On December 16, the FDA issued warning letters to six online retailers for selling “across state lines a tobacco product subject to a Not Substantially Equivalent (NSE) Order.” Once an NSE order has been issued for a particular tobacco product by the FDA’s Center for Tobacco Products, the products are considered “misbranded and adulterated” and therefore cannot be sold, marketed, or distributed.
In these six instances, the products in question were all smokeless tobacco products which had a NSE Order issued in August 2014. In addition to the NSE Order violation, two of the retailers in question were cited for Health Warning Statement violations, where the required warnings were not displayed alongside advertisements for smokeless tobacco products. In addition to violations on their main website, one of the retailers was also cited for violations occurring on their Facebook and Twitter pages.
Furthermore, one retailer was found to be using the descriptor “mild” in reference to smokeless tobacco products, as well displaying some products claiming to have “lower nicotine content” – statements which the FDA considers to qualify the products as a “modified risk tobacco products.” In order for a tobacco product to be considered “modified risk,” it must be evaluated by the FDA and an Order must be issued if the product in question is determined to carry a lower risk of tobacco-related disease. Such descriptors, when used in conjunction with a product that has not been through this process, are in violation of the FD&C Act.
If these violations are not appropriately and timely corrected, these retailers could face further action from the FDA including civil monetary penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Navigating the intricacies of the FD&C Act as they relate to online sales & marketing of tobacco products is not the easiest thing to do, and it could be that many of these cited violations were made unintentionally. If your business is currently selling tobacco products online, or looking to wade into those waters, protect yourself and your business investments by seeking counsel to ensure that your company is following all applicable federal and state requirements for legal sale.