(Editor's Note: The following is Brown & Williamson's summary of the tobacco companies' arguments against the FDA's proposed regulations restricting sales to minors and claiming jurisdiction over nicotine as a drug. Brown & Williamson contends that the FDA is incorrect in equating smoking with nicotine use. As Brown & Williamson points out, "Smokers want cigarettes, not nicotine delivery systems." Also, the consistency in nicotine delivery by different brands and different batches from year to year is "no more "remarkable" for cigarette manufacturers to achieve this than the consistency of quality achieved by any other producer of a consumer product based on an agricultural commodity, such as manufacturers of coffees, frozen orange juice or applesauce.")
Before The
United States Food and Drug Administration
Docket No. 95N-0253
Docket No. 95N-0253J
SUPPLEMENTAL COMMENTS OF
BROWN & WILLIAMSON TOBACCO CORPORATION TO
DOCKET NO. 95N-0253, REGULATIONS RESTRICTING THE SALE AND
DISTRIBUTION OF CIGARETTES AND SMOKELESS TOBACCO
PRODUCTS TO PROTECT CHILDREN AND ADOLESCENTS;
PROPOSED RULE
AND
DOCKET NO. 95N-0253J, ANALYSIS REGARDING FDA'S
JURISDICTION OVER NICOTINE-CONTAINING CIGARETTES AND
SMOKELESS TOBACCO PRODUCTS; NOTICE
Of Counsel:
Wiley, Rein & Fielding
1776 K Street, N.W.
Washington, DC 20006
Brown & Williamson
Tobacco Corporation
1500 Brown & Williamson Tower
Louisville, KY 40232
Submitted: January 2, 1996
TABLE OF CONTENTS
Page
INTRODUCTION........................1
I. CONTRARY TO FDA'S ACCUSATION THAT
B&W SEEKS TO DELIVER A "PRECISE AMOUNT
OF NICOTINE," B&W DESIGNS AND MANUFACTURES
ITS CIGARETTES FOR CONSUMER ACCEPTANCE
BASED UPON THE TOTAL, COMPLEX,
MULTIFACETED SMOKING EXPERIENCE.....4
A. Competition in the U.S. Cigarette
Market Has Resulted In Several
Product Styles, Giving Adult Smokers
A Wide Choice of "Tar" Levels.......5
B. Consumers Preference Testing
Measures A Range of Product Attributes
To Determine Overall Consumer
Preference..........................8
C. Tobacco Blend Selection, Other
Components, and Design Features are
Adjusted to Improve or Maintain
Consumer Preference.................9
1. Tobacco Blend Selection and
Purpose.............................9
2. Casings..........................12
3. Flavors..........................13
4. Design Features..................14
(a) Papers..........................14
(b) Filters.........................15
5. Cigarette Manufacture and Quality
Assurance...........................17
D. B&W's Product Development Efforts Over
the Last 40 Years Have Led to Dramatic
Declines in Nicotine Delivery.......18
II. CONTRARY TO FDA'S MISCHARACTERIZATIONS,
B&W AND BATCo. HAVE CONDUCTED RESPONSIBLE
RESEARCH, INCLUDING RESEARCH INTO NICOTINE,
SMOKING BEHAVIOR, AND PRODUCT DESIGN, NONE
OF WHICH INDICATES INTENT BY B&W OR BATCo.
TO OFFER CIGARETTES AS "DRUG DELIVERY
DEVICES."...........................20
A. BATCo.'s Research Into the Properties
of Nicotine is Distorted by FDA.....22
1. BATCo.'s Project Ariel Was an Attempt
in the Early 1960s to Product a No-"Tar"
Cigarette in Response to a Cigarette
Market Concerned About Smoking and
Health..............................23
2. BATCo.-sponsored Research in the
1960s Was Comparable to Work Pursued
and Published by Others at the Same
Time................................24
3. FDA Misuses Statements in BATCo.
Documents About "Addiction".........27
B. B&W and BATCo. Research into "Low`Tar,'
Medium Nicotine" Cigarettes, Undertaken
Largely in Response to Government Initiatives,
Revealed that Consumers Did Not Want Such
Cigarettes..........................30
1. Y-1 Tobacco Was Never Employed to
Increase Nicotine in B&W
Cigarettes..........................32
2. The Barclay Cigarette Was Not
Designed to "Boost" Nicotine
Delivery............................33
3. FDA's Contentions Regarding B&W's
Use of Ammonia Compounds are Erroneous
and Misleading......................35
(a) The Role of Ammonia Compounds
in Cigarette Manufacturing..........36
(b) Ammonia and "Impact"............37
C. BATCo.'s Knowledge Regarding Smoker
Compensation Was No Different or Better
Than That Which Was Widely Known
Elsewhere...........................39
1. Compensation.....................40
2. Elasticity.......................41
D. BATCo. Also Researched the Role of
Nicotine in Smoking Behavior in an
Attempt to Understand How to Design
Acceptable Low "Tar" Delivery
Product.............................43
E. B&W and BATCo. Have Never Determined
That Smokers Cannot Quit Smoking....44
CONCLUSION..........................46
SUPPLEMENTAL COMMENTS OF
BROWN & WILLIAMSON TOBACCO CORPORATION TO
DOCKET NO. 95N-0253, REGULATIONS RESTRICTING
THE SALE AND DISTRIBUTION OF CIGARETTES AND
SMOKELESS TOBACCO PRODUCTS TO PROTECT CHILDREN
AND ADOLESCENTS; PROPOSED RULE
and
DOCKET NO. 95N-0253J, ANALYSIS REGARDING FDA'S
JURISDICTION OVER NICOTINE-CONTAINING CIGARETTES
AND SMOKELESS TOBACCO PRODUCTS; NOTICE
INTRODUCTION
The Food and Drug Administration's ("FDA's") attempt to
overthrow 90 years of Congressional history - and its own
long record of prior statements that it lacks authority
over cigarettes as commonly marketed - is based totally on
the agency's assertion that "tobacco manufacturers `intend'
that their products have addictive and significant
