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RJ Reynolds

Briefing Book. The Food and Drug Administration and Tobacco Regulation.

Date: Sep 1995
Length: pages
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Fda
Congress
Ftc
Synar
Clinton
Wallop, M.
Koop, C.E.
Pertschuck, M.
Ti
Durbin, R.J.
House
Edwards, C.
Music Operators Assn
American Civil Liberties Union
Wa Legal Foundation
Lynn, B.
Freedomto Advertise Coalition
Fithian, J.
Jaffe, D.
Assn, O.F. Natl Advertisers
Usda
Hhs
Bureau, O.F. Alcohol Tobacco & Firearm
Dept, O.F. Transportation
Icc
Amtrak
General Services Administration
Us Postal Service
Dept, O.F. Fefense
Epa
Osha
List, O.F. Fed, A.G.
Magazine, A.M.
Health Industry Manufacturers Assn
Phillips, J.
Senate
Kassebaum
Shalala, D.
Ericksen, M.
Centers For Disease Control & Preve
Lipsett, M.B.
Harvard Univ
Univ, O.F. Helsinki
Rjr
Fishel, D.B.
Ellis, M.P.
Coyne
Kessler, D.A.
Blixt, C.A.
Us Surgeon General
Named Organization
Natl Institute on Drug Abuse
Natl Institute of Child Health & Hu
Site
External Relations
Fed Govt Aff
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Type
FORMAL LEGAL DOCUMEN
PUBLISHED DOC
LAW
REPORT
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US
Comprehensive
Request
140
Author
Ti
Date Loaded
07 Aug 2001
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Rjr5061
UCSF Legacy ID
djk56d00

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43. The Coalition submitted a new petition on March 7, 1994, adopting Dr. Kessler's theory and demanding that cigarettes be regulated by the FDA as drugs. ASH submitted a similar petition on March 4, 1994. 44. Dr. Kessler's February 25, 1994 letter to the Coalition stated that "the regulation of cigarettes raises societal issues of great complexity and magnitude. It is vital in this context that Congress provide clear direction to the agency. We intend therefore to work with Congress to resolve... the regulatory status of cigarettes under the Federal Food, Drug, and Cosmetic Act." 45. Thereafter, several Congressional hearings were held on the subject of nicotine and the FDA. 46. Despite Dr. Kessler's stated intention to obtain direction from Congress concerning FDA regulation of tobacco products, Congress did not subsequently amend the FDC Act to provide such direction. 47. Nevertheless, on August 10, 1995, Dr. Kessler announced that the FDA considers nicotine to be a "drug" and tobacco products to be drug delivery "devices." The FDA seeks to regulate the "combination" of these entities as devices. 48. Dr. Kessler's assertion of jurisdiction over tobacco products is unjustified by any change in facts. Whereas a product is a drug or a device only if it is represented for a therapeutic purpose or to affect the structure or function of the body, plaintiffs' smokeless tobacco products are represented only for tobacco enjoyment. Courts have uniformly held that tobacco products cannot be considered drugs or devices in the absence of N ROM1G0a21 V3 • 1ts -
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751, 753 (C.D. Ill. 1991); National Nutritional Foods Ass'n v. Mathews, 557 F.2d 325, 333 (2d Cir. 1977); and j~I tional Nutritional Foods Ass'n v. FDA. 504 F.2d 761, 789 (2d Cir. 1974). 37. In 1977, Action on Smoking and Health ("ASH") filed a petition with the FDA asking that the FDA assume jurisdiction over tobacco products on the theory that such products were "drugs " The FDA denied ASH's petition, stating that ASH's factual assertions, even if true, did not provide a basis for FDA jurisdiction: The interpretation of the Act by the FDA consistently has been that cigarettes are not a drug unless health claims are made by the vendors. The petitioners have presented no evidence that manufacturers or vendors of cigarettes represent that the cigarettes are "intended to affect the structure or any function of the body of man...." 21 U.S.C. § 321(g)(1)(C). Statements by the petitioners and citations in the petition that cigarettes are used by smokers to affect the structure or any functions of their bodies are not evidence of such intent by the manufacturers or vendors of cigarettes.... Letter from Donald Kennedy, Commissioner of Food and Drugs, to John F. Banzhaf III, at 3, 4 (Dec. 5, 1977) (emphasis added). 38. The FDA's denial of the ASH petition was sustained in Action on Smoking and Health v. Harris. 655 F. 2d. 236 (D.C. Cir. 1980). Subsequently, the FDA continued to advance the position set forth in the 1977 denial letter. 39. Contemporaneous with its 1977 petition to the FDA to regulate cigarettes as "drugs," ASH petitioned the FDA to classify cigarettes and cigarette filters as "devices." The FDA denied that petition in 1980. ASH did not seek judicial review of that FDA decision. N RGMi6at2t V3 - 16 -
