From: bill@smokescreen.org
Date: Wed, 02/21/07
Following are AHEAD's comments on FDA tobacco legislation, nearly all of which I
support. Bill Godshall
- - - - -
Some Constructive Comments and Views Regarding Legislative Proposals
to Give the Food and Drug Administration Authority over Tobacco Products
February 2007
Alliance for Health Economic and Agriculture Development (AHEAD)
6220 30th Street NW Washington DC 20015
Tel: 202 686-8898 Fax:202 244-0698, Contact: Scott D. Ballin
The Alliance is an informal organization whose purpose is to educate, stimulate
and facilitate discussions with and between health advocates, growers,
consumers, media the scientific community, policy makers, manufacturers, biotech
and pharmaceutical interests about a spectrum of issues related to the
production, processing, manufacture, distribution, sale, labeling and marketing
of tobacco and tobacco products. The Alliance is an outgrowth of the Southern
Tobacco Communities Project, established in the mid-1990's that brought growers
and the public health community together to engage in a dialogue about tobacco.
The Steering Committee members serve as individuals, each of whom has
significant and unique experience in dealing with tobacco related issues.
As the 110th Congress convened on January 4, 2007, statements from members in
both parties and in both Houses repeatedly committed to restoring democratic
processes and principles and to provide transparency, cooperation and civility.
We hope that this new era of civility will be the case, not only with the
legislators, but with the tobacco companies, public health community, growers,
pharmaceutical companies, biotech companies and others. It is with that in mind
that we provide these comments and suggestions for policy makers and
stakeholders to consider regarding potentially restructuring and improving the
legislation from the last Congress that would provide FDA with the authority to
regulate the manufacture, sale, distribution, labeling and marketing of tobacco
products.
There will undoubtedly be those who will oppose any changes to the legislation
or any discussions for improvement, or even clarification. Very few question the
importance of and need for this legislation, although we can expect to see some
argue that this legislation is not necessary or doesn't go far enough. But
given the fact that there have been no hearings on the legislation in either the
House or Senate; that there are significant changes occurring in the tobacco
environment, including technological changes, production and manufacturing
changes, new players and new opportunities; and that the legislation remains
very similar in form to legislation considered almost a decade ago, it seems
only right for this new and open congress to hold substantive/transparent
hearings on this legislation that will allow for the best and most effective
piece of legislation to move forward. While we recognize that the FDA has many
other issues and challenges before it, our position has been and remains that
the FDA is the most qualified agency to oversee the regulation of tobacco and
nicotine products.
What follows are some good faith suggestions that, if incorporated, could
provide greater clarity, consistency, continuity and flexibility in the way in
which tobacco and nicotine products are regulated - changes that will have a
positive impact for public health, consumers, the scientific community,
producers, and those in manufacturing (tobacco, pharmaceutical, biotech, etc).
We suggest changing the title of the legislation to the "Tobacco and Nicotine
Products Accountability Act", doing a careful review of the findings and
revisiting the purposes section of the bill, and ensuring that "reducing disease
and death attributed to tobacco" is made one of the primary purposes of the
legislation.
We are not providing specific language changes to the bill except in
consideration of some restructuring and enhancement of authorities.
I. A Separate Chapter under the Food, Drug and Cosmetic Act - "Tobacco and
Nicotine Products"
After more than a decade of debate, there seems to be almost universal agreement
that tobacco products should regulated under a separate chapter of the Food,
Drug and Cosmetic Act. The question today is what should such oversight entail?
How is it best accomplished? In today's changing environment, we might want to
consider looking at a more comprehensive integrated tobacco and nicotine policy
- one that makes far more rational sense than dealing with some nicotine
products under a separate tobacco section and others under the drug provisions.
By putting all tobacco and nicotine products under the same umbrella, it will be
easier to decide how to classify the spectrum of products and to label and set
marketing requirements based on relative risks and intended use.
