The U.S. Food and Drug Administration (FDA) has announced to permit the marking and sale of two new tobacco products made by 22nd Century Group Inc. – Moonlight and Moonlight Menthol. These new cigarettes are filter type and contain a low amount of nicotine as compared to an average cigarette.
These two new products are based on premarket tobacco product applications (PMTAs) review which was submitted to the FDA by the company. It says that approving these low nicotine cigarettes would protect public health which is otherwise at a higher risk with using high nicotine cigarettes.
This is an attempt to reduce dependence on nicotine in adult Americans. People are unlikely to get addicted to cigarettes if they have a low amount of nicotine in them. This approval allows these new cigarettes to be sold and marketed all over the USA legally. However, it doesn’t mean that these cigarettes are nondamaging for health or “FDA-approved products.”
Moonlight and Moonlight Menthol cigarette are a little different from the typical cigarettes but they have similar health risks for all people. The reason is that they both contain nicotine, lesser or more quantity is potentially damaging for health in long term use. So far, there are no “100% safe tobacco products”.
The conventional US-made cigarette contains the nicotine of 10 to 14 milligrams (mg) in every cigarette. The low nicotine cigarettes go to 0.4 to 7.4 mg of nicotine per cigarette. But these new products Moonlight and Moonlight Menthol have reduced it to 0.2 to 0.7 mg per cigarette.
Mitch Zeller (director) from Center for Tobacco Products by FDA says that;
“Today’s authorization represents the first product to successfully demonstrate the potential for these types of tobacco products to help reduce nicotine dependence among addicted smokers. Still, we must remain vigilant to ensure that the products authorized today actually deliver on that promise for consumers. We’ll be closely monitoring how Moonlight and Moonlight Menthol are marketed and will take action as necessary if the company fails to comply with any applicable statutory or regulatory requirements or if there is a notable increase in the number of non-smokers, including youth, using these products.”
PMTA pathway regulates all manufacturers to demonstrate how their product would be safe for the public and not cause a health problem. This is a standard that would make the FDA consider any product’s risks and benefits for the US population. Note that in the case of these new cigarettes, this population includes both smokers and non-smokers. The evaluation also considers ingredients, fillers, additives, labeling, manufacturing, packing along with health risks and benefits.
Moonlight and Moonlight Menthol match to the FDA’s definition of the cigarette under its Act so the manufacturers are required to follow the restrictions that the FDA has set. One of these restrictions is to prohibit TV and radio advertising for tobacco products. It further checks how online marketing is done through websites and social media.
FDA has issued a document that explains these requirements that it follows while reviewing any company’s application.
The FDA the federal agency that works with the U.S. Department of Health and Human Services. It takes steps to protect public health at large by regulating all possible products that are affecting health directly or indirectly. Approval of these products doesn’t mean that the FDA would not keep a track of advertisements after granting approval.
As per policy, the manufacturing company needs to report FDA about all its product advertisements and marketing plans along with sale data, changes in production, labeling, or anything that is different from the original.
The FDA can also withdraw its marketing order regarding any product if it determines that the product is no more suitable for the public and is damaging public health.