Why public health groups are joining retailers to oppose Iowa vaping bill

DES MOINES — A bill supported by the tobacco industry that would ban retailers from selling vape products not listed on a state-approved registry has united two disparate groups in opposition: vape shops and public health advocates.

The companion legislation, House Study Bill 682 and Senate File 2402, would require retailers, distributors and wholesalers who sell vapor products in the state to put them on a new registry. Retailers could sell only products listed on the registry — which would be limited to those the U.S. Food and Drug Administration has approved for sale. The registration fee is $100 per product.

Those that violate the provisions would be subject to a $300 a day penalty.

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Money collected from fees and penalties would be deposited into a trust fund to be used for substance use disorder treatment and prevention and tobacco prevention, cessation and enforcement.

At first blush, the bill seems to close a loophole leveraged by e-cigarette manufacturers and distributors.

Before manufacturers can sell new e-cigarette products, they must submit an application to the FDA to market the products. The FDA then can either grant their application, at which point they can sell their products indefinitely, or the FDA can deny their application — at which point they must cease selling them altogether.

But because of the lengthy time it takes the FDA to process applications, or because of legal challenges to denials, manufacturers and distributors keep their products in the marketplace until they receive a final answer.

Since 2020, 26 million tobacco products, the vast majority of which are vapor products, have been submitted for FDA approval. To date, the FDA has authorized just 23 e-cigarette products and related devices, all of them tobacco-flavored, while rejecting more than a million applications. And only three brands — all made by tobacco companies — have received FDA marketing authorization.

Manufacturers have challenged the denials in court, and use a variety of legal maneuvers to delay agency action. Most e-cigarette applications fall into limbo of having received approval or denial to market their product. Without the former, the products cannot be legally sold in the United States.

But as a result, thousands of e-cigarette products — including flavored products popular among youth — are being sold in Iowa and across the country without proper FDA authorization. The FDA has not aggressively pursued enforcement actions against manufacturers who either never applied for FDA approval or who did but persist in selling products that have not been approved.

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Thousands of unauthorized vapes pouring in

The tobacco-industry-backed registry law, which mirrors those passed and being considered in other states, is purportedly intended to fill the enforcement void left by FDA inaction and inability to control the tumultuous vaping market more than three years after the agency declared a crackdown on youth-friendly flavors.

Most of the unauthorized disposable vapes being sold in the United States, such as Elf Bar, come from China in sweet and fruity flavors that have made them a favorite nicotine product among teens. Hundreds of new varieties appear each month, the Associated Press reported.

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The influx has upended the FDA’s regulatory model. Instead of carefully reviewing individual products that might help adult smokers, regulators must now somehow claw back thousands of illegal products sold under-the-radar.

Why public health advocates oppose the bill

Public health advocates say lawmakers should carefully consider the public health implications of the bill and evaluate whose interests it advances.

The American Cancer Society is registered opposed to the bill, as is CAFE (Clean Air For Everyone) Iowa Citizens Action Network, an organization that advocates for tobacco control policies. The American Heart Association and Iowa Primary Care Association are registered undecided.

Opponents argue the bill does nothing to reduce youth consumption and instead benefits tobacco companies.

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“At the end of the day, this bill will do nothing to reduce youth consumption and nor adult (use), likely,” said Threase Harms, a lobbyist for CAFE Iowa Citizens Action Network. “ … We see it as an industry bill that does nothing other than help tobacco companies increase their market share and ultimately their profits.”

If serious about reducing youth vaping, lawmakers could consider advertising bans, taxing vape products the same as tobacco products and requiring a retail permit fee, Harms said.

How retailers would be impacted

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Corey Halfhill, owner of Central Iowa Vapors, which has stores in Cedar Rapids and Iowa City, said the bill would eliminate 99 percent of the vapor products on the market and force him to close his 15 stores, putting 80 workers out of a job.

“It would over-regulate us to the point where you can't conduct business,” Halfhill said. “We're not like a convenience store. You take a handful of items (out) at a convenience store, they're going to be able to continue to sell gas and be able to continue to sell soda, all of the snacks and things.”

He said the industry is frustrated by FDA inaction and is advocating for fair regulations that allow for vaping products to remain on the market while ensuring consumer safety.

He said he regularly meets with manufacturers and visits their facilities, including in China, and requests information and documentation that their products have either been approved, denied or pending review by the FDA.

