FDA Comprehensively Approaches Nicotine Replacement Product Development

The United States Food and Drug Administration has announced that it is going to re-evaluate and modernize its approach to regulate the nicotine replacement therapies (NRT) that are commonly sold as lozenges, patches and gums. The agency is looking forward to make available a wide range of other options for nicotine as they are less effective.

The new regulations can enable more e-cigarette companies for being accepted the devices as medical products that could give consumers major reassurance that they are performing as advertised as well as open the chances of being covered by health insurance.

American physician, and commissioner of the FDA, Scott Gottlieb said in a statement that, “the announcement “is a big deal because we haven’t talked a lot about what we can do to create additional pathways to bring additional nicotine replacement therapies to the market.”

However, the announcement is a part of broad nicotine policy, which has been outlined by FDA commissioner Gottlieb in July in order to reduce the disease occurrences and deaths due to the traditional cigarettes in transitioning smokers to the less harmful nicotine products like e-cigarettes.

President at the Campaign for Tobacco-Free Kids, Matthew Myers welcomed this initiative and said that, “Very few NRT products have been cleared in the last decade and very little change has been made to enhance the effectiveness of current NRTs. Sending a message that the FDA intends to be open to innovation and that it wants to talk about how to foster that innovation is different from where things have been.”

 

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