Lorillard
Briefing Book the Food and Drug Administration and Tobacco Regulation
Fields
- Area
- SPEARS,ALEXANDER/OFFICE
- Alias
- 89278328/89278505
- Document File
- 89278327/89278506/Briefing Book the Food and Drug
- Administration and Tobacco Regulation the Tobacco
- Institute 950900
- Administration and Tobacco Regulation the Tobacco
- Type
- REPT, OTHER REPORT
- Litigation
- Iwoh/Produced
- Characteristic
- PARE, PARENT
- Site
- G65
- Named Organization
- American Civil Liberties Union
- Amtrak
- Appropriations Subcomm on Agriculture
- Assn of Natl Advertisers
- Batf, Bureau of Alcohol,Tobacco and Firearms
- Centers for Disease Control + Prevention
- Comm on Appropriations
- Comm on Labor + Human Resources
- Commerce Comm
- Congress
- Dept of Defense
- Dept of Justice
- Dept of Transportation
- Epa, Environmental Protection Agency
- FDA, Food and Drug Administration
- Freedom to Advertise Coalition
- Ftc, Federal Trade Commission
- General Services Administration
- Health Industry Mfg Assn
- Hhs, Dept of Health and Human Services
- House
- Inside Washington FDA Week
- Interstate Commerce Commission
- Legal Backgrounder
- Natl Inst Child Health Human Development
- Natl Inst on Drug Abuse
- NC Middle District
- OSHA, Occupational Safety & Health Administration
- Price Waterhouse
- Senate
- Subcomm Rural Develop Agri Related Agenc
- Supreme Court
- TI, Tobacco Inst
- Treas, Dept of the Treasury
- US Postal Service
- Usda, U.S. Dept of Agriculture
- Wa Legal Foundation
- Wa Post
- Advisory Comm on the FDA
- Amtrak
- Author (Organization)
- TI, Tobacco Inst
- Named Person
- Clinton
- Durbin, R.J.
- Edwards, C.
- Ericksen, M.
- Fithian, J.
- Jaffe, D.
- Kassebaum
- Kessler, D.
- Koop, C.E.
- Lipsett, M.B.
- Lynn, B.
- Magazine, A.M.
- Pertschuk, M.
- Phillips, J.
- Shalala, D.
- Surgeon General
- Synar
- Wallop, M.
- Durbin, R.J.
- Master ID
- 89278328/8505
Related Documents:- 89278334-8336 Summary of Proposed FDA Regulations
- 89278337 Requirements for Commenting on Proposed FDA Regulations
- 89278338-8342 Department of Health and Human Services Food and Drug Administration 21 Cfr Parts 801, 803, 804, and 897 (Docket No. 95n-0253) Regulations Restricting Sale and Distribution of Cigarettes and Smokeless Tobacco Products to Protect Children and Adolescents
- 89278342A Department of Health and Human Services Food and Drug Administration (Docket No. 95n-0253j) Analysis Regarding the Food and Drug Administration's Jurisdiction Over Nicotine-Containing Cigarettes and Smokeless Tobacco Products
- 89278364 the Federal Tobacco Control Effort
- 89278367 State Tobacco Sales Restriction Laws 950900
- 89278374-8375 Daily Smoking Prevalence Among 12th Graders
- 89278380 An FDA Smoke Screen
- 89278381-8382 Can Gov't Stop Kids' Smoking?
- 89278383 Where There's Smoke
- 89278383A No Smoking at FDA
- 89278384 the President Versus Joe Camel
- 89278384A How to Fight Smoking
- 89278385 Nicotine Fit
- 89278386 Quit Regulating Our Lives
- 89278387 Tp Snuff Teens' Smoking
- 89278388 the Epidemic That Isn't
- 89278389-8390 Ban on Tobacco Ads Might Stall Auto Racing
- 89278391 Some Burning Questions About the Plan to Stop Teen-Age Smoking
- 89278392 Tobacco and Teens Clinton's Blowing Smoke
- 89278393 Clinton Preaching May Drive US to Anarchy
- 89278394 King Bill's Decree
- 89278395 Tackling Teen Smoking
- 89278395A Cut Back Kids' Smoking, Not the Rights of Adults
- 89278396 the Use and Abuse of Children
- 89278397 Cigarettes and Free Speech
- 89278397A Parents Should Teach Teens
- 89278398 If We Want to Curb Teen-Age Smoking, Here's What to Do
- 89278399-8401 FDA Draws First in Tobacco Wars
- 89278402 Advertisers Call Tobacco Proposal A Virtual Ban
- 89278403 Agencies Are Gearing Up to Fight Proposed Tobacco Regulations
- 89278404-8405 Ap Poll: Most Would Not Snuff Out Tobacco Advertising and Promotion
- 89278406 If We Want to Curb Teen-Age Smoking, Here's What to Do
