A new law set to take effect this month will see some vaping products using synthetic nicotine pulled from shelves if they fail to obtain authorization from the Food and Drug Administration (FDA).
President Joe Biden signed a $1.5 trillion omnibus spending bill on March 15, which included a provision that amends the definition of “tobacco product” to close a loophole for products containing lab-made synthetic nicotine. Can you
The federal Food, Drug and Cosmetic Act (FDCA) to define a tobacco product as “any product made from or derived from tobacco, or containing nicotine from any source that is intended for human consumption”. ) amended.
This change is generally not a ban on vaping or vaping products, but it could have major consequences for producers and consumers of e-cigarettes and could potentially lead to the withdrawal of popular products.
Previously, some producers of e-cigarettes had turned to synthetic tobacco in their products after a new rule went into effect in 2016 requiring e-cigarette companies to prove to the FDA that their products caused harm. did more good for public health.
Those companies were essentially taking advantage of a loophole that allowed them to continue selling synthetic nicotine-containing products through no fault of the FDA.
However, that loophole will close on April 14 when the new definition of a tobacco product with potential seismic implications for e-cigarette producers goes into effect.
Puff Bar, a major producer of disposable e-cigarettes, turned to synthetic nicotine after the FDA ordered the company to stop selling vapes in 2020 because it did not comply with the FDA application process. The company is likely to be affected by the upcoming changes.
Synthetic nicotine products can be sold on the market until April 14, but if companies want their products to remain on the market after that date, they must submit a Premarket Tobacco Product Application (PMTA) to the FDA by May 14. . ,
If PMTAs are deposited on time, the products can remain in the market for another three months till July 13. Any synthetic nicotine product that has not received FDA authorization by that date must be withdrawn from sale.
The change directly affects products that were originally based on nicotine derived from tobacco and had previously gone through the PMTA process.
If those products were denied authorization by the FDA and were later modified to use synthetic nicotine — and this was the only change — they would be banned effective April 13 and their manufacturers would use those products. You will not be able to submit new PMTA for Rs. To National law review.
Following the introduction of the new policy in 2016, e-cigarettes already on the market were supposed to obtain authorization from the FDA by September 2020, but the agency has been slow to process applications.
The FDA had to decide which products met its standards by September 2021, but the agency still hasn’t announced its decisions for major brands, including Juul.
The agency made its first authorization for the Vuss Solo vaping device and its e-liquid pods in October 2021. On March 24 of this year, the FDA granted authorization to several products from Logic Technology Development LLC.
In its announcement of the logic decision on March 24, the FDA said that authorization did not mean that the products were safe or “FDA approved.”
“All tobacco products are harmful and potentially addictive. People who do not use tobacco products should not start,” the agency said.
newsweek The FDA and the White House have been asked for comment.