What’s next in 2009 – FDA Regulation?

We’ve talked about it for some time now (years actually) but there is a good chance FDA regulation of Tobacco products will become reality this year.

PM USA has been for it all along, while their competitors see another agenda.

Assuming it does become reality – what is the most likely scenario – and how will FDA regulation unfold and change the business.

How long will this take? Will FDA regulators be reasonable and impartial?

Will there be tar ceilings, or perhaps a nicotine ceiling – avoiding the “tar wars?”

Will FDA implementation be along the lines of pharmaceuticals, improving tracability in manufacturing and trackability in the market?

Will it lead to ingredient disclosure and possibly to harm reduction?

Will consumers benefit?

7 comments ↓

#1 John Lauterbach on 02.17.09 at 4:08 PM

I am giving a presentation on “The Chemistry of Tobacco Regulation” at 6:30 p.m. on February 25 at Fort Valley State University, Fort Valley, GA, and I will cover some of the issues that could arise from FDA regulation.

Also, how many of the smaller companies have the GMP and factory hygiene practices in place that the larger companies have implemented?

#2 TAZ on 03.02.09 at 6:14 PM

Date: 3/2/2009

Support Youth Prevention and Tobacco Harm Reduction Act

Current Cosponsors: Buyer, Deal, McIntyre, McGovern

Dear Colleague:

The Centers for Disease Control and Prevention (CDC) reports that cigarette smoking accounts for an estimated 438,000 deaths (nearly
1 of every 5 deaths) each year in the United States. Smoking causes about 90% of lung cancer deaths in men and almost 80% of lung cancer deaths in women.

In the coming days, we look forward to introducing legislation that will promote the prevention of youth smoking, promote public education about the harmful effects of tobacco use, and support harm reduction strategies which enable smokers to understand the relative health risk of tobacco products and encourage them to make informed health decisions.

In October 2008, the American Association of Public Health Physicians (AAPHP) issued a “Resolution on Tobacco Harm Reduction.”
Highlights of this resolution include:

* “There is substantial scientific evidence that selected smokeless tobacco products can satisfy the nicotine addiction of inveterate smokers while eliminating most, if not all, risk of pulmonary and cardiovascular complications of smoking and while reducing the risk of cancer by more than 95%”

* “Current abstain, quit, or die tobacco control policies in the United States may have reached their maximum possible public health benefit because of the large number of cigarette smokers either unwilling or unable to discontinue their addiction to nicotine”

* “There is evidence that harm reduction works and can be accomplished in a way that will not increase initiation or impede smoking cessation”

* “Current federal policy requires tobacco product labeling that leaves the incorrect impression that all tobacco product present equal risk”

* “Be it Therefore Resolved that the AAPHP go on record as favoring Harm Reduction as a component of public health efforts to reduce tobacco-related illness and death.”

Please join us in cosponsoring bipartisan legislation to promote tobacco harm reduction policies as part of a comprehensive approach to tobacco legislation. Please contact Allison Hite (Rep.
Buyer) at 5-5037, Kim McClellan (Rep. McIntyre) at 5-2731 or Blake Fulenwider (Rep. Deal) at 5-5211 with any questions or to sign on as a co-sponsor.

Regards,

Steve Buyer Member of Congress
Mike McIntyre Member of Congress
Nathan Deal Ranking Member, Subcommittee on Health, Committee on Energy and Commerce

#3 TAZ on 03.03.09 at 8:06 PM

Joel Nitzkin of the American Association of Public Health Physicians sent this out today on Rep. Waxman’s FDA tobacco legislation.
Please contact House E&C Committee members before 10AM tomorrow (contact info below).
Bill Godshall
– – – –

Dear Tobacco Control Advocates

What follows is the text of a note I am sending today on behalf of the AAPHP Tobacco Control Task Force to the House Energy and Commerce Committee
— the committee Chaired by Waxman that will be considering the FDA/Tobacco bill tomorrow. The Wall Street Analysis referred to at the bottom of the memo is being posted on the AAPHP web site today.

FAX MEMORANDUM

To: House Energy and Commerce Committee
From: Joel L. Nitzkin, MD
Subject: Need Public Hearings and Amendments on FDA/Tobacco
Bill

The FDA/Tobacco Bill, if passed in its current form, will do more harm than good from a public health perspective (future rates of teen tobacco use and future tobacco related illness and death).

A properly amended bill could save the lives of 4 million of the 8 million current smokers who will die of tobacco-related illness over the next 20 years, while significantly reducing the number of teens initiating tobacco use.

No bill at all will result in a significant (guesstimate is 200,000 to
800,000) reduction in tobacco-related deaths, but with an increase in teens tobacco use.