- 89278407 Smoke Signals Teen Smoking Is Already Illegal
- 89278409-8447 Coyne Beahm, Inc. Plaintiffs, V. United States Food & Drug Administration and David A. Kessler, M.D., Commissioner of Food and Drugs, Defendants. First Amended Complaint for Dec Laratory and Injunctive Relief Civil Action, File Number 2 95cv00591
- 89278449-8475 United States Tobacco Company, Plaintiffs, V. Food and Drug Administration, and David A. Kessler, M.D., Commissioner O F Food and Drugs, Defendants. Complaint for Declaratory Jud Gement and Injunctive Relief
- 89278477-8479
- 89278480 News Release for Immediate Release
- 89278481-8483 Philip Morris U.S.A. Today Issued the Following Statement
- 89278484-8490 FDA Lawsuit Statement
- 89278491-8493 Tobacco Industry Files Suit Against Against FDA, Kessler
- 89278494-8497 Only Congress Can Change the Law to Give FDA the Authority to Regulate Cigarettes
- 89278498 Complaint Summary
- 89278500-8501 Advertising Industry Challenges FDA's Proposed Tobacco Advertising Restrictions As Violation of the First Amendment and Usurpation of Congressional Authority
- 89278502 A.N.A. Calls Administration Tobacco Proposal Blatantly Unconstitutional Censorship
- 89278503-8505 Statement by Harold A Shoup Executive Vice President American Association of Advertising Agencies
- Date Loaded
- 12 Feb 1999
- UCSF Legacy ID
- xcu20e00
Document Images
FDA regulations could have
dramatic economic effec:ts
The proposed FDA regulations would have immediate and devastating effects on the
advertising, publishing, public entertainment, vending machine, and retail industries. Yet
FDA bureaucratic oversight would do little, if anything, to af.Fect youth smoking rates. A
wide variety of commercial entities- from small, independently operated mom & pop
stores to advertising agencies - depend on revenues received from the tobacco industry
and will unnecessarily be hurt by these punitive and reckless regulations.
The advertising provisions of the proposed FDA regulations zanount to a de facto ban on
advertising. Advertising, graphic design and print ad shops that depend on tobacco
clients and the numerous publishers that sell advertising spaci: in order to keep their
publications in circulation will be profoundly affected by the ban.
Outdoor advertising provisions banning tobacco ads on billboards within 1,000 feet of
schools or playgrounds and text-only billboards beyond that distance would force many
boards to go unrented in cities and would needlessly put people out of work.
The outdoor advertising rules would also affect retailers, who would be prevented from
using exterior signage to advertise brands. Retailers within tLe "forbidden zone" would
be placed at a competitive disadvantage with those outside the 1,000 foot barrier.
In addition, retail outlets would suffer from a ban on open-shelf displays. Manufacturers
of most products compete for "shelf space" in stores. Retaile:rs receive revenues from
tobacco and other product manufactur6rs in exchange for prei erential product placement.
Placing cigarette packs behind the counter eradicates those revenues and limits both the
quantity and variety of product that the retailer can offer, lead ing to a reduction in sales.
In some cases retailers would be forced to make expensive physical renovations in order
to comply with FDA's overzealous regulations.
Why should cigarette sales be singled out from other age-resbicted products like beer and
wine that can be displayed openly - especially when the decision to sell or not to sell is
still dependent on the decision of the store owner, operator, or employ.e'!?
Likewise, the proposed rules dealing with corporate sponsorship of sporting and cultural
events do nothing to affect youth smoking rates, but will cause significant economic
injury. There is simply no compelling evidence that the spon:,oring of events under
, tobacco brand names causes people to smoke. However, it is clear that many sports and

