Link to House Bill regarding the Family Smoking Prevention and Tobacco Control Act (FDA Controlling Tobacco): http://thomas.loc.gov/cgi-bin/query/z?c111:H.R.1256:
I'm still in the process of reading all of this, but it seems to me that there are some pros and cons to this complex issue. I figured I'd put the info out for you all to do your own research. If you click the third option you can see the final bill that was passed in the House.
If you click on one of the older versions of the bill, you can read (at the end), some of the dissenting views. They are interesting, particularly in that they seem to argue more strongly for the harm-reduction viewpoint. I posted an excerpt from this below for your information, in order that you may review both sides of this issue.
"DISSENTING VIEWS
Forcing the Food and Drug Administration (FDA) to regulate tobacco products--products that will never qualify as `safe and effective'--could have significant negative impacts on all Americans. This Committee has spent a great deal of time investigating the ways in which the FDA has been unable to fulfill its core mission. Therefore, we are concerned that burdening the FDA with added responsibilities outside of the agency's expertise and core missions at this time will have dire consequences for the American people and the FDA's ability to ensure the safety and efficacy of our nation's food, drugs, and medical devices. We are also concerned that effectively giving the FDA stamp of approval on cigarettes will improperly lead people to believe these products are safer than they truly are.
H.R. 1256 also allows the use of FDA general funds for `startup costs' associated with the bill's new tobacco regulation activities. The bill allows the FDA to divert resources from its core mission, including funds from food safety inspections and drug and device approvals. While the bill specifies these funds must be reimbursed by manufacturer user fees, it does not provide a timeline for reimbursement, further straining FDA's limited resources. Regardless of how quickly FDA is able to collect manufacturer user fees, the bill requires use of general funds for tobacco startup costs for at least six months. Depending on the timing of user fee collection, additional resources would have to be diverted from FDA general funds as the agency awaits annual appropriations. At a time when FDA is struggling to perform many of its core functions, diversion of its limited resources will negatively impact the safety of the American public.
In order to rectify the concerns about H.R. 1256 outlined below, the Committee considered a substitute amendment offered by Congressman Steve Buyer to establish the Tobacco Harm Reduction Center under the Department of Health and Human Services (HHS). The substitute would have protected the already overburdened FDA from carrying out significant new tobacco regulations. The substitute was based on public health policies that acknowledge a continuum of risk among all tobacco products and referenced scientific literature which shows that smokeless tobacco products are 90-99% less hazardous than cigarettes in their risk of causing tobacco-related illness and death. The substitute would have ensured adult tobacco users are given complete, accurate and truthful information about the risks and relative risks of all tobacco products so that they can make informed health decisions. The substitute incentivized the development of reduced-risk tobacco products. Additionally, the substitute expressly prohibited regulations affecting tobacco growers, strengthened preventions against minors' tobacco use, was funded through the normal appropriations process instead of new user fees, and protected American jobs. All Republican members present at the markup voted in favor of this substitute.
H.R. 1256 purports to utilize a science-based approach to the regulation of tobacco products but ignores accepted scientific evidence that harm reduction strategies for moving people to less dangerous tobacco products will in fact lead to lower incidences of smoking-related illnesses. This is especially troublesome given the legislation's lack of incentives for States to use Master Settlement funds for smoking cessation and other public health programs.
If enacted, this legislation significantly curtails, if not entirely eliminates, incentives to develop and market products that reduce exposure to tobacco toxicants. In order to obtain approval of a modified-risk product, an applicant must demonstrate that the marketing and labeling of the product will not mislead consumers into believing that the product is or has been demonstrated to be less harmful. Further, it has to be demonstrated that the product reduces risk "
I'm still in the process of reading all of this, but it seems to me that there are some pros and cons to this complex issue. I figured I'd put the info out for you all to do your own research. If you click the third option you can see the final bill that was passed in the House.
If you click on one of the older versions of the bill, you can read (at the end), some of the dissenting views. They are interesting, particularly in that they seem to argue more strongly for the harm-reduction viewpoint. I posted an excerpt from this below for your information, in order that you may review both sides of this issue.
"DISSENTING VIEWS
Forcing the Food and Drug Administration (FDA) to regulate tobacco products--products that will never qualify as `safe and effective'--could have significant negative impacts on all Americans. This Committee has spent a great deal of time investigating the ways in which the FDA has been unable to fulfill its core mission. Therefore, we are concerned that burdening the FDA with added responsibilities outside of the agency's expertise and core missions at this time will have dire consequences for the American people and the FDA's ability to ensure the safety and efficacy of our nation's food, drugs, and medical devices. We are also concerned that effectively giving the FDA stamp of approval on cigarettes will improperly lead people to believe these products are safer than they truly are.
H.R. 1256 also allows the use of FDA general funds for `startup costs' associated with the bill's new tobacco regulation activities. The bill allows the FDA to divert resources from its core mission, including funds from food safety inspections and drug and device approvals. While the bill specifies these funds must be reimbursed by manufacturer user fees, it does not provide a timeline for reimbursement, further straining FDA's limited resources. Regardless of how quickly FDA is able to collect manufacturer user fees, the bill requires use of general funds for tobacco startup costs for at least six months. Depending on the timing of user fee collection, additional resources would have to be diverted from FDA general funds as the agency awaits annual appropriations. At a time when FDA is struggling to perform many of its core functions, diversion of its limited resources will negatively impact the safety of the American public.
In order to rectify the concerns about H.R. 1256 outlined below, the Committee considered a substitute amendment offered by Congressman Steve Buyer to establish the Tobacco Harm Reduction Center under the Department of Health and Human Services (HHS). The substitute would have protected the already overburdened FDA from carrying out significant new tobacco regulations. The substitute was based on public health policies that acknowledge a continuum of risk among all tobacco products and referenced scientific literature which shows that smokeless tobacco products are 90-99% less hazardous than cigarettes in their risk of causing tobacco-related illness and death. The substitute would have ensured adult tobacco users are given complete, accurate and truthful information about the risks and relative risks of all tobacco products so that they can make informed health decisions. The substitute incentivized the development of reduced-risk tobacco products. Additionally, the substitute expressly prohibited regulations affecting tobacco growers, strengthened preventions against minors' tobacco use, was funded through the normal appropriations process instead of new user fees, and protected American jobs. All Republican members present at the markup voted in favor of this substitute.
H.R. 1256 purports to utilize a science-based approach to the regulation of tobacco products but ignores accepted scientific evidence that harm reduction strategies for moving people to less dangerous tobacco products will in fact lead to lower incidences of smoking-related illnesses. This is especially troublesome given the legislation's lack of incentives for States to use Master Settlement funds for smoking cessation and other public health programs.
If enacted, this legislation significantly curtails, if not entirely eliminates, incentives to develop and market products that reduce exposure to tobacco toxicants. In order to obtain approval of a modified-risk product, an applicant must demonstrate that the marketing and labeling of the product will not mislead consumers into believing that the product is or has been demonstrated to be less harmful. Further, it has to be demonstrated that the product reduces risk "
