Food and Drug Administration: Regulation of Tobacco Products (Letter
Report, 09/29/97, GAO/HEHS-97-140).
Pursuant to a congressional request, GAO attempted to obtain internal
memorandums, notes from meetings or conversations, electronic and other
written communications, and other documents from the Food and Drug
Administration (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, GAO provided information on how
FDA developed the tobacco regulations, evaluated regulatory options, and
determined its jurisdiction over tobacco products.
GAO noted that: (1) its efforts to obtain information that would enable
it 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 Congress and by GAO; (2)
through interviews with FDA officials and staff, GAO obtained
testimonial evidence on some FDA actions prior to the publication of the
final rule and jurisdictional determination, but without the documents
requested, it could not verify this information; (3) FDA and HHS
officials refused most of GAO's 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; (4)
they cited several reasons for declining GAO's requests: (a) the
proposed tobacco regulation was part of an ongoing rulemaking and
release of the requested information would jeopardize the integrity of
this deliberative process; (b) releasing the requested information and
communications with officials employed by the Department of Justice
would negatively affect the government's position in ongoing litigation;
(c) the requested information was obtained from confidential sources and
its disclosure could undermine pledges of confidentiality; and (d)
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; (5) although GAO informed FDA and HHS that these factors do
not limit its statutory right of access to the information, officials
were unwilling to be forthcoming; (6) since FDA refused to provide GAO
many of the documents that it requested, the information GAO 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 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; and (7) 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.
--------------------------- Indexing Terms -----------------------------
REPORTNUM: HEHS-97-140
TITLE: Food and Drug Administration: Regulation of Tobacco Products
DATE: 09/29/97
SUBJECT: Agency proceedings
Smoking
Advertising
Labeling law
Congressional/executive relations
Information disclosure
Federal regulations
Tobacco industry
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Cover
================================================================ COVER
Report to Congressional Requesters
September 1997
FOOD AND DRUG ADMINISTRATION -
REGULATION OF TOBACCO PRODUCTS
GAO/HEHS-97-140
FDA Tobacco Regulation
(108264)
Abbreviations
=============================================================== ABBREV
FDA - Food and Drug Administration
HHS - Department of Health and Human Services
CRS - Congressional Research Service
OR - x
Letter
=============================================================== LETTER
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
------------------------------------------------------------ Letter :1
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 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
------------------------------------------------------------ Letter :2
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.
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
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
------------------------------------------------------------ Letter :3
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 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.
---------------------------------------------------------- Letter :3.1
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
RESPONSE TO THE SUBCOMMITTEE'S
REQUEST FOR INFORMATION ABOUT
FDA'S TOBACCO REGULATION
ACTIVITIES
=========================================================== Appendix I
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.
Table I.1
Primary Responsibilities of FDA Staff
Working on Tobacco Issues Between 1994
and 1996
Number
Unit of staff Primary responsibilities
--------------------- -------- --------------------------------------------------------
Commissioner of Food 1 Provided overall leadership and direction on the
and Drugs development of the proposed tobacco regulation and
accompanying jurisdictional analysis.
Office of the 4 Developed overall policy on regulating tobacco
Commissioner 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 14 Conducted background research related to legal issues in
Counsel 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 4 Participated in the agency's investigation of the
Investigations 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 3 Participated in the agency's investigation of the
Investigations 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.
Center for Drug 12 Participated in the agency's investigation of the
Evaluation and tobacco industry, with duties that included visiting
Research 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 3 Reviewed and analyzed scientific data on nicotine's
and Radiological pharmacological effects, including tobacco company-
Health 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 3 Participated in the agency's investigation of the
Safety and Applied tobacco industry, with duties that included collecting
Nutrition 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 1 Assisted in preparing the legal analysis of FDA's
Medicine jurisdiction over tobacco products, focusing on past
cases where FDA regulated products without promotional
claims.
Office of External 2 Prepared for anticipated hearings, wrote press
Affairs materials, and managed the agency's congressional
relations.
Office of Health 2 Researched a variety of policy, regulatory, and
Affairs scientific issues regarding the regulation of tobacco.
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 1 Researched policy and public health issues regarding the
Affairs regulation of tobacco products, and participated in
drafting portions of the preamble to the proposed rule.
Office of Planning 2 Organized and conducted research on potential economic
and Evaluation impact of the proposed rule, and wrote the analysis of
impacts published with the proposal.
Office of AIDS and 3 Reviewed and analyzed scientific data on nicotine's
Special Health pharmacological effects, and assisted in drafting
portions of the jurisdictional analysis.
Forensic Chemistry 24 Participated in the design of studies on smokeless
Center, Cincinnati tobacco, and performed analyses of cigarettes and
District Office, smokeless tobacco to determine their chemical
Office of Regulatory properties.
Affairs
St. Louis Laboratory, 15 Performed chemical analyses of tobacco products, and
Center for Drug provided consultation to FDA headquarters on scientific
Evaluation and matters related to jurisdictional issues.
Research
Baltimore District 3 Visited tobacco companies, collecting samples for
Office, Office of analysis where possible, and provided expertise on the
Regulatory Affairs chemistry and properties of tobacco products.
Los Angeles District 1 Investigated nicotine levels in commercial cigarettes,
Office, Office of and developed methods to look at the chemical
Regulatory Affairs properties of cigarettes.
Atlanta District 1 Visited tobacco companies; collected, analyzed, and
Office, Office of reviewed documentary evidence; and interviewed former
Regulatory Affairs 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
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 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 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.
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.
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 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.
--------------------
\1 FDA did not provide us information for eight staff members who
were no longer working at FDA.
GAO'S LEGAL AUTHORITY TO OBTAIN
FDA RECORDS
========================================================== Appendix II
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
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.
--------------------
\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).
CHRONOLOGY OF FDA'S TOBACCO
REGULATION ACTIVITIES
========================================================= Appendix III
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
------------------------------------------------------- Appendix III:1
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 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
------------------------------------------------------- Appendix III:2
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 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
------------------------------------------------------- Appendix III:3
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 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 officials initially discussed this subject, the final
rule and jurisdictional determination were published.
*** End of document. ***