United States General Accounting Office

GAO Report to Congressional Requesters

September 1997 FOOD AND DRUG

ADMINISTRATION

Regulation of Tobacco

Products

GAO/HEHS-97-140

GAO United States

General Accounting Office

Washington, D.C. 20548

Health, Education, and

Human Services Division

B-270742 

September 29, 1997

The Honorable Thomas W. Ewing

Chairman

The Honorable Gary Condit

Ranking Minority Member

Subcommittee on Risk Management

 and Specialty Crops

Committee on Agriculture

House of Representatives

On August 11, 1995, the Food and Drug Administration (FDA) proposed a

regulation to prohibit the sale of cigarettes and smokeless tobacco to

individuals under 18 years of age and to restrict advertising of these

products. In addition, the regulation requires manufacturers to comply

with labeling requirements and to fund public education programs that

discourage persons under 18 years of age from using cigarettes and

smokeless tobacco products. The final rule and jurisdictional

determination were published on August 28, 1996.

Between June 1994 and October 1995, the Subcommittee requested on

several occasions copies of FDA documents concerning the agency’s efforts

to regulate tobacco products and the potential effects of this regulation on

tobacco growers. FDA did not fully comply with these requests.

To assist the Subcommittee in understanding the potential impact of FDA

jurisdiction over regulating tobacco products, you asked us to obtain

internal memorandums, notes from meetings or conversations, electronic

and other written communications, and other documents from FDA related

to 12 specific requests for information concerning the activities that led to

FDA’s proposal to regulate the sale of tobacco products. In addition, you

asked us to describe how FDA developed the tobacco regulation, evaluated

regulatory options, and determined its jurisdiction over tobacco products.

Scope and

Methodology

Because we were not able to obtain many of the documents related to the

information you requested, most of the documents we examined were

from the public record accompanying FDA’s tobacco regulation. (See app. I

for details on the 12 specific requests and the information we were able to

obtain.) About a dozen documents we examined were, however, part of a

confidential record associated with the regulation. These documents were

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considered confidential because they contained trade secrets or

confidential commercial information.

To describe the actions taken by FDA to develop the proposed tobacco

regulation, evaluate regulatory options, and determine jurisdiction over

tobacco products, we obtained information on the duties and

responsibilities of each employee involved in tobacco regulation activities

at FDA and the Department of Health and Human Services (HHS) and

interviewed key FDA officials involved in these activities. We also obtained

a list of people from outside HHS and FDA who were contacted by agency

officials on tobacco-related issues.

Except for the limitations resulting from FDA’s refusal to provide us with

the documents we requested, we conducted our study between December

1995 and June 1997 in accordance with generally accepted government

auditing standards.

Results in Brief Our efforts to obtain information that would enable us to adequately

describe the activities that led to FDA’s proposal to regulate tobacco

products were obstructed by FDA’s and HHS’ refusals to provide many of the

documents requested by the Subcommittee and by GAO. Through

interviews with FDA officials and staff, we obtained testimonial evidence

on some FDA actions prior to the publication of the final rule and

jurisdictional determination on August 28, 1996. However, without the

documents requested, we could not verify this information.

Throughout our study, FDA and HHS officials refused most of our requests

for tobacco-related documents in the possession of agency officials that

were not included on either the public or confidential record or an index

of these documents. The officials cited several reasons for declining our

requests. They stated that first, the proposed tobacco regulation was part

of an ongoing rulemaking and release of the requested information would

jeopardize the integrity of this deliberative process; second, releasing the

requested information and communications with officials employed by the

Department of Justice would negatively affect the government’s position

in ongoing litigation related to the proposed tobacco rule; and third, the

requested information was obtained from confidential sources and its

disclosure could undermine pledges of confidentiality. In addition, they

noted that communications with officials employed by the White House

are subject to a possible claim by the President of executive privilege,

which only he can waive.

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Although we informed FDA and HHS that these factors do not limit our

statutory right of access to the information, officials were unwilling to be

forthcoming. (See app. II for a more detailed discussion of our legal

authority to obtain FDA documents.) Applicable law requires each federal

agency to “give the Comptroller General information the Comptroller

General requires about the duties, powers, activities, organization, and

financial transactions of the agency” (31 U.S.C. 716(a)). The law does not

exempt information that is litigation sensitive or confidential. It provides

an exception for information related to the deliberative process, but then

only if the President or the Director of the Office of Management and

Budget determines that disclosure “reasonably could be expected to

impair substantially the operations of the Government” (31 U.S.C. 716(d)).

While information can be exempt from disclosure to GAO based on a claim

of executive privilege, the President has made no such claim.

Since FDA refused to provide us many of the documents that we requested,

the information we obtained about FDA’s tobacco regulation activities

came primarily from interviews with key FDA staff who participated in FDA

tobacco-related investigations, developed regulatory options, and assessed

FDA’s jurisdiction to regulate tobacco. Although these staff participated in

regular meetings on these issues over several years, including numerous

briefings of the Commissioner, they could not recall whether there were

minutes of these meetings or written summaries of internal discussions.

