Congress has issued a clear directive to the FDA to crack down on vaping companies that violate the agency's rules. But there are growing signs that the agency isn't ready to do as instructed.

Congress moved swiftly in March to give the FDA the power to regulate so-called synthetic nicotine products — vaping products, often sold in fruit flavors such as watermelon berry, banana ice and rainbow cloud, that were scuttled by loopholes in the agency’s tobacco oversight. sale on the market. The loophole allows companies to sell their products as long as they use lab-grown nicotine rather than nicotine extracted from tobacco plants.

Federal data show that more young people are turning to these products because they still offer fruity flavors that formerly popular companies like Juul have discontinued. A synthetic e-cigarette brand, Puff Bar, is the most popular e-cigarette among current youth tobacco users, an annual survey conducted by the FDA and the Centers for Disease Control and Prevention found.

When Congress gave the FDA the power to regulate these products, it also gave the agency a clear deadline: Synthetic tobacco companies are required by law to submit so-called premarket applications by May 14, 2022, and any company that does not submit one Applying before that date will be considered illegal. Congress also said that any product not authorized by the FDA as of next Wednesday, July 13, would also be considered illegal.

But an FDA spokesman told the media on Friday that the agency has so far not taken action against any company that sells synthetic nicotine without filing an application.

A powerful senator has promised an investigation into the FDA's unacceptable delays.

“The FDA sounded the alarm on the synthetic nicotine issue that could upend its regulation of e-cigarettes. So I helped lead a bipartisan response that quickly provided the FDA with the tools to close the loophole. Instead, the FDA now appears to be stuck in a rut for years. The same mistakes that have been made with other e-cigarettes — failure to establish proper processes to monitor the market and neglect of enforcement responsibilities," Sen. Dick Durbin, D-Ill., said in a statement. .

"I'm outraged," said Matt Myers, president of the Campaign for Tobacco Free Kids. “If the FDA allows unapplied products to remain on the market, it would be both a direct violation of the law and put America’s children at risk. … There is no excuse.”

The FDA also said it was unable to say how many companies selling the products actually filed applications — and therefore could not estimate how many are currently on the market illegally — prompting further disdain from advocates.

"It's shocking that the FDA has yet to find a system that can count and track applications -- let alone disclose companies that already sell products," said Erika Sward, assistant vice president of national advocacy for the American Lung Association. "It's shocking that the FDA has apparently not figured out the system over the years."

The FDA has publicly supported synthetic tobacco laws. Officials published an op-ed in April praising the law, writing that the urgent need to clarify the FDA's authority over these products had been met.

The media asked if several of the largest synthetic nicotine makers had submitted applications to the FDA. Only one company, Puff Bar, responded. The company confirmed that it had submitted an application to the FDA, but declined to specify when the application was filed or what products were covered.

The anger of advocates is likely to continue into next week. Many expect the FDA to move swiftly by then to remove all pending applications from the market—because the law makes it clear that they are now illegal.

When asked if the FDA would take enforcement action against all companies with pending synthetic product applications, an agency spokesman declined to make that commitment.

Instead, the spokesperson said products with pending applications will be subject to FDA discretion to take enforcement action.

The FDA's response has advocates on high alert that the agency may not pull large numbers of products off the market.

There is precedent for their concerns.

The FDA has previously exceeded a court-imposed deadline for reviewing traditional tobacco-based vaping products -- leaving products with pending applications on the market for months while the agency completes its review.

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