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The FDA’s Confusing Rulings


America’s Food and Drugs Administration (FDA) has finally authorised a premarket tobacco product application (PMTA), but the decision leaves uncertainty in its wake. Any company wishing to sell its products in the USA had to apply for every single product, the FDA missed its September deadline to review them all. The granting of marketing orders to R.J. Reynolds received a muted celebration and widespread condemnation.

Today’s authorisations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation. The manufacturer’s data demonstrates its tobacco-flavoured products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals,” said Mitch Zeller, J.D., director of the FDA’s Centre for Tobacco Products.

We must remain vigilant with this authorisation and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth. We will take action as appropriate, including withdrawing the authorisation.”

The FDA issued 10 marketing denial orders (MDOs) to Reynolds for undisclosed non-tobacco flavoured products “due to potential confidential commercial information issues”, something so confidential all the flavoured products can be seen on the Vuse website.

Energy and Commerce Committee Chairman Frank Pallone, Jr (Democrat) responded to the announcement, saying: “The United States is in the middle of a youth tobacco epidemic that has been driven in large part by flavoured e-cigarette products that hook kids and teens into a cycle of nicotine addiction. This is a public health crisis that continues to demand our attention and action before we lose another generation of young people to a lifetime of tobacco and nicotine addiction.

“While I am pleased that FDA denied requests by the manufacturer to market certain flavours, I remain concerned given this product’s popularity with youth, as recently noted in the 2021 National Youth Tobacco Survey. I urge FDA to move swiftly on the other pending premarket review applications before the agency.”

Burying their heads in the sand and clinging onto the lie that there is an “epidemic” of teen vaping, it is clear that for all the benefit that an authorised product has to the overall image of ecigs, the press is still on to move for a prohibition of flavours and certain products.

The position is exemplified by Matthew Myers, the president of the Campaign for Tobacco-Free Kids. He stated: “The only way Vuse [products] could be used to reduce health harms relating to tobacco are if smokers switch entirely or near-completely from smoking to using the Vuse e-cigarette instead. Any other use will increase the health harms and risks to the users.”

Gregory Conley, president of the American Vaping Association explained the confusion: “It’s all up in the air. FDA has not issued any new [marketing denial orders] since Sept. 23, after a month of just non-stop shuttering tobacco-derived nicotine e-cigarette businesses in America. And then it all stopped.”

Sam Salaymeh, President, Kure CBD and Vape still feels there is room for celebration: “The U.S. FDA has issued its first-ever, marketing authorisation for electronic nicotine delivery system (ENDS) products. This historic win for adult smokers confirms these specific products have been scientifically proven ‘appropriate for the protection of public health,’ and therefore verifies that adult users are exposed to significantly fewer toxic aerosols and less harmful or potentially harmful constitutes than found in combustible cigarettes. The science has spoken, and this is a great public health win for countless adult smokers looking to transition from deadly cigarettes.

“Kure CBD & Vape on behalf of its numerous e-liquid brands, has submitted to the FDA many robust scientific studies proving its products are ‘appropriate for the protection of public health.’ We look forward to our continued dialogue with the Agency as we move forward in the regulatory process, especially as it relates to the importance of flavoured products for adult smokers.”

The dialogue that most are planning on having is one via a court, companies such as Triton Distribution’s (responsible for Suicide Bunny e-liquid among others). It achieved an emergency motion for a stay of the MDOs it received and the list of companies opting to go down the legal route continues to grow.

News from:https://www.planetofthevapes.co.uk/news/vaping-news/2021-10-18_the-fda-s-confusing-rulings.html