As a result, we could not verify the testimonial evidence provided to us

about FDA’s tobacco regulation activities. In addition, FDA officials would

not discuss the specific regulatory approaches they considered prior to the

rule’s publication nor would they provide internal documents addressing

the options they considered and their internal analyses of FDA’s

jurisdiction.

According to the FDA Commissioner at that time, the activities that led to

FDA’s decision to regulate tobacco products began during the first 6

months of 1991, when the Commissioner and senior FDA officials met to

discuss public interest petitions calling for FDA regulation of tobacco

products. (See app. III for more details on FDA’s tobacco regulation

activities.) The Commissioner told us that at that time he did not consider

tobacco regulation an immediate FDA priority. However, the Commissioner

encouraged several senior FDA officials to examine the addictive properties

of nicotine and whether tobacco manufacturers controlled nicotine levels

in cigarettes. According to several FDA staff who performed this work

during 1992 and 1993, the Commissioner briefed HHS officials on the initial

results of FDA’s study in September 1993 and sought the advice of the

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Assistant Secretary for Health about how to respond to the petitions. FDA

provided an informal response in a February 25, 1994, letter to the

petitioners. According to the letter, an accumulation of new evidence

suggested that cigarette manufacturers may intend for their products to

satisfy purchasers’ nicotine addiction. The letter further indicated that

“Should the agency make this finding based on an appropriate record or be

able to prove these facts in court, it would have a legal basis on which to

regulate these products under the drug provisions of the Act.”

According to FDA staff, they visited tobacco manufacturing facilities and

met with academicians, officials from other regulatory government

agencies, tobacco-industry informants, and other experts. FDA staff further

noted that following congressional hearings in March and June of 1994,

FDA’s investigation of the tobacco industry intensified.

According to FDA staff, FDA’s investigation culminated with its issuance of

the proposed rule and accompanying analysis regarding the agency’s

jurisdiction over nicotine-containing cigarettes and smokeless tobacco

products and its proposal to regulate the sale and marketing of tobacco

products to children and adolescents. After reviewing about 700,000 public

comments about the proposed rule and jurisdictional analysis, the final

rule and jurisdictional determination were published on August 28, 1996.

Agency Comments We received comments from HHS on a draft of this report and met with FDA

and HHS officials concerning their comments.

In general, HHS believed that our report focused too much on issues related

to their refusal to provide us access to documents rather than on what we

learned from those that were provided. They contended that the

documents provided to us and interviews with senior FDA officials and the

Commissioner were sufficient to ensure that GAO was informed of every

key event that led to the issuance of the tobacco regulation. Although HHS

acknowledged our authority to conduct legitimate oversight and indicated

that they attempted to accommodate our study, they reiterated the reasons

why they refused our request for documents not on the public record.

In our view, however, not having such documents limited our ability to

report fully on FDA’s investigation, development of regulatory options, and

jurisdictional analysis and determination or verify the information senior

FDA officials provided us during interviews. Moreover, since FDA and HHS

refused our request for an index of these documents, we could not narrow

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B-270742 

our document request. As a result of these limitations, we could not fully

address the 12 requests for information related to FDA’s investigation or the

development of the regulation.

HHS also provided technical comments, which we incorporated into the

final report where appropriate.

We are sending copies of this report to the HHS Secretary, congressional

committees, and other interested parties. We will also make copies

available to others upon request.

Major contributors to this report were John Hansen, Assistant Director;

Claude Hayeck; Peter Oswald; and Jonathan Barker. Please call Mr.

Hansen at (202) 512-7105 if you or your staff have any questions.

Bernice Steinhardt

Director, Health Services Quality

 and Public Health Issues

Page 5 GAO/HEHS-97-140 FDA Tobacco Regulation
Contents

Letter 1

Appendix I 

Response to the

Subcommittee’s

Request for

Information About

FDA’s Tobacco

Regulation Activities

8

Appendix II 

GAO’s Legal Authority

to Obtain FDA

Records

18

Appendix III 

Chronology of FDA’s

Tobacco Regulation

Activities

20

Public Petitions Prompt FDA Regulatory Involvement 20

FDA Intensifies Its Tobacco Investigation 21

Regulatory Options Considered by FDA 22

Table Table I.1: Primary Responsibilities of FDA Staff Working on

Tobacco Issues Between 1994 and 1996

9

Abbreviations

FDA Food and Drug Administration

HHS Department of Health and Human Services

CRS Congressional Research Service

Page 6 GAO/HEHS-97-140 FDA Tobacco Regulation
Page 7 GAO/HEHS-97-140 FDA Tobacco Regulation
Appendix I 

Response to the Subcommittee’s Request for

Information About FDA’s Tobacco

Regulation Activities

In a letter dated November 28, 1995, the Subcommittee asked that we

obtain 12 specific information items that included lists of individuals

involved in tobacco regulation and tobacco-related documents. With one

exception, FDA refused to provide us with documents that were not

included in either the public or confidential record. This appendix

summarizes our efforts to obtain each of these lists and documents.

1. A list of all FDA officials or employees participating in the consideration

of how the Federal Food, Drug, and Cosmetic Act would be applied to

tobacco products.

