FDA Tobacco Product Regulation: Regulatory History and Overview of Pending Legislation

FDA Tobacco Product Regulation: Regulatory History and Overview of Pending Legislation Mitch Zeller Pinney Associates 2009 Virginia Forum on Youth Tobacco Use April 15, 2009

Topics to Cover • Overview of FDA regulatory initiative in the 1990s • Resulting litigation • Summary of legislative efforts over the past decade • Key provisions in the pending legislation

Why Did FDA Decide To Investigate The Role Of Nicotine In 1994? • Evidence base needed • Intent • Context at launch

What Did FDA Learn From Its Two-Year Investigation? • Sources of information • Confidential informants • The companies themselves • Internal documents • Three principal ways to manipulate nicotine • Blending • Chemical manipulation • Breeding and genetic manipulation

What Did FDA Do With The Evidence? • 1996 final assertion of jurisdiction • Provided legal authority to issue regulations • Focused regulations on reducing number of kids and adolescents who started smoking • Supply and demand

Litigation • From Greensboro federal district court to the U.S. Supreme Court • The Supreme Court decision on its face • A more personal, if cynical view on why the tobacco industry won • Excerpts from the opinion

Past Legislative Efforts • 1997/1998: Provisions in proposed settlement of state lawsuits requiring legislative codification • Resulted in McCain bill • A divided public health community • Collapsed under its own weight on Senate floor • 2004/2005: Kennedy/DeWine and farmer buy-out “marriage of convenience” • Buy-out passed; FDA failed

2007/2008 Legislative Effort • As introduced was essentially the same bill as Kennedy/DeWine • Vastly different political environment • Democratic control of House and Senate • Supported by broad coalition of public health groups (and Philip Morris) • Bush Administration opposed; veto threat had been rumored

How Far Did The Bill Get Last Year? • Senate • Passed committee in 2007 • Had 60 co-sponsors but was never considered on Senate floor in 2008 • House • Passed the House overwhelmingly with over 300 votes

(1) New Chapter • One criticism of the legislation is that it fails to regulate tobacco products under the drug and device provisions of the FDCA. • That’s what we tried to do under Kessler, and the grounds on which we lost in the Supreme Court. • Congress certainly has it within its power to overturn the Supreme Court’s decision. But we face enough of an uphill battle on this issue politically as it is. • Critics may fail to realize that one neat thing about the bill is that it lifts many of the most relevant regulatory tools available under the drug and device sections of the statute (e.g. performance standards) and simply places them into a new chapter of the law.

(1) New Chapter One key benefit of creating a new chapter is that it frees Congress to establish new standards by which FDA will evaluate tobacco products. Had the bill placed tobacco products under the existing drug and device sections of the statute, exceptions to the safety and efficacy standard would have had to been created. Instead, in this new chapter, a completely different and more sensible standard exists built around the recognition of the inherent toxicity of tobacco products and captured in a broad standard that calls for regulation that is appropriate for the protection of public health.

(2) Submission of Health Information Section 904 mandates FDA receive brand-specific information on ingredients, nicotine delivery, and any smoke constituent FDA identifies as harmful or potentially harmful. Companies must also provide FDA with all documents developed after the bill is enacted related to health, toxicological, behavioral, or physiologic effects of current or future products. One criticism…documents created prior to the enactment of the bill do not need to be provided to FDA. But section 904(b) requires the companies to provide any such pre-enactment materials that FDA asks for (e.g. health, toxicological, etc.). The difference is that FDA has to make a request. So this is a minor defect in the bill.

(3) Product Standards For other products, FDA issues performance standards to prohibit or limit the allowable levels of substances in a finished product. FDA is granted this power in section 907. Products that don’t comply with the levels established in product standards can’t be sold. Critics point to a limitation on the agency’s power in section 907. While nicotine can be reduced (even to the point below some as-yet-unknown threshold level of addiction), FDA may not ban nicotine.

(3) Product Standards • Would it be better if FDA could ban nicotine? • Yes. • But if the agency retains the power to drive nicotine levels down below the threshold level of addiction, then we should be less concerned about this restriction on FDA’s authority. • Armed with the supporting science, product standards could enable FDA to regulate the synergistic and reinforcing effects of various compounds in smoke, such as nicotine and acetaldehyde, or nicotine and menthol.

(4) Pre-Market Evaluation of New Products Any product (even if only test-marketed) or product modification that was introduced after February 15, 2007 is considered a new product that must be evaluated by FDA. The only way to get around this is to demonstrate to FDA’s satisfaction that the new product is “substantially equivalent” to a pre-February 15, 2007 product. Section 910 of the bill defines "substantially equivalent" as a product that "has the same characteristics" as the product being compared to, or has different characteristics but "the product does not raise different questions of public health.” "Characteristics" is defined as "materials, ingredients, design, composition, heating source, or other features of a tobacco product."

