IN RE CIGAR ASSOCIATION OF AMERICA

Nos. 19-2130, 19-2132, 19-2198, 19-2242.

In re: CIGAR ASSOCIATION OF AMERICA; CIGAR RIGHTS OF AMERICA; PREMIUM CIGAR ASSOCIATION, f/k/a International Premium Cigar and Pipe Retailers Association, Appellants. AMERICAN ACADEMY OF PEDIATRICS; MARYLAND CHAPTER-AMERICAN ACADEMY OF PEDIATRICS; AMERICAN CANCER SOCIETY CANCER ACTION NETWORK; AMERICAN HEART ASSOCIATION; AMERICAN LUNG ASSOCIATION; CAMPAIGN FOR TOBACCO-FREE KIDS; TRUTH INITIATIVE; DR. LEAH BRASCH, MD; DR. CYNTHIA FISHMAN, MD; DR. LINDA GOLDSTEIN, MD; DR. STEVEN HIRSCH, MD; DR. DAVID MYLES, MD, Plaintiffs-Appellees, v. UNITED STATES FOOD AND DRUG ADMINISTRATION; NORMAN E. SHARPLESS, in his official capacity as Acting Commissioner of Food and Drugs; UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES; ALEX M. AZAR, II, in his Official capacity as Secretary of Health and Human Services, Defendants. STATE OF MARYLAND; MARYLAND ASSOCIATION OF COUNTY HEALTH OFFICERS, Amicus Supporting Appellees. AMERICAN ACADEMY OF PEDIATRICS; MARYLAND CHAPTER-AMERICAN ACADEMY OF PEDIATRICS; AMERICAN CANCER SOCIETY CANCER ACTION NETWORK; AMERICAN HEART ASSOCIATION; AMERICAN LUNG ASSOCIATION; CAMPAIGN FOR TOBACCO-FREE KIDS; TRUTH INITIATIVE; DR. LEAH BRASCH, MD; DR. CYNTHIA FISHMAN, MD; DR. LINDA GOLDSTEIN, MD; DR. STEVEN HIRSCH, MD; DR. DAVID MYLES, MD, Plaintiffs-Appellees, v. AMERICAN E-LIQUID MANUFACTURING STANDARDS ASSOCIATION; AMERICAN VAPING ASSOCIATION; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION-CALIFORNIA; ARIZONA SMOKE FREE BUSINESS ALLIANCE; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION-CONNECTICUT; INDIANA SMOKE FREE ASSOCIATION; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION-HAWAII; IOWANS FOR ALTERNATIVE TO SMOKING AND TOBACCO; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION-LOUISIANA; KENTUCKY SMOKE FREE ASSOCIATION; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION-RHODE ISLAND; MARYLAND VAPOR ALLIANCE; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION-TEXAS; NEW YORK STATE VAPOR ASSOCIATION; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION-WISCONSIN; OHIO VAPOR TRADE ASSOCIATION; RIGHT TO BE SMOKE-FREE COALITION; SMOKE FREE ALTERNATIVES TRADE ASSOCIATION; TENNESSEE SMOKE FREE ASSOCIATION; TEXAS VAPOR COALITION, Intervenors-Appellants, and UNITED STATES FOOD AND DRUG ADMINISTRATION; NORMAN E. SHARPLESS, in his official capacity as Acting Commissioner of Food and Drugs; UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES; ALEX M. AZAR, II, in his Official capacity as Secretary of Health and Human Services, Defendants, WASHINGTON LEGAL FOUNDATION; CONSUMER ADVOCATES FOR SMOKE-FREE ALTERNATIVES ASSOCIATION; MICHAEL SIEGEL, Amici Supporting Appellants. STATE OF MARYLAND, Amicus Supporting Appellees. AMERICAN ACADEMY OF PEDIATRICS; AMERICAN CANCER SOCIETY CANCER ACTION NETWORK; AMERICAN HEART ASSOCIATION; AMERICAN LUNG ASSOCIATION; LEAH BRASCH, MD; CAMPAIGN FOR TOBACCO-FREE KIDS; CYNTHIA FISHMAN, MD; LINDA GOLDSTEIN, MD; STEVEN HIRSCH, MD; DAVID MYLES, MD; TRUTH INITIATIVE; MARYLAND CHAPTER-AMERICAN ACADEMY OF PEDIATRICS, Plaintiffs-Appellees, v. UNITED STATES FOOD AND DRUG ADMINISTRATION; NORMAN E. SHARPLESS, in his Official capacity as Commissioner of Food and Drugs; UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES; ALEX M. AZAR, II, in his Official capacity as Secretary of Health and Human Services, Defendants-Appellants. STATE OF MARYLAND; MARYLAND ASSOCIATION OF COUNTY HEALTH OFFICERS, Amici Supporting Appellees. In re: AMERICAN E-LIQUID MANUFACTURING STANDARDS ASSOCIATION; AMERICAN VAPING ASSOCIATION; ARIZONA SMOKE FREE BUSINESS ALLIANCE; INDIANA SMOKE FREE ASSOCIATION; IOWANS FOR ALTERNATIVE TO SMOKING AND TOBACCO; KENTUCKY SMOKE FREE ASSOCIATION; MARYLAND VAPOR ALLIANCE; NEW YORK STATE VAPOR ASSOCIATION; OHIO VAPOR TRADE ASSOCIATION; RIGHT TO BE SMOKE-FREE COALITION; SMOKE FREE ALTERNATIVES TRADE ASSOCIATION; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION-CALIFORNIA; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION-CONNECTICUT; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION-HAWAII; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION-LOUISIANA; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION-RHODE ISLAND; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION-TEXAS; SMOKE-FREE ALTERNATIVES TRADE ASSOCIATION-WISCONSIN; TENNESSEE SMOKE FREE ASSOCIATION; TEXAS VAPOR COALITION, Appellants. AMERICAN ACADEMY OF PEDIATRICS; AMERICAN CANCER SOCIETY CANCER ACTION NETWORK; AMERICAN HEART ASSOCIATION; AMERICAN LUNG ASSOCIATION; LEAH BRASCH; CAMPAIGN FOR TOBACCO-FREE KIDS; CYNTHIA FISHMAN; LINDA GOLDSTEIN; STEVEN HIRSCH; DAVID MYLES; MARYLAND CHAPTER-AMERICAN ACADEMY OF PEDIATRICS; TRUTH INITIATIVE, Plaintiffs-Appellees, v. UNITED STATES FOOD AND DRUG ADMINISTRATION; SCOTT GOTTLIEB, in his Official capacity as Commissioner of Food and Drugs; NORMAN E. SHARPLESS, in his Official capacity as Commissioner of Food and Drugs; UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES; ALEX M. AZAR, II, in his Official capacity as Secretary of Health and Human Services; AMERICAN ASSOCIATION FOR RESPIRATORY CARE, Defendants. WASHINGTON LEGAL FOUNDATION; CONSUMER ADVOCATES FOR SMOKE-FREE ALTERNATIVES; MICHAEL SIEGEL, Amici Supporting Appellants. STATE OF MARYLAND; MARYLAND ASSOCIATION OF COUNTY HEALTH OFFICERS, Amici Supporting Appellees.

