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FDA approves discontinuation

Time: 2021-12-10

Views: 536

FDA approves discontinuation of smoke-free product Verve faces 46 lawsuits

About a week after the first e-cigarette was successfully approved for PMTA (Pre-market Tobacco Application) (previously it has rejected millions of applications), the U.S. Food and Drug Administration (FDA) approved the U.S. smokeless tobacco company under the Verve brand. Of four smokeless chewing tobacco products.


The only problem is that these products were discontinued in 2019 by Altria 7 years after they were on the market. FDA-approved Verve products contain nicotine extracted from tobacco, but do not contain tobacco, including Discs Blue Mint, Discs Green Mint, Chews Blue Mint and Chews Green Mint. Altria submitted the PMTA for these products in November 2017. Interestingly, the FDA determined that "the marketing of these products meets statutory standards-suitable to protect public health", even if they are, or used to, contain menthol.


Mitch Zelleri, director of the FDA Tobacco Products Center, said: "Although these are mint-flavored products, data submitted to the FDA shows that the risk of young people ingesting these specific products is very low. Strict marketing restrictions will help prevent young people from being exposed." The approved Verve product has been discontinued, but Altria said that at the beginning it applied Verve's technology for oral nicotine development-nicotine cartridges. The product has been marketed and approved by PMTA, and is awaiting FDA review.


According to Bloomberg News, Zeller said in a speech at the Food and Drug Research Institute online conference that the FDA still has about 80,00 products to review, many of which are in the "final stage." He added that the FDA refused to sell 200,00 products and faces 46 lawsuits.


Among them, Triton Distribution filed a lawsuit that challenged the FDA's rejection of its PMTA application and put it on hold. The U.S. Court of Appeals for the Fifth Circuit approved the application. The FDA "changed suddenly and unexpectedly." Early guidelines stated that manufacturers do not need to submit long-term research reports before obtaining PMTA. But the rules were suddenly changed in August last year. The agency announced that manufacturers need to submit long-term studies to prove that the use of their products can help adult smokers quit smoking and bring less risk to teenagers.



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