly we will lose all our rights!

#5 Cowboys Stink on 09.12.08 at 1:52 PM

……..especially if Obama wins. All of our liberties will be regulated or socialized.

#6 deep throat on 09.12.08 at 2:00 PM

Where does Mr. Stink get off with this stuff?

#7 Cowboys Stink on 09.12.08 at 2:14 PM

Let’s face it. With a republican congress, the tobacco bills died on the vine. It took the liberal, socialist, current do nothing congress to put it on the front burner during an election year. Now it dies again in the Senate because of the Bush veto threat.

#8 TAZ on 10.25.08 at 1:30 PM

Looks like the FDA is busy.

An analysis of Federal data by the health industry watchdog group the Institute for Safe Medication Practices found that the US Food and Drug Administration received 20,745 reports of serious drug reactions during January – March 2008, 38% higher than the average for the previous four calendar quarters, with Pfizer’s smoking cessation drug Chantix accounting for 1,001 cases, higher than any other medication. (Associated Press – AP 10/22)

#9 Smoker Babe on 10.31.08 at 12:40 AM

The FDA can’t even control what it does now. How will it oversee a product that is harmful? Doesn’t FDA regulation make one think that it is ok? I guess that’s why folks call it the Marlboro Protection Act. Please folks less government is best!

#10 Bill Godshall on 12.02.08 at 11:07 AM

Today the Pittsburgh Post-Gazette published a letter I wrote (below) respondiing to a press release from WV DHHR and WVU “Experts say new tobacco product targets young adults: Camel Snus spitless tobacco called ‘highly addicting’”
http://www.health.wvu.edu/newsreleases/news-details.aspx?ID=1015 and a Post-Gazette article
“New snuff marketing makes W.Va. spittin’ mad”

Although harm reduction should be a primary goal of tobacco product regulation, the PM/CTFK/Waxman/Kennedy FDA tobacco legislation protects far more hazardous cigarettes from market competition by prohibiting new smokefree products into the market without FDA approval (which will never occur if GSK, CTFK, ACS, AHA, ALA get their way), by deceiving tobacco consumers to believe that all smokefree tobacco products are just as hazardous as cigarettes, and by prohibiting smokefree tobacco products from truthful informing smokers or smokeless users that smokeless is a less hazardous alternative to cigarettes.

– – –

Smoke-free facts

Regarding “New Snuff Marketing Makes W.Va. Spittin’ Mad” (Nov. 20): Several anti-tobacco extremists at the West Virginia health department and West Virginia University are deceiving smokers and the public about the health risks of different tobacco products, about nicotine and about a new smoke-free and spit-free product called snus.

Cigarettes are 100 times deadlier than moist snuff or chewing tobacco, while pasteurized snus poses even fewer health risks (similar to nicotine gum and lozenges).

By switching to smoke-free tobacco products, smokers can sharply reduce their health risks (almost as much as by quitting all tobacco) and eliminate secondhand smoke risks for others. Smokers also can reduce health risks for themselves and others by using smoke-free tobacco/nicotine products as every dose of nicotine obtained from a smoke-free product otherwise would be obtained by inhaling toxic cigarette smoke.

R.J. Reynolds is now marketing Camel Snus (stored in small refrigerators at convenience stores) to adult smokers as an alternative to cigarettes, and other new smoke-free and spit-free products are available in tobacco specialty stores.

All cigarettes and smoke-free tobacco products are addictive, regardless of how much nicotine they contain. Nicotine lozenges, gums and skin patches, marketed as smoking cessation aids, also contain different levels of nicotine.

Smokers have a human right to be informed that smoke-free tobacco/nicotine products are far less hazardous alternatives to cigarettes, and public health officials have an ethical duty to inform smokers of this lifesaving fact.

Executive Director
SmokeFree Pennsylvania

#11 Copenhagen Charlie on 12.02.08 at 9:29 PM

I appreciate your work Mr. Godshall. It’s evident that you are aware of the reduction in harm of smokeless products. It just amazes me that our politicians are so ignorant of the truth and are so severely mislead! I for one think that our government should stop trying to control our lifes like they do by spending time manipulating the truth as they see beneficial to their re-election efforts!

#12 Copenhagen Charlie on 12.02.08 at 9:31 PM

Oh Mr. Bill – Why do folks rely so heavily on the thoughts of Matt Myers rather than Michael Siegel? Seems to me that the later is more rational and has thought out his cause with less manipulation!

#13 Bill Godshall on 12.03.08 at 1:07 PM

Today, the Pittsburgh Post-Gazette published the following letter by Brad Rodu. The Post-Gazette is
the most widely read newspaper in western PA, northern WV and southeastern OH.


Smokeless benefits

I was disappointed to read in the Nov. 20 article “New Snuff Marketing Makes W.Va. Spittin’ Mad” comments by West Virginia University researchers and state health officials that misled West Virginia smokers with irresponsible allegations about smokeless tobacco.

Bruce Adkins, director of the state Bureau for Tobacco Prevention, is purposefully misleading when he says, “Here in West Virginia, 4,000 people die every year from tobacco-related illness.” He knows that the deaths are due to smoking.

Britain’s Royal College of Physicians, one of the world’s most prestigious medical societies, documented that smokeless tobacco is vastly safer than smoking. Unlike cigarettes, smokeless does not cause lung cancer, heart disease or emphysema. Research clearly shows that the risk for mouth cancer with smokeless is far lower than it is with cigarettes. Statistically, smokeless users have about the same risk of dying from mouth cancer as automobile users have of dying in a car wreck.

American anti-tobacco extremists don’t want smokers to know that smokeless tobacco works as a cigarette substitute because it delivers nicotine almost as efficiently as cigarettes. Nicotine is highly addictive but does not cause any smoking-related diseases. That makes it similar to caffeine, which is addictive but safely consumed by millions of Americans in coffee, tea and cola drinks. Modern smokeless tobacco products provide a socially acceptable way for smokers to achieve virtually all the health benefits of being smoke-free without abstaining altogether from nicotine and tobacco.

Professor of Medicine
Endowed Chair, Tobacco Harm Reduction Research
University of Louisville
Louisville, Ky.

Editor’s note: The writer’s research is supported by unrestricted grants from smokeless tobacco manufacturers to the University of Louisville. The writer says he has no personal relationship or conflict of interest regarding any manufacturer.

#14 Bill Godshall on 12.03.08 at 4:12 PM

Per Copenhagen Charlie’s inquiry: Mike Siegel has yet to acknowledge that smokefree tobacco products are less hazardous alternatives to cigarettes, even though I’ve sent him hundreds of scientific and news articles, e-mails and blog postings, and even though he introduced me and sat several feet away from me when I presented at the 2005 National Conference on Tobacco OR Health about the PM/CTFK FDA tobacco legislation’s many provisions that attempt to halt tobacco harm reduction.

Although Matt Myers has privately acknowledged that smokefree products are far less hazardous alternatives for smokers than are cigarettes, Myers and CTFK continue to deceive Congress, the public health community and the news media into believing that smokefree products are just as hazardous as cigarettes.

The good news is the American Association of Pulbic Health Physicians is now advocating for harm reduction changes to the FDA tobacco legislation. See the Tobacco Issues page at http://www.aaphp.org

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