Coyne Beahm, Inc. v. U.S. Food & Drug Admin., No. 2:95CV00591.

CourtUnited States District Courts. 4th Circuit. Middle District of North Carolina
Writing for the CourtOsteen
Citation966 F.Supp. 1374
PartiesCOYNE BEAHM, INC., Brown & Williamson Tobacco Corporation, Liggett Group, Inc., Lorillard Tobacco Company, Philip Morris, Incorporated, and R.J. Reynolds Tobacco Company, Plaintiffs, v. UNITED STATES FOOD & DRUG ADMINISTRATION and David A. Kessler, M.D., Commissioner of Food and Drugs, Defendants. AMERICAN ADVERTISING FEDERATION, American Association of Advertising Agencies, Inc., Association of National Advertisers, Inc., Magazine Publishers of America, Outdoor Advertising Association of America, Point of Purchase Advertising Institute, Plaintiffs, v. David A. KESSLER, M.D., Commissioner of Food and Drugs, and United States Food & Drug Administration, Defendants. UNITED STATES TOBACCO COMPANY, Brown & Williamson Tobacco Corporation, Conwood Company, L.P., National Tobacco Company, L.P., the Pinkerton Tobacco Company, Swisher International, Inc., Central Carolina Grocers, Inc., J.T. Davenport, Inc., N.C. Tobacco Distributors Committee, Inc., Plaintiffs, v. UNITED STATES FOOD & DRUG ADMINISTRATION and David A. Kessler, M.D., Commissioner of Food and Drugs, Defendants. NATIONAL ASSOCIATION OF CONVENIENCE STORES, ACME Retail, Inc., Plaintiffs, v. David A. KESSLER, M.D., Commissioner of Food and Drugs, and United States Food & Drug Administration, Defendants.
Decision Date25 April 1997
Docket NumberNo. 6:95CV00665.,No. 2:95CV00591.,No. 2:95CV00593.,No. 2:95CV00706.
966 F.Supp. 1374
COYNE BEAHM, INC., Brown & Williamson Tobacco Corporation, Liggett Group, Inc., Lorillard Tobacco Company, Philip Morris, Incorporated, and R.J. Reynolds Tobacco Company, Plaintiffs,
v.
UNITED STATES FOOD & DRUG ADMINISTRATION and David A. Kessler, M.D., Commissioner of Food and Drugs, Defendants.
AMERICAN ADVERTISING FEDERATION, American Association of Advertising Agencies, Inc., Association of National Advertisers, Inc., Magazine Publishers of America, Outdoor Advertising Association of America, Point of Purchase Advertising Institute, Plaintiffs,
v.
David A. KESSLER, M.D., Commissioner of Food and Drugs, and United States Food & Drug Administration, Defendants.
UNITED STATES TOBACCO COMPANY, Brown & Williamson Tobacco Corporation, Conwood Company, L.P., National Tobacco Company, L.P., the Pinkerton Tobacco Company, Swisher International, Inc., Central Carolina Grocers, Inc., J.T. Davenport, Inc., N.C. Tobacco Distributors Committee, Inc., Plaintiffs,
v.
UNITED STATES FOOD & DRUG ADMINISTRATION and David A. Kessler, M.D., Commissioner of Food and Drugs, Defendants.
NATIONAL ASSOCIATION OF CONVENIENCE STORES, ACME Retail, Inc., Plaintiffs,
v.
David A. KESSLER, M.D., Commissioner of Food and Drugs, and United States Food & Drug Administration, Defendants.
No. 2:95CV00591.
No. 2:95CV00593.
No. 6:95CV00665.
No. 2:95CV00706.
United States District Court, M.D. North Carolina, Greensboro Division.
April 25, 1997.

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Keith W. Vaughan, Womble Carlyle Sandridge & Rice, Winston-Salem, NC, for plaintiffs in No. 2:95CV00591.

Gerald C. Kell, U.S. Department of Justice, Washington, DC, Walter Clintin Holton, Jr., Office of U.S. Attorney, Greensboro, NC, for U.S. Food and Drug Admin., David A. Kessler, M.D. in Nos. 2:95CV00591, 2:95CV00593 and 2:95CV00706.