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Congress Has Considered and Rejected Granting the FDA Jurisdiction Over Tobacco 40. Congress is well aware of the FDA's long-standing interpretation that there is no jurisdiction in the FDC Act to regulate tobacco products and has acquiesced in that interpretation. Congress declined to amend the FDC Act to grant such authority to the FDA on at least twenty occasions. The scope of federal regulation of tobacco products is set forth in laws written on the assumption that the FDA lacks jurisdiction to regulate tobacco. 5gg 15 U.S.C. §§ 1331-1341 (Federal Cigarette Labeling and Advertising Act); 15 U.S.C. §§ 4401-4408 (Comprehensive Smokeless Tobacco Health Education Act of 1986). Those laws are intended to be exhaustive of agency jurisdiction and do not include the FDA. Congressional acquiescence constitutes a clear presumption of legislative intent. Zemel v. ~i , 381 U.S. 1, 11, 85 S.Ct. 1271, 14 LEd.2d 179 (1965). DR. KESSLER'S ACTION 41. On February 25, 1994, Dr. Kessler sent a letter to Scott Ballin, Chairman of the Coalition on Smoking OR Health ("Coalition"). Dr. Kessler stated that there was evidence that nicotine in cigarettes is intended "to satisfy an addiction" and, therefore, that cigarettes may be subject to regulation as a drug. 42. Although Dr. Kessler's letter referred to petitions filed by the Coalition, those petitions had already been pending for several years, including one submitted as early as 1988. -17- N RGM160P121 V3
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products. This model includes vending machine restrictions, a licensing system, proof- of-age requirements, and a graduated schedule of penalties for violations. (b) Regulation of tobacco advertising - an important part of Dr. Kessler's proposal - is WEeadv within the purview of the FTC Congress specifically granted the FTC broad authority to oversee tobacco advertising and promotional practices. Under the FCLAA and the CSTHEA, the FTC -- not the FDA -- has express authority to regulate deceptive ads or promotional practices concerning tobacco products. In addition, Congress gave the Department of Justice the authority to enforce the ban on broadcast advertising of tobacco products. (c) An example of a government program already aimed at preventing youth tobacco product use is the Safe and Drug-Free Schools and Communities Act of 1994, 20 U.S.C. §§ 7101 gl Lg6 which provides for tobacco education in the schools by reauthorizing the Drug-Free Schools and Communities Act of 1988 and providing $655 million for programs to prevent, among other things, the illegal use of tobacco. 52. Moreover, Dr. Kessler's proposed regulations for controlling the advertising, marketing, and distribution of tobacco products would be an unprecedented and unauthorized departure from the FDA's regulatory mandate. Dr. Kessler has stated that under the FDC Act, the FDA's declaration that a product is a "drug" or "drug delivery device" ordinarily requires the FDA to determine that the product is "safe and effective" for N ILGMIG0421 VS - Z0"
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64. Congress explicitly prohibited any federal agency from requiring any statements relating to the use of smokeless tobacco products and health other than, those prescribed in the CSTHEA. 15 U.S.C. § 4406(a). 65. Although Congress has chosen to delegate some of its reserved regulatory power to federal agencies, Congress has repeatedly refused to enact legislation that would give the FDA any role in the regulation of tobacco products. 66. The FDA's assertion of jurisdiction is thus contrary to, and precluded by, the CSTHEA COUNT III THE FDA'S DECISION TO REGULATE TOBACCO PRODUCTS AS DRUGS IS ARBITRARY AND CAPRICIOUS. AND OTHERWISE NOT IN ACCORDANCE WITH LAW 67. Plaintiffs reiterate and reallege the allegations of 111 through 66, as set forth above. 68. The FDA's assertion of jurisdiction over smokeless tobacco products as having an intended drug or device use is arbitrary, capricious, an abuse of discretion, and otherwise not in accordance with law and plaintiffs are therefore entitled to judicial review in accordance with 5 U.S.C. §§ 702 and 704 as provided in 5 U.S.C. § 706(2)(A). N RGMIW421 v3 - 24 '
