The FDA has recently started to regulate e-cigarettes as a tobacco product, but the agency still has some work to do in determining how rigorously these products should be tested before they’re sold to the public.
Lovelace Biomedical is working with the FDA and industry groups to help answer the question of just how risky e-cigarettes may be. Last month, Lovelace served as the host organization of the 21st Congress of the International Society for Aerosols in Medicine (ISAM), which featured a workshop on e-cigarettes that included Lovelace’s own Philip Kuehl, Ph.D., director of Scientific Core Laboratories, and Matt Reed, Ph.D., director of Preclinical Drug Development – Toxicology.
The Lovelace team has been performing cigarette-smoke inhalation exposure studies for more than 25 years, ranging from characterization of smoke to comparison of whole-body and nose-only exposure systems. We also are experts in measuring the toxicological effects of cigarette smoke inhalation exposure, using a variety of innovative methods and models depending on the needs of the study.
Because of this expertise, we’re uniquely positioned to work with companies developing alternative tobacco products. We can help navigate the regulatory landscape and generate the data necessary to understand the utility and limitations of given products. We have 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, cytotoxicity, genotoxicity and aerosol delivery.
Our foundational work already is carrying over into groundbreaking research on e-cigarettes. For those who are active in (or curious about) the e-cigarette space, here are some key things you should know:
- A deadline is approaching. E-cigarette manufactures have until August of 2018 to submit an application with the FDA to remain in the marketplace. For now, these products — an estimated 500 brands and 7,700 flavors — are largely unstudied.
- “Electronic cigarettes” is an encompassing term. According to the American Lung Association, e-cigarettes include devices such as e-pens, e-pipes, e-hookah, and e-cigars. E-cigarettes are generally battery-operated and use a heating element to heat e-liquid from a refillable cartridge, releasing a chemical-filled aerosol.
- E-Cigarette liquid includes a mix of many components. At the core of an e-cigarette is the “e-liquid” contained in cartridges. To create this e-liquid, nicotine is extracted from tobacco and mixed with a base (usually propylene glycol), and may also include flavorings, colorings and a host of other chemicals, many of which are potentially harmful.
- Certain flavoring chemicals come with inhalation risks. Flavoring is one of the top reasons youth and young adults use e-cigarettes, according to a study by the U.S. Surgeon General. Diacetyl, a buttery flavored chemical often added to food products such as popcorn, caramel, and dairy products, has also been found in some flavored e-cigarettes. Diacetyl can cause a serious and irreversible lung disease commonly known as “popcorn lung.”
- Emission testing isn’t just for cars. While e-cigarettes do not contain smoke, they do expose others to secondhand emissions. Studies have found formaldehyde, benzene and tobacco-specific nitrosamines (all carcinogens) coming from those secondhand emissions. Other studies have shown that chemicals in the emissions contain formaldehyde, acetaldehyde and other potential toxins.
For more information on Lovelace Biomedical’s capabilities to perform preclinical work on alternative tobacco products, contact us today.