Edwin M. Speas, Jr., Thomas F. Moffitt, N.C. Department of Justice, Office of Attorney General, Raleigh, NC, for amici James B. Hunt, Comm. of Agriculture, James A. Graham in No. 2:95CV00591.

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Claude A. Allen, Commonwealth of Virginia, Office of the Attorney General, Richmond, VA, for amicus Cmwlth. of Virginia in No. 2:95CV00591.

George M. Cleland, Winston-Salem, NC, for amici Public Citizen, National Center for Tobacco-Free Kids, American Academy of Pediatrics, American Cancer Society, American College of Preventive Medicine, American Heart Association, American Lung Association, American Medical Association, American Medical Women's Association, American Public Health Association, HMO Group, National Association of Elementary School Principals, National Association of Secondary School Principals, National PTA, American Society of Addiction Medicine in Nos. 2:95CV00591, 2:95CV00593, 6:95CV00665 and 2:95CV00706.

James S. Alexander, Office of Minnesota Attorney General, St. Paul, MN, for movant State of Minnesota in Nos. 2:95CV00591, 6:95CV00665 and 2:95CV00706.

Eric C. Rowe, C. Allen Foster, Patton Boggs, L.L.P., Greensboro, NC, Garret G. Rasmussen, Patton Boggs, L.L.P., Washington, DC, for American Advertising Federation, American Association of Advertising Agencies, Association of National Advertisers, Inc., Magazine Publishers of America, Outdoor Advertising Association of America and Point of Purchase Advertising Institute in No. 2:95CV00593.

Robert W. Kaylor, Law Office of Robert W. Kaylor, P.A., Raleigh, NC, Penelope Kilburn Shapiro, Washington Legal Foundation, Washington, DC, for amici Washington Legal Foundation, Mario Andretti, Don Garlits, Al Unser, Rusty Wallace, Cale Yarborough, Richard Burr, Cass Ballenger, Howard Coble, David Funderburk, Lauch Faircloth in No. 2:95CV00593.

Peter S. Pappas, Daniel W. Fouts, Adams Kleemeier Hagan Hannah & Fouts, Greensboro, NC, for amicus Commonwealth of Kentucky in No. 2:95CV00593.

George M. Cleland, Winston-Salem, NC, Alan B. Morrison, Public Citizen Litigation Group, Matthew L. Myers, National Center for Tobacco-Free Kids, Washington, DC, for amici Public Citizen, National Center for Tobacco-Free Kids, American Academy of Pediatrics, American Cancer Society, American College of Preventive Medicine, American Heart Association, American Lung Association, American Medical Association, American Medical Women's Association, American Public Health Association, HMO Group, National Association of African Americans for Positive Imagery, National Association of Elementary School Principals, National Association of Secondary School Principals, National PTA in No. 2:95CV00593.

George M. Cleland, Winston-Salem, NC, for amicus American Society of Addiction Medicine in No. 2:95CV00593.

Robert W. Kaylor, Law Office of Robert W. Kaylor, P.A., Raleigh, NC, Richard A. Samp, Washington Legal Foundation, Washington, DC, for movant Washington Legal Foundation in No. 2:95CV00593.

Larry B. Sitton, Smith Helms Mulliss & Moore, Greensboro, NC, for plaintiff United States Tobacco Company in No. 6:95CV00665.

Norwood Robinson, Robinson & Lawing, Winston-Salem, NC, for Brown & Williamson Tobacco Corporation, Conwood Company, L.P., National Tobacco Company, L.P., Pinkerton Tobacco Company, Swisher International, Inc., Central Carolina Grocers, Inc., Davenport, J.T., Inc. in No. 6:95CV00665.

John R. Jordan, Jr., Jordan, Price, Wall, Gray & Jones, L.L.P., Raleigh, NC, for N.C. Tobacco Distributors Committee, Inc. in No. 6:95CV00665.

Gill P. Beck, Walter Clintin Holton, Jr., Office of U.S. Attorney, Greensboro, NC, Gerald C. Kell, U.S. Department of Justice, Washington, DC, for United States Food & Drug Administration, David A. Kessler, M.D. in No. 6:95CV00665.