On March 28, 1996, we requested a list of FDA employees involved in the

tobacco rule’s development, excluding employees who provided only

administrative support. For each employee, we requested that FDA provide

us

• a description of the employee’s primary activities,

• when the employee first became involved with tobacco issues,

• the employee’s supervisor,

• whether the employee possessed original documents not part of the public

record,

• whether the employee had contacted individuals outside HHS, and

• whether the employee had undertaken any tobacco-related travel.

During April 1996, HHS provided us a list of 119 FDA and 20 HHS staff

members who were involved in tobacco issues, along with the additional

information requested on these employees.1

 Table 1 summarizes this

information.

1

FDA did not provide us information for eight staff members who were no longer working at FDA.

Page 8 GAO/HEHS-97-140 FDA Tobacco Regulation
Appendix I 

Response to the Subcommittee’s Request for

Information About FDA’s Tobacco

Regulation Activities

Table I.1: Primary Responsibilities of FDA Staff Working on Tobacco Issues Between 1994 and 1996

Unit

Number

of staff Primary responsibilities

Commissioner of Food and Drugs 1 Provided overall leadership and direction on the development of the

proposed tobacco regulation and accompanying jurisdictional analysis.

Office of the Commissioner 4 Developed overall policy on regulating tobacco products.

Investigated the content and control of nicotine in cigarettes and the

marketing of cigarettes, and analyzed assorted tobacco products.

Drafted, edited, and reviewed drafts of the regulation, and jurisdictional

analysis. 

Advised other FDA staff on the jurisdictional analysis and on the

development of the proposed regulation.

Office of Chief Counsel 14 Conducted background research related to legal issues in the proposed

regulation, the agency’s enforcement discretion, and private litigation

involving tobacco issues.

Provided legal advice on the development of the legal theory for the

proposed regulation and jurisdictional analysis and the interpretation of

the medical device provisions of the statute.

Assisted in compilation of the administrative record for the jurisdictional

analysis.

Prepared and reviewed drafts of the jurisdictional analysis.

Office of Policy 8 Participated in drafting the 1994 letter to the Coalition on Smoking OR

Health, and analyzed tobacco regulation in other countries.

Organized and oversaw the development of the proposed regulation.

Researched scientific, policy, and legal issues involved in the preparation

of the proposed rule.

Analyzed evidence relevant to FDA’s jurisdiction over tobacco products.

Provided advice on the Federal Trade Commission’s tar and nicotine

testing methodology.

Drafted, edited, and reviewed drafts of the regulation.

Researched, drafted, and reviewed drafts of the jurisdictional document.

Office of Special Investigations 4 Participated in the agency’s investigation of the tobacco industry, with

duties that included visiting cigarette filter and paper companies, and

tobacco farms; interviewing former tobacco company employees; and

collecting, analyzing, and reviewing documentary evidence.

Office of Criminal Investigations 3 Participated in the agency’s investigation of the tobacco industry, with

duties that included visiting tobacco companies and cigarette filter

companies; interviewing current and former tobacco company employees;

and collecting, analyzing, and reviewing documentary evidence.

(continued)

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Appendix I 

Response to the Subcommittee’s Request for

Information About FDA’s Tobacco

Regulation Activities

Unit

Number

of staff Primary responsibilities

Center for Drug Evaluation and

Research

12 Participated in the agency’s investigation of the tobacco industry, with

duties that included visiting tobacco companies, reviewing and analyzing

tobacco company documents, and coordinating the review of tobacco

industry-sponsored scientific articles related to nicotine pharmacology. 

Provided advice on FDA’s past treatment of tobacco products and the

physiological effects of nicotine. 

Researched legal, policy, and scientific issues involved in the preparation

of the proposed rule. 

Summarized patents relating to tobacco.

Reviewed the Federal Trade Commission’s tar and nicotine data to

determine trends in tar and nicotine from 1982 to 1997.

Reviewed and analyzed scientific data on nicotine’s pharmacological

effects, and provided advice on the chemistry and properties of nicotine.

Center for Devices and

Radiological Health

3 Reviewed and analyzed scientific data on nicotine’s pharmacological

effects, including tobacco company-sponsored data, and provided

scientific advice on and analyses of these data and consumer use of

tobacco products.

Helped draft portions of the jurisdictional analysis, and reviewed drafts of

the rule.

Researched a variety of policy and regulatory issues concerning the

regulation of devices.

Center for Food Safety and

Applied Nutrition

3 Participated in the agency’s investigation of the tobacco industry, with

duties that included collecting and analyzing documentary evidence and

researching the potential economic costs and benefits of the proposed

rule.

Coordinated research with other laboratories performing analytical tests of

cigarettes, flavorings, and other parts of tobacco products.

Center for Veterinary Medicine 1 Assisted in preparing the legal analysis of FDA’s jurisdiction over tobacco

products, focusing on past cases where FDA regulated products without

promotional claims.

Office of External Affairs 2 Prepared for anticipated hearings, wrote press materials, and managed

the agency’s congressional relations.

Office of Health Affairs 2 Researched a variety of policy, regulatory, and scientific issues regarding

the regulation of tobacco.

