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FDA to Regulate New Tobacco Products, E-Cigarettes

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On April 24, 2014, the U.S Food and Drug Administration (FDA) announced its publication of newly proposed regulations pertaining to new tobacco products, as permitted by the Family Smoking Prevention and Tobacco Control Act of 2009. The products covered under the newly-proposed regulations are any tobacco related products that fall under the statutory definition of tobacco products, including presently uncontrolled, advertised products like pipe tobacco, electronic cigarettes (e-cigarettes), nicotine gels, water pipe tobacco, cigars and other related products. While some products, like electronic cigarettes, don't directly consist of tobacco, these products fall under FDA’s tobacco authority, as promulgated by Congress,…
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FDA Considering Rulemaking for Menthol Cigarettes

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On July 23, 2013, the U.S. Food and Drug Administration (FDA) issued an Advanced Notice of Proposed Rulemaking (ANPRM) to request information regarding the agency’s regulation of menthol cigarettes. Menthol is a common flavoring additive used in tobacco products and is currently the only flavor permitted for use in cigarettes. The FDA is considering further regulation as a way to address certain public health risks that are raised by menthol cigarettes, particularly in comparison to regular cigarettes. You can read the ANPRM here. The FDA has authority to regulate tobacco products pursuant to the Federal Food, Drug, and Cosmetic Act…
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FDA Issues Substantially Equivalent Marketing Orders for New Tobacco Products

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On June 25, 2013, the U.S. Food and Drug Administration (FDA) issued substantially equivalent (SE) marketing orders for two new tobacco products marketed by Lorillard Tobacco Company, Newport Non-Menthol Gold Box 100s and Newport Non-Menthol Gold Box. This is the first time that the FDA has approved the marketing of new tobacco products since the Family Smoking Prevention and Tobacco Control Act (FSPTCA) gave the FDA jurisdiction over the manufacturing, distribution, and marketing of tobacco products in 2009. The announcement is provided at this link, and you can read the marketing orders for the new tobacco products here and here. Pursuant…
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FDA Issues Warning Letters to Online Cigarette Companies

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In April 2013, the U.S. Food and Drug Administration (FDA) issued warning letters to certain online cigarette retailers, finding many of their products adulterated and misbranded in violation of the Federal Food, Drug, and Cosmetic Act (FDCA). One of the companies is located in Indonesia but offers its cigarettes for sale to customers in the United States. It is unclear where the other company is based, as it is an internet retailer with no available address information. You can read the warning letters by clicking here and here. The FDA sent similar warning letters to other online retailers of cigarettes…
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FDA Warns Online Cigarette Retailers for Marketing Violations

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In January 2013, the U.S. Food and Drug Administration (”FDA”) sent out several warning letters to online retailers of cigarettes, detailing certain marketing or product statements made that are in violation of federal laws that govern the practice. Several companies were targeted, including those with websites located at: www.smoke-cash.com and www.cheap-cig.com. A complete list of companies that were sent warning letters can be seen by clicking here. In the warning letters, these firms were strongly advised to correct marketing practices on specific products immediately and to submit a response to the warning letters with a specific plan to get their…
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