The U.S. Food and Drug Administration (FDA) is giving wide leeway to electronic cigarettes as it attempts to push people away from traditional tobacco products.
In the last year, the agency has taken initial steps to place further curbs on traditional cigarettes even as it has eased new rules on the vaping industry that were issued by the Obama administration.
FDA officials say the goal is to spur innovation of products that may be less harmful for adults, but health advocates are skeptical. They argue the research on the health affects of e-cigarettes is still too new for products to remain on the market unregulated.
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“I personally believe Dr. [Scott] Gottlieb is truly dedicated to reducing the death and disease from tobacco, but I think he’s made a mistake by giving e-cigarettes a free pass for the next several years,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids.
Gottlieb, President Trump’s FDA commissioner, announced in July that FDA was delaying agency reviews for e-cigarette products until August 2022. The FDA approvals are required before manufacturers can release a new product into the marketplace or keep an existing product on store shelves.
At the same time, the agency announced its plan to work toward a regulation that reduces the level of nicotine in traditional, combustible cigarettes to nonaddictive levels.
If that rule comes to fruition, it would be the first product standard for traditional cigarettes since passage of former Rep. Henry Waxman’s (D-Calif.) Family Smoking Prevention and Tobacco Control Act in 2009. That law for the first time gave the FDA the authority to regulate the manufacture, distribution and marketing of tobacco products. It also banned any artificial or natural flavor other than tobacco or menthol.
At the E-Cigarette Summit, a conference on regulatory and public health developments held in D.C. this week, Mitch Zeller, director of the FDA’s Center for Tobacco Products, called for a national dialogue about the difference between nicotine use and cigarettes.
“If we are being bold enough to envision a world where cigarettes are no longer capable of creating or sustaining addiction, but the alternative products need to be out there for smokers who need them and so many people are walking around not understanding that nicotine doesn’t directly cause cancer, that’s a challenge and that’s a problem,” he said.
But health advocates say the administration is potentially pushing smokers away from one harmful product and into the arms of another.
“There’s still so much we don’t know,” said Erika Sward, assistant vice president for national advocacy at the American Lung Association. “We shouldn’t be comparing anything to cigarettes in terms of safety. It’s a fallacy. We should be understanding the impact these kinds of products have on heart health and cardiovascular health.”
But in a call with reporters in July, Zeller said FDA has a responsibility to make nicotine available in alternative and less harmful ways than combustible cigarettes, which he said is the deadliest and most harmful form of the drug.
Gottlieb noted that those nicotine offerings can include medicinal products that help people quit smoking, including patches and candy.
“The challenge for us as regulators is really to strike the appropriate balance between smart regulation that encourages innovation of those satisfying, less harmful products for people who need them all the while being guided by the best possible regulatory and scientific foundation for our actions,” Zeller said Monday.
The vaping industry, meanwhile, is encouraged by FDA’s decision to delay what are expected to be high-cost product reviews, but still says the agency could be doing more.
“They are supportive in the abstract, but in terms of actual regulatory decisions that truly matter to the manufacturers trying to stay in business, not a great deal has been done yet,” said Greg Conley, founder of the American Vaping Association, an advocacy group for vapor products.
Conley said the industry is still waiting for final guidance on the product reviews and to see if FDA will lower the costs on manufacturers by requiring fewer studies.
“We need a clearer indication that staying on the market will not require millions of dollars for one single product,” he said.
Conley is also worried about the FDA’s attempts to stop e-cigarette use by teenagers, viewing it as a prelude to tougher regulation of the industry.
“We’re concerned we could end up with a market where only the largest tobacco companies can play in it and have no incentive to innovate and get smokers off cigarettes,” Conley said.
“If you take away choice and innovation, you are going to see stagnation in the decline in American smokers we’ve helped.”
The FDA last week sent 40 warning letters to both-brick and-mortar and online retailers that sold Juul brand e-cigarettes to minors. Zeller said the products administer high levels of nicotine, look like a USB flash drive and have emissions that are hard to see.
“We’ve all heard the anecdotal reports of kids who are able to use these products literally in class in front of their teachers without their teachers knowing,” he said Monday.
And on Tuesday, FDA and the Federal Trade Commission sent 13 warning letters to companies they caught selling e-cigarette liquid in packaging that resembles kid-friendly food products like juice boxes, candy and cookies.
Gottlieb said in a press call that the attempt to sell such products to children could put at risk the careful balance the agency has tried to strike with the vaping industry.
For now, he said FDA plans to continue to create a regulatory pathway for less harmful products while also cracking down on manufacturers that market products to kids and retailers who sell to minors.