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 earlier this year.
In the warning letters, the FDA explains that the companies are required to immediately correct the violations. Also, they have 15 working days from the date that they received the warning letters to submit a written response to the agency. The response must describe all corrective actions that the company has taken to bring their cigarette products and advertisements into compliance with the FDCA and accompanying FDA regulations, especially the Family Smoking Prevention and Tobacco Control Act (FSPTCA), which gives the FDA jurisdiction over the manufacturing, distribution, and marketing of tobacco products.
In particular, after reviewing the companies’ websites, the FDA found that several cigarette products were adulterated under section 902(8) of the FDCA because they are were marketed as modified risk tobacco products without FDA approval. According to section 911(b)(2)(A), a product is considered a modified risk tobacco product if its labeling or advertising represents that the product contains a reduced level of a substance or uses the descriptors light, mild, or low. For example, certain cigarettes were labeled as containing reduced levels of tar and nicotine. A modified risk tobacco product cannot be marketed without an FDA order pursuant to section 911(g). Otherwise, it is adulterated in violation of the FDCA.
Additionally, the FDA notes that many of the cigarettes are either adulterated or misbranded because they are marketed as flavored cigarettes in violation of the FDCA as amended by the FSPTCA. Under section 907(a)(1)(A), a cigarette or any of its components shall not contain a natural or artificial flavor, other than tobacco or menthol, as a constituent or additive that is a characterizing flavor. Cigarettes marketed and sold in violation of this provision are considered adulterated. Otherwise, if the cigarettes do not actually contain a characterizing flavor, they are misbranded as their labeling or advertising is false or misleading.
More information about the requirements for selling a modified risk tobacco product can be found here. If you have any questions about FDA regulations regarding the marketing of tobacco products or need a FDA attorney to help you respond properly to warning letters, please contact us at contact@sglawfl.com.