Issue link: http://read.dmtmag.com/i/743340
20 tobaccoasia / Issue 5, 2016 November / December Nahuan Photo testing and the cost is estimated by industry pro- fessionals at US$10,000 at least, by product. New products and limited editions are an important part of the cigar market. Product verification and government approval prior to the release of new products would seriously slow down the process of getting products in retail outlets, and would greatly add to the cost of business. It also means higher retail prices, as the costs of approval will logically be passed onto the consumers. A small note about Cuban cigars: since they were not legally on the US market in 2007, they will obviously not be grandfathered in and will be considered as new brands, with the huge amount of paperwork and costly applications that the new procedure will require. When FDA released the new regulation guide- lines, Glynn Loope, executive director of the Ci- gar Rights of America, told Cigar Aficionado that "the associations are focusing on two parts: one is advancing the legislation… which calls for an ex- emption on premium and large cigars, and getting that through the full House of Representatives and adopted by the Senate, which probably won't happen until this year. Secondly, we're going to be evaluating immediately all of our legal options for litigation." The lawsuits And that's what they did. On July 15, the three major lobbying groups representing the cigar and pipe industries (Cigar Association of America, International Premium Cigar and Pipe Retailers, and Cigar Rights of America) filed a joint lawsuit against FDA in the US District Court for the Dis- trict of Columbia. They were challenging FDA's final rule, claiming it "violates numerous federal statutes as well as the federal rulemaking process." Another lawsuit has been filed by Global Pre- mium Cigars LLC, which is seeking to set aside the entire set of deeming regulations. The lawsuits focus on: - FDA's decision to apply the date of February 15, 2007 as the grandfather date to cigars and pipe tobacco, which subjects those products to more intrusive regulations than cigarettes and smokeless tobacco; - FDA's failure to perform an adequate cost- benefit analysis to take into account the effects of the final rule on small businesses as is required by the Regulatory Flexibility Act; - FDA's unjustified decision to require warn- ing labels on 30% of the two principal display pan- els of a cigar box. And on August 16, tobacco companies have won a partial victory in the fight against FDA: Judge Amit Mehta of the DC District Court ruled in favor of Altria, Lorillard, and Reynolds America (the three largest American tobacco companies) List of new rules for cigar manufacturing: The final rule will subject all manufacturers, im- porters and/or retailers of newly regulated tobacco products to any applicable provisions related to tobacco products in the Federal Food, Drug, and Cosmetic Act and FDA regulations, including: Rules aimed at manufacturers: ▪ Manufacturers must register all production facilities and providing product listings to FDA; ▪ Manufacturers must report all ingredients, and harmful and potentially harmful constituents; ▪ Manufacturers must apply for pre-market au- thorization selling cigar products. ▪ Health warnings will be required on all cigar product packages and advertisements; ▪ Products listed as "light" or "low" cannot be sold unless otherwise authorized by FDA. Rules aimed at combating underage use: ▪ Cigar products may not be sold to persons under the age of 18 years (both in-person and on- line); ▪ Customers will now be required to provide age verification by photo ID; ▪ Cigars cannot be sold in vending machines (unless in an adult-only facility); ▪ Free cigar samples are banned. The ruling includes: • Establishing a federally mandated minimum of 18 years for the purchase of any tobacco prod- uct, including sales made online, and age verifica- tion made by photo ID; • The banning of free tobacco samples; • The requirement of products released after February 15, 2007 to be verified by FDA before going to market.