(continued)

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Appendix I 

Response to the Subcommittee’s Request for

Information About FDA’s Tobacco

Regulation Activities

Unit

Number

of staff Primary responsibilities

Office of Operations 3 Coordinated administrative support for the overall project, including

investigative activities and analytical activities with laboratories.

Coordinated the agency’s review of scientific data on nicotine’s

pharmacological effects, including tobacco company-sponsored data,

and provided scientific advice on and analyses of these data.

Attended internal agency meetings on regulation and enforcement

activities by state governments and FDA contacts with state officials.

Office of Public Affairs 1 Researched policy and public health issues regarding the regulation of

tobacco products, and participated in drafting portions of the preamble to

the proposed rule.

Office of Planning and Evaluation 2 Organized and conducted research on potential economic impact of the

proposed rule, and wrote the analysis of impacts published with the

proposal.

Office of AIDS and Special Health 3 Reviewed and analyzed scientific data on nicotine’s pharmacological

effects, and assisted in drafting portions of the jurisdictional analysis.

Forensic Chemistry Center,

Cincinnati District Office, Office of

Regulatory Affairs

24 Participated in the design of studies on smokeless tobacco, and

performed analyses of cigarettes and smokeless tobacco to determine

their chemical properties.

St. Louis Laboratory, Center for

Drug Evaluation and Research

15 Performed chemical analyses of tobacco products, and provided

consultation to FDA headquarters on scientific matters related to

jurisdictional issues.

Baltimore District Office, Office of

Regulatory Affairs

3 Visited tobacco companies, collecting samples for analysis where

possible, and provided expertise on the chemistry and properties of

tobacco products.

Los Angeles District Office, Office

of Regulatory Affairs

1 Investigated nicotine levels in commercial cigarettes, and developed

methods to look at the chemical properties of cigarettes.

Atlanta District Office, Office of

Regulatory Affairs

1 Visited tobacco companies; collected, analyzed, and reviewed

documentary evidence; and interviewed former tobacco company

employees.

Based on the information provided to us on each employee, we learned

that the most-often mentioned supervisor of tobacco-related activities

(cited by 27 staff) was the FDA Commissioner. In addition, 41 staff reported

that they possessed tobacco-related documents that were not included on

the public record, 59 staff had contacted individuals outside HHS on

tobacco-related issues, and 33 staff had tobacco-related travel.

2. A list of any government employees, organizations, or individuals with

whom FDA officials discussed the potential requirements of any FDA rule

related to tobacco products.

On July 26, 1996, and on November 22, 1996, we requested from HHS

information on FDA and HHS employee contacts with individuals outside

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Response to the Subcommittee’s Request for

Information About FDA’s Tobacco

Regulation Activities

HHS. HHS’ General Counsel replied on January 30, 1997, stating that FDA was

gathering and would provide the information to us, with three exceptions.

First, confidential sources would not be identified because, according to

HHS, doing so would undermine FDA’s pledge of confidentiality. Second, HHS

would not disclose the identity of persons employed by the Department of

Justice in order to protect the U.S. government’s position in pending

litigation. Third, HHS would not identify contacts with persons employed

by the White House because, according to HHS, it could not waive

privileges available to the White House regarding this matter. However, in

an August 2, 1996, letter responding to our request for this information, an

Associate Counsel to the President referred us back to HHS and FDA. HHS

and FDA officials said that this did not alter their original position.

On March 19 and April 9, 1997, HHS provided lists of outside contacts made

by FDA and HHS employees in connection with the investigation and

jurisdictional analysis related to the regulation of tobacco products.

The contacts included 34 staff from other federal government agencies,

including the Department of Agriculture; the Bureau of Alcohol, Tobacco,

and Firearms; the Occupational Safety and Health Administration; the

Centers for Disease Control and Prevention; the Federal Trade

Commission; and the U.S. Patent and Trademark Office. In addition, FDA

staff contacted 42 people with private companies, such as tobacco

manufacturers and suppliers. FDA staff also contacted 26 people who

represented law firms and 23 people who worked for state governments,

including several who represented state attorneys general or academic

institutions. There also were contacts with 8 representatives of public

interest groups.

3. Any memorandums, notes from conversations, or electronic or other

written communications describing the procedures to be used or activities

to be pursued by FDA in considering the regulatory options available to FDA

once it asserted jurisdiction over tobacco products.

FDA and HHS officials would not provide us with tobacco-related

documents in the possession of FDA staff who participated in developing

the regulatory options available to FDA that were not on the public record.

As a result, we could not determine to what extent, if at all, documents

fitting this description existed.

FDA and HHS officials told us that they believed the public record

adequately described the processes for determining FDA’s final rule and

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Appendix I 

Response to the Subcommittee’s Request for

Information About FDA’s Tobacco

Regulation Activities

jurisdictional determination. For example, the final rule described several

regulatory options that were not included in the final rule and the process

that FDA followed in conducting its jurisdictional analysis.

4. Any memorandums, notes from conversations, or electronic or written

communications prepared by any FDA employees, or by any other

individuals at the request of or on behalf of either FDA or HHS, of any

analysis of the regulatory options (or lack thereof) available to FDA once it

asserted jurisdiction over tobacco products, including any discussion of

what type of regulation would be required under the Federal Food, Drug,

and Cosmetic Act and related regulations.