Tobacco and Nicotine Products
It is clear that in today's environment, we are dealing with a marketplace in
which there is increasing competition and overlap between a spectrum of tobacco,
pharmaceutical, biotech, grower and other manufacturing interests. A common
suggestion is that we need a more coherent tobacco and nicotine policy. This
approach may be the most useful way to proceed in the short term as well as in
the long term.
A restructured regulatory scheme will allow the FDA to prescribe labeling and
marketing requirements based upon the risks and relative risks of those
products, allowing consumers to fully understand the risks and relative risks of
the products available to them, from highly toxic combustible products to
significantly lower-risk noncombustible products to even lower-risk nicotine
products designed for cessation. For many, it has been convenient to look at all
tobacco products as being equally harmful - clearly a supposition that is not
supported by the science or even common sense. There has also been a tendency
to separate tobacco from other nicotine products used for cessation even though
most (if not all) of the products on the market today have one thing in common -
they contain nicotine derived from tobacco.
The challenge that we face, whether as public health advocates, scientists,
policy makers, consumers, manufacturers (broadly speaking) or producers is to
consider the most effective way in which to take all of these products and to
craft a coherent policy that will allow these products to be regulated in a
consistent manner, based on their risks and relative risks.
The Comparative Risk Reduction Continuum Chart
The following chart is a hypothetical representation of the relative risks that
are presented by spectrum of products-from those that are highly toxic and in
the form of combusted tobacco to those that are at the other end of the
spectrum, where risks are very small or even negligible. In each case, the
regulation of the product should be based on risk. The higher the risk, the more
the more regulation (labeling, warnings, marketing restrictions, taxation etc.)
The lower the risk, the less regulation. If we begin to develop better and more
consistent methods for testing tobacco products (and NRT), we can in fact plot
where we would expect products to fall on the continuum. [Note: Chart not
available in text format]
Definitions of Products
The first thing that should be done in this restructuring is to revisit how
products are defined. Clarifying these definitions (including making
distinctions as to what might be differences between recreational or
therapeutic products) would go a long way in determining the labeling and
marketing requirements for not only a category of products (e.g., combustible,
noncombustible, therapeutic) but also for specific products within the various
categories.
Tobacco and Nicotine Product Categories
Within that framework, it seems to make sense that given the wide spectrum of
risks and relative risks associated with tobacco and other nicotine containing
products, we use a model similar to that used under the medical device section
of the FDC Act by establishing three distinct categories and panels to review,
classify and recommend labeling and marketing requirements for products. This
would also include determining the most useful and effective labeling and
disclosure requirements related to claims for lower risk products, not only
between the categories but for specific products within each category as well.
Each panel would be charged with ensuring that consumers are provided with
accurate and non-misleading information about the spectrum of products on the
market so that they can readily understand the risks and relative risks of those
products.
Legislation should not be too proscriptive, but should establish the appropriate
parameters under which the panels can do their work. Many of the requirements
currently spelled out in great detail in current legislative proposals could be
refined to require the scientific panels to make appropriate science-based
decisions. How differences between categories and specific products are
established should be determined by the scientific experts. All of the
provisions of the current bill such as submission of data, registration, the
establishment of good manufacturing practices, and the payment of user fees,
etc. would obviously remain in effect.
The three categories we suggest for consideration are:
Category I - Combustible Products (cigarettes, cigars, pipe tobacco, etc.)
Category II - Noncombustible Tobacco and Nicotine Products (recreational
use)
- Noncombustible products containing tobacco (traditional smokeless products,
new novel noncombustible tobacco-based products )
- Noncombustible products containing nicotine derived from tobacco (new
products that are not regulated as drugs and are not intended for therapeutic
purposes)
Category III - Noncombustible Tobacco and Nicotine Products for Therapeutic
Use
- Tobacco-based products that are used for therapeutic use (no products are
currently on the market)
- Products containing nicotine derived from tobacco
- Products that contain synthetically manufactured nicotine (no products are
currently on the market)
Tobacco and Nicotine Classification Panel (and Sub-panels)
A Tobacco and Nicotine Classification Panel (TNCP) should be established at the
FDA, to be composed of three sub-panels organized along the basis of the
categories noted above. The panel (TNCP) would be charged with overseeing the
spectrum of regulatory issues (manufacturing, sales, distribution, labeling,
advertising, marketing, etc.) for all tobacco and nicotine containing products.
