SS August 2016

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16 SMOKESHOP August 2016 Industry NEWS >>>PRODUCTION, DISTRIBUTION, REGULATION, TRADE Bits&Pieces > Canada, which currently requires cigarette packs to be hidden from cus- tomer view in retail stores and mandates that 75% of packs must be covered with graphic health warn- ings, will become the third nation in the world follow- ing Britain and Australia to mandate plain packag- ing of cigarettes, Health Minister Jane Philpott announced. The measures, which will be finalized after a three-month period of public input, would require a uniform, standardized color and font on packag- es and restrict the use of logos and trademarks. > Nicholas Melillo, owner of Foundation Cigar Company, announced the appointment of Miami Cigar Company as the exclusive distributor for his upcoming newest cigar, Upsetters, which is set for release just prior to the 2016 IPCPR Show in Las Vegas. Melilo says that Upsetters—which pairs Nicaraguan and Jamaican tobaccos—is possibly his "most exciting and thought out product to date." > The World Health Organization (WHO) has called for governments around the world to enact plain packaging regulations for all tobacco products as a "demand reduction mea- sure" restricting the use of product packaging as a form of advertising. Let the litigation begin. While a coalition of premium cigar associations continues to strategize on its next move, including a possible lawsuit of its own against the Food & Drug Administration (FDA), a total of five lawsuits have already been filed to date against the agency throughout the tobacco and vaping industries. On May 10, Nicopure Labs, LLC, a leading manufacturer of American made e-liquids, was the first to file suit in the U.S. District Court for the District of Columbia, chal- lenging the FDA's deeming rule that would subject electronic cigarettes and other vaping products to more onerous restrictions than combustible cigarettes under the Tobacco Control Act. In its court filing, Nicopure Labs contends the FDA's rule-making process violated the Administrative Procedure Act, and that the deeming rule violates the First Amendment to the United States Constitution, prohibiting manufacturers from making truthful and non-misleading statement about vaping prod- uct. The lawsuit also claims the FDA exceed- ed its statutory authority and that the deem- ing regulations are an unfair interpretation of the Family Smoking Prevention and Tobacco Control Act; that the deeming regulations are arbitrary and capricious due to the extraordi- nary burdens these place on manufacturers; that the regulations overstate their benefits which are not quantified and erroneously conclude that the benefits outweigh the costs. "Through one voice, Nicopure Labs has taken a stand to ensure the voices of all vapers are heard and that vapers are treated fairly and not with a single stroke of a broad brush by the FDA," said Jeff Stamler, CEO and co-founder of Nicopure Labs. "We fully support reasonable regulation that protects consumers, accomplishes the public health priority to reduce the grave harm caused by conventional cigarette smoking, and allows businesses to survive and innovate for a greater public health vision for our society as a whole." A week later, two more lawsuits were filed. John Middleton Company LLC sued to set aside and enjoin the enforcement a provi- sion that prohibits the company from using the word "mild" in its Black & Mild trade- mark. In addition to claims that banning the descriptor is arbitrary and capricious and that commercial speech is restricted, the compa- ny also claims that the deeming regulations constituted a taking its property without just compensation by prohibiting the use of its trademark. A third lawsuit by Lost Art Liquids LLC seeks to set aside the entire set of deeming regulations, filed in the U.S. District Court for the District of Central California, claim- ing the FDA failed to consider the impact of the regulations on small businesses; that the agency's fiscal analysis on the impact of the regulations does not quantify the costs on small businesses nor investigate alternatives or exceptions for small businesses; that the agency grossly underestimates the cost of compliance and is erroneous in its conclusion that benefits of the regulations outweigh the cost; and that the regulations violate the protection of free speech. A fourth lawsuit was filed by Global Pre- mium Cigars LLC and its owner Enrique Fer- nando Sanchez Icaza against the FDA seeking to set the entire set of deeming regulations. In addition to other claims, the company con- tents that requiring warning labels on cigar boxes violates the First Amendment, and also represents a taking of property in violation of the Fifth Amendment. The fifth lawsuit filed to date is by far the largest, comprising 11 vaping organizations and trade associations. In addition to similar claims made in earlier lawsuits, it claims that the FDA's failure to establish a new predicate date violated the Federal Adminis- trative Procedures Act; that the agency's fail- ure to treat vapor products differently that combustible cigarettes prevents newer and safer products from being marketed; and that the agency violated the Federal Regu- latory Flexibility Act by failing to consider significant alternatives to the regulations in order to minimize the economic impact on small businesses. Deluge of Lawsuits Filed by Tobacco, Vaping Interests Against FDA Over Deeming Regulations; More are Likely

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