The U.S. Food and Drug Administration has announced the authorization marketing of two new tobacco products today. These tobacco products are manufactured by 22nd Century Group Inc.-Moonlight and Moonlight Menthol. These filtered, combusted cigarettes contain a low amount of nicotine as compared to typical cigarettes and thus relatively less damaging to health.
The company submitted the premarket tobacco product application by following the rigorous science-based review. The agency is aimed to protect public health by authorizing the reduced nicotine products for selling in the U.S. This is beneficial as it potentially reduces the dependence of nicotine among all smokers. By using these low nicotine-containing cigarettes, the exposure level is reducing in addicted individuals.
The agency is also able to determine that the usage of products among non-smokers is increased and those who are involved in the experiment showed that they become less addicted as compared to those who use conventional cigarettes.
According to today’s action plan the new product is permitted to be sold or distributed legally in the U.S. this doesn’t mean that these products are safe to use of FDA approved. The Moonlight and Moonlight Menthol cigarette products are different from conventional cigarettes regarding the nicotine content.
The product also has similar adverse health risks as conventional cigarettes. Tobacco products are not safe to use, and its usage is prohibited in healthy people.
According to Mitch Zeller, who is the director of the FDA’s Center for Tobacco Products that in July 2017 FDA made a comprehensive plan for regulating tobacco and nicotine. So, our company takes it on a serious note and does actions for making the products that reduce the addiction among smokers.
Also, it lowers the likelihood of addiction in future generations. The product successfully shows the potential in reducing the dependence of addiction among smokers. The moonlight and moonlight menthol are monitored closely how the company is marketed and necessary action will be taken if the company is failed to fulfill the conditions and regulatory requirements or if there is no reduction in the number of nonsmokers by using the products.
Under the PMTA pathway, the marketing of the product would be beneficial for protecting the public health. The agency is trying to meet the standards of FDA for considering the risks and benefits to the public that include users and non-users of the tobacco.
The evaluation from the agency includes a review of the tobacco product ingredients, components, additives, and health risks. Also including the product manufacturing and packaging
The conventional cigarettes contain 10 to 14 milligrams of nicotine per cigarette. Previously The researches show that modified cigarettes contain the reduce level of nicotine content that ranges from 0.4 to 7.4 mg per cigarette.
The product launched by Moonlight and Moonlight Menthol has a nicotine content range from 0.2 to 0.7 mg per cigarette. Generally, it is determined that the number of cigarettes per person in the day reduces but the intensity of the puff did not decrease as they want to attain the same level of nicotine as from conventional cigarettes.
Since the product meets the standard of the cigarette that is defined by the FDA, its marketing is prohibited as thorough media, tv advertisements. Also, limit the access of youth to such products to prohibit the addiction.
FDA has a strong restriction on product marketing, for this purpose agency, issued a document for postmarking requirements, that contains the rationale for its marketing.so FDA evaluated this product after having the view of the data regarding its post-market records and reports. It is necessary for the company to regularly report the FDA about the marketing information of the product.
Today’s action is not describing the decision on the separate modified risk of tobacco product (MRTP) application, which is submitted by the company to the market, but it defines the product with the specific risk information that is modified.
The company must receive the MRTP from the FDA for officially introducing or selling the tobacco product in the market as it elicits the claims about the reduction of nicotine addiction among smokers. If the company is marketing its product with receiving the MPTP from FDA, so it would violate the law and it may face FDA advisory and enforcement actions.