When may FDA decide to seek civil money penalties and/or no-tobacco-sale orders?
• Procedures that apply if FDA seeks civil money penalties and/or no-tobacco-sale orders • What amount of civil money penalty may be assessed for a violation of the FDCA relating to tobacco products (including a violation of regulations issued under Section 906(d) of the FDCA) ? • What factors must FDA consider when seeking a no-tobacco-sale order, and how long may such an order run? FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. II. Background On June 22, 2009, President Obama signed the Tobacco Control Act into law. The Tobacco Control Act amended the FDCA to give FDA important new authority to regulate the manufacture, marketing and dis