The current bill, in its current form, would assure current levels of tobacco-related deaths, while doing nothing of significance to reduce the number of teens who would initiate tobacco use with no bill at all.

These surprising conclusions are based on detailed analyses of this bill and literature reviews done by the Tobacco Control Task Force of the American Association of Public Health Physicians. Our analyses, literature reviews and recommendations are posted on the tobacco issues page at our http://www.aaphp.org web site.

Those of you who signed on to this bill based on the summary generated by the Campaign for Tobacco Free Kids (CTFK) and the American Lung Associations projections that this will would “save millions of lives” may wish to consider the possibility that, despite the best of intentions, the CTFK representative who negotiated this bill with Altria/Philip Morris was not up to date on the science relative to how tobacco products cause illness and death, and may have been too generous to Altria/Philip Morris when including the many restrictions on federal agency authority written into the bill.

There is no urgency to immediate House passage without amendment, as Senate processing of this bill may yet be months away. In the unlikely event that current proponents are correct in their suggestion that the current bill is the best possible, from a public health perspective – this should become obvious in the hearing process. Thus, there should be nothing to loose by full committee exposure to what both proponents and opponents of the bill have to say. the information provided to and summarily rejected by the Chairmans office recommending amendments to improve the bill from a public health perspective.

Key AAPHP findings include 1) Cigarettes are the problem, not “all tobacco products” since the risk of death from cigarettes is 20 times more than the most hazardous smokeless product and more than 99 times the risk of low risk smokeless products. 2) Cigarettes cannot be made safer through manipulation of the tobacco. 3) The additives that must be removed are not toxic in their own right – but added to the cigarettes to cover the harsh taste and enhance nicotine absorption. Removal of these additives is not covered in the current bill. 4) The themes used to advertise tobacco products, not the placement of the ads must be addressed if we are to reduce teen smoking. 5) A Wall Street Analyst agrees with our finding that passage of this bill, in its current form will assure maintenance of Altria/Philip Morris (American cigarettesales) profitability.

JLN:jln 20090303EnergyCommerceFDATobc .doc

Joel L. Nitzkin, MD, MPH, FACPM
Chair AAPHP Tobacco Control Task Force
c/o JLN, MD Associates LLC
4939 Chestnut Street
New Orleans, LA 70115-2941
Phone: 504 899 7893 or 800 598 2561
Cell phone 504 606 7043
Fax: 504 899 7557
Skypename jlnitzkin
jln-md@mindspring.com
http://www.aaphp.org

#4 Bill Godshall on 03.04.09 at 5:42 PM

http://www.house.gov/apps/list/press/in04_buyer/pragmatic_tobacco_reform.html

For Immediate Release: Wednesday, March 04, 2009

BUYER CALLS FOR PRAGMATIC TOBACCO REFORM;
Promotes the Prevention of Youth Smoking, Public Education on Harmful Effects of Tobacco, and Harm Reduction Strategies

Washington, D.C.Cigarette smoking accounts for over 400,000 deaths each year in the United States and is very costly to our society through the loss of production, illness, disability and death. Congressman Steve Buyer (IN-04) introduced the Youth Prevention and Tobacco Harm Reduction Act, H.R. 1261, which would put into law a workable regulatory framework to better protect our children from tobacco use and to significantly increase public health benefits through the creation of a harm reduction strategy for the country. The Buyer, which has bipartisan support, was considered today in a markup of the House Energy and Commerce Committee.

Congressman Buyers legislation seeks to promote the prevention of youth smoking, provides for public education about the harmful effects of tobacco use, and supports harm reduction strategies which give adult smokers the information they need to understand the relative health risks of all tobacco products so that they can make informed health decisions.

I have been told by many public health officials that my legislation would greatly assist efforts to encourage Americans to quit smoking and provide the tools to do so. For Americans who cannot or who will not end their addiction to tobacco, the Youth Prevention and Tobacco Harm Reduction Act would provide them with less harmful alternatives to satisfy their nicotine desires. Research clearly shows that smokeless tobacco products, depending on the product, are 90 percent to 99 percent less hazardous than cigarettes in terms of risk of tobacco-related illness and death, said Buyer.

The House Energy and Commerce Committee, Subcommittee on Health, held a mark-up today on the regulation of tobacco. The Chairman of the Committee, Congressman Henry Waxman (CA), introduced legislation to regulate tobacco within the Department of Health and Human Service under the regulation of the Food and Drug Administration (FDA). Placing tobacco regulation under the watchful eye of the FDA, Congressman Buyer warns, is detrimental to the stability of the Agency, Adding more stress on an agency that already has strained resources and unfulfilled missions in regulating Americans food, drugs, and medical advices is hazardous.