The panel would be composed of "persons who are qualified by training and
experience" to evaluate issues and make recommendations related to the
manufacture, distribution, sales, labeling, and marketing of tobacco and
nicotine products. Persons qualified for such a panel might include experts in:
- Public Health
- Pharmacology
- Addiction
- Toxicology
- Biotechnology (including GMO)
- Advertising, marketing, and promotion
- Production and agronomy
- Labeling
- Epidemiology
- Good manufacturing practices
- Consumer affairs, surveillance
- First Amendment
Each of the three sub-panels would do the majority of work in looking at the
science related to a particular category and the products in that category.
Each panel would develop proposed labeling and marketing requirements and
allowances for not only the category, but for individual products within each of
those categories. The panels would have the authority to convene hearings and
call witnesses to assist them in their duties. Classification panels would make
recommendations to the larger panel which would then, on behalf of or through
the Commissioner (Secretary), publish proposed rules and issue final regulations
governing the labeling and marketing of products. New products that do not meet
substantially equivalent requirements would require pre-market review and
approval.
Any interested party would be allowed to petition the panel for reclassification
of a product or even removal of a product not meeting regulatory specifications.
In addition each panel might also include nonvoting members representing the
interests of consumers, tobacco manufacturers, biotech, pharmaceuticals,
producers, etc.
The classification panels would also draw on the expertise of the proposed
restructured Tobacco and Nicotine Scientific and Surveillance Advisory Committee
noted below.
II. Tobacco and Nicotine Scientific and Surveillance Advisory Committee
To assist the Food and Drug Administration and the Tobacco and Nicotine
Classification Panel with its work (as well as other agencies), we suggest that
provisions in the currently proposed Tobacco and Scientific Advisory Committee
(Section 918) and the surveillance functions be expanded to include not only
science but surveillance. These two areas have, and will have, significant
ramifications on the ability of the agency to do its job in not only the review
of products but also in determining how the public (both the individual consumer
and the population as a whole) may be using such products. There is no doubt
that the science pertaining to the production, manufacture and marketing of
tobacco and nicotine products is changing, and changing very rapidly.
Surveillance is an essential and critical component of any tobacco and nicotine
regulatory effort. In addition to making sound science-based policy and
regulatory decisions, we regard surveillance as one of the top two or three
functions that will needed to be carried out, and as one that will play an
important role in deciding how the spectrum of tobacco and nicotine products
should be labeled and marketed to ensure that any users of these products are
interpreting the information in a way that allows them to make a fully informed
choice.
Having a "high level" advisory committee in place to assist the FDA (and other
agencies) in their efforts will go a long way to ensuring that policy is being
made with the most up to date science and surveillance data.
The Advisory Committee should consist of a spectrum of members who are
technically qualified by training and experience in medicine, medical ethics,
pharmacology, addiction, biotechnology, toxicology, marketing, labeling, data
collection and evaluation. It should also include ex officio representatives
from the CDC, the FTC, the NIH, the USDA, the EPA, and the IoM who have
expertise in science and surveillance issues. Nonvoting public members could
include consumer representation and industry scientific representation (tobacco,
pharmaceutical, producers, etc).
The Advisory Committee would be required to issue an annual report to be
submitted to the Secretary of HHS and to the Congress (and other appropriate
agencies such as the FDA, the CDC, NIH, USDA, EPA, DHS, ATF, FTC).
