FDA Creates, Decries Illegal E-Cigarette Tsunami

 

An article in the LA Times January 2^nd bemoaned the “thousands of new flavored products…pouring into the country from China.”  It claimed, “Nearly all the new products are disposable e-cigarettes, according to sales data gathered from gas stations, convenience stores and other shops. The products generated $3.2 billion in the first 11 months of this [sic] year.”

The response from Brian King, director of the FDA Center for Tobacco Products, was naïve: “Those committing illegal acts don’t advertise their crimes, and those trying to import illegal tobacco products into the United States are no different.  The FDA and our federal partners are using tools, like import alerts, to stop these illegal tobacco products at the border and to deter countless others.” (emphasis added)

Dr. King ignores history.  A contemporary account of the first day of Prohibition in the U.S., January 17, 1920, noted, “Canadian liquor in quantities from one gallon to a truckload is being hidden in the northern woods and distributed by automobile, sled and iceboat, on snowshoes and skis.”

Neither Dr. King nor his FDA colleagues are going to stop the illegal vape tsunami.  When the FDA issued a toothless warning letter last May to the Chinese maker of Esco Bars e-cigarettes, it failed to note that the product’s name is a salute to one of history’s most successful illegal importers – Pablo Escobar. 

My readers will recognize another tobacco prohibitionist in the LA Times article -- Stanford University’s Bonnie Halpern-Felsher.  I’ve criticized her previous research, but here she comes across as a realist: “FDA whacks one product and then the manufacturers get around it and the kids get around it.  It’s too easy to change your product a little bit and just relaunch it.”

Halpern-Felsher wants all vapes banned… for the children, foreseeing a vaping apocalypse: “If we continue down this path that we’re on, we’re just going to have new and continuing generations of young people addicted to nicotine.”

Yes, regardless of what the FDA or anyone else does, some teens and young adults will become addicted to nicotine.  But as shown in the chart below, few will die from nicotine over the next 30 years, as almost none of these vaping youth smoke.  

 

 

Exploiting Outlier Lung Disease Cases Does a Disservice to Public Health

In her excellent August 28 USA Today article on the recent emergence of vaping-related lung illnesses, Jayne O’Donnell noted that “Some state health department and news reports suggest many of the cases of lung problems involve tetrahydrocannabinol, known as THC, the chemical in marijuana that causes psychological effects.”

I fully agree with Boston University’s Dr. Michael Siegel, who said, “The Centers for Disease Control and Prevention is being ‘unnecessarily vague’ about describing the injuries as simply vaping-related when many people might have been injured by vaping THC oil.”  As he and New York University public health professor Ray Niaura pointed out, millions of Americans have vaped nicotine e-liquids over the last ten years, yet no lung problems were reported until recently.  The sudden appearance of these cases and links to THC strongly suggest that contaminated street liquids are at fault, not legitimate retailers’ e-cigarettes or vape products.

Despite this, as noted by Jacob Sullum, the CDC Office on Smoking and Health’s Dr. Brian King focused his public remarks primarily on a purported general link between e-cigarettes and vapor products with lung disease:

“So there’s a variety of harmful ingredients identified, including things like ultrafine particulates, heavy metals like lead and cancer causing chemicals. And flavoring used in e-cigarettes to give it a buttery flavor.  Diacetyl and it’s been related to severe respiratory illness.  That being said we haven’t specifically linked any of those specific ingredients to the current cases but we know that e-cigarette aerosol is not harmless…But the bottom line is there’s a variety of things in e-cigarette aerosol that could have implications for lung health.  A review recently identified a number of adverse health effects associated with e-cigarette use.”  

Dr. Siegel excoriated federal officials for this approach:

“In a disease outbreak such as this one, responsible public warnings need to be as specific as possible about the risk. In an outbreak of E. coli caused by a contaminated batch of lettuce, we don't tell the public that the disease is associated with eating, or even that it is associated with eating lettuce. People need much more specific guidance if they are to take appropriate action to avoid or reduce the risk of further spread of the outbreak.

“Here, we need to start telling the public the truth. However much physicians or anti-nicotine groups may not like it, the truth is that the outbreak we are seeing is not due to the risks of using standard vaping products. It appears much more likely that the outbreak is mostly, if not completely attributable to illicit products--especially THC extracts--that are being sold by unlicensed sellers on the black market. Unless people are provided with this specific information, they will not take action to avoid the products that could put them at risk.”

The potential downside of this scaremongering is even worse.  How many thousands of former smokers who currently vape will conclude that the risks aren’t worth it, and return to smoking?  How many millions of smokers will never consider this vastly safer smoke-free option?

CDC’s hypocrisy was demonstrated in the August 23 statement of Director Dr. Robert R. Redfield:

“We are saddened to hear of the first death related to the outbreak of severe lung disease in those who use e-cigarette or ‘vaping’ devices…This tragic death in Illinois reinforces the serious risks associated with e-cigarette products. Vaping exposes users to many different substances for which we have little information about related harms – including flavorings, nicotine, cannabinoids, and solvents.”

The lung disease fatality was tragic, but Dr. Redfield exploited it by implicating all e-cigarettes and vapes.  Where is CDC’s sorrow for the 1,300+ smokers who die every day from cancers, circulatory diseases and emphysema?

September 5, Reported by the Washington Post: "State & federal health officials investigating mysterious lung illnesses... have found the same chemical in samples of marijuana products used by people sickened in different parts of the country. The chemical is an oil derived from vitamin E."

TPSAC: Copenhagen Has Lower Lung Cancer Risk

The FDA Tobacco Products Scientific Advisory Committee (TPSAC) met on February 6 and 7  to consider smokeless manufacturers’ advertising and marketing claims that their products are safer than cigarettes (making them modified risk tobacco products, or MRTPs).

Altria, whose U.S. Smokeless Tobacco Company subsidiary sought MRTP status for its Copenhagen snuff product, was the clear winner, as the committee approved the statement, “Switching completely to this product from cigarettes reduces risk of lung cancer.” (here)

Clearly, Altria seeks to underscore the message that their form of smokeless tobacco, which is placed in the mouth and not inhaled, eliminates the risk for lung cancer that is high with cigarette use.  This obvious but important distinction was endorsed 8-0 by the TPSAC panel, with one abstention.

Swedish Match, the other company pursuing an MRTP application (that is now almost five years old), was not as fortunate.  The panel rejected their claim that “Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis.” 

As I commented two months ago, “The term ‘lower risk’ is an understatement, as the risk is almost zero” (here), but the diseases weren’t the problem.  Some TPSAC members thought that approval would send the message to kids that snus was “safe.”  Brian King, a deputy director at the CDC Office on Smoking and Health, expressed concern about future unknowns: “…just because [snus usage] is low now we have to completely dismiss what the relevance could be in the future.” he said. “My response to that is one word: Juul.” (here)

King also said that Swedish Match’s “continued absence of any youth data is preposterous to me.”  He seemed to be faulting the company for not surveying teens about snus products, even though, as the company pointed out, such research could run afoul of a ban on teen marketing. 

Panel member Ken Warner supported the Swedish Match application.  “I think the health (benefits) are really clear compared to smoking -- more so than for any other smokeless tobacco product.  My sense is that if this is not approved, it might be the death knell for the [MRTP] process because we would be basically saying you can't get anything through this process.”