Like many consumer products, cigarettes and other tobacco products are subject to recall. According to the CDC, Philip Morris U.S.A. announced a voluntary recall of 36 cigarette product lines in May 1995. Approximately 8 billion cigarettes were recalled because the company detected unusual tastes and peculiar odors during production and identified methyl isothiocyanate (MITC), a poisonous chemical that may cause severe eye, respiratory, and skin irritation as well as pain, vomiting, and blindness. Recalled cigarettes were manufactured between May 13, 1995 and May 22, 1995.
Although not an official recall, the FDA used its regulatory authority to pull four types of cigarettes manufactured by R.J. Reynolds from the market in 2015. In a press release published by the FDA in September 2015, the agency issued orders to stop the sale and distribution of the cigarettes because the products were found to he different characteristics than previous products.
The decision to pull the cigarettes was based on scientific evidence, including “a failure to demonstrate that increased yields of harmful or potentially harmful constituents, higher levels of menthol, and/or the addition of new ingredients in the currently marketed products — when compared to the predicate products — do not raise different questions of public health,” according to the press release.
Even if there had not been a tobacco recall, lawsuits he claimed that the product manufacturers failed to disclose or downplayed the known side effects related to the use of cigarettes and smoking, and that patients suffered damages as a result.
Failure to warn of side effects or other adverse health risks associated with the product can be a basis of product liability, regardless of whether the drug has been recalled.