FDA ORDERS 88,000 PRODUCTS WITH SYNTHETIC NICOTINE OFF THE MARKET

The FDA’s chief tobacco regulator said Wednesday that the agency has sent “refused-to-accept” letters to the makers of more than 88,000 products containing lab-made nicotine, your host reports.

This latest update from the Center for Tobacco Products director Brian King sheds a little more light on the agency’s progress on regulating products with nicotine that comes from sources other than tobacco, which the FDA was authorized to regulate this spring. Previously, the agency could regulate products only with nicotine derived from the tobacco plant, creating a regulatory loophole that allowed some electronic cigarette manufacturers to avoid being pulled off the market.

A regulatory gray area: King’s update said that the letters to manufacturers whose applications weren’t up to snuff “state that it is illegal to sell or distribute in the U.S. marketplace any new tobacco product that has not received premarket authorization.” The agency hasn’t blessed any synthetic nicotine products with marketing orders.

The law allowing the FDA to regulate the products stated that, as of July 13, all unauthorized synthetic nicotine products were illegal — so technically, all the makers of those products that received letters stating their deficiencies weren’t allowed to be sold after that date anyway.

But, the agency also noted that it would continue to assess more than 350 synthetic nicotine product applications that appear to have adequate materials. Though these products — most of which are vapes — aren’t technically allowed to be sold, it remains unclear whether the FDA will pull them from the market while it evaluates the required materials. The agency has used its enforcement discretion on e-cigarettes containing tobacco-derived nicotine, allowing them to stay on shelves while it continues to weigh their applications.

A stacked process: Jonathan Foulds, a professor of public health sciences who specializes in tobacco addiction at Penn State College of Medicine, told Pulse that, among synthetic nicotine e-cigarette manufacturers, some were absolutely bad actors who used the regulatory loophole to stay on the market while their products attracted teens.

But other manufacturers probably never stood a chance, given their crunched timeline to pull together materials. “I would be surprised if any of them get authorized, to be honest,” he told Pulse. “It’s a big job requiring lots of information, including proper research that actually takes time. You can’t do it in two months.” He pointed out that even the makers of vapes with tobacco-derived nicotine had problems meeting the FDA’s bar for evidence even though they had multiple years to apply for marketing orders.

“I’d be OK if all of them were pulled from the market [while the agency conducts its review], but they deserved an adequate period of time to put together an application,” he added.

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