Nicotine patches: FDA is considering a “modified risk” classification – European influences may also be coming

The classification – if granted – would not only mean a more formal recognition of the product category’s risk profile compared to cigarettes, but also that manufacturers would be able to communicate this to adult consumers; According to Index, the development may also affect European markets.

The FDA has previously approved the marketing of a nicotine patch product line (ZYN), and according to the agency’s assessment, switching from cigarettes to nicotine patches may have more benefits than risks for adult smokers overall. However, Hungarian regulations are already strict: a patch can contain a maximum of 17 mg of nicotine, a box can contain a maximum of 20 patches, and the packaging must be child-resistant.