United States Court of Appeals, Fourth Circuit.

Decided: May 4, 2020.


Attorney(s) appearing for the Case

ARGUED: Eric P. Gotting , KELLER AND HECKMAN LLP, Washington, D.C., for Intervenor-Appellants.

Mark S. Raffman , GOODWIN PROCTER LLP, Washington, D.C, for Appellants.

Joshua Revesz , UNITED STATES DEPARTMENT OF JUSTICE, Washington, D.C., for Appellant United States Food and Drug Administration. Jeffrey B. Dubner , DEMOCRACY FORWARD FOUNDATION, Washington, D.C., for Appellees.

ON BRIEF: Joseph H. Hunt , Assistant Attorney General, Mark B. Stern , Lindsey Powell , Civil Division, UNITED STATES DEPARTMENT OF JUSTICE, Washington, D.C.; Robert P. Charrow , General Counsel, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES, Washington, D.C.; Stacy Cline Amin , Chief Counsel, Annamarie Kempic, Deputy Chief Counsel for Litigation, Wendy S. Vicente , Senior Counsel, Peter G. Dickos , Associate Chief Counsel, UNITED STATES FOOD AND DRUG ADMINISTRATION, Rockville, Maryland, for Appellants.

Andrew Kim , Benjamin Hayes , GOODWIN PROCTER LLP, Washington, D.C., for Appellant Cigar Association of America. Azim Chowdhury , KELLER AND HECKMAN LLP, Washington, D.C., for Intervenor-Appellants.

Michael J. Edney , STEPTOE & JOHNSON LLP, Washington, D.C., for Appellants Premium Cigar Association and Cigar Rights of America. Dennis A. Henigan , Swati Rawani , CAMPAIGN FOR TOBACCO-FREE KIDS, Washington, D.C.; Mark E. Greenwold , Washington, D.C.; Sean A. Lev , Nitin Shah , DEMOCRACY FORWARD FOUNDATION, Washington, D.C.; Eve L. Hill , BROWN GOLDSTEIN & LEVY, LLP, Baltimore, Maryland, for Appellees.

Corbin K. Barthold , Cory L. Andrews , WASHINGTON LEGAL FOUNDATION, Washington, D.C., for Amicus Washington Legal Foundation. Keith D. Price , Andrew D. Ryan , Timothy C. Sansone , Zachary S. Merkle , SANDBERG PHOENIX & VON GONTARD, P.C., St. Louis, Missouri, for Amici Consumer Advocates for Smoke-Free Alternatives Association and Michael Siegel, M.D. , M.P.H. Kathleen Hoke , UNIVERSITY OF MARYLAND SCHOOL OF LAW, Baltimore, Maryland, for Amicus Maryland Association of County Health Officers. Brian E. Frosh , Attorney General, Steven M. Sullivan , Solicitor General, John M. Leovy , Assistant Attorney General, Sarah W. Rice , Assistant Attorney General, OFFICE OF THE ATTORNEY GENERAL OF MARYLAND, Baltimore, Maryland, for Amicus State of Maryland. Rachel S. Bloomekatz , Columbus, Ohio, for Amici Public Health Law Center; Action on Smoking and Health; American Academy of Allergy, Asthma and Immunology; American College of Chest Physicians; American College of Occupational and Environmental Medicine; Americans for Nonsmokers' Rights; American Medical Association; American Public Health Association; American Thoracic Society; NAATPN, Inc.; National Association for the Medical Direction of Respiratory Care; and National Medical Association.

Affirmed in part, dismissed in part by unpublished per curiam opinion.


UNPUBLISHED

Unpublished opinions are not binding precedent in this circuit.

This case involves a challenge to an August 2017 Guidance issued by the Food and Drug Administration ("FDA") which set a compliance deadline for certain newly deemed tobacco products. That Guidance was superseded by another Guidance issued by the...

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