oversight

Food and Drug Administration: Regulation of Tobacco Products

Published by the Government Accountability Office on 1997-09-29.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

                  United States General Accounting Office

GAO               Report to Congressional Requesters




September 1997
                  FOOD AND DRUG
                  ADMINISTRATION
                  Regulation of Tobacco
                  Products




GAO/HEHS-97-140
              United States
GAO           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.


              Because we were not able to obtain many of the documents related to the
Scope and     information you requested, most of the documents we examined were
Methodology   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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                   B-270742




                   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.


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



Page 3                                  GAO/HEHS-97-140 FDA Tobacco Regulation
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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.


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



                  Page 4                                  GAO/HEHS-97-140 FDA Tobacco Regulation
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                                                                                         8

Response to the
Subcommittee’s
Request for
Information About
FDA’s Tobacco
Regulation Activities
Appendix II                                                                                       18

GAO’s Legal Authority
to Obtain FDA
Records
Appendix III                                                                                      20
                        Public Petitions Prompt FDA Regulatory Involvement                        20
Chronology of FDA’s     FDA Intensifies Its Tobacco Investigation                                 21
Tobacco Regulation      Regulatory Options Considered by FDA                                      22
Activities
Table                   Table I.1: Primary Responsibilities of FDA Staff Working on                9
                          Tobacco Issues Between 1994 and 1996




                        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
                                        Number
Unit                                     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)


                                         Page 9                                          GAO/HEHS-97-140 FDA Tobacco Regulation
                                      Appendix I
                                      Response to the Subcommittee’s Request for
                                      Information About FDA’s Tobacco
                                      Regulation Activities




                                 Number
Unit                              of staff          Primary responsibilities
Center for Drug Evaluation and         12           Participated in the agency’s investigation of the tobacco industry, with
Research                                            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                  3           Reviewed and analyzed scientific data on nicotine’s pharmacological
Radiological Health                                 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              3           Participated in the agency’s investigation of the tobacco industry, with
Applied Nutrition                                   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)




                                      Page 10                                        GAO/HEHS-97-140 FDA Tobacco Regulation
                                             Appendix I
                                             Response to the Subcommittee’s Request for
                                             Information About FDA’s Tobacco
                                             Regulation Activities




                                        Number
Unit                                     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,                    24           Participated in the design of studies on smokeless tobacco, and
Cincinnati District Office, Office of                      performed analyses of cigarettes and smokeless tobacco to determine
Regulatory Affairs                                         their chemical properties.
St. Louis Laboratory, Center for              15           Performed chemical analyses of tobacco products, and provided
Drug Evaluation and Research                               consultation to FDA headquarters on scientific matters related to
                                                           jurisdictional issues.
Baltimore District Office, Office of           3           Visited tobacco companies, collecting samples for analysis where
Regulatory Affairs                                         possible, and provided expertise on the chemistry and properties of
                                                           tobacco products.
Los Angeles District Office, Office            1           Investigated nicotine levels in commercial cigarettes, and developed
of Regulatory Affairs                                      methods to look at the chemical properties of cigarettes.
Atlanta District Office, Office of             1           Visited tobacco companies; collected, analyzed, and reviewed
Regulatory Affairs                                         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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Appendix I
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.

FDAand 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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Appendix I
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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Appendix I
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



Page 16                                      GAO/HEHS-97-140 FDA Tobacco Regulation
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.


                   According to the former FDA Commissioner, FDA initiated its examination
Public Petitions   of the need to regulate tobacco products in early 1991, in response to
Prompt FDA         citizen petitions from such organizations as the Coalition on Smoking OR
Regulatory         Health and the American Medical Association. These petitions, submitted
                   from the late 1980s through 1991, asked FDA to regulate low-tar and
Involvement        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.


                        In March and June 1994, the House Energy and Commerce Subcommittee
FDA Intensifies Its     on Health and the Environment held hearings focusing on allegations that
Tobacco Investigation   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.


                     By late 1994, FDA staff had considered the agency’s jurisdictional
Regulatory Options   authorities and the types of restrictions FDA could apply and began drafting
Considered by FDA    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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