III. More Effective Coordination Between Governmental Agencies
One of the things that is often ignored or forgotten is that oversight and
control over the manufacture, sale, distribution, labeling and marketing of
tobacco and tobacco products does not and cannot rest within one agency or even
within one department. The current legislation (as introduced in the 109th
Congress) does recognize this to a certain extent (see page 56 "Involvement of
other agencies; informed persons," as well as provisions instructing FDA to
"endeavor" to involve other agencies). We believe this interagency function
should be strengthened. Strengthening these functions would not only benefit
the FDA, but would benefit other departments and agencies that deal with
tobacco, as well. We would like to recommend that these interagency efforts be
strengthened by establishing a broader and more comprehensive Interagency
Tobacco and Nicotine Coordinating Committee within the government that ensures
ongoing cooperation, communication and integration on a spectrum of issues.
While an interagency committee currently exists in the Department of HHS, it has
not been used as effectively as it could or should be. The proposed Interagency
Tobacco and Nicotine Coordinating Committee should include representation from
the following Departments and agencies:
· The Department of Health and Human Services (HHS)
- Food and Drug Administration (FDA)
- Centers for Disease Control and Prevention (CDC)
- National Institutes of Health (NIH)
- Centers for Medicare and Medicaid Services (CMS)
· The United States Department of Agriculture (USDA)
· The Environmental Protection Agency (EPA)
· Alcohol Tobacco and Firearms (ATF)
· Federal Trade Commission (FTC)
· Department of Homeland Security (DHS)
· Department of Commerce
· US Trade Representative (USTR)
IV. Providing Incentives to Industry to Develop Lower Risk Products
Both the IOM and several organizations within the public health community have
called for incentives and the encouragement for the industry to develop
scientifically based lower risk products. Yet, there are no provisions in the
current legislation in the way of using competitive market forces (in a
regulated environment) for stimulating change in both the tobacco industry (as
well as biotech/pharmaceutical industries) and in the products that are
developed. Consideration should therefore be given to either incorporating
incentives into legislation or in committee report language suggesting ways that
such efforts could be achieved. One obvious example is to tax products based
upon their risks and relative risks: higher taxes for combustible products,
lowers taxes for noncombustible products, no or minimal tax on
medicinal/therapeutic products.
V. Tobacco Agriculture
A little over two years ago, the Congress provided tobacco growers with an
industry-funded tobacco buyout. At the same time, the Congress intentionally or
unintentionally repealed most of the old tobacco program, leaving both domestic
and foreign tobacco virtually unregulated. In an environment in which tobacco
is considered an inherently risky product, such action makes little sense,
especially when considered against the recognized need for FDA oversight over
manufactured products. All stakeholders must realize that what is done at the
production level has significant impacts on the health and safety of the final
product.
For example: How do different growing techniques and curing processes impact the
nicotine levels and other characteristics of the plant? What are the
technologies that exist to remove tobacco-specific nitrosamines (TSNA's)? What
pesticides and other chemicals are being used, and should we be reducing the use
of those pesticides and chemicals? What should US producers be doing to move
toward production standards that will have a positive effect in reducing the
level of risk posed by tobacco products currently on the market? What is the
role that genetically modified tobacco can play in not only reducing risks
associated with tobacco products but also in the development of medicines and
industrial enzymes? What incentives and training should be given to producers
to begin changing their methods of production to meet the challenges of the 21st
century (both here in the US and abroad)? What system do we need to monitor
tobacco production in the US as well as abroad?
While we recognize that the Senate HELP Committee and the House Energy and
Commerce Committee do not have jurisdiction over the agricultural issues
pertaining to tobacco, we encourage the committees to take these issues into
account and to officially request that the Senate and House Agriculture
Committees hold hearings on these important issues - issues that not only impact
domestic tobacco production and health issues but also internationally as well.
These issues are also well-suited for consideration in the Oversight and
Government Reform Committee in the House and the Homeland Security and
Government Reform Committee in the Senate. While other agricultural commodities
have integrated regulated strategies between USDA, FDA, and EPA, tobacco does
not. It is time that is changed.
For additional information and background materials: Go to:
www.tobaccoatacrossroads.com (Tobacco and Tobacco Products at a Crossroads in
the 21st Century):
Call 202 686-8898 for a copy of: Reforming National Tobacco Policy - a Rational
Approach
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