FDA proposes tobacco rules to make manufacturing more consistent and ingredients more transparent

By Jen Christensen, CNN

The US Food and Drug Administration announced Wednesday that it is proposing new requirements for tobacco companies that would help prevent contamination of their products and set some standards for the way they make and package products so regulators and consumers will know precisely what is in them.

The proposed rules would apply to all FDA-regulated bulk and finished tobacco products, including cigarettes, cigars, chewing tobacco and e-cigarettes.

They would require companies to investigate and identify products that don’t meet standards and recall the ones that had made it to market. All ingredients and components or additives and materials would also be be traceable, so if an investigation found a product that didn’t meet standards, it could easily be recalled.

Products that didn’t meet these manufacturing standards wouldn’t be allowed on the market, the FDA said.

The FDA says there have been inconsistencies between what’s in e-cigarettes and what’s on the label. The agency noted that under the current system, some Americans have bought tobacco products that were even contaminated with metal, plastic and glass.

“While no tobacco product is safe, this proposed rule is intended to minimize or prevent additional risks associated with these products,” Dr. Brian King, director of the FDA’s Center for Tobacco Products, said in a news release. “Once finalized, it would establish requirements for tobacco product manufacturers that will help protect public health.”

The FDA will hold a public hearing April 12 about the proposed rules. When finalizing its rules, the agency weighs the public’s perspective as well as the perspective of stakeholders like the tobacco companies that make these products.

The FDA will also bring together its Tobacco Products Scientific Advisory Committee on May 18 to get the opinions of those independent experts.

E-cigarettes may be dramatically affected

Although the rules would affect the entire tobacco industry, e-cigarettes may see the most change if the rules become permanent, according to Clifford E. Douglas, director of the Tobacco Research Network at the University of Michigan School of Public Health.

Research shows that some vaping products have more than what the vaper bargained for, he said.

“It’s kind of a wild west. They’ll have more or less nicotine or other substances and ingredients in them than appears on the label,” Douglas said. “It’s a little bit too much of a crapshoot.”

He said one motivation for the new rules is found in reports from 2020 on what health officials call EVALI, an abbreviation for “e-cigarette or vaping product use-associated lung injury.” The reports showed that thousands of people had been injured and dozens died after using illicit e-cigarette products. It appeared at the time that most of the cases involved THC products and that a thickener called vitamin E acetate was associated with lung injury. But the US Centers for Disease Control and Prevention couldn’t rule out harms caused by other chemicals, and there haven’t been other cases of similar injuries since then.

A manufacturing standard probably would also force some changes at vape shops, Douglas said.

“It is likely to chill further efforts by vape shops, the small local retailer, to continue to do what some of them do, which is to blend and bottle their own liquids on-site,” he said. Retailers would probably have to sell more traditional major-market vaping products authorized by the FDA.

“It would be making this a more conservative, more tightly controlled marketplace,” Douglas said.

Such rules could also give cigarette smokers more confidence if they were to switch to e-cigarettes.

“All with an eye toward enhancing public health and, at a certain level, enhancing the value and reliability of these alternative products to help an increased number of smokers stop smoking, and to not use anything wherever possible, but when they do, to ensure that they know what they’re getting,” Douglas said.

Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers Association, said he’s disappointed by timing of the proposed rules.

“The vaping industry has tried in vain for more than a decade to work with FDA on sensible manufacturing standards, only to be ignored while the agency recklessly vilified nicotine vaping. It is disappointing, but not at all surprising, that the FDA would wait to propose these regulations until it had already committed itself to banning 99.99 percent of the vaping market,” Conley said in an email. “The millions of Americans who rely on vaping to stay off cigarettes could benefit from the FDA’s proposal, but only if the agency stops thumbing its nose at its critics and starts to regulate the category in good faith.”

Setting standards

The new rules would treat tobacco products like a lot of others, in that people can expect a certain standard, said Erika Sward, assistant vice president of national advocacy for the American Lung Association.

“Consumers take this kind of standard in our food and other consumer products for granted, and so this kind of disclosure is needed for any consumer product and will also hopefully mean better consistency and transparency,” she said. “It’s an important baseline for FDA to be setting so that consumers understand how much nicotine is in their product as well as to the specifics of what they are trying to buy.”

Matt Meyers, president of the Campaign for Tobacco-Free Kids, said it is also important to keep in mind that the proposed rules would not make tobacco products safe.

“Consumers shouldn’t be confused. This rule is designed to bring consistency of manufacturing but doesn’t make the product less harmful,” he said.

The state of tobacco regulations

Although fewer US adults are smoking cigarettes than ever, smoking remains the cause of the most preventable disability and death, according to the CDC. And more people are starting to use tobacco every day.

In 2022, nearly 17% of high school students — more than 2.14 million adolescents — reported that they currently used e-cigarettes, according to the CDC. And 1 out of every 30 middle school students, about 3.3%, said that they had used an e-cigarette in the previous 30 days. For high schoolers, it was 1 in 7 students, the CDC said.

The agency has gotten stricter about e-cigarette products recently. Although these products have been allowed to remain on the market for years, in 2020, the FDA asked manufacturers to submit applications to keep selling them.

The FDA said in March that it had reviewed 99% of the nearly 6.7 million e-cigarette products that have been submitted for premarket authorization, but many of those companies were small players in the market, and there still are several outstanding decisions concerning companies that have a larger share.

The FDA had commissioned an independent review of its tobacco programs in 2022 that found that it needed to be much more proactive in tackling tobacco. In February, the Center for Tobacco Products announced its plan to do a better job regulating tobacco products.

In April, the FDA proposed eliminating two tobacco products popular with children: flavored cigars and menthol cigarettes. But it could be years before that becomes a reality. Even if that rule is finalized this year, manufacturers will probably sue to keep it from going into effect.

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