SS June 2016

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34 SMOKESHOP June 2016 W hen Congress passed the Fam- ily Smoking Prevention and Tobacco Control Act (TCA) in 2009, the Food and Drug Administration (FDA) initially regulated cigarettes, roll your own tobacco, and smokeless to- bacco products. However, the TCA also authorized the FDA to "deem" other products that met the definition of "to- bacco products" to be subject to federal tobacco regulations. On May 5, 2016, the FDA released the deeming regulations to exercise its regulatory authority over all cigars (both premium and domestic), pipe tobacco, e-cigarettes, and hookah tobacco. The deeming regulations go into effect on August 8, 2016. MINIMUM AGE TO PURCHASE Under the deeming regulations, retailers are prohibited from selling the deemed tobacco products (including over the In- ternet) to individuals under 18 years of age. It is important to note that state and local lawmakers have the authority to adopt a higher minimum age to purchase tobacco products. The FDA does not have the authority to raise the federal legal age; that authority rests with Congress. MANUFACTURER REQUIREMENTS The manufacturers of the deemed tobac- co products must comply with the fol- lowing FDA regulations: • Submission of ingredient lists for each deemed tobacco product and reporting of harmful or potentially harmful constit- uents (HPHCs). • Registration of tobacco product man- ufacturing establishments and a list of all tobacco products manufactured. • Prohibition against the sale and distri- bution of products with modified risk de- scriptors (e.g., "light," "low," and "mild" descriptors) and claims unless the FDA issues an order authorizing the market- ing of a modified risk product. • Premarket review requirements for products introduced in the market- place after the predicate date (grandfa- ther date) of February 15, 2007. REGULATION OF PREMIUM CIGARS As originally proposed, the deeming regulations included two options, with Option 1 regulating premium cigars and Option 2 not regulating premium cigars. The FDA concluded that deeming all ci- gars, both premium and domestic, more completely protects the public health and therefore adopted Option 1 in the final deeming regulations. NO FREE SAMPLES The deeming regulations prohibit man- ufacturers, wholesalers, and retailers from giving out free samples of the deemed tobacco products. The FDA has decided that allowing prospective adult buyers to smell or handle a cigar is not considered the distribution of a "free sample" as long as the cigar is not ac- tually consumed in the retail store and the prospective buyer does not leave the store with a free cigar. However, if the prospective buyer lights and draws or puffs on the cigar to keep the cigar lit, or otherwise leaves a store with a free cigar, this would constitute a "free sample" in violation of the deeming regulations. CIGAR HEALTH WARNINGS The deeming regulations add two new health warnings to four existing cigar health warnings that have been in place since 2000 under a settlement between the Federal Trace Commission and the seven largest cigar manufacturers. The current four warnings include the following: WARNING: Cigar smoking can cause cancers of the mouth and throat, even if you do not inhale. WARNING: Cigar smoking can cause lung cancer and heart disease. WARNING: Cigars are not a safe alternative to cigarettes. WARNING: Tobacco smoke increases the risk of lung cancer and heart disease, even in nonsmokers. Challenges for Cigars & Pipe Tobacco Under Deeming Regs The impact of the FDA's deeming regulation is a game changer for all segments of specialty tobacco. >BY THOMAS BRIANT NATO NEWS > > One of the doz- ens of varieties of pipe tobaccos, hand blended by J.M. Boswells Handmade Pipes, a retail shop in Chambersburg, Pa.

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