- The FDA authorizes the marketing of eight snus smokeless tobacco products made by Swedish Match (OTCPK:SWMAF)(OTCPK:SWMAY). The approvals are the first under the agency's premarket tobacco application (PMTA) pathway, established under the Family Smoking Prevention and Tobacco Control Act of 2009, which gave the FDA the authority to regulate the manufacturing, marketing and distribution of tobacco products.
- Under the PMTA pathway, manufacturers must show that the marketing of the new tobacco product(s) would be appropriate for the protection of the public health. The review process includes an assessment of the product's components, ingredients, additives and health risks and also takes into account the increased/decreased likelihood that existing tobacco users will cease using such products and the increased/decreased likelihood that non-users will start using.
- As a condition of approval, the company is required to report regularly to the FDA with information regarding the products on the market, including advertising, sales data, information on current and new users and adverse experiences. The agency can withdraw its marketing order if it determines that the continued marketing is inappropriate for the protection of public health.