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representations for intended therapeutic use. ee, FTC v. & Myers Tobacco Co., 108 F. Supp. 573 (S.D.N.Y. 1952), affd on opinion below, 203 F.2d 955 (2d Cir. 1953); Action on Smoking and Health v. Harris. 655 F.2d 236 (D.C. Cir. 1980). 49. Dr. Kessler's assertion of jurisdiction purports to be based on newly discovered facts but in reality the only change in circumstance since the FDA disclaimed jurisdiction over tobacco products is that Dr. Kessler has decided that regulating those products would advance his views, and the views of anti-tobacco activists, as to what constitutes desirable public policy. 50. Dr. Kessler's proposed regulations, which seek, among other things, to restrict tobacco product sales, advertising and promotion, do not fit within the framework of the FDA's regulatory authority and are largely duplicative of programs already in place. 51. In fact, the issue of youth smoking is currently being addressed by Congress, state governments, and the private sector - all of which have the authority and ability (unlike the FDA) to implement the type of actions proposed by Dr. Kessler: (a) In 1991 Congress determined in the Alcohol, Drug Abuse, and Mental Health Amendments Reorganization Act that, as a matter of federal policy, restricting minors' access to tobacco products is a task for the states. 42 U.S.C. § 300x-26. That Act conditions federal substance abuse block grants to the states on the enactment and enforcement of state laws prohibiting tobacco product sales to minors. DHHS has proposed regulations to implement this law, which would recommend a "model law" for the states aimed at reducing minors' access to tobacco ~ N RGM1G0A2I V] . ly -
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access, the best way to keep kids away from cigarettes is to keep cigarettes away from kids. This lawsuit is W about youth smoking. We believe this lawsuit is our only option in the face of an illegal action that, if successful, even Commissioner Kessler has admitted could lay the groundwork for far more radical action in the future -- action that could ultimately lead to more severe restrictions or a ban on the sale of cigarettes to adults. ### 3
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its intended use. But Dr. Kessler and others have stated that the FDA will not conclude that tobacco products are safe for their intended use. 53. The inapplicability of the FDC Act to tobacco products can also be seen from the fact that dictating the content of labels of drugs and devices is an integral part of FDA regulation. Yet, as shown above, Congress has retained exclusive control over the content of the health warnings on cigarette and smokeless tobacco packages pursuant to the FCLAA and the CSTHEA, which would preempt any effort by the FDA to add to or alter these warnings. 54. Indeed, the very advertising and distribution restrictions of the proposed regulations are inconsistent with the proper limits of FDA authority over even true "drugs" or "devices:" The FDA is not authorized to impose on "drugs" advertising and distribution limits of the type Dr. Kessler has proposed. Dr. Kessler attempts to side-step this limitation by invoking "device" jurisdiction, while simultaneously conceding that the FDA's sole basis for = jurisdiction, however fallacious, is the properties of nicotine, whose primary mode of action Dr. Kessler says is that of a "drug." Under the FDC Act, a "drug" must be regulated as a "drug." 21 U.S.C. §§ 321(g) and (h) and 353(g)(1). 55. In addition, even assuming the device definition applied, the "restricted device" authority of 21 U.S.C. § 360j(e) does not authorize "restrictions" to achieve whatever general public health goal the agency believes is desirable, but only those necessary to assure that there is "reasonable assurance of [a device's] safety and effectiveness:" Dr. Kessler rejects these concepts as inherently inapplicable to smokeless tobacco products; and the restrictions _2i. N [2GM160421 V3
