Tobacco Documents Online

CONFIDENTIAL: MINNESOTA TOBACCO LITIGATION October 19, 1994 1994 ACTIVITY FOOD & DRUG ADMINISTRATION PROPOSALS TO REGULATE TOBACCO PRODUCTS FebruarL25 FDA Commissioner Kessler writes to Coalition on Smoking OR Health, stating that he believes FDA has authority to regulate tobacco products and points to "manipulation of nicotine" as basis. However, he wants Congressional guidance before embarking on regulation. February 28 ABC-TV airs story alleging "nicotine spiking" on "Day One" program. M r Congressmen Synar and Durbin circulate "Dear Colleague" letter seeking cosponsors for H.R. 2147, to give FDA regulatory authority over tobacco products. March 4 ASH files petition to FDA for regulation of cigarettes. March 7 Coalition on Smoking OR Health submits new petition to FDA asking for classification of cigarettes as drugs. Day One airs second story on nicotine and ingredients. M r h 1 Congressman Waxman writes Attorney General Reno calling for Justice Department investigation of "the tobacco industry's failure to report the addition of nicotine to cigarettes as required by Federal law" on ingredients reporting. March 14 Kessler submits Freedom of Information request to Federal Trade Commission for data on nicotine values. Similar requests are made by Congressman Lancaster and Dr. John Slade, on behalf of the American Society of Addiction Medicine. Day One airs third story on nicotine. TIMN 0029918

CONFIDENTIAL: MINNESOTA TOBACCO LITIGATION March 16 In hearing on agriculture appropriations bill, Kessler and Subcommittee Chairman Durbin discuss potential for regulation of tobacco by FDA. HHS official states that department has asked for Justice Department investigation of cigarettes and nicotine; later, HHS issues clarification that such a request has been discussed with the DoJ, but not formally referred for action. Same day, Tobacco Institute holds briefing for 23 Members on nicotine issues. Coalition on Smoking OR Health also holds congressional briefing. M r h 24 Philip Morris files lawsuit against ABC-TV for libel on Day One. March 25 House Energy & Commerce Subcommittee on Health & the Environment holds oversight hearing on issues related to tobacco products and nicotine. Kessler and Tobacco Institute are among witnesses. April 7 President Clinton mentions FDA investigation of nicotine in response to question at Town Hall Meeting. April 8 National Public Radio airs story on cigarette ingredients. A ri 1 Six tobacco companies release list of ingredients added to tobacco in the manufacture of cigarettes. Aril1 Waxman holds press conference to release material he alleges shows nicotine manipulation. A riI 14 Waxman Subcommittee holds oversight hearing for chief executive officers of seven tobacco companies. Subcommittee requests documents from companies. A i 1 Coalition on Smoking OR Health testifies before Durbin Subcommittee urging regulation of tobacco products by FDA. A ri Waxman Subcommittee holds oversight hearing for two former Philip Morris scientists, Victor DeNoble and Paul Mele. 2 TIMN 0029919

CONFIDENTIAL: MINNESOTA TOBACCO LITIGATION May 1 New York Times story reports that 91-percent of respondents to telephone survey believe cigarettes are addictive. May2 New York Times story includes statement by Federal Trade Commission official that FTC is studying altemative tar and nicotine test methods. May 12 Coalition on Smoking OR Health filed statements from April 14 hearing with FDA in support of petitions for regulation of cigarettes. May 17 Waxman Subcommittee hears Joseph Califano, representing Columbia University's Center on Addiction and Substance Abuse. MaX23 Congressman Meehan and six other Members write Attorney General Reno requesting DoJ to "ini'tiate a series of criminal investigations into tobacco company activities and statements." May 26 Waxman Subcommittee hears James Glenn, president of Council for Tobacco Research. May 31 President Clinton mentions FDA's study of nicotine in remarks at swearing-in ceremony for Council on Physical Fitness. June 13 Coalition on Smoking OR Health writes all Members of Congress urging FDA regulation. June 15 House Rules Committee rejects Synar and Durbin request to be allowed to offer language from H.R. 2147 as amendment to agriculture appropriations bill. June 21_ Waxman Subcommittee hears Kessler on recent FDA activities regarding high-nicotine tobacco leaf, Y-1. Justice Department officials meet with Meehan to discuss request for investigation. June 22 Waxman Subcommittee hears chief executive officer of Brown & Williamson. 3 TIMN 0029920

CONFIDENTIAL: MINNESOTA TOBACCO LITIGATION June 30 Senator Ford writes Attorney General Reno regarding Meehan request. 1 _ Federal Trade Commission asks National Cancer Institute to convene consensus conference to study cigarette testing methodology and to recommend any changes. 1 21 Republican members of Waxman Subcommittee send two separate letters to FDA requesting information and documents as follow-up to June 21 hearing. August 2 FDA Drug Advisory Committee holds public hearing and considers staff questions on tobacco products and nicotine. Committee agrees that "Cigarettes and other forms of tobacco are addicting" and that "Nicotine is the drug in tobacco that causes addiction" but declines to recommend threshold level that causes addiction. Auau,st5 Waxman Subcommittee was to hold oversight hearing on tobacco sponsorship and advertising, but postpones hearing indefinitely. Auugst19 Congressman Barlow writes Kessler opposing FDA regulation of tobacco. [Throughout the summer, additional Members write FDA on the issue.] Auqust 28 Jack Anderson column asserts that Kessler may have "October surprise" for tobacco industry. SeRtember 12 FTC's expert on tobacco advertising is detailed to FDA to work on tobacco issues. Seomber 13 Institute of Medicine issues report including call for regulation of tobacco products to fight youth smoking. September 29 FTC announced proposed consent agreement with American Tobacco Company regarding advertising of Carlton cigarettes. FTC states "Consumers will not necessarily get less tar because the ratings published in the ads are obtained by smoking machines that do not reflect actual smoking, in part because they do not take into account such behavior as "compensatory smoking."" TIMN 0029921

CONFIDENTIAL: MINNESOTA TOBACCO LITIGATION October 3 Waxman writes Kessler urging response to Bliley's July 21 request for information "within the next two weeks." OcCoalition on Smoking OR Health announces nationwide petition drive by "Citizens to Protect Our Children From Tobacco" through early December. Will collect signatures calling on Congress, the Administration and FDA "to ensure that tobacco products are regulated (without banning them), including the way they are manufactured, sold, labeled, advertised and promoted; that the public's health is protected from the dangers of tobacco use to the greatest extent possible; and that children are not encouraged to smoke or given access to tobacco products." FDA official says that agency is continuing its "investigation into whether there is a basis for the agency asserting jurisdiction over nicotine-containing tobacco products." OcRepublican members of Waxman Subcommittee and selected members of full committee write Kessler expressing concern that FDA has been unresponsive to their July 21 requests for information. OctobQL$ Congress recesses for elections. H.R. 2147 is effectively dead for the session. October 14 USA Today editorial calls for FDA regulation of tobacco products as well as ban on vending sales and $1 per pack tax increase. Response from Tobacco Growers Information Committee is printed. November 3-4 American Society of Addiction Medicine to hold conference on "nicotine dependence." Early December FTC and NCI to hold consensus conference on tar and nicotine test method. Early December FDA Drug Advisory Committee to meet. May consider additional recommendations on tobacco products and nicotine. January 1995 Coalition on Smoking OR Health to present petitions calling for FDA regulation. 5 TIIVIN 0029922