# Presentation: 713395

## Proposed FDA Authority to Regulate Tobacco Presented to National Cancer Advisory Board June 14, 2007Robert T. Croyle, Ph.D.DirectorDivision of Cancer Control and Population Sciences

## Family  Smoking Prevention and Tobacco Control Act (S. 625/ H.R. 1108)

- Currently, FDA does not have authority to regulate tobacco products, the leading cause of cancer deaths
- February 15, 2007 - FDA legislation introduced in U.S. House and Senate
- Senate sponsors:  Senators Edward Kennedy (D-MA) and John Cornyn (R-TX)
- House sponsors:   Representatives Henry Waxman (D-CA) and Tom Davis (R-VA)

**Notes:**
 Currently, very limited regulation of tobacco products

Bureau of Alcohol, Tobacco and Firearms (BATF): Prevent illegal trafficking of tobacco products (to avoid loss of tax revenues and to ensure that illegal sales profits from tobacco do not flow to criminal activities)
Federal Trade Commission (FTC): Only very limited authority to regulate tobacco advertising.  
Consumer Product Safety Commission (CPSC): Tobacco products specifically excluded from CPSC jurisdiction 
EPA/USDA:  Regulate pesticide use in tobacco growing and test domestic and imported tobacco for unapproved pesticides

2. Background to FDA

The concept of providing FDA with authority to regulate tobacco products is not new.
In 1996, then FDA Commissioner David Kessler “asserted” FDA’s authority over tobacco products, calling smoking a “pediatric disease.”  The agency and put forth a “Final Rule” which focused on reducing youth tobacco use.
The agency was sued by the tobacco companies.  In 2000, the US Supreme Court struck down FDA’s assertion of authority over tobacco, saying only Congress could grant FDA this.  Congressional efforts date from that time.

## Reinstates FDA Rule on Youth Tobacco Use

**Reinstates the 1996 FDA Final Rule restricting the sale and distribution of cigarettes and smokeless tobacco to children and adolescents**
- Science base
- Overwhelmingly, tobacco use (both cigarettes and smokeless) is initiated by children and adolescents
- Measures that limit access and appeal can be expected to decrease youth’s tobacco use

**Notes:**
Rule bans certain types of advertising and event sponsorship, and restricts certain marketing efforts on part of retailers – all with them aim of reducing youth’s access to tobacco products, and the appeal of those products to them.

“Joe” Camel: cartoon character introduced in early 1990s, widely believed to have helped increase youth smoking during that period
(now withdrawn from the market)

## Restricts Tobacco Marketing

**Authorizes FDA to restrict tobacco marketing when appropriate for the protection of public health, consistent with first amendment**
- Science base
- Cigarettes are heavily marketed:  >$13 billion, 2005
- Cigarette advertising increases young people’s risk for smoking
- Marketing of filtered and low-yield cigarette brands is deceptive

**Notes:**
1,  FDA will be granted broad authority over tobacco advertising

2.  For decades, tobacco industry misled the public about health hazards of “light cigarettes” 
”Advertisements of filtered and low-tar cigarettes were intended to reassure smokers (who were worried about the health risks of smoking) and were meant to prevent smokers from quitting based on these same concerns.” NCI Monograph 13

## Example:  Marketing of “Camel No. 9”

**Example:  Marketing of “Camel No. 9”**

- Product Packaging

- Magazine Advertising

- Giveaways &
- Promotions

**Notes:**
Camel No. 9 cigarettes, introduced in January 2007 by the R.J. Reynolds Tobacco Company (RJR), are the latest effort to market cigarettes to women and girls. 

Shown in this slide are cigarette packages, advertising, and promotional items (‘give-aways”).  These include lighters, wristbands, tattoos, etc.  Public health groups have expressed great concern that these materials will appeal to teenagers and young girls.

FDA authority would make it significantly harder for tobacco companies to employ these types of promotional strategies.

## Requires Extensive Information Disclosure

**Requires extensive                                                            disclosure for ingredients,                                                   nicotine, design features, ****health, toxicology, etc.**
- Science base
- Currently, public has little knowledge and no control over tobacco product ingredients or design features
- Valuable new information for the scientific community

**Notes:**
1 Manufacturers must provide very detailed information on ingredients, nicotine, and other harmful constituents for all their brands.

2.  They must also provide information related to health, toxicology, behavioral and physiologic effects, marketing research etc., as requested by the Secretary.

3.  NCI supported researchers at Harvard School of Public Health analyzed MA data and documented nearly 10% increase in smoke nicotine 1997-2005
“increased nicotine may be intended to make it easier for smokers to maintain their addiction, including lower income smokers who may be smoking fewer cigarettes as the price of tobacco products increases.”

