FDA struggles with limited powers on e-cigarettes

The U.K. government snuffed out vaping almost before it began, providing a lesson for the U.S.

The Trump administration, led by outgoing FDA Commissioner Scott Gottlieb, is struggling to curb the rise of teen e-cigarette use by issuing rules with authority only recently given to it by Congress. The U.K. avoided a similar rise in vaping by quickly enacting sweeping laws limiting the production and sale of vaping products.

Electronic cigarette use is considerably lower in the U.K. than in the U.S. In 2018, about 37.3 percent of U.S. teenagers reported trying e-cigarettes, versus only 13 to 22 percent of U.K. teens.

“We have different rules regarding nicotine content, regarding advertising and marketing, as well as regulatory oversight. It shouldn’t make it terribly surprising that we’re seeing different results,” said Matthew Myers, president of the Campaign for Tobacco-Free Kids.

The European Union Parliament, with jurisdiction over the U.K., enacted the Tobacco Products Directive in 2016, two years before Gottlieb called teen vaping an “epidemic.” The directive regulates the sale and marketing of tobacco and e-cigarette products, prohibits flavored tobacco, which appeals particularly to teens, and sets safety and quality standards for e-cigarettes. One year later, the regulation was amended to set a cap on nicotine content for e-cigarettes, limiting their addictiveness.

The United Kingdom has a long tradition of aggressive tobacco regulation. It has enacted measures to protect youth from tobacco since 1933. The landmark Tobacco Advertising and Promotion Act of 2002 banned public advertising of tobacco on television and radio, in print, and online.

[Related: Gottlieb warns the FDA could ban e-cigarettes like Juul altogether]

President Obama signed a similar bill in 2009 called the Family Smoking Prevention and Tobacco Control Act, to monitor tobacco advertisements, marketing strategies, and health warning transparency. Before Obama signed it into law, the FDA had no authority over the tobacco industry.

After the FDA gained authority over tobacco regulations, Gottlieb, who had previously been regarded as a deregulator, rushed to try to limit teen vaping, fearing that e-cigarette use could lead young people to smoke and thus reverse the decline of smoking. As commissioner, he ruled in 2016 — the same year the EU had passed stringent e-cigarette restrictions — that e-cigarettes and vape pens qualify as tobacco products and should be regulated in the same way as cigarettes.

“We don’t have the ability to quickly put in place the kind of marketing restrictions they have,” explained Myers.

In some ways, U.S. regulations also make it harder to sell products that would ensure people don’t get hooked on tobacco. If an e-cigarette manufacturer wanted to introduce a lower-level nicotine liquid into the U.S. markets, the company would have to submit a new application, including numerous clinical trials, to the FDA to be reviewed for approval.

Because U.K. e-cigarettes contain a less damaging concentration of nicotine, leading to lower rates of abuse, researchers in the U.K. have said that vaping can serve as a sustainable smoking cessation tool for adults trying to quit smoking combustible tobacco. The FDA disagrees, although vaping advocates say that e-cigarettes are safer smoking alternatives and warned that Gottlieb’s crackdown will hurt the people it’s meant to help.

[Opinion: While the FDA punishes vapers, new study touts vapings’ benefits]

The Royal College of Physicians, a U.K. doctor-led organization that works with politicians and regulators to improve the healthcare system, released a report in 2016 that found that the benefits of using low-nicotine vaping pens far outweigh the risks compared to smoking combustible cigarettes.

While effectively preventing the upward trend in youth vaping seen in the U.S., the U.K.’s attitude toward vaping may change as a Brexit deal looms. U.K. e-cigarette advocates and public health officials are pushing for more lenient policies toward marketing vaping products. If Brexit comes to pass, the Tobacco Products Directive would no longer have force, so the U.K. could drastically alter its established regulations of vaping products.

Secretary of State for Health and Social Care and member of the House of Commons Jeremy Hunt wrote in PoliticsHome, “We have already committed to looking closely at the legislation on tobacco control, including on e-cigarettes. We can be more ambitious for health improvement and public health, not less, when we leave the EU.”

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