Peter G. Pappas, Daniel W. Fouts, Adams Kleemeier Hagan Hannah & Fouts, Greensboro, NC, for amicus Commonwealth of Kentucky in No. 6:95CV00665 and 2:95CV00706.

Margaret C. Lumsden, Hunton & Williams, Raleigh, NC, R. Timothy Columbus, Collier, Shannon, Rill & Scott, Washington, DC, Frank A. Hirsch, Jr., Andrew Dean Shore, Hunton & Williams, Charlotte, NC,

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for Nat. Assoc. of Convenience Stores, Acme Retail, Inc. in No. 2:95CV00706.

MEMORANDUM OPINION

OSTEEN, District Judge.


This case comes before the court on Plaintiffs' Motion for Summary Judgment.1 In August 1996, the Food and Drug Administration ("FDA") published in the Federal Register "Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents" ("Regulations"). 61 Fed.Reg. 44,396 (1996). Plaintiffs now seek summary judgment claiming that Congress has withheld the authority to regulate tobacco products as customarily marketed from FDA and that the Federal Food, Drug, and Cosmetic Act ("FDCA" or "Act")2 does not authorize FDA to regulate tobacco products as "drugs" or "devices."

For the reasons discussed herein, Plaintiffs' Motion for Summary Judgment will be granted in part and denied in part.

I. DISCUSSION

A. SUMMARY JUDGMENT PRINCIPLES.

Summary judgment is appropriate in those cases where it is established through pleadings, affidavits, depositions, and other discovery documents that there exists no genuine issue of material fact and the moving party is entitled to judgment as a matter of law. Fed.R.Civ.P. 56(c); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48, 106 S.Ct. 2505, 2510, 91 L.Ed.2d 202 (1986). Thus, it is the burden of the moving party to show the court that no material factual issues exist for trial. Of course, the court must draw any permissible inference from the underlying facts as established in the record in the light most favorable to the nonmoving party. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587-88, 106 S.Ct. 1348, 1356-57, 89 L.Ed.2d 538 (1986); Pulliam Inv. Co. v. Cameo Properties, 810 F.2d 1282, 1286 (4th Cir.1987).

When the moving party has carried its burden, the nonmoving party must come forward with evidence which shows more than some "metaphysical doubt" that genuine and material factual issues exist. Matsushita, 475 U.S. at 586, 106 S.Ct. at 1356. A mere scintilla of evidence presented by the nonmoving party is insufficient to circumvent summary judgment. Anderson, 477 U.S. at 252, 106 S.Ct. at 2512. Rather, the nonmoving party must convince the court that, upon the record taken as a whole, a rational trier of fact could find for the nonmoving party. Id. at 248-49, 106 S.Ct. at 2510-11.

B. CONGRESS HAS NOT WITHHELD JURISDICTION TO REGULATE TOBACCO PRODUCTS FROM THE FOOD AND DRUG ADMINISTRATION.

Plaintiffs assert that Congress clearly intended to withhold jurisdiction to regulate tobacco products from FDA. Plaintiffs urge that the general structure and history of the FDCA and three federal statutes which address tobacco products reveal Congress' intent to reserve to itself the authority to shape federal policy regarding tobacco products and, moreover, that the Regulations directly conflict with and are precluded by the three congressional tobacco-specific statutes.

The court reviews FDA's construction of the FDCA under the analysis set forth in Chevron, U.S.A., Inc. v. Natural Resources Defense Council, Inc., 467 U.S. 837, 104 S.Ct. 2778, 81 L.Ed.2d 694 (1984). The first responsibility is to determine whether Congress has directly spoken to the precise question at issue for "[i]f the intent of Congress is clear, that is the end of the matter." Id. 467 U.S. at 842, 104 S.Ct. at 2781. If, however, the statute "is silent or ambiguous with respect

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to the specific issue, the question for the court is whether the agency's answer is based on a permissible construction of the statute." Id. 467 U.S. at 843, 104 S.Ct. at 2782.

1. Congress Expressed No Clear Intent in the Federal Food, Drug, and Cosmetic Act to Withhold Jurisdiction to Regulate Tobacco Products from the Food and Drug Administration.

a. The Text of the Federal Food, Drug, and Cosmetic Act.

