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FDA Extends Authority Over E-Cigarettes, Receives ASCO's Praise

Surabhi Dangi-Garimella, PhD
With reports documenting the shockingly rising use of e-cigarettes by middle and high school children, the announcement today that the FDA will extend its regulatory authority to include e-cigarettes is welcome news.
With reports documenting the shocking increase in use of e-cigarettes by middle and high school children, the announcement today that the FDA will extend its regulatory authority to include e-cigarettes is welcome news.

The increased use by young children is not a coincidence—rather, the tobacco industry seems to be targeting this population, what with flavors such as kool aid, gummi bear, and chocolate. Additionally, data released by the CDC showed that nearly 70% of teenagers are exposed to advertisements for these products, which should be a major public policy concern. Under the new regulations, sale of e-cigarettes would be banned to those below 18 years of age, in addition to the need for proper identification for age confirmation. The new rules will be effective in about 3 months.

The FDA is also forcing manufacturers of these products to increase the transparency on product ingredients, manufacturing processes, and scientific data. Ban on distributing free samples, regulatory inspections of production sites, and certain marketing limitations are also expected.

The reaction to the new laws have been mixed, as would be expected. The American Society of Clinical Oncology (ASCO) has welcomed the announcement. “ASCO applauds the FDA for exercising its congressionally-mandated authority to regulate cigars, hookah tobacco, electronic cigarettes (e-cigarettes) and other electronic nicotine delivery systems (ENDS). This is a crucial step in further regulating deadly tobacco products and ascertaining the true risks and potential health benefits of using ENDS,” said Julie Vose, MD, MBA, FASCO, president of ASCO, in a statement released in response to the announcement.

Addressing the negative impact of these products on children, Vose added, “Most importantly, we are concerned that e-cigarettes may encourage nonsmokers, particularly children, to start smoking and develop a nicotine addiction. FDA regulation will minimize the potential negative consequences of e-cigarettes and other ENDS without undermining their potential to reduce harm as a smoking cessation tool.”

A trade organization representing the tobacco industry, the American Vaping Association, however, believes that the FDA has gone too far. Citing the high costs associated with submitting documents for approval to the FDA, the trade group equated the rule to prohibition.

According to the FDA, companies that already have products on the market will have 2 years to submit an application for their product.

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