FDA approves nicotine patches: a milestone in tobacco harm reduction

By: Trademagazin Date: 2025. 01. 31. 09:10

The U.S. Food and Drug Administration (FDA) has approved a new smokeless tobacco alternative for the U.S. market after reviewing extensive scientific evidence. The FDA has determined that nicotine patches reduce the risk of cancer compared to traditional cigarettes. However, it has emphasized that while the products can be legally marketed, they are not considered safe.

Scientific study results

The FDA’s approval decision was preceded by a comprehensive scientific review process. According to the results:

Nicotine patches emit significantly fewer harmful substances than traditional cigarettes.

The new products pose a lower risk of developing cancer and other serious health problems.
Nicotine patches can be legally marketed to adults over 21 in nicotine strengths of 3 to 6 milligrams.

However, the FDA emphasized that the decision does not mean that these products are safe. The US agency continues to monitor the market presence and use of nicotine patches and maintains its position that no tobacco product is completely risk-free.

The FDA’s Role and the Transformation of the Tobacco Industry

The FDA, part of the US Department of Health and Human Services, is responsible for regulating medical devices, drugs, food, cosmetics, and tobacco products. The agency’s ratings are authoritative worldwide and it makes independent, evidence-based decisions.

The tobacco industry is undergoing a major transformation, with the shift from traditional cigarettes to alternative, smokeless products. E-cigarettes, heated tobacco products, and nicotine patches are all part of this shift. While these products still contain nicotine and carry some risks, the FDA’s decision recognizes that their use poses fewer health risks than smoking cigarettes.

Current data shows that nicotine patch use among U.S. middle and high school students is relatively low, at just 1.8 percent. The FDA remains committed to protecting young people and strictly controls the marketing and availability of tobacco products.