Congressman Buyer offered H.R. 1261, the Youth Prevention and Tobacco Harm Reduction Act, as an alternative to House Energy and Commerce Committee Chairman Henry Waxmans legislation, H.R. 1108. It is to provide for a strong harm reduction strategy as part of a comprehensive approach to regulating tobacco. Buyers alternative is a bipartisan measure with Congressmen Nathan Deal (R-GA), Mike McIntyre (D-NC), Heath Shuler (D-NC), Joe Wilson (R-SC), Howard Coble (R-NC), Michael Burgess, M.D. (R-TX), Phil Gingrey, M.D. (R-GA), Sue Myrick (R-NC), and John Shadegg (R-AZ) as original co-sponsors.

Congressman Buyers alternative has marked differences to Chairman Waxmans tobacco regulation legislation. First and far most, the Youth Prevention and Tobacco Harm Reduction Act focuses on preventing minors from using tobacco products, going much farther than H.R. 1108. Buyer notes that his measure encourages states to penalize youths for the purchase, possession, and use of tobaccoaligning tobacco laws with states alcohol laws. Additionally, Congressman Buyers alternative enhances tobacco prevention and cessation programs, which H.R. 1108 does not employ.

Under current law, retailers are prohibited from selling tobacco products to minors. My substitute would strengthen current law by encouraging states to make it illegal for minors to purchase and possess tobacco products, similar to the laws for alcohol, Buyer stated. My substitute also calls upon states to increase the percentage of the funds, up to 25 percent, that they receive from the 1998 Master Settlement Agreement to fund tobacco cessation and public health programs, putting billions of additional dollars into these important efforts and restoring the intent of the MSA made between the 46 state Attorneys General and the tobacco companies. In the last 10 years, states have spent only 3.2 percent of their total tobacco generated revenue on tobacco prevention and cessation programs, and in Fiscal Year 2009, no state is funding tobacco prevention programs at the CDC recommended levels.

My substitute provides regulatory oversight for the development of products that reduce the risk of death and disease due to tobacco use while ensuring that adult tobacco consumers are fully and accurately informed by HHS and others, of the relative risks of all tobacco and nicotine products, added Buyer.

Second, Congressman Buyers alternative will not place the regulation of tobacco under the FDA. Congressman Buyer strongly disagrees with Waxmans measure placing tobacco regulation under the underfunded and under-resourced FDA. Instead, Buyers bill creates a streamlined and focused Tobacco Harm Reduction Center housed within the Department of Health and Human Services (HHS) and completely separate from FDA.

The Tobacco Harm Reduction Center will house all tobacco regulation and will be an agency entirely committed to addressing the tobacco epidemic in our country, commented Buyer. H.R. 1108, on the other hand, places tobacco regulation under the jurisdiction of our failing FDA. Lawmakers on both sides of the aisle agree that there is overwhelming evidence suggesting the FDA cannot handle its current scope of responsibilities, therefore greatly jeopardizing FDA’s focus on the safety of our drugs, devices, and food. So, to place another huge task within the mission of FDA makes no sense, not if we are serious about reducing tobacco use.

H.R. 1108 would also enable federal authorities to be intrusive into the nations farms, Congressman Buyer noted, Make no mistake, under H.R. 1108, our nation’s tobacco farmers will be directly or indirectly impacted by federal regulations. My substitute expressly prohibits the feds from affecting our nation’s farming practices, Buyer expressed.

Furthermore, Congressman Buyers substitute does not include the many 1st Amendment violations that H.R. 1108 includes. Therefore, under Buyers proposal, tobacco regulation has a better chance of going into effect immediately while H.R. 1108 is sure to be sent straight into years of litigation before any tobacco regulation can begin to take place.

The Buyer bill also seeks to take another look at how children are affected by advertisements and said, My substitute calls for a Blue Ribbon study of tobacco advertisements and a report back to Congress on methods by which we can ensure tobacco advertisements are not affecting our children. Combined with the substantial results of the MSA, my substitute addresses tobacco advertising in a constitutionally acceptable and meaningful way stated Buyer.

