SS December 2015

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36 SMOKESHOP December 2015 S wedish Match North America has been given the green light to mar- ket eight new snus products under the General brand in the U.S., represent- ing the first time the U.S. Food and Drug Administration (FDA) has authorized the marketing of any new tobacco products through the premarket tobacco applica- tion (PMTA) pathway since the agency was given the authority to regulate the industry as part of the Family Smoking Prevention and Tobacco Control Act of 2009. The marketing orders became effec- tive immediately upon FDA's November 10, 2015 announcement. "The law is clear," Mitch Zeller, di- rector of the FDA's Center for Tobacco Products, said in a statement. "Compa- nies must apply to the FDA first, and then the FDA uses a rigorous scientific review to determine if new tobacco products should come to market under this path- way." Zeller said that the action "demon- strates that the premarket tobacco appli- cation process is a viable pathway under which products can be marketed as long as the public health can be protected." The FDA reviewed the ingredients and additives of the smokeless tobacco products, as well as how they are pack- aged and labeled, and determined they are unlikely to attract new smokers. "The FDA's review also determined that these products would likely provide less toxic options if current adult smoke- less tobacco users used them exclusively," the agency wrote. The process, though, raised more questions that answers for the industry. WHAT THE FDA SAID Following a rigorous, science-based re- view, the U.S. Food and Drug Adminis- tration announced that for the first time it has authorized the marketing of new to- bacco products through PMTA pathway. This action permits the tobacco products to be sold in the U.S., but does not mean that they are safe or "FDA approved." The Family Smoking Prevention and Tobacco Control Act of 2009 granted the FDA authority to regulate the manufac- turing, marketing, and distribution of to- bacco products. The law gave the agen- cy the authority to permit new tobacco products to be introduced to the U.S. market under specific circumstances. Under the PMTA pathway, manufac- turers must demonstrate to the agency, among other things, that marketing of the new tobacco product would be ap- propriate for the protection of the public health. That standard requires the FDA to consider the risks and benefits to the population as a whole, including users and non-users of tobacco products. The FDA's scientific evaluation in- cludes reviewing a tobacco product's com- ponents, ingredients, additives and health risks, as well as how the product is man- ufactured, packaged and labeled. The re- view also takes into account the increased or decreased likelihood that existing to- bacco product users will stop using such products, and the increased or decreased likelihood that those who do not use to- bacco products will start using them. The marketing orders are for eight Swedish Match North America Inc. snus smokeless tobacco products under the General brand name. The PMTA deci- sions for these products reflect evidence > REGULATION INSIGHT FDA touts its first-ever approval of new smokeless tobacco products as proof that its path-to-market gateway works. But the process for Swedish Match was costly and grueling, and the snus products were actually variations of well-studied existing ones, raising doubts about the broken approach for less risky products. >STAFF REPORT After EightYears, the FDA's first-ever PMTA Approval Swedish Match North America PMTA Marketing Orders Approved for Snus Brands, November 2015 • General Loose • General Dry Mint Portion Original • General Portion Original Large • General Classic Blend Portion White Large • General Mint Portion White Large • General Nordic Mint Portion White Large • General Portion White Large • General Wintergreen Portion White Large

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