Research Implications of FDA Tobacco Regulation Authority

Dear colleagues:

Now that the FDA regulation of tobacco is law – with remarkable bi-partisan support by the way, the real challenge to researchers, funders and tobacco control supporters begins.  The regulatory framework contemplated will give the agency tools appropriate to regulate tobacco (a category of product with no medical use) in a manner that gives the agency broad authority over how the product is marketed and sold, claims made about the product and the content of the product, but does not give FDA the authority to impose an outright ban all cigarettes or all smokeless products. The approach could contribute to a reduction in prevalence of tobacco use by actions that are expected to contribute to prevention and cessation interventions, and possibly reduce the harmful consequences (including addiction risk) of products that remain on the market.  To accomplish these goals there is a need for scientists to be heavily involved and to further develop a science base to guide regulatory approaches and evaluate the actual effects of the regulation (desired and unintended).

The bill gives the FDA authority in 6 broad categories:  1) Requires extensive disclosures by the tobacco industry to the FDA, including substantial scientific information (Section 904); 2) Includes specific restrictions on tobacco marketing, and gives FDA authority to further restrict tobacco marketing “to protect the public health” to the extent permitted by the First Amendment (Section 906 and 102); 3) Strengthens restrictions on sales to youth (Section 102); 4) Has new tools to provide more accurate, more relevant information to consumers – improved warning labels (Sections 201 – 204); replaces the current tar and nicotine testing system (Sections 915 and 206); and imposes scientific standards and a review process to govern any explicit or implicit health claims (Section 911); 5) Gives FDA authority over the content of tobacco products, including smokes constituents (Section 907); and 6) Lays out the continued authority of the states to pursue tobacco prevention and cessation (Section 916).

The regulatory tools FDA will have will lead to the creation of evidence-based policy.  Support for the creation of that evidence base could comes from direct funding of needed research and testing capacity, as well as support via existing NIH and CDC mechanisms. The legislation also requires FDA to consult with other governmental agencies, professional scientific organizations (such as ours) and experts (such as many of you).  This provides an opportunity for us to continue to contribute to tobacco control.  Indeed, it provides an opportunity for an expanded role for the scientific community because it both provides the scientific community with access to additional information and requires that the most important decisions to be made by FDA be based on science.

One model of potential research and testing capacity that is supported by the World Health Organization may be of interest in your own thinking about the range of needs and strategies that may be worth consideration for FDA (see WHO TobReg “Guiding Principles for the Development of Tobacco Product Research and Testing Capacity and Proposed Protocols for the Initiation of Tobacco Product Testing” at http://www.who.int/tobacco/global_interaction/tobreg/goa_2003_principles/en/index.html).

I encourage you to take a look at the bill itself H.R. 1256, FAMILY SMOKING PREVENTION AND TOBACCO CONTROL ACT, at www.tobaccofreekids.org), and to see some of the summaries of its major provisions (www.tobaccofreekids.org).   The bill requires FDA to create a new center with funding guaranteed through the assessment of annual user fees on the tobacco industry.

Some of FDA’s actions are mandated in the bill and will occur within specified time points.  These include items such as banning candy-flavored and branded cigarettes (3 months),  banning the marketing and branding of cigarettes as “light”, “mild” and  “low tar” (12 months), new stronger warnings smokeless products covering 30% of the front and back package panels (12 months), graphic warnings on cigarettes covering 50% of the top front and top back of packs as have proven so effective in Canada and Australia (not more than 39 months), a ban on explicit and implicit health claims that have not been reviewed by the FDA (immediate) and development regulations or guidance on the scientific evidence required for assessment and ongoing review of all health related claims for tobacco products.  Marketing restrictions will include limiting advertising and promotion to a black and white text-only format in stores that children can enter. (12 months)

However, most of FDA’s regulatory decision making will be based on the evolving science base and driven by public health considerations built into the legislation. These include the evaluation of product designs and ingredients, including the by products of combustion and naturally occurring components of tobacco products, that FDA determines should be regulated to “protect the public health”, a broad standard that includes control over anything that can, for example, affect harm and addictiveness.  Section 907 gives FDA the the authority to set standards for compounds that can be prohibited or restricted or, if the science warrants increased.  For example, nicotine could be reduced to negligible and non addicting levels, though not to zero.  In addition, menthol levels could be reduced or eliminated.  Ingredients such as ammonia compounds, burn accelerating chemicals and various flavorings could be limited or banned altogether (H.R. 1256, Section 907).

Claims for products with a potential to reduce harm whether as a modification to a conventional product or when used in place of conventional products are given a pathway to market but will be evaluated by FDA using a rigorous set of science-based standards(H.R. 1256, Section 911).

Both FDA’s authority of the content of tobacco products and claims for products instructs FDA to look at both the impact on tobacco users and on the population as a whole, taking into account the predicted impact on potential tobacco users, potential quitters and former tobacco users.  This means FDA will be looking at the overall impact of a tobacco industry action or a new FDA mandate, not just a narrow look at whether a product is itself less harmful than a conventional product.

FDA is required to consider innovative treatments for tobacco dependence.  The legislation encourages FDA to explore potential applications of current medications such as relief of withdrawal, relapse prevention, exposure reduction, and regulatory tools such as Fast Track approval processes as appropriate (H.R. 1256, Section 918).

Much of this will require greatly expanded and rapidly implemented research to provide direction and assess desired and unintended consequences.  Research in a broad range of areas will be needed to guide many aspects of implementation of the regulation (e.g., behavioral testing on the effects of potential alterations in tobacco product design and contents including abuse liability testing), surveillance research to determine the effects of regulation implementation and the need for potential modification of the regulatory approach, and exploration of potential “innovative” medications development and applications.

You can learn more about the various aspects of implementation of the bill, at the following website(s).  You might also contact NIDA and NCI for information concerning potentially applicable existing RFP’s and to recommend and assist in the development of new RFPs relevant to FDA regulation of tobacco products.  There will likely be many opportunities and avenues to influence FDA’s regulatory approach and actions through advisory meetings, Institute of Medicine Reports, Rule Making and federal dockets for commenting, and more.

For researchers, this legislation marks the beginning of the real work and a call to action to develop and implement research to assist the FDA in achieving former Surgeon General C. Everett Koop’s vision of a 21^st century which ends with tobacco associated disease the rarity that it was in the 19^th century (Nicotine and Tobacco Research, 5:611-6-20, 2003).

____________________________________
Jack E. Henningfield, Ph.D.
Vice President, Research and Health Policy Pinney Associates
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Bethesda, MD 20814-3472
Voice: 301-718-8440
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and
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