###

#5 ... on 03.11.09 at 11:19 AM

THE BEST THING I HAVE SEEN THAT MAKES SENCE

RALEIGH (WTVD) — Saying that the Food and Drug Administration is “ill equipped and unsuited to regulate tobacco and tobacco products,” Senator Richard Burr (R-NC) and Senator Kay R. Hagan (D-NC) offered what they call “a reasonable, bipartisan alternative to the proposed FDA tobacco regulation.”
What they want is an entirely new Federal Tobacco Regulatory Agency separate from the FDA.
“I am opposed to giving the FDA the authority to regulate tobacco. The FDA is overburdened already, and lacks the capacity or the expertise to take on a large, complicated new industry,” said Hagan in a news release.
The senators pointed to the recent problems with recalling thousands of potentially salmonella contaminated peanut products as evidence of problems with the FDA. They say the tobacco industry employs some 65,000 people in North Carolina.
Story continues belowAdvertisement”I will not stand idly by while the FDA is put in charge of such a critical industry to North Carolina,” said Hagan. “I am offering this alternative and will work with my colleagues to garner additional support.”
The senator’s move comes after a House committee approved legislature that would put cigarettes under government regulation for the first time.
The House proposal wouldn’t let the FDA ban tobacco or nicotine, but it could reduce or eliminate cancer-causing chemicals in cigarette smoke. It would also outlaw candy-flavored cigars and cigarettes and give the FDA authority to ban menthol.
The Bush administration opposed the bill, but President Obama is in favor. According to published reports, some cigarette makers like Philip Morris have been supportive, but others like R.J. Reynolds and Lorillard are not.
Under Hagan and Burr’s proposal, the Federal Tobacco Regulatory Agency would enforce new and existing federal rules governing tobacco products. All tobacco makers selling in the U.S. would be required to register, and user fees would fund the agency.
Hagen’s office said the proposal “would virtually eliminate the advertising and marketing of tobacco products and the use of terms such as “light,” “mild,” “ultra-light,” “medium,” and “low,” as product descriptors. Companies would not be permitted to use their brand to sponsor events or conduct consumer sweepstakes or contests. Cigarettes would not be permitted to be sold in packs of less than 20, and the backs of tobacco packages would be reserved for mandated disclosure requirements, including surgeon general’s warnings and ingredient disclosures.”

#6 Bill Godshall on 04.01.09 at 12:02 PM

Smokefree Pennsylvania sent the following letter to US House members today.

April 1, 2009

The Honorable
U.S. House of Representatives
Washington, D.C. 20515

RE: Tobacco Regulatory Legislation (HR 1256 & HR 1261)

Dear Representative

Smokefree Pennsylvania urges you to oppose Rep. Waxman’s FDA tobacco bill (HR 1256) and to also oppose Rep. Buyer’s substitute tobacco bill (HR 1261) because both bills contain outrageous clauses that protect future cigarette markets at the expense of public health.

We oppose Rep. Waxman’s legislation, a deal negotiated by Philip Morris and the Campaign for Tobacco Free Kids in 2004, because it protects the most hazardous tobacco product (cigarettes) from market competition by the least hazardous (smokefree) tobacco products, as it:
– bans all new and recently introduced smokefree products, while keeping cigarettes on the market,
– deceives consumers to believe that smokefree tobacco products are just as hazardous as cigarettes,
– prohibits industry from telling smokers that smokefree products are less hazardous than cigarettes.

Sound product regulations truthfully inform consumers (and the public) about risks of different products, and encourage industry to make lower risk products. Cigarettes are 100 times deadlier than smokefree tobacco products, but 85% of smokers incorrectly believe that smokefree tobacco products are just as hazardous as cigarettes. 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. Public health agencies have an ethical duty to inform smokers that smokefree tobacco/nicotine products are less hazardous alternatives to cigarettes, and smokers have a human right to this important information. I coauthored a report “Tobacco harm reduction: an alternative cessation strategy for addicted smokers” at http://www.harmreductionjournal.com/content/3/1/37

While Smokefree Pennsylvania supports the harm reduction provisions in Rep. Buyer’s substitute (HR 1261), we oppose the bill since it contains clauses that would increase cigarette sales to minors.

Since 1990, Smokefree Pennsylvania has advocated policies to protect people from 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.

Thank you for your consideration, and feel free to contact me anytime.

Sincerely,

William T. Godshall, MPH
Executive Director

#7 TAZ on 04.02.09 at 11:54 AM

House Approves FDA Tobacco Bill

Under the bill, the FDA would have the power to block or approve new products, regulate products’ ingredients and restrict advertising and marketing.

WASHINGTON — In a 298-112 vote, the House passed the Family Smoking Prevention and Tobacco Control Act, a bill that would give the Food and Drug Administration (FDA) authority to regulate the tobacco industry, according to an Associated Press report.

Under the bill, the FDA would have the power to block or approve new products, regulate products’ ingredients and restrict advertising and marketing, as well as require larger warnings on packages. It would also require the FDA to set up a new Center for Tobacco Products, and its operations would be financed with up to $712 million annually in fees paid by the tobacco industry, based on market share, according to published reports.

The Senate could take up its version of the bill later this month. Supporters are confident they can get Senate passage and President Barack Obama’s signature on the bill, the AP reported.

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