Organizations opposed to e-cigarettes have asked the FDA to regulate synthetic nicotine as a drug
Tobacco control groups said small e-cigarette companies excluded from the flavoring E-liquid market would use Synthetic Nicotine as a loophole. The request was made in a letter to Janet Woodcock, acting director of the FDA, on September 2.
The letter was issued after the FDA announced the first batch of marketing refusal orders (MDOs) for flavored e-cigarette liquid submitted to the agency for pre-market approval. So far, the FDA tobacco products center (CTP) has sent more than 30 rejection letters – all aimed at small electronic cigarette oil manufacturers. The agency has not authorized any e-cigarette products.
Some manufacturers who have been denied pre marketing tobacco application (PMTA) have publicly announced that they will use synthetic nicotine to reconstitute their products. They believe that synthetic nicotine is not regulated by CTP.
The panic letter from tobacco free kids and its allies refers to a Facebook post by a small company that claims that switching to smokeless nicotine will make their products exceed FDA regulations. (smokeless nicotine is a trademark of a nicotine manufacturer’s synthetic products, but the name is usually used to refer to all synthetic nicotine.)
“Now the FDA has begun to reject marketing orders for e-cigarette products,” smokeless children wrote to the FDA. “There are good reasons to expect thousands of these products to become Synthetic Nicotine products again to avoid the clear purpose of the FDA.” this is the third time since 2018 that tobacco free children have asked the FDA to regulate synthetic nicotine to prevent e-cigarette manufacturers.
CTP regulated tobacco products – the term includes all consumer products containing tobacco derived nicotine and its components or parts. The agency can try to regulate synthetic nicotine products as components or components, but this may pose a greater legal challenge than throwing the regulatory hot potato to the FDA Center for drug evaluation and Research (CDER). So far, CTP has only indicated that products containing Synthetic Nicotine will be evaluated on a case by case basis.
For years, tobacco control organizations have urged CDER to regulate Synthetic Nicotine. For example, in a paper in 2018, three tobacco control lawyers provided a series of strategies and strategies that the FDA could use to capture synthetic nicotine as a drug – because they said that allowing Synthetic Nicotine products to be marketed without any FDA review could have a long-term negative impact on consumers.
CDER currently regulates nicotine replacement therapy (NRT) products (not made from Synthetic Nicotine) because they have a clear therapeutic purpose (quitting smoking) and are not intended for consumer entertainment (which will make them the tobacco definition of tobacco product act under tobacco control). But the FDA drug office may also try to assert power over drugs that are not intended for therapeutic purposes, although the legal debate will be more difficult.
CDER has twice tried to regulate nicotine as a drug in entertainment products: cigarettes in the 1990s and e-cigarettes in 2009. On both occasions, federal agencies were suspended by the ruling of the federal court. The first court defeat led to the enactment of the Tobacco Control Act 2009, which gave the agency power over tobacco products. The second leads to the presumption rule, in which CTP gives itself power over e-cigarettes and other nicotine products.
In a lawsuit filed by e-cigarette manufacturers smoking everywhere and sottera (now known as njoy) in 2009, the Federal Circuit Court told FDA that CDER could regulate nicotine products only if the manufacturer requested treatment. (the FDA tobacco products center was created under the tobacco control act, which became law in 2009 when sotera v. FDA was in litigation. Even after obtaining tobacco authorization, FDA continued to seek to regulate e-cigarettes as drug devices – derived nicotine products.)
However, previous attempts by the FDA to regulate nicotine as a drug did not involve the Synthetic Nicotine. Some legal experts believe that CDER can regulate synthetic nicotine even without a typical rule-making process. “They can come out tomorrow and say that these nicotine products are unauthorized drugs,” a regulatory lawyer told the media. It may be that since sottera, the FDA has avoided regulating nicotine as a drug because it is afraid of losing and setting a precedent.
If the agency decides to start developing rules to capture Synthetic Nicotine, the process may give manufacturers an additional year or more to sell their products and they develop a long-term strategy. However, if the agency now only advocates power – without going through a time-consuming rule-making process – manufacturers will have to sue the FDA and ask the court to issue an injunction to continue selling synthetic products while the legal dispute is resolved.
If CTP denies their PMTA, many small and medium-sized electronic cigarette oil manufacturers have planned to sell products containing Synthetic Nicotine. In fact, many companies are following this route, so that some nicotine wholesalers say that their existing supplies have been exhausted and new customers will face the problem of delayed access to Synthetic Nicotine.
Some companies have adopted Synthetic Nicotine PMTA solutions. Five pawns, a pioneer of high-quality electronic cigarette oil, even reconstituted their electronic cigarette juice with synthetic cigarette oil before the PMTA submission deadline on September 9, 2020. Gray market disposable brand puff bar announced earlier this year that it would evade FDA regulation by selling synthetic versions of its products. And many new nicotine bags using smokeless nicotine or other synthetic materials have been launched.
Manufacturers turning to Synthetic Nicotine must also consider other legal threats. One is Congress: legislators can amend the tobacco control act to include synthesis by simply deleting a few words from the definition of tobacco products. Legislators can include all nicotine products (and their ingredients and components), rather than products “made or derived from tobacco”.
Another major threat is the state legislature. Earlier this year, with the support of tobacco giant Altria, a new Alabama law was passed to prohibit the sale of e-cigarettes containing Synthetic Nicotine unless they are first approved as therapeutic devices by the FDA.
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