FDA and HHS officials refused to provide us with this information and

reiterated that the final rule discussed the rationale for selecting certain

options and included some discussion of why other options were not

selected.

5. Any memorandums of any meetings involving representatives of FDA

convened to discuss the potential requirements of any FDA rules related to

tobacco products.

FDA and HHS officials were not sure whether documents fitting this request

actually existed. However, we could not determine whether or not any of

these documents were in the possession of FDA staff because FDA refused

us access to documents that were not included in the public record.

6. Any memorandums or other written communications (including

electronic mail) from any government officials reviewing, criticizing,

endorsing, authorizing, or approving potential requirements of any FDA

rules related to tobacco products.

Although the FDA Commissioner told us that he could not recall any FDA

staff indicating that they opposed the final rule or disagreed with FDA’s

determination that it had jurisdiction to regulate tobacco products, we

could not verify this because we were not provided documents in the

possession of FDA staff that were not on the public record.

7. All memorandums, reports, correspondence, or other memorialization

of contacts between representatives of FDA and representatives of any of

the following respecting potential requirements of any FDA rules related to

tobacco products, including discussions of potential conflicts or

overlapping or conflicting jurisdiction between other applicable federal

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Appendix I 

Response to the Subcommittee’s Request for

Information About FDA’s Tobacco

Regulation Activities

and state laws and any such potential requirements: the Federal Trade

Commission; the Department of Justice; the Bureau of Alcohol, Tobacco,

and Firearms; any state official; the U.S. Patent and Trademark Office; or

any component part of HHS.

We obtained one letter from a Department of Justice attorney to an

attorney representing a tobacco company and one letter from FDA

requesting information from the Federal Trade Commission on tar and

nicotine in cigarettes. Both documents were on the public record. Neither

concerned the potential requirements of the proposed rule or conflicting

jurisdiction.

FDA’s Associate Chief Counsel for Enforcement told us that other

Department of Justice documents not on the public record were protected

from disclosure because disclosure of communications with officials from

the Department of Justice would negatively affect the government’s

position in the ongoing civil litigation between the U.S. government and

the tobacco companies. He noted that the final rule describes

correspondence from the Bureau of Alcohol, Tobacco, and Firearms,

which submitted comments that were addressed by FDA. He also cited

information from states that was in the administrative record and in the

comments to the rule. For example, a state official provided information

on smokeless tobacco, which is included in the jurisdictional analysis, and

attorneys general from several states submitted comments on the

proposed rule. These comments, some of which we reviewed, are a matter

of public record. The Associate Chief Counsel for Enforcement also noted

that some materials on the public record are from the Centers for Disease

Control and Prevention. FDA’s jurisdictional analysis also contains

comments referring to published studies from the National Institute on

Drug Abuse.

FDA informed us that agency officials contacted representatives of the

Patent Office regarding the Y1 Brazilian tobacco patent and other patents

for Philip Morris and R. J. Reynolds products. An HHS official told us that

most contacts with other federal and state agencies were oral.

8. All memorandums of conversations, reports, or any documents

(including notes and electronic mail) reflecting any meetings or

conversations occurring since January 1, 1993, between any FDA officials

or employees and any party or lawyer representing any party involved in

any lawsuit filed against one or more cigarette manufacturers.

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Response to the Subcommittee’s Request for

Information About FDA’s Tobacco

Regulation Activities

The FDA Commissioner told us that while he tried to limit his contacts to

state government officials, it was possible that private lawyers hired by

states to assist them in the litigation may have been present at some

meetings he attended.

We examined correspondence between FDA and tobacco companies and

their attorneys that were on the public record. We also examined letters

regarding petitions to regulate nicotine and the validity of the agency’s

jurisdiction over tobacco. The public record also contains documents

involving state and private litigants.

9. Any internal memorandums, reports, or documents (including notes and

electronic mail) concerning (a) the economic impact of regulations under

the Federal Food, Drug, and Cosmetic Act for tobacco products; (b)

consideration of alternative regulatory proposals considered by FDA

concerning tobacco products; and (c) the views of anyone at FDA

supporting or opposing the approach to regulations set forth in FDA’s

proposed regulations concerning cigarettes and smokeless tobacco,

including views that FDA lacks statutory authority to regulate tobacco

products.

The FDA economist responsible for developing FDA’s economic analysis

told us how he developed the analysis that was included in the rule and

identified the government and private sector officials he contacted

regarding the analysis. He also gave us copies of several supporting

documents that were identified in the proposed rule, including a Price

Waterhouse report prepared for the Tobacco Institute and internal

memorandums and electronic mail involving discussions with other

economists and Department of Agriculture officials knowledgeable about

the tobacco industry.

In February 1996, the FDA economist told us, based on his analysis, that

over a 10-year period, a 4-percent reduction in tobacco sales would

displace about 10,000 tobacco industry jobs, about 6,000 of which would

be among tobacco growers. The final rule reduced the estimated loss of

jobs among tobacco growers to about 5,700.

