April 18, 2017 Honorable Thomas E. Price, M.D. U.S. Department Of
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April 18, 2017 Honorable Thomas E. Price, M.D. U.S. Department of Health & Human Services Hubert H. Humphrey Building 200 Independence Avenue, S.W. Washington, D.C. 20201 Dear Secretary Price: I write today as a small business owner in the vapor products industry in strong opposition to the FDA's May 2016 Final “Deeming” Rule and ask that you utilize any available options you have to repeal, halt, or dramatically delay this rule. This rule, which has been hastily implemented, does nothing to address product standards or consumer safety issues, and is so overly burdensome that it is tantamount to a ban on these new and innovative vapor products. Vapor products represent the first real game-changing technology in the ongoing campaign to reduce cigarette smoking and smoking-related disease. In fact, they represent a tremendous example of the free market working! Smokers have been voluntarily switching to these products by the millions, reducing their own health risks from smoking and modeling this better choice for future generations. These products, quite literally, could be the key to finally making combustible cigarette smoking in this country obsolete. However, the FDA’s current one-size-fits-all regulatory approach will remove nearly all vapor products from the market in short order by pulling these non-tobacco products into their regulatory jurisdiction as defined by the 2009 Tobacco Control Act (“Act”). The Act was written in response to the public health crisis generated by combustible cigarettes at a time when vapor products were virtually unknown. The Act actually proposed harm reduction through development of non-smoking alternatives. But, the FDA has taken that well-intentioned legislation and used it to punish a very low-risk, smoke-free product which is the first promising alternative for adult smokers by regulating them even more harshly than combustible cigarettes. However, the FDA issued regulations created for vapor products which do the opposite, actually punishes a very low-risk, smoke-free product and will quash the first promising alternative for adult smokers to come to market in history. Moreover, FDA has required a retroactive “premarket” review of all products currently on the market. This review process is opaque, prohibitively expensive, and offers no pathway to success even for those who are able to attempt to navigate it. As a result, the deeming regulation not only will eliminate small and midsize vapor businesses from the market but also will protect the dominance of Big Tobacco. Most American manufacturers will begin the process of closing their businesses, rather than even try to gamble on this daunting and risky Premarket Tobacco Application process. If there are no manufacturers left to make the products, American retailers also go out of business. Business Letter to Secretary Price April 18, 2017 Page 2 of 59 If the FDA does not immediately suspend or significantly extend each of the remaining compliance deadlines contained in the deeming regulation, we simply will not survive. Our small business cannot afford the millions of dollars