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April 24, 2017 Honorable Thomas E. Price, M.D. U.S. Department Of

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April 24, 2017 Honorable Thomas E. Price, M.D. U.S. Department Of April 24, 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. Letter to Secretary Price April 24, 2017 Page 2 of 77 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, SYLVIA STANFORD JAY HARDESTY MEGHAN HARDESTY LEET VAPING LLC VAPENJAYS VAPENJAYS ATHENS, ALABAMA AUBURN, ALABAMA AUBURN, ALABAMA SINAN ALNASIRY SCOTT EICHELBERGER WENDY EICHELBERGER VAPE ROYALE DOC IKE RETAIL LLC DOC IKE RETAIL LLC DBA BAMA VAPOR BAGHDAD, ALABAMA BIRMINGHAM, ALABAMA BIRMINGHAM, ALABAMA MICHAEL IBE CHASE STAPLES DONNIE COLLINS CAHABA VAPES LLC SMOKIN' VAPOR BIRMINGHAM THE VAPE SHOP BIRMINGHAM, ALABAMA BIRMINGHAM, ALABAMA CULLMAN, ALABAMA ZACK CARPENTER BLAKE STACEY KEITH LEWIS CYCLOPS VAPOR LLC THE VAPOR HUT NORTH ALABAMA VAPE DAPHNE, ALABAMA DAPHNE, ALABAMA FLORENCE, ALABAMA Letter to Secretary Price April 24, 2017 Page 3 of 77 SHAUN MELTON WILLIAM ROBERTS CHRISTY BOYD KALEIDOSCOPE VAPOR / NU WAY VAPE SOUTHERNVAPE PAPA VOO DOO'S TONICS FLORENCE, ALABAMA FLORNCE, ALABAMA FLORENCE, ALABAMA ANTIONETTE CANCELENO CHRIS SHANNON RANDALL TOFFEL TLC VAPES PARADOX LIQUIDS VAPEOLOGY, LLC FOLEY, ALABAMA FOLEY, ALABAMA HOOVER, ALABAMA KRISTEN HEPLER JOSHUA REGISTER, SR. GISELA CAMPOS VAPE SOUTH NOCTURNE VAPORS, LLC. STACKIN' VAPORZ HUNTSVILLE, ALABAMA IRONDALE, ALABAMA LANETT, ALABAMA STOKES YARBROUGH ALBERT OWEN ROBERT WARE VAPE ON! LLC VAPOR DREAMZ TIGER VAPOR MADISON, ALABAMA MOBILE, ALABAMA OPELIKA, ALABAMA KEVIN WILHOITE ERIC SLAICK SCOTT LEWIS MT. CHEAHA ECO-SMOKES LLC SAVE A SMOKER BUCKY'S VAPE SHOP OXFORD, ALABAMA OZARK, ALABAMA PHENIX CITY, ALABAMA BRANDI THOMASON JON ROUNDY DAVID TUCKER S & S VAPES TASTY HAZE COCONUT BLENDZ 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 GENE SHAFFRAN CHRISTAL BLAIR GARY HARRIS 4 COG L.L.C. KICKN MY HABIT VAPORS CLOUD 9 VAPES HARTSELLE, ALABAMA HUNTSVILLE , ALABAMA MOBILE, ALABAMA Letter to Secretary Price April 24, 2017 Page 4 of 77 DS HOGAN JESSI WALTON STEVEN MAPES LMA ICE FOG VAPOR INC MAPES VAPES ANCHORAGE, ALASKA FAIRBANKS, ALASKA KENAI, ALASKA MARK MASSERA DOUG SHRADER STEVEN MAPES MAPES VAPES ROCK CITY VAPES MAPES VAPES KENAI, ALASKA LITTLE ROCK, ALASKA SOLDOTNA, ALASKA TAMERA MAPES MARK MASSERA SARAH EATON MAPES VAPES MAPES VAPES ALASKA ELIXIRS VAPE LLC SOLDOTNA, ALASKA SOLDOTNA, ALASKA WASILLA, ALASKA BROOK BEIERLE ALISON HALPIN PAUL MALCHOW CAFE DE VAPOR JABBERWOCK TRADES THE DRIPPING WICK ANCHORAGE, ALASKA ANCHORAGE, ALASKA CHANDLER, ARIZONA GRECIA RASCON JAMES COPLEY KATHLEEN COOK VAPEPOINT, GNJ ENTERPRISE, LLC STEAMERS LOUNGE LLC SUNSHINE VAPORS, LLC