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07/14/2022

FDA Begins Slow Enforcement of Synthetic Nicotine Products

The agency is processing premarket applications from nearly 200 companies.
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Logos for the FDA's Center for Tobacco Products

SILVER SPRING, Md. — The Food and Drug Administration (FDA) issued its first two warning letters to companies marketing synthetic nicotine products without its authorization.

The two companies, AZ Swagg Sauce LLC and Electric Smoke Vapor House, have listed a combined total of approximately 10,000 products with the FDA. However, neither company submitted a premarket application for its non-tobacco nicotine products by the May 14 deadline as required by the new law, according to the agency.

Synthetic nicotine officially fell under the FDA's regulatory umbrella on April 14, one month after President Joe Biden signed a federal appropriations bill that included a section granting the FDA authority to regulate tobacco products that contain nicotine not made or derived from tobacco (e.g., synthetic nicotine), as Convenience Store News reported.

The FDA's warnings letters to two companies falls short of what some have expected of the agency. On July 12, Sens. Dick Durbin (D-Ill.) and Susan Collins (R-Maine) sent a letter to the agency urging it to remove all unauthorized synthetic nicotine electronic cigarettes from the market as required by law.

Durbin and Collins were behind the bipartisan provision in the Fiscal Year 2022 Omnibus Appropriations bill that clarified FDA's ability to regulate products containing synthetic nicotine as tobacco products. The legislative fix closed legal loopholes that allowed manufacturers of flavored e-cigarettes to sidestep FDA regulation, according to the legislators.

As Durbin and Collins pointed out, the provision established a timeline for synthetic nicotine e-cigarettes to submit premarket applications to the FDA — including mandating that any product that did not submit an application by May 14 would be subject to market removal; and any product not authorized by FDA by July 13 would also be subject to market removal. 

The letter requested the FDA answer a number of questions outlined by the senators regarding the agency's enforcement actions by July 20.

"We find it deeply disappointing and unacceptable that [the] FDA appears to be on the brink of failing yet again at protecting our nation's children from the dangers of nicotine addiction," the legislators wrote. "When presented with an emerging public health challenge identified by [the] FDA, Congress took swift bipartisan action to provide FDA with the tools needed to properly regulate synthetic nicotine. We encourage [the] FDA to immediately use these tools and follow the law."

The FDA said it is currently processing applications for approximately 1 million non-tobacco nicotine products submitted by more than 200 manufacturers by the May 14 deadline. According to the agency, it is preparing to issue refuse-to-accept (RTA) letters soon for those applications that do not meet the criteria for acceptance. 

"FDA is working diligently to process the substantial number of applications submitted and, as always, will make marketing decisions based on the best available science and will pursue compliance and enforcement actions when warranted," said Brian King, director of the FDA's Center for Tobacco Products. "We remain fully committed to taking whatever steps are necessary to protect the public health and to provide timely updates on our ongoing progress regulating non-tobacco nicotine products."

Kaival Brands Innovations Group Inc., the U.S. distributor of all products manufactured by Bidi Vapor LLC, announced its support of statements from Bidi Vapor regarding its continuing support of the FDA's authority over electronic nicotine delivery systems (ENDS) devices using non-tobacco derived or synthetic nicotine.

With the arrival of the July 13 deadline that will make the continued retail and distribution of all such products illegal, the company said it hopes the agency will use its powers to properly enforce its new policies.

"Now, with this new authority given to the FDA, all products containing nicotine from any source will have to undergo the same rigorous authorization process to legally go to market here in the United States," said Niraj Patel, chief science and regulatory officer of Kaival Brands. "More importantly, it focuses manufacturers who use synthetic nicotine to align with the FDA's priority of making these types of adult consumer products appropriate for the protection of the public health."