we will be forced to spend in the coming months simply to keep our existing products on the market. This means thousands of vapor businesses like ours will be closing their doors, putting tens of thousands of Americans out of work. Furthermore, the millions of consumers who rely on vapor retailers for access to vapor products will be forced to seek out alternative sources. Rather than protecting consumers, the FDA regulations will create a new and vast black market that will operate outside of even common sense regulation. The urgency of this issue cannot be overstated. With no certainty as to how our businesses might survive beyond any of the deeming regulation’s deadlines, we will have no choice but to shut our doors in the coming months. In order to save our industry and ensure that these life-changing products remain on the shelves, I urge you to take action now to suspend or indefinitely delay all of the remaining filing deadlines under the deeming regulation. On behalf of America's small and midsize vapor businesses and all of our employees, I thank you for your consideration. Sincerely, DS HOGAN JESSI WALTON STEVEN MAPES LMA ICE FOG VAPOR INC MAPES VAPES ANCHORAGE, ALASKA FAIRBANKS, ALASKA KENAI, ALASKA MARK MASSERA DOUG SHRADER TAMERA MAPES MAPES VAPES ROCK CITY VAPES MAPES VAPES KENAI, ALASKA LITTLE ROCK, ALASKA SOLDOTNA, ALASKA MARK MASSERA BROOK BEIERLE ALISON HALPIN MAPES VAPES CAFE DE VAPOR JABBERWOCK TRADES SOLDOTNA, ALASKA ANCHORAGE, ALASKA ANCHORAGE, ALASKA SYLVIA STANFORD JAY HARDESTY SINAN ALNASIRY LEET VAPING LLC VAPENJAYS VAPE ROYALE ATHENS, ALABAMA AUBURN, ALABAMA BAGHDAD, ALABAMA Business Letter to Secretary Price April 18, 2017 Page 3 of 59 MICHAEL IBE SCOTT EICHELBERGER WENDY EICHELBERGER CAHABA VAPES LLC DOC IKE RETAIL LLC BAMA VAPOR BIRMINGHAM, ALABAMA BIRMINGHAM, ALABAMA BIRMINGHAM, ALABAMA ZACK CARPENTER BLAKE STACEY SHAUN MELTON CYCLOPS VAPOR LLC THE VAPOR HUT KALEIDOSCOPE VAPOR / PAPA VOO DOO'S TONICS DAPHNE, ALABAMA DAPHNE, ALABAMA FLORENCE, ALABAMA KEITH LEWIS WILLIAM ROBERTS CHRISTY BOYD NORTH ALABAMA VAPE NU WAY VAPE SOUTHERNVAPE FLORENCE, ALABAMA FLORENCE, ALABAMA FLORNCE, ALABAMA CHRIS SHANNON ANTIONETTE CANCELENO RANDALL TOFFEL PARADOX LIQUIDS TLC VAPES VAPEOLOGY, LLC FOLEY, ALABAMA FOLEY, ALABAMA HOOVER, ALABAMA JOSHUA REGISTER, SR. GISELA CAMPOS STOKES YARBROUGH NOCTURNE VAPORS, LLC. STACKIN' VAPORZ VAPE ON! LLC IRONDALE, ALABAMA LANETT, ALABAMA MADISON, ALABAMA ALBERT OWEN ROBERT WARE ERIC SLAICK VAPOR DREAMZ TIGER VAPOR SAVE A SMOKER MOBILE, ALABAMA OPELIKA, ALABAMA OZARK, ALABAMA SCOTT LEWIS DAVID TUCKER JON ROUNDY BUCKY'S VAPE SHOP COCONUT BLENDZ TASTY HAZE PHENIX CITY, ALABAMA RAINBOW CITY, ALABAMA RAINBOW CITY, ALABAMA DEBBIE COWAN BYRON SLATON BRETT SAGNAR VAPORS HEAVEN VAPORS HEAVEN VAPERRIFIC, LLC. RUSSELLVILLE, ALABAMA RUSSELLVILLE, ALABAMA TALLADEGA, ALABAMA KAREN GEAN BRETT SABIO GARY HALE SOUTHERN VAPE BRETT'S VAPE DEEP SOUTH VAPORS, LLC WATERLOO, ALABAMA BIRMINGHAM, ALABAMA DOTHAN, ALABAMA Business Letter to Secretary Price April 18, 2017 Page 4 of 59 GENE SHAFFRAN CHRISTAL BLAIR GARY HARRIS 4 COG L.L.C. KICKN MY HABIT VAPORS CLOUD 9 VAPES HARTSELLE, ALABAMA HUNTSVILLE, ALABAMA MOBILE, ALABAMA NICHOLAS LABANCA MIKE ELIAS SCOUT