cultural organizations are dependent on the underwriting of events that tobacco
companies have provided and will suffer under these regulations. Smokers and
nonsmokers alike may be deprived of this free or low-cost entertainment. No other adult-
oriented products face the censorship ax being wielded by Dr. Kessler's FDA.
While at first glance banning cigarette vending machines might seem like an effective
way to reduce youth smoking, the vast majority of machines are located in areas where
kids generally don't have access, such as industrial plants and bars. Instead of simpiy
restricting the machines to make sure that they are not youth accessible, the FDA
cynically bans them all. According to the Amusement and Music Operators Association,
the ban on vending machines could eliminate 10,000 jobs in ihis industry overnight.
The economic contribution of the U.S. tobacco industry reaches far beyond the tobacco-
growing states. Over 2.2 million people nationwide depend on jobs directly or indirectly
provided by the tobacco industry. In addition, federal, state, and municipal excise taxes
on tobacco products totaled more than $12.2 billion in 1994, and well over $14 billion
when sales taxes on those products are included.

FDA Regulations Would Trample the First Amendment

The FDA's proposal would constitute a
de facto ban on tobacco advertising --
violating the First Amendment
FDA's proposal to mandate a"tombstone" format and black and. white text-only a
advertisements for tobacco products would create a virtual ban on such ads. The United
States Supreme Court has consistently affirmed significant prote;ctions for commercial
speech, specifically ruling that the use of pictures, other illustralions and color in
advertising is futly protected by the First Amendment. The broad restrictions proposed
would violate First Amendment protections against restricting s:peech "more extensively
than necessary "
In what some might consider an unusual situation, both the American Civil Liberties
Union and the Washington Legal Foundation are on record in agreement on this issue.
Calling legislative proposals to restrict tobacco advertising unconstitutional, Barry Lynn
of the American Civil Liberties Union stated in a Washington Legal Foundation Legal
Backgrounder:
"The 'words only' approach is really nothing short of a
ban in sheep's clothing, providing potential customers
with virtually nothing to alert them to the existence of
lawful tobacco products."
Advertising interests consider the FDA proposal a very serious threat to the First
Amendment and the Constitutional protections afforded to freE: speech. The members of
the Freedom to Advertise Coalition (FAC) filed suit in the Middle District of North
Carolina against the FDA, strongly denouncing the Agency's proposed restrictions on
tobacco ads as "a frontal assault on the Constitution." "The sweeping regulations
proposed by FDA demonstrate that agency's disregard for the First Amendment," asserts
John Fithian, legal counsel to FAC.
Says Dan Jaffe, executive vice president of the Association of National Advertisers:
"They want the ads to become invisible. The government
has now become the copywriter and the ad dire,,-tor for
tobacco advertising. They can speak through your ads, but
you can't. It's a very substantial step in a free society."
Further, Congress gave the Federal Trade Commission (FTCI ) jurisdiction over all
advertising, including tobacco product advertising. While th.- FDA and the FTC -- in a
successful partnership - effectively share responsibility to re gulate other products, FTC

retains the responsibility over all advertising concerns. The FTC has demonstrated that it
has the capability and expertise to regulate advertising in a responsible manner.
In addition, the FDA proposal to assess the tobacco companies S150 million per year to
fund an anti-smoking advertising campaign, 80 percent of whic:ii would consist of
television spots, also violates the First Amendment. Under a long line of Supreme Court
and other case law, this item would violate the First Amendment by compelling tobacco
companies to order "corrective advertising" and represents a forbidden taking of private
property for a public purpose without just compensation.
The $150 million per year assessment would be used for gover.nment-approved ads - like
those state-sponsored ads in place in California and Massachusetts. In California,
according to "Tobacco Use in California: An Evaluation of the Tobacco Control
Program, 1989-1993," the state spent $72.9 million on anti-smDking ads and an additional
$147 million on school-based programs. After spending $220 million over four years,
"Smoking prevalence among California adolescents has not declined since the start of the
Tobacco Control Program" (p. 53 of the above report).
As the FDA has acknowledged, the FTC did not require the industry to fund an anti-
smoking television campaign in the 1960s. Rather, television stations that ran cigarette
commercials were required under the Fairness Doctrine to provide time for anti-smoking
messages. (According to the FDA, $75 million was the appro ximate annual value, in
"commercial air time," of the anti-smoking messages, but most of the messages ran at
reduced non-commercial rates.) The government did not require cigarette companies to
pay for those messages.

