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Debunking FDA’s ‘Deeming’ Claims

UPDATE: A spokesperson for the U.S. Food and Drug Administration said that although states can and have regulated the sale of cigars to minors, the federal minimum age of sale for tobacco products does not apply currently to products such as hookah, e-cigarettes or cigars. When the FDA’s final deeming rule goes into effect on Aug. 8, 2016, an enforceable federal minimum age of 18 will be set nationwide for the first time.

OAKBROOK TERRACE, Ill. — It’s been nearly two weeks since the U.S. Food and Drug Administration (FDA) announced its final “deeming” regulations on cigars, pipe tobacco, hookah tobacco and electronic cigarettes. Since then, concerns have been raised, a lawsuit has been filed and the expected consolidation of tobacco and vaping manufacturers has already begun.

Advocates of cigars, electronic cigarettes and vaping have been vocal about some of the statements the FDA made as part of the deeming announcement. Here’s what the industry had to say about three claims made by the FDA’s Center for Tobacco Products (CTP):

There Was No Minimum Purchase Age for Cigars Prior to Deeming

As part of the press release on deeming, the FDA stated, “Before today, there was no federal law prohibiting retailers from selling e-cigarettes, hookah tobacco or cigars to people under age 18.”

Patrick Semmens, co-founder, publisher and web editor for Stogie Guys, investigated this claim, first by asking the FDA if they could point to anywhere in the United States where the sale of cigars to minors was legal. The FDA eventually referred Semmens to the CDC, “or a group like the Campaign for Tobacco-Free kids,” which Semmens noted “seemed strange given that the FDA had just designated itself the chief regulator of cigars.”

In his correspondence with a CDC spokesman, Semmons confirmed that the sale of cigars to minors was already prohibited under federal law, not new to the deeming regulations.

“In response to your question about selling tobacco products to persons under the age of 18,” the CDC wrote, “the federal minimum age of sale for tobacco products is 18. States are free to make it higher, but not lower.”

Strict Regulations are Justified Because the Products Kill People

Professor of Community Health Sciences at the Boston University School of Public Health and e-cig advocate Michael Siegel responded to a recent claim a FDA Center for Tobacco Products spokeswoman made while appearing on The Source, a Texas Public Radio news show. When asked to defend regulations that stood to drive the entire vaping industry out of business, the spokeswoman stated, “It’s important to remember that we’re talking about products that kill people.”

“Let’s get the facts straight,” Siegel wrote on his Tobacco Analysis blog. “Yes, it is true that we’re talking about products that kill people. But those products are not called e-cigarettes; they’re called real tobacco cigarettes.”

“If there were a legitimate public health reason for putting an onerous, expensive burden on vaping businesses that is going to drive most of them out of business, I’m sure that the FDA would immediately be able to tell us what it is,” he continued. “Destroying thousands of small businesses is not something that we in public health take lightly. But the FDA cannot tell us what the reason is. The only thing they can resort to in defending their onerous regulations is lying.”

The Difference Between the U.S. and U.K. is Youth Usage

When asked if the FDA acknowledged the recent report by the Royal College of Physicians, which found e-cigs were at least 95% safer than combustible cigarettes, CTP director Mitch Zeller said he had “enormous respect” for the organization but that their findings didn’t apply in the United States.

“There’s one fundamental difference in the marketplace for electronic cigarettes in the United Kingdom and the marketplace for e-cigs here,” he said during a FDA media briefing. “We have skyrocketing use of e-cigarettes by kids. For whatever reason, you don’t see those kinds of numbers on the other side of the pond.”

David Sweanor, an adjunct professor of law at the University of Ottawa’s Center for Health Law, Policy & Ethics, said the difference is not in youth usage, but in how the data is tracked.

“The data’s actually very similar if you measured it the same,” Sweanor told Tobacco E-News. “In the States, close to 80% of youth who say they’ve used e-cigs have used one that doesn’t even have nicotine in it. To then say that this is a huge problem is pretty ridiculous. You need to identify the problem and carefully tailor what you’re doing to address that problem.”

Additionally, Semmons of Stogie Guys pointed out that the FDA repeatedly referred to “youth and young adult(s)” in the deeming rule. When he questioned what age range qualified as “young adult,” the FDA said it depended on some studies. Some used 25 while others used 29 as the upper limit for “young adults.”

“So while the FDA is using the age-old justification that their rules are necessary ‘for the children,’ the fact is they are citing studies about the choices made by 29-year-old adults, men and women,” Semmons wrote.

“They’re misrepresenting the data on the use of e-cigarettes by kids,” Sweanor added. “It has that ‘Reefer Madness’ sort of cape to it.”

Author(s): 
Melissa Vonder Haar

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