STUBBS VAPOR-RIFFIC LECIG ELECTRONIC CIGARETTES DRIPPERS VAPE SHOP CONWAY, ARKANSAS DE QUEEN, ARKANSAS GREENBRIER, ARKANSAS WILLIAM MCCULLOUGH ELIZABETH SYKES CYNTHIA HETTESHEIMER MY HOME TOWN VAPOR THE VAPOR CONNECTION, LLC AQUASHIELD LITTLE ROCK, ARKANSAS LITTLE ROCK, ARKANSAS NORTH LITTLE ROCK, ARKANSAS TOPHER KENT FARRAH SOK ARNEVA DAVIS ROGUE VAPERS VAPE CITY [ARKANSAS] ARKANSAS CUSTOM VAPOR NORTH LITTLE ROCK, ARKANSAS NORTH LITTLE ROCK, ARKANSAS SEARCY, ARKANSAS BRETT DAVIS TERESA COLLINS PAUL MALCHOW ARKANSAS CUSTOM VAPOR 412 VAPORS LLC THE DRIPPING WICK SEARCY, ARKANSAS SILOAM SPRINGS, ARKANSAS CHANDLER, ARIZONA JAMES COPLEY KATHLEEN COOK STEPHANIE MCCARTY STEAMERS LOUNGE LLC SUNSHINE VAPORS, LLC CHASE CREEK VAPES AND ORGANICS CHANDLER, ARIZONA CHINO VALLEY, ARIZONA CLIFTON, ARIZONA JOSEPH RHODES JOSEPH BRADLEY DEBBIE PEARSON BIG DADDY VAPE THE BRADLEY'S BRAND, INC. RED VAPOR GILBERT, ARIZONA GILBERT, ARIZONA GLENDALE, ARIZONA STEPHEN MARTIN RANDY MILLER CRAIG LARSEN STEVE"S VAPOR HUT LLC THE VAPOR PIMP, LLC KIDNEY PUNCHER LLC GLOBE, ARIZONA LAVEEN, ARIZONA MESA, ARIZONA GREG ROCQUE KEVIN DAUGHERTY GRANT WILLIAMSON MT BAKER VAPOR MY BEST JUICE MUMS FANTASY FACTORY LLC MESA, ARIZONA MESA, ARIZONA PARADISE VALLEY, ARIZONA Business Letter to Secretary Price April 18, 2017 Page 5 of 59 JAMES SHUMAKER AARON CERICOLA AMIR HAKAK PARROT NATION VAPE SHOP PARROT VAPORS SMOKING VAPOR PEORIA, ARIZONA PEORIA, ARIZONA PHOENIX, ARIZONA DANEY GLENN GEOFF HABICHT STEVE LASKY SONORAN VAPE SV3, LLC VAPE ESCAPES PHOENIX, ARIZONA PHOENIX, ARIZONA PHOENIX, ARIZONA JOURDAN WHEELER MICHAEL KING CONOR RAUEN JVAPES LLC THE VAPOR DEN LLC MUMS VAPES PRESCOTT, ARIZONA SCOTTDALE, ARIZONA TEMPE, ARIZONA PRISCILLA SEABOLD KORY ESTEP JOSHUA STEWART CLOUD CHASER VAPING CO. VAPR TUCSON LLC VAPOR PROS LLC YUMA, ARIZONA TUCSON, ARIZONA TUSCON, ARIZONA CHRIS JIMENEZ ARAM ZIYALYAN ANTHONY GARCIA BANKCARD USA LEGACY LLC CYBERLIQUIDS AGOURA HILLS, CALIFORNIA ALTADENA, CALIFORNIA ANAHEIM, CALIFORNIA JOHN CAVANAUGH JANET GRIFFIS MICHAEL YPUNG FLAWLESS VAPE DISTRO RJVAPES, INC LOADUP VAPE SUPPLY ANAHEIM, CALIFORNIA ANAHEIM, CALIFORNIA ANTIOCH, CALIFORNIA MATTHEW SHELBOURN HAROLD HERNANDEZ ROBERT SCHIRMER CALICLECTIC VAPE NAKED INC HIGH VOLTAGE VAPORZ ARCADIA, CALIFORNIA BARSTOW, CALIFORNIA BELLFLOWER, CALIFORNIA RICHARD EVANS MARY TODD ABID VAKIL BIGTASTYCLOUDS BIG BEAR VAPE ESSENTIALS VAPE HEADQUARTERS BERKELEY, CALIFORNIA BIG BEAR CITY, CALIFORNIA BREA, CALIFORNIA DALON VINCENT DEWEY ALTENHOFEN MAX VELINSKY KILO ELIQUIDS COUSINS VAPE MIX VAPES, LLC BUENA PARK, CALIFORNIA CARLSBAD, CALIFORNIA CARLSBAD, CALIFORNIA Business Letter to Secretary Price April 18, 2017 Page 6 of 59 DAN PRASAD GARRETT BLANKENSHIP JOHN COAKLEY VAPOR BEAST DARTH VAPOR MAD HATTER JUICE CARLSBAD, CALIFORNIA CHATSWORTH, CALIFORNIA CHATSWORTH, CALIFORNIA JAMESON RODGERS ROBERT HACKETT ALENA OBERG MAD HATTER JUICE STEAM DISTRIBUTION BUCKSHOT VAPORS INC. CHATSWORTH, CALIFORNIA CHINO, CALIFORNIA COSTA MESA, CALIFORNIA GABRIEL BENSON LAURA MCCOLLUM KRIKOR JEKELIAN THE VAPING ADVOCATE LLC SOUTH COAST VAPOR CO MILLBRAE VAPE COSTA MESA, CALIFORNIA EL CAJON, CALIFORNIA EL CAMINO, CALIFORNIA KRAIG LOCKWOOD DANIEL CASCINO JIMMY RAYMOND SWELL VAPES INC. SOUTH