This is the kind of work that would be greatly facilitated by FDA.  (note that the above research was made possible because MA has a state law requiring companies to disclose certain limited information to the state).

## Bans Cigarette Flavorings

**Bans all cigarette flavorings, other than tobacco or menthol, that are “characterizing flavors” of the product**
- Science base
- Manufacturers add flavorings to enhance their appeal to specific target groups, such as women or young people
- Banning characterizing flavorings may decrease these products’ appeal, benefiting public health

**Notes:**
Ban covers artificial and natural flavors, herbs and spices, e.g. strawberry, clove, chocolate, and licorice.
*Because of the large number of menthol flavored cigarette brands (about 25% of market) , this compound is treated separately, under tobacco product standards.  

## Tobacco “Product Standards”

**Grants FDA the authority to establish and periodically re-evaluate tobacco “product standards**”
- Science base
- Wide variation in levels of carcinogens and other constituents
- Some ingredients and design features are known to make the cigarette product more dangerous

**Notes:**
Per the Bill:  “The Secretary may adopt tobacco product standards...for the protection of public health.”
 FDA will have broad authority to require changes in current and future products to protect the public health. 
 FDA may require changes in construction, components, ingredients (including menthol), additives, constituents, smoke constituents and properties of the tobacco product.
 FDA may require manufacturers to adjust nicotine yields to any level, except zero.  Only Congress has the authority to adjust nicotine to ZERO.

5.  Product standards must consider risks and benefits to the population as a whole.

## Bans Terms: “Light,” “Low,” and “Mild”

**Bans descriptors ****that imply ****that some cigarettes are less hazardous**
- Science base
- NCI Monograph “Risks Associated with Smoking Cigarettes with Low Machine-Measured Yields of Tar and Nicotine”

**Notes:**
1. Legislation cites NCI Monograph 13 “Risks Associated with Smoking Cigarettes with Low Machine-Measured Yields of Tar and Nicotine.”  
2. These cigarettes are also popularly known as “low-yield” or “low-tar.”

## Regulates “Modified Risk” Products and Their Accompanying Health Claims

**FDA granted authority to ****regulate “modified risk” ****products - “those sold or ****distributed for use to ****reduce harm or risk of ****tobacco-related disease”****- considering the impact ****on both the individual ****and the population**
- Science base
- Tobacco companies are already marketing “modified risk” products and making health claims for them, without any oversight
- FDA authority would bring science to bear on understanding and regulating “modified risk” products

**Notes:**
Requires prior approval of “modified risk” products before their introduction to the marketplace.
The Secretary may approve an application for a “modified risk” product only if the product “as actually used by consumers” will significantly reduce harm at the individual and population level.
Rigorous set of criteria must be met before FDA may approve explicit or implicit health claims for these products.
FDA is required to consider the impact of these products at both the individual and population level, to help ensure “modified risk” products and their health claims do not discourage quitting by current tobacco users, or encourage new users to start.  This is CRUCIAL, given past experience with “low-yield/low-tar” cigarettes.  
Requires post-market surveillance of products’ actual usage.

## Strengthens Tobacco Product Warning Labels

**Grant FDA authority to ****revise cigarette package ****warning labels**
- Science base
- Tobacco product warning labels are an effective way to directly reach tobacco users
- Effectiveness of the warning increases with size
- Labels that incorporate pictures are more effective than text-only warnings

**Notes:**
The bill would immediately increase the cigarette package warning labels to cover the top 30% of front and rear of cigarette pack, and would strengthen the messages.
 FDA is also given the authority to further revise the warnings, which may take up 50% of the package, AND include pictures.
FDA granted similar authority to revise smokeless tobacco package warning labels.
Social psychology theory and research have been used to guide the development and evaluation of warning labels in other countries – this will help FDA as it moves forward in this area.

## Other Provisions

- Establishes Tobacco Products Scientific Advisory Committee
- User fees paid by manufacturers
- FDA may “fast-track” research and approval of cessation products

**Notes:**
1.  User fees are based on cost of FDA activities (up to $85 million in FY 2008 – up to $300 million in FY 2010).
2.  State and local authority is preserved in areas such as secondhand smoke exposure, sale of tobacco products, etc.