Again, FDA would not provide us copies of internal documents addressing

regulatory options or internal views addressing policy or regulatory issues

that were not on the public record. Therefore, we could not verify this

information.

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Response to the Subcommittee’s Request for

Information About FDA’s Tobacco

Regulation Activities

10. Any internal memorandums or other communications (including notes

and electronic mail) concerning discussions relating to the “additional

requirements” that may be imposed by the FDA if the goals set forth in the

proposed regulations are not met.

This proposed requirement was dropped from the final rule. While the

preamble to the rule discusses “other alternatives” that were considered in

setting up the current rule, the rule does not address “additional

requirements” that would be imposed if the objective of reducing smoking

among children and adolescents by 50 percent in 7 years was not achieved.

11. All internal memorandums or other communications (including notes

and electronic mail) concerning how the following letters would be or

were covered: June 24, 1994, letter from Chairman Charlie Rose to FDA

Commissioner David Kessler; October 27, 1994, letter from Chairman Rose

to FDA Commissioner Kessler; December 14, 1994, letter from Chairman

Rose to HHS Secretary Donna Shalala; and May 30, 1995, letter from

Chairman Thomas W. Ewing to FDA Commissioner Kessler.

An HHS official told us that notes of meetings and records of discussions

concerning how to handle these requests were not retained by the persons

involved. We could not, however, verify this statement because we were

not provided an opportunity to examine documents in the possession of

the staff who worked on this issue that were not included in the public or

confidential record.

12. With respect to the letters listed in query 11 above, the names of any

individuals who participated in conversations, meetings, or other

communications concerning the manner in which FDA or HHS would

answer the letters; the names of any individuals who participated in the

development and approval of responses dated October 11, 1994, and

December 19, 1994; and the names of any individuals who made the

decision to withhold documents from the Congress.

In a July 15, 1996, letter to the Chairman, the Deputy General Counsel of

HHS addressed this issue. Her letter identified FDA and HHS staff involved in

handling the Subcommittee’s request.

FDA and HHS officials also provided us with copies of internal

memorandums related to the four Subcommittee requests. These

memorandums, sent by the Associate Commissioner for Legislative Affairs

to “each person involved in the nicotine/tobacco effort,” requested certain

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Appendix I 

Response to the Subcommittee’s Request for

Information About FDA’s Tobacco

Regulation Activities

FDA staff to provide the requested documents, except for copies of

sensitive documents that relate specifically to the agency’s confidential

investigative operations, including such items as notes of interviews,

summaries of meetings, interview schedules, and summaries of questions

to be asked. However, FDA refused our request for copies of these

documents and would not provide us a list of the documents provided by

FDA staff.

In response to the third part of this query, an HHS official told us that no

decision was made to withhold documents from the Congress. Instead, FDA

and HHS contend that certain documents were not provided to the

Subcommittee because their release would (1) jeopardize the integrity of

the deliberative process, (2) negatively affect the government’s position in

ongoing litigation related to the proposed tobacco rule, and (3) identify

confidential sources and undermine pledges of confidentiality.

Page 17 GAO/HEHS-97-140 FDA Tobacco Regulation
Appendix II 

GAO’s Legal Authority to Obtain FDA

Records

FDA and HHS officials have refused to comply with requests by both the

Subcommittee and GAO for certain tobacco-related documents or an index

to such documents. These documents were in the possession of agency

officials and were not included in either the public or confidential record

of the tobacco rulemaking.

As discussed earlier in this report, the officials cited four reasons for

declining both the Subcommittee’s and our requests for documents: (1) the

proposed tobacco regulation was part of an ongoing rulemaking and

release of the requested information would jeopardize the integrity of this

deliberative process, (2) releasing the requested information and

communications with officials employed by the Department of Justice

would negatively affect the government’s position in ongoing litigation

related to the proposed tobacco rule, (3) the requested information was

obtained from confidential sources and its disclosure could undermine

pledges of confidentiality, and (4) communications with officials employed

by the White House are subject to a possible claim by the President of

executive privilege which only he can waive.

In an opinion prepared for the Subcommittee, the Congressional Research

Service (CRS) considered the four arguments advanced by FDA and

concluded that none “would appear to raise a substantial legal basis” for

withholding the information from the Subcommittee.2

 According to CRS,

numerous decisions of the Supreme Court “establish and support a broad

and encompassing power in the Congress to engage in oversight and

investigations that [reach] all sources of information that enable it to carry

out its legislative function.”

Following unsuccessful efforts to persuade FDA to provide the information,

GAO wrote to the Secretary of HHS on November 22, 1996, explaining our

legal right of access to FDA records. GAO’s request relied on section 716 of

title 31, U.S. Code, which requires each federal agency to “give the

Comptroller General information the Comptroller General requires about

the duties, powers, activities, organization, and financial transactions of

the agency.”

In our letter, we told the Secretary that the four arguments relied on by

FDA for withholding the information we requested did not restrict our

statutory right of access and that

2

Congressional Research Service, Refusal by the FDA of Document and Information Requests with

Respect to its Proposed Regulation of the Sale and Distribution of Cigarettes and Smokeless Tobacco

Products (Washington, D.C.: The Library of Congress, Aug. 19, 1996).

