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 marketing practices in line with the requirements of the Federal Food, Drug and Cosmetic Act (“FDCA”). These warning letters can be read in their entirety by clicking here and here. Under the terms of the warning letters, the companies were also directed to submit a written response within 15 business days from the receipt of the warning that details the corrective actions they have taken to become compliant with the FDCA and FDA regulations.
The violations these companies have been targeted for fall into two general categories. Marketing cigarettes as “light”, or “ultra-light”, and marketing flavored cigarettes. The FDA does regular compliance checks to make sure tobacco retailers are in compliance with FDA regulations, the FDCA and its various amendments, including the Family Smoking Prevention and Tobacco Control Act. This Act, which was signed into law by President Barack Obama in 2009, gives the FDA the power to regulate the manufacture, distribution, and marketing of the tobacco industry.
Provisions of the Family Smoking Prevention and Tobacco Control Act require placement of new warnings and labeling statements on tobacco products and specifically ban flavored cigarettes. The Act also requires FDA approval to use marketing terms such as “mild”, “light”, or “low” that can give a false impression that the product poses less of a health risk than a conventional tobacco product. The ban on flavored cigarettes is an attempt by the federal government to discourage young people from taking up the habit, as it is the government’s stance that these flavors particularly appeal to younger consumers. More information about FDA guidelines for marketing tobacco products can be accessed here.
Failure to comply with federal law and accompanying FDA regulations can result in serious consequences. While warning letters are typically the FDA’s first course of action against companies for alleged non-compliance with the FDCA and/or FDA regulations, failure to resolve the issues cited therein may result in more stringent action. Because appropriate corrective measures may often preclude further enforcement measures, it is critical to be vigilant when mounting a response to perceived deficiencies in compliance and doing so may help a company remain in business without further problem.
For questions about FDA regulations regarding the manufacturing, distribution, and marketing of tobacco products or how you can effectively respond to an FDA warning letter, please contact us at firstname.lastname@example.org.