Tobacco is Hithly RmulatE:d

Tobacco products are
already highly regulated
Many of those pushing the FDA's regulation of cigarettes and smokeless tobacco
products cry out that tobacco is "unregulated." That claim is patently false. Tobacco
products are subject to dozens of federal laws and regulations, as well as laws in al150
states. The federal regulation of tobacco starts at the seedbed and follows the product
through its manufacture, packaging, taxation, advertising, sales, and use.
From seedbed to factory
Federal regulation begins before the tobacco is planted, with Department of Agriculture
production quotas and price levels for tobacco leaf. USDA also grades tobacco for
auction, inspects imported leaf, and regulates the use of pesticides. By law, tobacco
growers pay an assessment to cover USDA's requirements in the production control and
"no net cost" price support program.
Manufacture and packaging
By law, the ingredients used in cigarettes and smokeless tobacco products are monitored
by the Department of Health & Human Services. Manufacturers must submit annually
a list of all ingredients to HHS. The Secretary of HHS is required to submit to Congress
information on any ingredient that the Secretary deems "pose;; a health risk."
In 1993, Congress imposed a requirement that U. S. cigarette manufacturers must use at
least 75 percent domestic tobacco leaf in their products. International trade agreements
prompted Congress to alter this requirement, but it remains in effect until a new tariff rate
quota is ordered by the President.
With the oversight of the Federal Trade Commission, manufacturers are required to
support a testing laboratory for the measurement of "tar," nicotine and carbon monoxide
yields for each cigarette.
The labeling of cigarette packages is set by law, with govermnent-specified warnings that
Congress has updated. The Bureau of Alcohol, Tobacco & Firearms regulates certain
packaging practices.

Taxation
By law, the first tax on each pack of cigarettes or container of srr,okeless tobacco is paid
to the Department of the Treasury when the product is removed from the factory.
Every state in the U.S. also taxes cigarettes, and 44 states tax smokeless products. Most
states add the sales tax on top of the excise. Taken together, these federal, state and local
taxes on all tobacco products amount to more than $14 billion a,year--financing a broad
range of services enjoyed by all Americans, not just those who buy the product.
Advertising & sales
Cigarette advertising on television, radio and other electronic mE;dia has been banned by
law for 25 years. Recently, the Department of Justice entered into a consent agreement
that will restrict cigarette advertising in sports stadiums.
By law, all product advertising must carry certain government warnings, and the FTC
ensures compliance with these requirements. The FTC requires manufacturers to submit
detailed information on product advertising and promotion to the FTC for its annual
report to Congress.
By a 1970 agreement with the FTC, cigarette manufacturers have included "tar" and
nicotine information in their advertising and submit that information to the FTC for an
annual report to Congress.
In 1992, Congress passed a law, known as the Synar Amendment, that directs the 50
states to take action to reduce sales of tobacco products to minors. Since that law was
enacted, more than half the states have adopted their own new laws and restrictions on
the sale of tobacco products even though - three years later - HHS has failed to
promulgate a rule setting standards for enforcement.
Restrictions on use
As if the alphabet soup of federal agencies involved in getting tobacco products to the
consumer weren't thick enough, these agencies limit the publii:'s use of cigarettes and
other products:
. DOT - The Department of Transportation is required by la.w to ban smoking on most
domestic airline flights, and the Secretary of DOT has sigrked agreements banning
smoking from certain international routes.

. ICC - The Interstate Commerce Commission prohibits smoking on most bus trips that
cross state lines.
. AMTRAK - Smoking is banned on almost all passenger trains.
GSA - The General Services Administration requires smoking to be restricted in
nearly all buildings owned or occupied by federal agencies. Many agencies have
banned smoking entirely.
USPS - The Postal Service has banned smoking in all its facilities.
. DoD - The Department of Defense prohibits smoking in all As facilities, except
residential accommodations and private clubs.
. EPA - While it has no Congressional authority to regulate i:adoor air, the
Environmental Protection Agency created a"voluntary" prc gram to encourage office
building owners to ban smoking in their property.
. OSHA - The Occupational Safety & Health Administration is considering a
regulation that would ban or severely restrict smoking in all. indoor workplaces.
Continuing oversight
Congress has set in place for itself a process for considering potential need for new
requirements to tobacco products. In addition to the FTC reparts to Congress on
advertising expenditures and on smoke constituents, and the HHS reporting requirement
for ingredients, HHS and the Surgeon .General are required to submit an annual report on
tobacco and health issues, together with any recommendations for legislative or
administrative action.
Congress has declined repeatedly, however, to take any action toward granting the
Food & Drug Administration any regulatory powers over tobacco products.

w
4.)
E-4
