On Tuesday, U.S. Reps. Debbie Wasserman Schultz, D-Fla., and Diana DeGette, D-Col., led more than 40 members of Congress in sending a letter the U.S. Food and Drug Administration (FDA) to prioritize the need to protect youth from nicotine and tobacco products as it conducts its reviews of e-cigarettes and other flavored tobacco products.
The FDA is currently reviewing premarket tobacco applications (PMTAs) for flavored electronic cigarettes. The FDA has permitted many of these flavored products – which have proven to be highly addictive and attractive to children – to remain on the market pending FDA review. In the letter, the lawmakers specifically call on FDA to remove from the market all flavored e-cigarettes that are currently under FDA review, to deny applications for any flavored e-cigarettes and other flavored tobacco products, and to deny issuing a marketing order for any e-cigarette that poses an increased risk of youth initiation or addiction.
Other members who signed the letter include U.S. Rep. Kathy Castor, D-Fla., Ted Deutch, D-Fla., and Darren Soto, D-Fla.
The Campaign for Tobacco-Free Kids, American Heart Association, Parents Against Vaping e-cigs (PAVe), National Association of Secondary School Principals (NASSP), Preventing Tobacco Addiction Foundation/Tobacco 21 and American Lung Association are backing the letter which is below.
Dear Acting Commissioner Woodcock,
We are writing to express our concern about increased youth tobacco use. According to a February 16 report titled, “Perspective: FDA’s Progress on Review of Tobacco Product Applications Submitted by the Sept. 9, 2020 Deadline,” (FDA Progress Report) the FDA currently is in the process of reviewing premarket tobacco applications (PMTAs) submitted by the September 9, 2020 court-ordered deadline. This includes numerous applications for flavored electronic cigarettes (e-cigarettes) that currently are available on the market. As FDA conducts its science-based reviews of these products, we urge you to prioritize the need to protect youth from nicotine and tobacco.
Flavored e-cigarettes are putting a new generation of kids at risk of nicotine addiction and the serious health harms that result from tobacco use. And these products are widely available and popular with kids. Unfortunately, the vast majority of these tobacco products that are undergoing premarket review have already been on the market for several years with observable negative consequences for public health. As such, we believe the FDA should take the following actions: (1) end its enforcement exemptions for both menthol and disposable e-cigarettes and clear the market of all flavored e-cigarettes until properly reviewed; (2) deny any premarket tobacco applications for flavored e-cigarettes and other flavored tobacco products; and (3) deny authorizing the marketing of any e-cigarette that poses an increased risk of youth initiation or addiction.
Flavored e-cigarettes and other flavored tobacco products have been widely available on the market for several years without FDA review to evaluate their effects on public health. Today, e-cigarette use by youth remains at what FDA calls “epidemic proportions” and e-cigarettes have been the most commonly used tobacco products among youth since 2014 – and flavors are a key reason why. The National Youth Tobacco Survey (NYTS) data show that 3.6 million young people used e-cigarettes in 2020—the same number that led FDA and the U.S. Surgeon General to first declare youth e-cigarette use an “epidemic” in 2018. In 2020, 38.9% of high school users (up from 34.2% in 2019 and 15.5% in 2014) and 20% of middle school users (up from 18% in 2019) were frequent users of e-cigarettes, reporting use on at least 20 of the preceding 30 days.
This escalating youth addiction data reflects the market dominance of products, like Juul, that have a high abuse liability, due to their high nicotine content. E-cigarette makers have lured kids with appealing flavors and hooked them with massive doses of nicotine. According to the CDC, most e-cigarettes contain nicotine and nicotine is a highly addictive drug that can harm adolescent brain development and can negatively impact attention, learning, mood, and impulse control in youths. This stark reality should guide FDA in implementing premarket review and preclude the authorization of e-cigarettes likely to contribute to the current crisis.
FDA’s Progress Report indicates that PMTAs for products with the greatest market share will be reviewed first, which may suggest that companies with a strong market presence, like Juul, may be the first product to receive, or be denied, FDA authorization. We believe companies such as Juul have been primarily responsible for fueling the youth e-cigarette epidemic. As such, continued marketing of this product and similar products should not be found “appropriate for the protection of the public health,” the statutory standard that must be met for an order allowing new tobacco products to be sold. We fear that authorizing a marketing order for Juul would establish a dangerous precedent, paving the way for authorization of thousands of other flavored and/or highly addictive e-cigarette products, which would cause damage to public health for many years to come.
We strongly recommend that FDA’s premarket review process require manufacturers to provide convincing evidence that their products do not increase youth use of nicotine and tobacco in ways that increase the risk of abuse and addiction among youth. Products that quickly addict new users, including youth, and then sustain addiction should not be allowed to stay on, or enter, the market.
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