Lovelace Biomedical has been performing cigarette smoke inhalation exposure studies for more than 25 years. These studies include characterization of the cigarette smoke, testing of the cigarette smoke generation and exposure systems, effects of puffing modes, deposition of the cigarette smoke in laboratory animals, comparison of whole-body and nose-only cigarette smoke exposure systems. Beyond this, Lovelace Biomedical has been working to understand to understand the toxicological effects of cigarette smoke inhalation exposure in laboratory animals and in vitro exposure to cells.
As part of this rich history, Lovelace Biomedical has developed hundreds of protocols for the study of tobacco or tobacco constituents that can be executed under GLP or non-GLP conditions. These include:
- cell culture
- analytical chemistry
- aerosol delivery (of tobacco products)
Beyond this, we are also involved in clinical trials to assess pharmacokinetics, safety and abuse liability. Our work has helped the FDA and other to better understand the safety of these products, and to help define the regulatory needs to help ensure the safety of potential consumers.
The FDA Center for Tobacco Products (CTP) is responsible for carrying out the Family Smoking Prevention and Tobacco Control Act, which Congress passed in 2009. This law—commonly called the Tobacco Control Act—gives them broad authority to regulate the manufacturing, distribution, and marketing of tobacco products. In 2016, the FDA’s regulatory authority was extended to e-cigarettes and other alternative tobacco products. Lovelace Biomedical is uniquely positioned to work with companies developing alternative tobacco products to navigate this regulatory landscape and generate the data necessary to understand their utility and limitations.