American e-cigarette company rejected PMTA by FDA to explore synthetic nicotine substitution
According to foreign reports, the U.S. Food and Drug Administration (FDA) rejected the first marketing application of about 55000 flavored e-cigarette products from three small companies. According to an FDA press release, applicants lack sufficient evidence that they have sufficient benefits for adult smokers to overcome the public health threat posed by the well-documented and shocking level of use of such products by adolescents.
In early August, FDA refused to submit about 4.5 million product applications to JD Nova on the grounds that the company failed to conduct a full environmental assessment of these products. Allowing the agency to reject these applications without fully considering any corresponding scientific or behavioral data that may have been included is largely bureaucratic.
This new rejection is equivalent to the first direct rejection of e-cigarette products through the FDA’s pre marketing tobacco application (PMTA) procedure, which requires manufacturers to prove through substantive scientific review that their products are suitable for protecting public health. The FDA determined that this was not the case for the products of three applicants: Great American vapes, vapor salon and (again) JD nova.
Tobacco harm reduction (THR) advocates were shocked by the decision, saying that the agency said it would not approve bottled electronic liquids of any flavor other than tobacco. Nevertheless, although it is undeniable that this development is not a source of optimism for thr supporters, it did not bring immediate disaster.
It is unclear what FDA will do before the September 9, 2021 deadline, when it should decide which steam products can legally remain on the market. It is unclear which companies and tastes, if any, the agency may eventually authorize.
More and more manufacturers see synthetic nicotine as a means to bypass FDA regulations.
However, e-cigarette manufacturers, consumers and advocates are generally worried that the FDA will only authorize companies with the largest market share, resulting in the closure of most family e-cigarette stores and small and medium-sized manufacturers.
Or these manufacturers will design new and unique ways to potentially get rid of FDA regulatory crosshairs. Like vapor salon, a small manufacturer in Fort Worth, Texas, its products have just been rejected by the FDA.
In a public post on Facebook, on the same day that the company refused to comment on an article in the Washington Post, vapor salon wrote that it would switch to Synthetic Nicotine by Friday, August 27 – its products came from the market less than 24 hours after the FDA ordered the company to remove them.
“Vapor salon will switch to smokeless nicotine on Friday, August 27, 2021,” the Post wrote. “The main purpose of this is not to meet the strict PMTA requirements of FDA, which will come into full force on September 9, 2021. You need to obtain an approved PMTA, otherwise your product will not be sold. So far, 0 pmtas related to ends have been approved.”
As previously reported, more and more manufacturers have begun to study the possibility of synthetic nicotine – that is, nicotine is manufactured in the laboratory rather than extracted from tobacco – as a means of possibly bypassing FDA regulations.
FDA defines a tobacco product as any tobacco made or derived from any component, component or accessory intended for human consumption, including tobacco products. In the closest and most technical interpretation, the wording will prevent the agency from treating Synthetic Nicotine like other nicotine products almost always extracted from tobacco.
Nevertheless, Synthetic Nicotine is still expensive – vapor salon said that many of their re adjusted products will now increase prices – how long will the FDA wait if another wild west scenario develops, because the agency has issued more PMTA denials and additional manufacturers are trying to inevitably transition to synthetic nicotine.
Eric Lindblom, a senior scholar at the O’Neill Institute of national and global health law at Georgetown University and former director of the Policy Office of the FDA tobacco products center, explained that the FDA usually waits until a crisis occurs before taking action or Congress orders the agency to do something. “We are unlikely to see many e-cigarette enterprises close down immediately after marketing rejects orders.”
Lindblom analyzed two potential responses from the FDA: the first, which he considered unlikely, was that the agency could exercise jurisdiction over Synthetic Nicotine as a tobacco product. No one had the foresight to consider Synthetic Nicotine when enacting legislation. The second is that the agency can claim that synthetic nicotine has no special privileges for tobacco products – so it must be regulated like any other drug.
Nevertheless, regulators seem to ignore the views of manufacturers and thr advocates, who have long said that the gray and black markets will develop as the federal government takes more measures similar to the ban.
“Despite the FDA’s best efforts, we are unlikely to see many e-cigarette enterprises shut down immediately after issuing a marketing refusal order,” said Greg Conley, President of the American e-cigarette Association.
“Synthetic Nicotine products still have to comply with the national age limit, but the tobacco product center lacks the ability to regulate them as tobacco products,” he continued. “We will not support the efforts of small businesses to continue to provide their products to adult customers until FDA authorizes a sufficient number of flavoring products to keep current smokers away from cigarettes.”
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