Ed Carmines PhD brings over a three decades of experience in regulatory and compliance solutions within the tobacco and nicotine industry. He is a proven leader with the ability to merge science and business. He has extensive experience with the Center for Tobacco Products at the FDA. He has a proven track record with Premarket Tobacco Applications, Modified Risk Tobacco applications, Substantial Equivalence, and Exemptions Requests. He is known for his detailed knowledge of the technical aspects of all types of e-cigarettes, oral tobacco, tobacco leaf free oral products, cigars, Heat Not Burn products and cigarettes as well as the regulatory requirements for product authorization. He is known for his ability to understand complex scientific problems and to develop business relevant solutions.
During his tenure at Altria, Ed was initially responsible for the safety of cigarettes worldwide. He played a pivotal role in designing and executing a program to test the safety of ingredients and materials used in the manufacture of cigarettes. He was intimately involved in the development of new reduced risk products including the original Heat Not Burn product, Accord. This product was the precursor to IQOS. At the end of Ed’s career at Altria, he was responsible for innovation. His team was involved in finding and evaluating new technology and products. After retiring from Altria, Ed was employed by Reynolds. His role there was shepherding product safety review of novel and oral products. He was involved in the early development of the VUSE e-cigarette.
Ed has been a consultant to the tobacco industry for over 20 years. He single handedly designed the program, executed the studies, and wrote the PMTA and MRTP applications for VLN reduced nicotine cigarettes (over 20 million pages of documents). The PMTA was authorized in 2019 and the MRTP in 2021. This is the only cigarette ever to receive market authorization. He joined Chemular in 2019 as the Chief Scientific Officer. Ed directs all aspects of the scientific studies involved in PMTA and MRTP applications. During his tenure with Chemular, Ed has directed the work on over 1000 PMTAs on all types of ENDS, smokeless tobacco, modern oral products, and novel products.
