Should the FDA Deem Tobacco Lozenges a “Modified Risk” Product
Star Scientific Inc. is asking the FDA to certify its tobacco products as less harmful than other tobacco products. Star Scientific sells tobacco lozenges that dissolve in your mouth, and they have asked the FDA to approve the lozenges as a product that is a “modified risk” commodity. The Virginia-based company claims that the levels of some cancer-causing chemicals prevalent in tobacco and tobacco smoke are “below detectable.” However, the wintergreen-flavored product contains nicotine, which is tobacco’s most addictive ingredient.
The marketability of this product is huge; as the demand for cigarettes declines, tobacco companies are concentrating on providing consumers with alternatives to cigarettes including snuff, cigars and chewing tobacco. Still, the FDA expressed concern that the lozenges, called Ariva-BDL, might appeal to young adults and children and asked that Star Scientific produce information and research so that this issue can be addressed.
Whether Ariva-BDL has below detectable amounts of certain cancer-causing chemicals or not, it still contains nicotine – a chemical that has been linked to mouth cancer. In fact, recent research has produced evidence that indicates nicotine levels in smoking cessation products can worsen genetic mutations common in mouth cancer. Simply put, nicotine could be more carcinogenic than we thought.
While nicotine replacement products are, for the most part, much less dangerous than cigarettes, smokers are already at a higher risk of oral cancer. Some may already have lesions of which they are unaware. Doctors worry that habitually consuming nicotine via replacement products after quitting smoking may keep people at a high risk of mouth cancer.
Whether the FDA deems Ariva-BDL or any nicotine replacement product as a “modified risk” product in the future, consumers should heed product labeling; labels usually advise that consumers cut down their use of the product after three months and stop altogether after six.
Michael Monheit is the managing lawyer at Monheit Law, outside Philadelphia, Pennsylvania. He has practiced law since 1989. Michael Monheit was the managing attorney of the law offices of Herbert Monheit — now Silverman and Fodera — a firm... Michael Monheit→