On February 10, 1997, the tobacco industry filed a motion for a summary judgment in their suit against the Food and Drug Administration, hoping to end attempts by the FDA to regulate tobacco production and advertising. The tobacco industry claims that the FDA has no jurisdiction to regulate tobacco and that given the power, it would “do everything it can to stamp out tobacco use in the United States, without regard to economic or other consequences and in violation of established congressional policy.”

Civil Action, File No. 2:95CV00591

COYNE BEAHM, INC.,et al
Plaintiffs.

v.

UNITED STATES FOOD & DRUG ADMINISTRATION, et al.,
Defendant

PLAINTIFFS' MOTION FOR
SUMMARY JUDGMENT

Pursuant to Rules 56 and 6S, Fed. R. Civ. P., plaintiffs move for summary judgment invalidating and permanently enjoining enforcement of the Federal Food & Drug Administration (FDA) Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco, 61 Fed. Reg. 44,396 (1996) ("Tobacco Regulations").

The Tobacco Regulations mark the first time in the history of the FDA that the agency has asserted jurisdiction over cigarettes and smokeless tobacco products as customarily marketed. The regulations impose unprecedented requirements on the manufacture, distribution, advertising, promotion and sale of tobacco products.

What is most troubling in FDA's action is its assertion of authority to regulate all cigarettes and smokeless tobacco products. That assertion of authority overturns FDA's own settled interpretation of food and drug law dating back to 1914, and violates longstanding reliance by Congress and the tobacco sector of the national economy on the established understanding of the limits of FDA's jurisdiction. FDA's assertion of authority also portends continuing future encroachments by FDA on the domain of public policy with respect to tobacco products, a domain Congress has reserved to itself.

FDA's regulations impose many prohibitions and requirements with respect to tobacco products, including the following:

the same manufacturing requirements that apply to sophisticated medical equipment;

prohibitions and requirements as to retail sales (e.g., in grocery and convenience stores and gas stations), enforceable by prosecutions in federal district courts;

a requirement that every tobacco product package and advertisement bear the statement: "Nicotine-Delivery Device for Persons 18 or Older"; and

a ban on the use of colors and images in most tobacco advertisements, a virtual ban on outdoor signs and billboards in many urban areas, a ban on tobacco brand-name sponsorships of artistic, cultural, and sports events, and other severe restrictions on tobacco product advertising and promotion.

These regulations are only the beginning. If FDA's assertion of jurisdiction is sustained, there can be no reasonable doubt that FDA will do everything it can to stamp out tobacco use in the United States, without regard to economic or other consequences and in violation of established congressional policy.

Although plaintiffs contend that the Tobacco Regulations suffer many infirmities, their initial motion for summary judgment focuses on three issues that go to the heart of the regulations and that can be decided without detailed review of the lengthy administrative record. If the case can be resolved on these grounds, other narrower and more record- intensive issues will not have to be addressed. Thus, this motion seeks summary judgment on the following three independently sufficient grounds, which are discussed in three separate memoranda:

First Brief:

Congress has withheld from FDA the authority to regulate cigarettes and smokeless tobacco as customarily marketed, in favor of Congress' own tobacco specific legislation;

Second Brief:

The Federal Food, Drug, and Cosmetic Act (FDCA) does not authorize FDA to regulate cigarettes and smokeless tobacco as "drugs," "medical devices," or "restricted devices, " nor does it authorize the particular restrictions FDA seeks to impose; and

Third Brief:

The First Amendment to the United States Constitution forbids the restrictions that the Tobacco Regulations impose on advertising and other forms of promotional speech.

Two supplemental briefs will be submitted by other plaintiffs in parallel actions. Consistent with the Court's instructions to minimize duplication, the three briefs proceed in sequence and incorporate by reference, rather than restate, previously discussed materials.

The arguments presented in plaintiffs' three briefs do not require the Court to reject any of the "facts. that FDA has identified to support its Tobacco Regulations. Thus, although FDA's factual analysis is deeply flawed, and plaintiffs reserve all factual issues, the present motion raises no genuine issue of material fact. It can and should be resolved as a matter of law.

In sum, for the reasons set forth in Briefs One, Two, and Three, plaintiffs respectfully request the Court to grant summary judgment declaring the Tobacco Regulations contrary to law and permanently enjoining enforcement of them by FDA.

Respectfully submitted,

Keith W. Vaughan
NC State Bar No. 6895
WOMBLE CARLYLE SANDRIDGE & PICK, PLLC
1600 BB&T Financial Center
200 West Second Street P.O. Drawer 84
Winston-Salem, NC 27102
(910) 721-3600

Attorneys for Plaintiffs Coyne Beahm, et al.

October 15, 1996

===================================================== ===========

UNITED STATES DISTRICT COURT FOR THE MIDDLE DISTRICT OF NORTH CAROLINA GREENSBORO DIVISION

Civil Action, File No. 2:95CV00591 Civil Action, File No. 6:95CV00665
Civil Action, File No. 2:95CV00706

Plaintiffs

COYNE BEAHM, INC., et al.,

v.

Defendants

UNITED STATES FOOD & DRUG ADMINISTRATION, et al.,

Plaintiffs,

UNITED STATES TOBACCO COMPANY, et al.,

v.

Defendants

UNITED STATES FOOD & DRUG ADMINISTRATION, et al.,

Plaintiffs.

NATIONAL ASSOCIATION OF CONVENIENCE STORES, et al.,

v.

Defendants

DAVID KESSLER, M.D., et al.,

FIRST BRIEF IN SUPPORT OF PLAINTIFFS& McNAMARA
700 Thirteenth Street, NW
Washington, DC 20005

WILEY, REIN & FIELDING
1776 K Street, NW
Washington, DC 20006

WILLIAMS & CONNOLLY
725 12th Street, NW
Washington, DC 20005

Keith W. Vaughan
NC State Bar No. 6895 WOMBLE CARLYLE SANDRIDGE & RICE,
PLLC 1600 BB&T Financial Center 200 West Second Street P.O. Drawer
84 Winston-Salem, NC 27102 (910) 721-3600

Attorneys for Plaintiffs Coyne Beahm, et al.

Larry B. Sitton
NC State Bar No. 4020
SMITH HELMS MULLIS & MOORE
300 N. Greene Street
P. O. Box 219