CHANDLER, ARIZONA CHANDLER , ARIZONA CHINO VALLEY, ARIZONA STEPHANIE MCCARTY JOSEPH BRADLEY JOSEPH RHODES CHASE CREEK VAPES AND ORGANICS THE BRADLEY'S BRAND, INC. BIG DADDY VAPE CLIFTON, ARIZONA GILBERT, ARIZONA GILBERT, ARIZONA PRINCE PAULS DEBBIE PEARSON TAELOR PEARSON VAPOR WORLD LLC RED VAPOR RED VAPOR GLENDALE, ARIZONA GLENDALE, ARIZONA GLENDALE, ARIZONA STEPHEN MARTIN NOLAN ROBERTSON RANDY MILLER STEVE"S VAPOR HUT LLC FIVE DIAMOND VAPOUR THE VAPOR PIMP, LLC GLOBE, ARIZONA LAKE HAVASU CITY, ARIZONA LAVEEN, ARIZONA KEVIN DAUGHERTY CRAIG LARSEN ANTHONY PERKINS MY BEST JUICE KIDNEY PUNCHER LLC ORACLE VAPORY MESA, ARIZONA MESA, ARIZONA MESA, ARIZONA Letter to Secretary Price April 24, 2017 Page 5 of 77 GREG ROCQUE GRANT WILLIAMSON AARON CERICOLA MT BAKER VAPOR MUMS FANTASY FACTORY LLC PARROT VAPORS MESA, ARIZONA PARADISE VALLEY, ARIZONA PEORIA, ARIZONA JAMES SHUMAKER DANEY GLENN GEOFF HABICHT PARROT NATION VAPE SHOP SONORAN VAPE SV3, LLC PEORIA, ARIZONA PHOENIX, ARIZONA PHOENIX, ARIZONA AMIR HAKAK STEVE JOHNSON STEVE LASKY SMOKING VAPOR SONORAN VAPE, LLC VAPE ESCAPES PHOENIX, ARIZONA PHOENIX, ARIZONA PHOENIX, ARIZONA JOHN FISHER JOURDAN WHEELER ROBERT WHITE JVAPES JVAPES LLC CLOUD SLINGER PRESCOTT, ARIZONA PRESCOTT, ARIZONA PRESCOTT, ARIZONA MICHAEL KING IAN BURKHART MANDY MUDER THE VAPOR DEN LLC CRIMSON COILS AZ SMOKE FREE SCOTTDALE, ARIZONA SEDONA, ARIZONA SHOW LOW, ARIZONA DAVID AKERS CONOR RAUEN KYLE BARNETT ECIGS SMOKING ALTERNATIVES MUMS VAPES THE VAPE ZONE SMOKELESS LLC SURPRISE, ARIZONA TEMPE, ARIZONA TUCSON, ARIZONA JIM DUPONTE MICHAEL SWINIUCH PRISCILLA SEABOLD FULL PULL VAPES LLC THE VAPE ZONE SMOKELESS, LLC CLOUD CHASER VAPING CO. TUCSON, ARIZONA TUCSON, ARIZONA YUMA, ARIZONA KORY ESTEP JOSHUA STEWART JUDY ALFORD VAPR TUCSON LLC VAPOR PROS LLC BAD BOYZ VAPORZ TUCSON , ARIZONA TUSCON , ARIZONA CABOT, ARKANSAS NICHOLAS LABANCA MIKE ELIAS BENNY GROVER VAPOR-RIFFIC LECIG ELECTRONIC CIGARETTES VAPOR ESSENTIALS CONWAY, ARKANSAS DE QUEEN, ARKANSAS FARMINGTON, ARKANSAS Letter to Secretary Price April 24, 2017 Page 6 of 77 SCOUT STUBBS WILLIAM MCCULLOUGH ELIZABETH SYKES DRIPPERS VAPE SHOP MY HOME TOWN VAPOR THE VAPOR CONNECTION, LLC GREENBRIER, ARKANSAS LITTLE ROCK, ARKANSAS LITTLE ROCK, ARKANSAS KIMBERLY ARFORD CYNTHIA HETTESHEIMER TOPHER KENT AMERICAN VAPEZ LLC AQUASHIELD ROGUE VAPERS MOUNTAIN HOME, ARKANSAS NORTH LITTLE ROCK, ARKANSAS NORTH LITTLE ROCK, ARKANSAS FARRAH SOK ARNEVA DAVIS BRETT DAVIS VAPE CITY [ARKANSAS] ARKANSAS CUSTOM VAPOR ARKANSAS CUSTOM VAPOR NORTH LITTLE ROCK, ARKANSAS SEARCY, ARKANSAS SEARCY, ARKANSAS TERESA COLLINS CHRIS JIMENEZ ARAM ZIYALYAN 412 VAPORS LLC BANKCARD USA LEGACY LLC SILOAM SPRINGS, ARKANSAS AGOURA HILLS, CALIFORNIA ALTADENA, CALIFORNIA
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