SS June 2016

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36 SMOKESHOP June 2016 The two new warnings are: WARNING: This product contains nicotine. Nicotine is an addictive chemical. WARNING: Cigar use while pregnant can harm you and your baby. Or, as an optional alternative statement: SURGEON GENERAL WARNING: Tobacco Use Increases the Risk of Infertility, Stillbirth and Low Birth Weight. The cigar health warnings are required to appear on at least 30 percent of each of the two principal display panels of the ci- gar package and on at least 20 percent of the area of the print advertisements and other advertisements with a visual com- ponent (website ads, etc.). The font used for warnings on packaging and advertise- ments must be at least 12-point in size. For advertisements of cigars, the warn- ings must be rotated quarterly in alternat- ing sequence in each advertisement for each brand of cigar in accordance with a warning plan submitted to, and approved by, the FDA. Manufacturers, distributors, importers, and retailers that create their cigar advertisements must also draft and submit a cigar health-warning plan to the FDA by May 10, 2017. The same warning statement require- ments will apply to cigars sold individu- ally and not in product packages. In this case, retailers will be required to post with- in three inches of each cash register a sign that measures at a minimum 8-1/2 by 11 inches with all six of the health warnings. Since all six health warnings will appear on the sign placed in retail stores, there is no quarterly rotation requirement for the six warnings nor is a retailer required to submit a health warning plan to the FDA for cigars sold individually. These adver- tising health-warning requirements will take effect on May 10, 2018. PREDICATE (GRANDFATHER) DATE FDA has concluded that the agency lacks the authority to change the predicate date or grandfather date for the newly deemed tobacco products. The original predicate date or grandfather date is February 15, 2007. Based on this predicate date, any to- bacco product that was on the market as of February 15, 2007 is "grandfathered" and not required to have a Substantial Equivalency application (SE) or Pre-Mar- ket Tobacco Application (PMTA) filed with the FDA to remain on the market. A manufacturer can submit a SE appli- cation if a product introduced to the mar- ket after February 15, 2007 is substantially similar to a product that was already on the market on or before February 15, 2007. A substantially similar product is known by the FDA as a "predicate product." If there were no substantially similar pred- icate products for a manufacturer to rely on, then the manufacturer would need to file a PMTA with the FDA. Based on the fact that the predicate date/grandfather date has not been changed, and that a significant majority of cigars and pipe tobacco were introduced in the market after February 15, 2007, manufacturers will be required to file SE or PMTA applications for a substantial number of cigars and pipe tobacco prod- ucts. The number of SE and PMTA appli- cations will be so high because the FDA believes that a separate SE or PMTA ap- plication will likely be necessary for just about each product SKU. However, the time involved preparing SE and PMTA applications plus the cost of doing so may be too expensive for some manufacturers, possibly resulting in various deemed to- bacco products no longer being manufac- tured and removed from the marketplace. Moreover, the FDA intends to enforce the SE or PMTA application require- ments for cigar products that have tobac- co-blending changes (including those ci- gars that have seasonal blends and those cigars that are boutique blends) that are intended to alter the chemical or percep- tion properties of a new cigar (e.g., nico- tine level, pH, smoothness, harshness). RETAILERS AS MANUFACTURERS The definition of "tobacco product man- ufacturer" under the TCA includes "any person, including any repacker or rela- beler, who manufactures, fabricates, as- sembles, processes, or labels a tobacco product." Additionally, the Food, Drug & Cosmetic Act defines "manufacturing, preparation, compounding, or process- ing" to include "repackaging, or other- wise changing the container, wrapper, or labeling of any tobacco product package from the original place of manufacture to the person who makes the final delivery or sale to the ultimate consumer or user." The TCA authorizes the FDA to regulate the manufacture of all newly deemed tobacco products, including those products manufactured at the retail level. This means that tobacco re- tailers that blend pipe tobacco will meet the definition of a "tobacco product manufacturer" and be regulated by the FDA as a manufacturer. Persons who own or operate a retail store and blend different pipe tobaccos together by repackaging bulk pipe to- bacco meet the definition of a "tobacco product manufacturer" under the TCA. These retailers will be required to reg- ister with FDA and submit product list- ings to the agency as of August 8, 2016. NATO's comments about the pro- posed deeming regulations submitted to the FDA expressed a serious concern that retailers who blend pipe tobacco would be subject to all of the requirements for manufacturers of tobacco products. The NATO comments requested that retail- ers blending up to 5,000 pounds of pipe tobacco per year be exempt from the reg- ulatory requirements of manufacturers under the TCA. However, in the deeming regula- tions, the FDA replied that all entities that meet the definition of "tobacco product manufacturer" in the TCA, in- cluding retail establishments that blend pipe tobacco, are subject to and must comply with all applicable statutory and regulatory requirements for tobacco product manufacturers. NATO NEWS > > The deeming regulations enable the FDA to issue further regulations related to tobacco products that are "appropriate for the protection of the public health."

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