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32. Subparagraphs (B) and (C) of 21 U.S.C. § 321(g)(1) define a drug in terms of a product's "intended use," not its physical properties. 33. The legislative history of the FDC Act states that, under 21 U.S.C. \ § 321(g)(1)(B) and (C), "intended use" is determined by the seller's representations: The use to which the product is to be put will determine the category into which it will fall. If it is to be used only as a food, it will come within the definition of food and none other. If it contains nutritive ingredients but is sold for drug use only, ... it will come within the definition of drug, but not that of food. ... The manufacturer of the article, through his representations in connection with its sale, can determine the use to which the article is to be put. For example, the manufacturer of a laxative which is a medicated candy or chewing gum can bring his product within the definition of drug and escape that of food by representing the article fairly and unequivocally as a drug product. S. Rep. No. 361, 74th Cong., 1st Sess. 4 (1935). 34. The FDA's regulations acknowledge that the "objective intent of the manufacturer determines a product's intended use: The words "intended uses" ... refer to the objective intent of the persons legally responsible for the labeling of drugs. 21 C.F.R. § 201.128. 35. The word "device" is defined in terms essentially identical to those in the drug definition, and the "intended use" of a product as a "device" is based on the same objective intent analysis that applies to drugs. 21 U.S.C. § 321(h)(2) and (3); 21 C.F.R. § 801.4. 36. Case law holds that the manufacturer's representations are controlling in the determination of whether a product is intended for a use that would create ''drug" or "device" status. See United States v. 2 Plastic Drums of an Article of Food, 791 F. Supp. N H(iMl&0.t2I V3 -15-
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August 10, 1995 CONTACT: (212) 907-5830 FOR IMMEDIATE RELEASE PHILIP MORRIS U:S.A. TODAY ISSUED THE FOLLOWING STATEMENT: Today Philip Morris U.S.A. joined the four other major U.S. cigarette manufacturers and an advertising firm in filing suit in the U.S. District Court for the Middle District of North Carolina in order to stop the Food and Drug Administration from proceeding on a course of action that clearly is illegal. Philip Morris U.S.A. is the domestic tobacco subsidiary of Philip Morris Companies Inc. The suit follows FDA Commissioner David Kessler's release of proposed regulations governing cigarettes. The regulations are based on President Clinton's decision to allow FDA to assert jurisdiction over cigarettes under a federal law that gives him power to regulate medicines, medical devices and pharmaceutical products. The purported justification for FDA regulations is to prevent minors from smoking. On the issue of youth smoking, we share a common goal with all Americans: minors should not smoke and should not have access to cigarettes. We support a number of steps, both voluntary and legislative, that will make a real difference on this issue, We will fight against the idea that the FDA is the right way to make a difference on youth smoking. We will fight just as vigorously for our alternative program, which combines state level regulation and enforcement with voluntary efforts to make a real impact on this critical social issue. Having opted to pursue more federal regulation, the Administration has ensured that the more effective and expedient course of cooperative action takes second place to those who want to expand the federal bureaucracy and its unwanted intrusion into the private lives of adult Americans. The Adininistration's decision is all the more troubling in light of the fact that Philip Morris, several weeks ago, committed itself to a comprehensive program, Action Against Access, designed to prevent kids from obtaining cigarettes by any legal means. Once all the elements are implemented, the result WILL be a retail 1

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