The precise question presented to the court is whether Congress has evidenced its clear intent to withhold...

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6 practice notes
  • Brown & Williamson Tobacco Corp. v. Food & Drug Admin., Nos. 97-1604
    • United States
    • United States Courts of Appeals. United States Court of Appeals (4th Circuit)
    • August 14, 1998
    ...held that Congress did not "[intend] to withhold from FDA" the jurisdiction to regulate tobacco products. Coyne Beahm, Inc. v. FDA, 966 F.Supp. 1374, 1388 (M.D.N.C.1997). The district court also concluded that the FDA had authority to regulate tobacco products under the device provision of ......
  • F.D.A. v Brown & Williamson Tobacco, 981152
    • United States
    • United States Supreme Court
    • March 21, 2000
    ...in United States District Court for the Middle District of North Carolina challenging the regulations. See Coyne Beahm, Inc. v. FDA, 966 F. Supp. 1374 (1997). They moved for summary judgment on the grounds that the FDA lacked jurisdiction to regulate tobacco products as customarily marketed......
  • United States v. Facteau, Criminal No. 15-cr-10076-ADB
    • United States
    • United States District Courts. 1st Circuit. United States District Courts. 1st Circuit. District of Massachusetts
    • September 14, 2020
    ...no court has held that intended use can be established solely by promotional representations." Coyne Beahm, Inc. v. United States FDA, 966 F. Supp. 1374, 1390 (M.D.N.C. 1997). In contrast, the Government cites sufficient support from other jurisdictions for the proposition that objective ev......
  • Flue-Cured Tobacco Co-Op. v. U.S.E.P.A., No. 6:93CV00370.
    • United States
    • United States District Courts. 4th Circuit. Middle District of North Carolina
    • July 17, 1998
    ...did not so limit the definition of "indoor air pollutant" under the Radon Research Act. See generally Coyne Beahm, Inc. v. U.S. FDA, 966 F.Supp. 1374, 1379-80 (M.D.N.C.1997) (declining to infer preemption of FDA authority to regulate tobacco products from other tobacco-specific legislation ......
  • Request a trial to view additional results
6 cases
  • Brown & Williamson Tobacco Corp. v. Food & Drug Admin., Nos. 97-1604
    • United States
    • United States Courts of Appeals. United States Court of Appeals (4th Circuit)
    • August 14, 1998
    ...held that Congress did not "[intend] to withhold from FDA" the jurisdiction to regulate tobacco products. Coyne Beahm, Inc. v. FDA, 966 F.Supp. 1374, 1388 (M.D.N.C.1997). The district court also concluded that the FDA had authority to regulate tobacco products under the device provision of ......
  • F.D.A. v Brown & Williamson Tobacco, 981152
    • United States
    • United States Supreme Court
    • March 21, 2000
    ...in United States District Court for the Middle District of North Carolina challenging the regulations. See Coyne Beahm, Inc. v. FDA, 966 F. Supp. 1374 (1997). They moved for summary judgment on the grounds that the FDA lacked jurisdiction to regulate tobacco products as customarily marketed......
  • United States v. Facteau, Criminal No. 15-cr-10076-ADB
    • United States
    • United States District Courts. 1st Circuit. United States District Courts. 1st Circuit. District of Massachusetts
    • September 14, 2020
    ...no court has held that intended use can be established solely by promotional representations." Coyne Beahm, Inc. v. United States FDA, 966 F. Supp. 1374, 1390 (M.D.N.C. 1997). In contrast, the Government cites sufficient support from other jurisdictions for the proposition that objective ev......
  • Flue-Cured Tobacco Co-Op. v. U.S.E.P.A., No. 6:93CV00370.
    • United States
    • United States District Courts. 4th Circuit. Middle District of North Carolina
    • July 17, 1998
    ...did not so limit the definition of "indoor air pollutant" under the Radon Research Act. See generally Coyne Beahm, Inc. v. U.S. FDA, 966 F.Supp. 1374, 1379-80 (M.D.N.C.1997) (declining to infer preemption of FDA authority to regulate tobacco products from other tobacco-specific legislation ......
  • Request a trial to view additional results

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