Page 18 GAO/HEHS-97-140 FDA Tobacco Regulation
Appendix II 

GAO’s Legal Authority to Obtain FDA

Records

The law provides an exception from [section 716] only for certain kinds of information, and

then only if it is determined by the President or the Director of the Office of Management

and Budget that disclosure “reasonably could be expected to substantially impair the

operations of the Government.” . . . Information could also be exempt from disclosure to

GAO based on a claim of executive privilege. However, assertion of that privilege has been

reserved to the President.

In her January 30, 1997, response to our letter, the Deputy General

Counsel of HHS declined to provide us the documents we requested, citing

essentially the same four reasons previously cited.

Page 19 GAO/HEHS-97-140 FDA Tobacco Regulation
Appendix III 

Chronology of FDA’s Tobacco Regulation

Activities

The following summary of FDA’s tobacco regulation activities is based

primarily on interviews with the FDA Commissioner and key FDA staff

involved in this effort. In general, we could not verify the testimonial

evidence they provided because FDA refused to give us notes,

memorandums, and other documents in the possession of FDA staff that

were not on the public or confidential record.

Public Petitions

Prompt FDA

Regulatory

Involvement

According to the former FDA Commissioner, FDA initiated its examination

of the need to regulate tobacco products in early 1991, in response to

citizen petitions from such organizations as the Coalition on Smoking OR

Health and the American Medical Association. These petitions, submitted

from the late 1980s through 1991, asked FDA to regulate low-tar and

low-nicotine cigarettes and denicotinized cigarettes as drugs under the

Federal Food, Drug, and Cosmetic Act.

Shortly after joining FDA, the Commissioner said he met with several top

FDA officials, including the Chief Counsel and the Associate Commissioner

for Public Affairs, to discuss these public petitions. The Commissioner

said that he and the other officials agreed that tobacco regulation was an

important issue that warranted FDA’s consideration, but that it was not

among the top priorities at that time. Nevertheless, the Commissioner said

he requested these individuals to develop a working knowledge of tobacco

issues as a framework for responding to the petitions. He also asked them

to consider broader approaches to tobacco regulation than suggested by

the petitions.

According to the Commissioner, a small team was formed to initiate work

on the tobacco issues raised in the petitions. The Commissioner and other

FDA officials indicated that the team included representatives from the

Offices of the Commissioner, Chief Counsel, and Policy. According to the

Commissioner, from mid-1991 through 1992, the team reviewed the

scientific evidence on the addictive nature of nicotine and researched how

tobacco companies could reduce or remove nicotine from cigarettes. The

team used this information to consider the appropriate regulatory role for

FDA and to develop options for responding to the petitions.

During 1993, the Commissioner said he met periodically with the team to

discuss the possible manipulation of nicotine by tobacco manufacturers as

well as FDA’s regulatory role and response to the petitions. According to

the Commissioner’s calendar, a representative of the principal public

petitioner, the Coalition on Smoking OR Health, attended an August 1993

Page 20 GAO/HEHS-97-140 FDA Tobacco Regulation
Appendix III 

Chronology of FDA’s Tobacco Regulation

Activities

meeting with the Assistant Secretary for Health. Subsequently, in

September 1993, the Commissioner and team members told us that they

met with the HHS Assistant Secretary for Health to obtain his guidance on

how FDA should respond to the petitions. According to FDA staff who

attended the meeting, the Assistant Secretary encouraged FDA to address

the issues in the petitions. Subsequent to the meeting, in late 1993, the

Commissioner instructed the team to draft a response to the petitions. In a

letter dated February 25, 1994, FDA provided an informal response to the

Coalition on Smoking OR Health that intended “to frame the issues for the

broader public debate that will be necessary to resolve them.” The letter

indicated that if the agency were to conclude, based on an appropriate

record, that cigarette vendors intend people to buy their products to

satisfy their nicotine addiction, then FDA would have the legal basis to

regulate these products under the provisions of the Federal Food, Drug,

and Cosmetics Act.

FDA Intensifies Its

Tobacco Investigation

In March and June 1994, the House Energy and Commerce Subcommittee

on Health and the Environment held hearings focusing on allegations that

tobacco manufacturers controlled the nicotine content of cigarettes to

maintain their addictive effect. In preparing for these hearings, the number

of FDA staff working on this issue grew from about 5 to more than 30,

according to agency officials. During this period, FDA staff told us they

visited three cigarette manufacturers and other tobacco-related industries,

including a manufacturer of cigarette paper in France.

At the March 25, 1994, hearing, the Commissioner presented the results of

FDA’s study up to that time. He testified that accumulating evidence

suggested that cigarette manufacturers may control smokers’ choice by

controlling the levels of nicotine in their products in a manner that creates

and sustains an addiction in the vast majority of smokers. The

Commissioner concluded that this was sufficient cause to consider the

question of whether cigarettes should be regulated as drugs.

