With a chaotic regulatory process and a bad reputation, the FDA's Center for Tobacco Products is doing what it has been doing during challenging times: touting enforcement actions against small businesses.

Today, CTP's new director, Brian King, released an update on the synthetic nicotine product review process and the agency's actions against manufacturers and sellers.

July 13 -- Last day of two-month grace period to allow sales of synthetic nicotine products after May 14 premarket tobacco application (PMTA) deadline -- FDA to issue companies with unauthorized sales of synthetic nicotine-based products The first warning letter was announced. There are only two, and more than a hundred retailers cited for selling synthetic nicotine products to minors.

Now, two weeks later, the agency has issued a warning to 17 other manufacturers, including premium e-liquid pioneer Five Pawn. The warning letter gives the manufacturer 15 business days to respond to the FDA and describe the actions taken to bring your tobacco product into compliance with the Food, Drug, and Cosmetic Act.

In addition to the letter to manufacturers, the FDA provided a list of an additional 102 stores that have been warned to sell to underage customers. Almost all of them are convenience stores, smoke shops or gas stations, and the purchases seem to be disposable e-cigarettes.

In the statement, King reiterated that CTP has received nearly 1 million PMTAs for synthetic nicotine products from more than 200 manufacturers, and boasted that the FDA has issued more rejection-to-accept (RTA) letters in the past three weeks alone. Over 88,000 products did not meet acceptance criteria in the application.

RTA is the first (and easiest) step in the PMTA process - a quick look to ensure that the application itself complies with legal and regulatory requirements.

Some of the RTA letters described by King were sent because the manufacturer used an older version of the required form, which was changed two weeks before the PMTA submission deadline for synthetic products. Some manufacturers use the old form because small e-cigarette makers do not have a government compliance office.

According to Amanda Wheeler, president of the American Association of Vapor Manufacturers (AVM), the only difference between the old and new versions of the form is the addition of a pair of checkboxes for tobacco or menthol flavors (the company checks a frame).

"The application needs to provide important information required for processing and review," King wrote. "Without the required information, the application will fail the acceptance stage of the review process."

At CTP — a federal regulatory office with a $700 million budget — tripping up small businesses with paperwork is a source of pride. More importantly for the FDA, the more manufacturers drop out of the process before reaching the stage where they must reject their applications, the fewer legal challenges the agency has to answer.

King also announced that the CTP had accepted 350 applications. But as far as the FDA is concerned, any synthetic-based vaping product currently being sold is illegal and needs to be enforced. The agency has yet to respond to the AVM's citizen petition to expand enforcement discretion to small companies submitting PMTA synthetic nicotine e-liquids.

The FDA followed the same playbook in the months following the September 9, 2020, PMTA submission deadline. Beginning in January 2021, and every few weeks thereafter, the agency has issued a statement on its tough enforcement actions, as well as a list of warning letters sent to small e-liquid manufacturers and retailers.

The first enforcement announcement of 2021 comes two days after Senator Dick Durbin and 11 colleagues sent a letter to then-FDA Commissioner Stephen Hahn asking the agency to ignore its separate assessment of the PMTA , but only to impose a wholesale ban on flavoured products.

King's communiqué today also appears to be aimed at deflecting attention from recent blunders caused by -- you guessed it -- pressure from Senator Durbin and his allies in Congress. It's doubtful, however, that any number of warning letters could cover up the FDA's poor July.

On June 23, the FDA issued a Marketing Denial Order (MDO) to Juul Labs, requiring the immediate removal of all Juul products from the market. News that the agency would ban Juul was mysteriously leaked to the Wall Street Journal a day earlier. The leak comes just a day after Senator Durbin suggested in a news conference that FDA Commissioner Robert Califf should resign if he fails to protect our children from vaping products.

Less than two weeks later, on July 5, the FDA was forced to back down and suspend Juul Labs MDO. The agency allegedly left out 6,000 pages of Juul's PMTA that contained evidence about the toxicology issues on which the FDA's denials were based. Judging by recent evidence, the mistake may have kept Juul away from the FDA for years.

Shortly after the Juul fiasco, Califf announced that he had asked the Reagan-Udall Foundation — a semi-independent FDA partner organization — to review the agency's tobacco processes and procedures, resource allocation and organizational structure. This is almost certainly to give Galiff cover when dealing with Congress, but you never know when some rogue advisors will start paying too close attention to the TPS report. The e-cigarette trade group AVM has announced that Reagan-Udl has agreed to a meeting.

Then came the most embarrassing news: Matthew Holman, director of the CTP's Office of Science, was leaving the agency to join tobacco giant Philip Morris International. This of course raises the usual complaints, but what's worse for CTP is the suggestion that its respected head of science thinks he will do more for public health by helping PMI sell IQOS and other new nicotine products than he was at CTP Do more things.

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