Alternative Tobacco & Cannabis Products
Lovelace Biomedical has been performing cigarette smoke and alternative tobacco inhalation exposure studies for more than 25 years. These studies include characterization of the atmosphere composition, development of the generation system to match the product (e.g. cigarette, electronic cigarette, hookah, etc.), and merger with the in vitro or in vivo exposure systems. These systems can be utilized to evaluate almost any aspect required but often include: effects of puffing protocol, deposition of the in laboratory animals, changes in the composition (particulate and gas phase) of the atmosphere, evaluation of pharmacokinetics and evaluation of toxicology in in vivo models.
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
- bioanalytical chemistry
- cytotoxicity
- genotoxicity
- aerosol delivery (of tobacco products)
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.