On July 21 and 22, 1994, the Commissioner convened a day-and-a-half

meeting, which focused solely on regulating tobacco products. In addition

to the Commissioner, meeting participants included seven staff from the

Office of the Commissioner, FDA’s Chief Counsel and two other attorneys

from her office, three staff from the Center for Drug Evaluation and

Research, three investigators, and three staff from the Office of Public

Affairs, including a speech writer. According to the meeting agenda, FDA

staff discussed the agency’s policy objectives, goals, and message, as well

Page 21 GAO/HEHS-97-140 FDA Tobacco Regulation
Appendix III 

Chronology of FDA’s Tobacco Regulation

Activities

as the agency’s investigative and regulatory strategies. According to the

Commissioner, papers were disseminated at the meeting. However, none

of the staff we interviewed who attended this meeting could recall

whether meeting minutes were recorded or whether summaries of the

regulatory or investigative strategies discussed were written.

Following the July 1994 meeting, FDA staff told us that their

tobacco-related activities became more focused on the agency’s authority

to regulate tobacco products, how tobacco companies manipulate

nicotine, and how the tobacco industry markets cigarettes to children and

adolescents. To carry out this work, FDA officials told us that two teams of

high-ranking staff members were established. The first team, headed by

the Commissioner, assessed whether FDA had authority to regulate tobacco

products under the Federal Food, Drug, and Cosmetic Act; the second

team focused on developing options for regulating the sale and marketing

of tobacco products and was headed by the Director of the Policy

Development and Coordination Staff in FDA’s Office of Policy.

The FDA teams were assisted by the agency’s criminal and special

investigators, research scientists, and attorneys. FDA team members met

with confidential tobacco-industry informants; searched and analyzed the

scientific literature, including epidemiological information and studies on

nicotine addiction; discussed with academic and industry researchers the

pharmacology of tobacco products and nicotine; examined patents and

statistical materials; and obtained marketing data. They also reviewed

confidential tobacco-industry documents, including some received

anonymously in the mail, concerning cigarette manufacturing and control

of nicotine levels. In completing their work, the teams sought advice from

federal officials with many government agencies. These included officials

from HHS; the Department of Justice; the U.S. Customs Service; the

Department of Agriculture; the Bureau of Alcohol, Tobacco, and Firearms;

the Occupational Safety and Health Administration; the Centers for

Disease Control and Prevention; the Federal Trade Commission; the U.S.

Patent and Trademark Office; and the White House.

Regulatory Options

Considered by FDA

By late 1994, FDA staff had considered the agency’s jurisdictional

authorities and the types of restrictions FDA could apply and began drafting

a regulatory proposal. According to FDA staff, one of the reports on which

they based the regulatory proposal was a 1990 Public Health Service

report called “Healthy People 2000.” This report established the objective

of reducing the use of tobacco by children and adolescents by roughly half

Page 22 GAO/HEHS-97-140 FDA Tobacco Regulation
Appendix III 

Chronology of FDA’s Tobacco Regulation

Activities

by the year 2000. Although FDA staff said they considered a number of

regulatory options, they would not reveal any information about the

alternatives, other than those that were presented in the proposed rule and

final rule. HHS’ Deputy General Counsel and FDA’s Associate Chief Counsel

for Enforcement told us that staff could not discuss matters that were part

of the deliberative process. FDA staff acknowledged, however, that a draft

outline of the proposed rule regulating the sale and marketing of tobacco

products to children and adolescents and proposed jurisdictional

determination were reviewed and approved by the Commissioner. FDA

officials, including the Commissioner, stated that senior HHS officials also

were consulted as the draft proposed rule and jurisdictional analysis

moved forward in early 1995. Subsequently, a draft of the proposed rule

and jurisdictional analysis was provided to the Office of Management and

Budget and the White House for review and comment.

In August 1995, after receiving approvals from HHS, the Office of

Management and Budget, and the White House, the proposed rule and

jurisdictional analysis were published in the Federal Register. The

supplemental information accompanying the proposed rule cited several

options considered by FDA officials. These include (1) advertising

restrictions, ranging from a full ban on advertising to restrictions on

advertising and promotional practices that children actually view;

(2) requiring tobacco manufacturers to monitor the sales and distribution

of retail establishments; (3) requiring package inserts to contain

educational information on cigarettes and smokeless tobacco products;

(4) setting the permissible age for purchase at 19 instead of 18; and

(5) restricting rather than prohibiting sales from vending machines.

Although FDA officials declined to discuss internal agency considerations

of regulatory options, the proposed rule explained why some options were

not selected and why a decision was made to focus on restrictions on

marketing to adolescents.

From the publication of the proposed rule and jurisdictional analysis in

August 1995 until January 1996 and from mid-March to

mid-April 1996—when FDA reopened the comment period to permit

comments on specific documents added to the public record—FDA officials

reported that they received a record volume of comments on the

rule—about 700,000 pieces of mail. Many of the FDA staff members who

served on the two investigative teams were assigned responsibility for

analyzing these comments; comments involving legal issues were referred

to the Office of General Counsel. In August 1996, about 5 years after FDA

Page 23 GAO/HEHS-97-140 FDA Tobacco Regulation
Appendix III 

Chronology of FDA’s Tobacco Regulation

Activities

officials initially discussed this subject, the final rule and jurisdictional

determination were published.

(108264) Page 24 GAO/HEHS-97-140 FDA Tobacco Regulation
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