PSI’s TobaccovigilanceSM experts support the tobacco industry with consultation services regarding FDA compliance. We offer solutions to implement increased Federal regulation and support components of tobacco applications, and we empower the tobacco industry’s clientele with medical knowledge for effective preventative care. We are solution motivated and have the tools and experience necessary to tackle regulatory compliance and ensure your success. We are prepared to help you through our guidance, expertise, and dedication to succeed.
Definition of Tobaccovigilance
TobaccovigilanceSM is the science related to the collection, assessment, and prevention of adverse health effects and product quality complaints with tobacco and tobacco related products. The etymological roots for the word ” tobaccovigilanceSM ” are: tobacco originates from the Spanish and Portuguese word “tabaco” As such, tobaccovigilanceSM heavily focuses on adverse events (aka. adverse product effects) and product quality-related issues that are systematically coded and evaluated using a standardized terminology (e.g., MedDRA).
Information received from tobacco users and healthcare providers as well as other sources such as the medical literature and the scientific (government or nongovernment) or academic communities involved in assessing the toxicity and various effects of tobacco constituents, plays a critical role in providing the data necessary for tobaccovigilanceSM to take place. In fact, in order to market or to test a tobacco product in most countries, adverse product effect data received by the license holder (usually a tobacco company) must be submitted to the local regulatory authority.
Ultimately, TobaccovigilanceSM is concerned with the adverse effects (both health related and product related) associated with tobacco products and with minimizing the risk of any harm that may come to tobacco users or those exposed to smoke or smokeless tobacco products. Companies must conduct a comprehensive safety and tobaccovigilanceSM audit to assess their compliance with global laws, regulations, and guidance.