Halfhill emphasized the importance of addressing youth vaping, but believes the government should focus on holding social media giants accountable for promoting vaping products to minors and work with the industry to promote tobacco-harm reduction and support products proven to be safer than tobacco.

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Halfhill and Sarah Linden, owner of Generation V in Council Bluffs and Davenport, said vape users will find other ways to get their product if it is unavailable in their stores — whether online or just across the border in neighboring states.

“If this bill goes into effect, businesses like mine — because we are good actors — we will close,” Linden said. “But there's going to be stores that don't, and then they're going to be selling whatever illicit products to whatever age group,” including potentially teens.

“Where we screen and only sell to 21-plus,” she said. “It's just a 10 minute drive across the border to Illinois or Nebraska (from her shops in Davenport and Council Bluffs), where those states have no intention of passing these bills.”

What supporters, others say

David Scott, a lobbyist for tobacco giant Altria Group that’s pushing the bill, said the measure prevents illegal products from overseas popular with youth.

"China has over 50 percent of the (products) that are illegal," Scott recently told a House Ways and Means subcommittee. "Three out of the five youth brands are illicit but they are still being brought in."

Gregory Conley, director of legislative and external affairs for the American Vapor Manufacturers, said the FDA uses U.S. Customs and Border Protection to stop illegal products before they enter the United States and conduct inspections and issue civil penalties to manufacturers and retailers of illegal products.

“The FDA with their $712 million budget has decided, oh yeah, we're just going to only target specific products that have youth use problems,” he said. “That's something you could do in this bill. But just saying all these products have to be banned? Terrible, terrible policy. … There's a reason why Barclays and Goldman Sachs and Altria investors are so interested in this policy. Both Barclays and Goldman Sachs have said that one way for Altria to recover their falling cigarette sales is to put people like” Halfhill and Linden out of business.

Conley said the bill imposes a confusing and complicated registration scheme that has been challenged in courts in other states.

The FDA in 2016 deemed e-cigarettes to be tobacco products like traditional cigarettes subject to agency review under the Tobacco Control Act, and said manufacturers of the products would need to apply for approval to continue selling them.

It initially considered e-cigarettes as having some promise in helping adult smokers transition from conventional cigarettes, but faced pressure from anti-smoking groups to restrict flavored e-cigarettes amid a rise in youth vaping.

Conley said the FDA has not released a comprehensive list of products that have received denials or injunctions, making it difficult for retailers and law enforcement to know what is legal. Instead, he suggested the legislation be amended to prohibit the sale of products that have not submitted their ingredients to the FDA.

Tony Phillips, a lobbyist representing tobacco company Reynolds American, called the bill a “reasonable approach” to limit the sale of illegal products.

“Yes, it's a difficult process through the FDA. We've had our own challenges with it,” Phillips said. But even if the registry completely weeds out e-cigarettes that never applied through the FDA process or that have received denials, tens of thousands of products can still qualify because of the FDA backlog.

To register with the state, a manufacturer would have to provide proof of marketing authorization or a similar order from the FDA, a pending application that remains under FDA review or a court order was stayed by either the FDA or a federal court. Only those products that have been appropriately entered into the registry could then be sold in Iowa.

Mike Triplett, a lobbyist representing Iowans For Alternatives To Smoking And Tobacco, said removing all flavored vaping products from the market will only increase cigarette sales, cost Iowa taxpayers millions, shutter hundreds of small businesses and throw Iowans out of work.

A 2021 study conducted for the U.S. vapor industry estimates the Iowa industry employs 752 people, generating $37.5 million in wages and a direct economic output of roughly $127.8 million.

Where the bills go from here

The House and Senate bills were approved by subcommittees and will be heard by the Ways and Means committees in their respective chambers.

“My big concern is public safety, making sure that these products that people are consuming … is safe in the marketplace,” said Rep. John Forbes, D-Urbandale, who served on the House subcommittee. “My other concern is, you know, passing legislation here that has an impact on businesses here in the state of Iowa. People are going to still vape regardless, but I'd hate to have us pass legislation that's going to affect jobs and, you know, viable, ongoing businesses that could be out of business or severely restricted in sales.”

Republicans signed off on the bills to continue the conversation and work on possible amendments to the legislation.

Comments: (319) 398-8499; tom.barton@thegazette.com