(4) Pre-Market Evaluation of New Products A provision in section 910 allows a product introduced up to 21 months after the bill is signed into law to remain on the market unless FDA makes a determination that such a product is not substantially equivalent to a product marketed prior to February 15, 2007. The 21-month provision was added because FDA would not be able to have a regulatory program in place any time soon following enactment of the law. According to this rationale, no new products would be able to come to market until FDA devised and implemented the new product approval process. But this 21-month provision makes it essential that FDA be prepared to rule that a given product is not substantially equivalent.

(4) Pre-Market Approval of New Products 21 months and one day after the bill is enacted into law, the provision disappears. From that point forward, a company files a new product application with FDA for marketing approval, or notifies FDA 90 days prior to marketing that a product is substantially equivalent. FDA has 90 days to say the product is not substantially equivalent and that a new product application is required. While this creates a duty on FDA to take an action, by issuing a “not substantially equivalent” ruling, this seems reasonable and not too difficult a burden to meet.

(5) “Light” and Similar Terms Banned • The bill bans the use of terms like “light,” “low tar,” “mild,” and similar terms. • This is accomplished by rendering such claims unapproved exposure or risk reduction claims under section 911.

(6) Mandatory Pre-Market Evaluation of All Health-Related Claims • Section 911 of the bill requires any express or implied harm reduction claim, including an exposure reduction claim, to be evaluated by FDA prior to marketing. • Approval for such a claim is subject to a very high standard of scientific substantiation. Industry opponents of the bill, and public health advocates of expanded use of smokeless tobacco, have complained that the standard in this section is too high. • The rigorous nature of the standard set is in this section is one of the strengths of the bill as introduced.

(6) Mandatory Pre-Market Evaluation of All Health-Related Claims The bill provides an exception for certain exposure reduction claims that could theoretically be approved without meeting the rigorous standards outlined above. Those of us who fought to prevent even the possibility of exposure reduction claims lost. Under this exception, an exposure reduction claim can be approved if a company can demonstrate that a substantial reduction in morbidity and mortality in individual users is anticipated in future studies. A company must also present consumer perception data proving that consumers will not be misled into believing that the product is less harmful or presents less of a risk of disease than a currently marketed product.

(7) Product Testing Authority The bill does away with the FTC testing method and orders FDA to develop regulations to require testing and reporting of ingredients and smoke constituents by brand and sub-brand. FDA must determine how to disclose ingredient/constituent information to the public in a way that will not mislead consumers about the risk of tobacco-related disease.

(8) FDA’s 1996 Youth Access and Advertising Rules Reinstated The bill reinstates the comprehensive final rules promulgated by FDA in 1996 to restrict youth access to tobacco products, and the advertising and marketing of tobacco products to young people. FDA need not re-issue the 1996 rules as proposed rules. This would have entailed considerable delay in implementation of the rules. One bad provision in the bill forbids FDA from raising the minimum age for sale of tobacco products above the age of 18. States remain free to do so.

(9) Warning Label Authority The bill gives FDA the authority over warnings on tobacco packages and in advertising. A new set of rotating warnings is specified, including a warning that cigarettes are addictive. FDA has the power to revise the label warnings, including mandating graphic warnings, and increase the size of the warning to/up to 50 percent of the front and rear panels. Warnings in advertising can also be revised, but cannot exceed more than 20 percent of the area of an advertisement.

(10) More Flexible Approach on Treatment Policy • Section 918 contains provisions that neither amend the FDCA nor order FDA to take mandatory actions. • Instead, Section 918 is hortatory in nature. It is designed to send a strong signal to FDA that the agency needs to take a more flexible, progressive and enlightened approach to its role in the evaluation and approval of products to treat tobacco dependence. • FDA is encouraged to consider: • granting fast track status to applications from all meds • approving NRT for longer periods of use • expanding the allowable uses of NRT such as craving relief and relapse prevention

(11) Industry User Fee Funding • The entire FDA regulatory program is to be funded by tobacco industry user fees…really more of a market share allocation by company. • The program budget grows from $85 million in Year 1, to $235 million in Year 2, to $450 million in Year 3, and ultimately to $712 million in Year 11 and subsequent years.

(12) Opportunities For States If FDA Bill Passes • Activities that are not pre-empted by the bill • Fire-safe laws • Product reporting and disclosure • Time, place, and manner restrictions on sales, marketing, and promotion • Restrictions (bans?) on discounting and other price promotions

(12) Opportunities For States If FDA Bill Passes • Activities that are not pre-empted by the bill • Rx status • Product bans (specific types or complete) • Minimum age of sale • Enforcement of the MSA • Enforcement of state consumer protection laws

(12) A Word About Time, Place, and Manner Restrictions • Some examples • Restrict sale of tobacco products to certain outlets (e.g. adult-only stores) • Forbid free or discounted sampling • Restrict (ban?) in-store advertising

Prospects for Passage This Year • Would have been high even if McCain had won • Even higher because Obama won • H.R. 1256 passed the House two weeks ago 298-112 • Now it’s on to the Senate • Stay tuned…

FDA Tobacco Product Regulation: Regulatory History and Overview of Pending Legislation