## Some Questions Raised by Legislation

- Will FDA regulation harm public health by misleading consumers to believe tobacco products are “endorsed” by FDA?
- How will FDA regulate new and “modified risk” products in the absence of a complete science base?
- IOM Report “Clearing the Smoke,” and other reports provide a possible framework  for evaluating “modified risk” tobacco products
- Legislation provides the flexibility for regulation to evolve as scientific knowledge and expertise increases

## New IOM Report on Tobacco Control

***Ending the Tobacco Problem:  A Blueprint for the Nation*****. (May 2007)**
- FDA should have  “have broad regulatory authority over the manufacture, distribution, marketing and use of tobacco products.”
**Many smokers think FDA **_**already**_** regulates tobacco***
- 43.6% of smokers think “cigarettes are evaluated for safety by the U.S. FDA before they are sold to consumers”
- 78.8% of smokers think FDA should be required to evaluate cigarettes
- *Beliefs About Nicotine Delivery Survey, Roswell Park Cancer Center

## NCI and NIDA Funding Initiative

- Program Announcement: PA-07-174 (R01) and PA-06-361 (R21)
- “Testing Tobacco Products Promoted to Reduce Harm”
- http://grants.nih.gov/grants/guide/pa-files/PA-07-174.html
- http://grants.nih.gov/grants/guide/pa-files/PA-06-361.html
- (*)The applications accepted through May and March 2009, respectively
- Key research question
- “Do potential reduced-exposure tobacco products  (PREPs) provide a truly, less-harmful alternative to conventional tobacco products, both on the individual and population level?"

**Notes:**
This PA began in 2004, and was reissued very recently.  A collaboration between NCI and NIDA.

## Currently Funded Grants

## NCI Research and Development Contract

**R&D Contract: “Laboratory Assessment of Tobacco Use Behavior and Exposure to Toxins among Users of New Tobacco Products Promoted to Reduce Harm”**
- Awarded to:		Georgetown University
- P.I.:			Peter Shields, M.D.
- Time frame:		September 2006 to September  2011
- Annual cost:	 	~ $ 3 million/year (Years 1-5)
- Potential investment: 	$ 17 million
- Collaborating study sites
- University of Minnesota (Drs. Dorothy Hatsukami and Steve Hecht)
- Roswell Park Cancer Institute (Dr. Michael Cummings)
- Harvard University, School of Public Health (Dr. Gregory Connolly)
- Arista Laboratories (Dr. Richard Higby)

## R&D Contract Objectives

- Assess how differences in individual smoking behaviors influence exposure and uptake of addictive, toxic, and carcinogenic agents among users of new and modified tobacco products
- Review, develop, and validate laboratory methods for assessing exposure and risk (e.g., smoking topography, biomarkers, *in vitro* testing) from tobacco products
- Create a public database of laboratory and clinical research methods and protocols for studying new and modified tobacco products

## Important Research Questions

- How do changes in ingredients and product design impact
- tobacco use behaviors?
- emissions of nicotine and toxic chemicals?
- What methods and measures can be used to assess the impact of changes in ingredients and product design on
- actual human exposure to nicotine and toxic chemicals?
- addictive potential? disease risk?

**Notes:**
These are just a few of the research questions that will arise if FDA is granted authority	

## Nicotine Modification:  Strasser et al. 2007

- Tested *Quest* cigarettes – 3 levels of nicotine

**Notes:**
To some degree, we have become inured to heavy toll of tobacco, and enormous number of cancers caused by tobacco use.  

Can we instead, imagine a time when tobacco use and tobacco caused diseases are not a “fixture” of the landscape?  When the resources we use to prevent, diagnose and treat cancers caused by tobacco can be redirected toward other cancers?  

We can reach that goal more quickly if the painfully slow decline in tobacco use we’ve seen in the past decades is sharply accelerated

Many people believe that FDA authority will be an important step helping make this happen.

## Important Research Questions (cont.)

- How will the introduction and marketing of “reduced risk” tobacco products change consumers’ perceptions of risk and tobacco use behavior?
- What is the effect of new tobacco products and marketing on population-level patterns of tobacco use, including initiation and cessation?
- What changes in tobacco product warning labels will have the greatest impact on consumers?

**Notes:**
These are just a few of the research questions that will arise if FDA is granted authority	

## Conclusions

- Many challenges and opportunities surrounding FDA implementation
- Proposed legislation provides flexibility for regulations to evolve as scientific knowledge and experience increases
- NCI-supported research has made a critical contribution to the underlying science
- Increased urgency of research questions if proposed legislation is enacted

**Notes:**
To some degree, we have become inured to heavy toll of tobacco, and enormous number of cancers caused by tobacco use.  

Can we instead, imagine a time when tobacco use and tobacco caused diseases are not a “fixture” of the landscape?  When the resources we use to prevent, diagnose and treat cancers caused by tobacco can be redirected toward other cancers?  

We can reach that goal more quickly if the painfully slow decline in tobacco use we’ve seen in the past decades is sharply accelerated

Many people believe that FDA authority will be an important step helping make this happen.