In the case of Camel Crush Bold, the addition of a menthol capsule was considered a significant change to the product. Menthol is a flavoring agent that can mask the harshness of tobacco smoke and make it more appealing to consumers, particularly young people. The FDA has recognized that menthol can make it easier to start smoking and harder to quit, and has therefore expressed concerns about the use of menthol in tobacco products.
R. J. Reynolds was required to demonstrate that the addition of a menthol capsule in Camel Crush Bold did not result in a product that was more appealing to young people or had other negative public health consequences. However, the company failed to provide sufficient evidence to support this claim. They were unable to show that the new formulation did not raise different public health questions compared to the original version of Camel Crush.
It is important to note that this decision was specific to Camel Crush Bold and its particular formulation. Other tobacco products with different formulations may have undergone separate evaluations and may have been allowed to remain on the market. The decision to ban a specific product is based on the evidence and information provided by the manufacturer, as well as the FDA's assessment of the product's potential impact on public health.
The ban on Camel Crush Bold highlights the FDA's commitment to ensuring that tobacco products are safe and do not pose undue risks to public health. It also underscores the importance of manufacturers providing robust evidence to support their claims regarding the safety and impact of new product formulations.