FDA Proposes to Ban Unauthorized Flavored e-Cigarettes

flavored e-cigarettes

The FDA issued a statement that it would be concluding a compliance policy in the next few weeks to end the sales of all unauthorized, non-tobacco-flavored e-cigarettes.

The September 11, 2019, announcement comes as public concern over these products spiked following a recent rage of severe respiratory illnesses linked to vaping, including several deaths.

The Centers for Disease Control and Prevention (CDC) updated the number of confirmed and probable cases of lung disease to 380 reported in 36 states and the U.S. Virgin Islands. The previous case count was higher because it included possible cases still under investigation. Six related deaths have been confirmed.

The CDC has declared youth e-cigarette use an epidemic. Preliminary numbers from the National Youth Tobacco Survey have shown that e-cigarette consumption among young people continues to rise, with more than a quarter million high school students indicating they are users of e-cigarette. A significant majority cited using popular fruit, menthol or mint flavors, according to the FDA.

“The Trump led Government is making it clear that we intend to clear the market of flavored e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use that is impacting children, families, schools, and communities,” said Health and Human Services Secretary Alex Azar in a press release. “We will not stand idly by as these products become an on-ramp to combustible cigarettes or nicotine addiction for a generation of youth.”

Len Horovitz, MD, a pulmonologist at Lenox Hill Hospital in New York City, welcomes the proposed ban.

“We know that at the very least e-cigarettes can be a pathway to smoking real cigarettes, which are certainly the worst habit that a person can encounter,” he says. “A nicotine-containing e-cigarette is certainly something that leads to health problems, and we really don’t know about all the additives in addition to nicotine.”

Outbreak of Lung Illnesses Spells Dangers

Health officials have been pleading people across the country to stop vaping as they investigate hundreds of cases of mysterious pulmonary illness, mostly among teenagers and young adults.

All those affected so far have used e-cigarettes. Reports show that products may have contained the cannabinoid THC oil and/or nicotine. Officials suspect that exposure to a chemical contaminant is the cause, but they have not identified the toxin or any specific products that contain the harmful ingredient.

An oil derived from vitamin E has been a suggested culprit, according to some reports, but the info so far is insufficient to draw a conclusion.

“We know that some laboratories have identified vitamin E acetate in product samples, and we have connected those laboratories with the FDA forensic laboratories to compare results,” said Dana Meaney Delman, MD, the incident manager heading up the CDC 2019 Lung Injury Response, in a telebriefing. “At this time, no one device, product, or substance has been linked to all cases.”

The NY State Department of Health says that samples from the cannabis vaping products it tested revealed very high levels of vitamin E acetate.

Though the recent illnesses have been linked to cannabis, the new e-cigarette ban leaves out marijuana-related products. Marijuana, however, is already illegal under federal law.

Ban Is Part of an Established Meltdown

On August 8, 2016, the FDA introduced regulations requiring e-cigarette products to get premarket authorization. The compliance policy the FDA anticipates announcing in the coming weeks will reveal how the agency intends to enforce rules regarding the sale of nontobacco-flavored e-cigarette products that lack premarket authorization.

The FDA has already been holding retailers and manufacturers accountable for practices that led to increased sales to youngsters. It has issued more than 8,600 warning letters and more than 1,000 fines to retailers regarding sales to minors of electronic cigarettes and their components.

Recently, the FDA warned e-cigarette maker Juul Labs about marketing its product as a less harmful alternative to smoking cigarettes. In a letter dated September 9, 2019, the FDA said that the company’s claims were “particularly concerning” because they were directed at youths. The FDA gave Juul 15 working days to submit a response describing what corrective actions it is taking.

“The perpetual progress we’ve made in reducing youth tobacco use in the U.S. is jeopardized by this onslaught of e-cigarette use,” said acting FDA Commissioner Ned Sharpless, MD in a press release. “Nobody wants to see children becoming addicted to nicotine, and we will continue to use the full scope of our regulatory authority thoughtfully and thoroughly to tackle this mounting public health crisis.”

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