New FDA chief’s first move: Vaping

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Trine K. Tsouderos HRI Regulatory Center Leader, PwC US January 10, 2020

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In its first major policy move since Dr. Stephen Hahn took the helm in December, the FDA on Jan. 2 announced that the agency will prioritize its enforcement efforts against most e-cigarettes with flavors that appeal to children.

In 2016, companies marketing electronic nicotine delivery systems, also known as e-cigarettes, were required to gain premarket authorization from the FDA, but the agency has generally deferred enforcement of those requirements.

The January guidance warns the industry that it will use its regulatory powers over e-cigarettes and vaping liquids to focus on cartridge-based e-cigarette products, except tobacco and menthol flavors. The agency also said it would be targeting products that appear to be aimed at children.

“As we work to combat the troubling epidemic of youth e-cigarette use, the enforcement policy we’re issuing today confirms our commitment to dramatically limit children’s access to certain flavored e-cigarette products we know are so appealing to them – so-called cartridge-based products that are both easy to use and easily concealable,” Hahn said in a statement. “We will continue to use our full regulatory authority thoughtfully and thoroughly to tackle this alarming crisis that’s affecting children, families, schools and communities.”

The agency decided to target most flavored products in reaction to a dramatic surge in vaping among minors and a sweep of serious illnesses associated with it. The 2019 National Youth Tobacco Survey found that more than 5 million American middle and high school students had used an e-cigarette within the past 30 days; 1.6 million vape 20 or more days a month.

As of Jan. 9, the CDC had received reports of nearly 2,600 hospitalizations and had confirmed 57 deaths from an outbreak of lung injuries related to e-cigarettes that began in June. Additionally, a recent study found that e-cigarette use alone or with traditional cigarettes increased adults’ risk of developing chronic obstructive pulmonary disease, chronic bronchitis, emphysema or asthma.

Starting in early February, companies that do not stop the manufacture, distribution and sale of most e-cigarettes risk FDA enforcement action, which could include fines and product seizures. The policy excludes tobacco- and menthol-flavored e-cigarettes because they are less popular with minors than those with flavors like mint and fruit. Liquids and devices for open-tank vaping systems, typically sold in vape shops and not as popular among kids, also aren’t a priority.

HRI impact analysis

Hahn’s first major policy announcement as FDA chief attempts to address two competing perspectives on vaping: that the industry is creating too many new, young nicotine users attracted to its fruity and minty flavors and that it is helping adult smokers transition away from tobacco products.

Still, the FDA policy fell short of the actions health advocates say are needed to prevent minors from vaping. “The AMA is disappointed that menthol flavors – one of the most popular – will still be allowed, and that flavored e-liquids­ ­will remain on the market, leaving young people with easy access to alternative flavored e-cigarette products,” its president, Dr. Patrice Harris, said in a statement.

The FDA held open the door for more action against e-cigarette makers if it becomes aware of increased use among youth of products not included in the new policy. The agency also vowed enforcement against manufacturers of any vaping products that promote use by or are targeted to minors via kid-friendly advertising.

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Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Crystal Yednak

Senior Manager, Health Research Institute, PwC US

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