FDA should be final authority on vaping


In late June, I wrote about how a global public health issue — vaping by young people — had made its way to a US court. It was a case of legal review, before a Washington DC appeals court, after the US Food and Drug Administration (FDA) banned global vaping producer Juul Labs from selling its e-cigarettes in the United States.

But while that case is pending, the New York Times reported on Tuesday that Juul “tentatively agreed to pay $438.5 million to settle a multi-state investigation into the company’s role in the teen vaping crisis.” The settlement “would prohibit the company from marketing to youth, funding education in schools, and misrepresenting the level of nicotine in its products.”

Locally, the Philippine Star published an Agence France Presse (AFP) report that Juul Labs would pay hundreds of millions over six to 10 years “to settle a probe by 34 US states that found the vaping company marketed to underage smokers.” Juul would pay “individual US states and pledge to not employ cartoons in ads or otherwise market to younger consumers.”

The AFP report, quoting an Oregon Department of Justice (DoJ) press release, also said Juul was found to have “willfully engaged in an advertising campaign that appealed to youth, even though its e-cigarettes are both illegal for them to purchase and unhealthy for children.” It also said Juul “relentlessly marketed to underage users with launch parties, advertisements using young and trendy-looking models, social media posts, and free samples.”

The Oregon DoJ also noted that Juul “used age verification techniques ‘that it knew were ineffective,’” prompting Oregon Attorney General Ellen Rosenblum to comment that “the conduct that led to this settlement was reprehensible and demonstrates pure corporate greed at its most damaging.” She added, “Just when we were starting to make serious progress reducing tobacco use among our young people, Juul came along and hooked another generation.”

Over at Washington DC, Juul went to court after the FDA banned its products but allowed e-cigarettes made by British American Tobacco and NJOY. Juul wants the Washington DC appeals court to keep its temporary restraining order on the ban, which it claimed was premature since the US FDA has yet to fully evaluate all of the company’s regulatory submissions for the approval of its e-cigarettes to be sold in the US.

A previous news report noted that the crux of the matter is the “potential risks of using” Juul Labs products, and “whether potentially harmful chemicals could leak from Juul pods” or e-cigarettes while in use. The legal issue is whether the FDA actually gave Juul a fair chance to prove the safety of its products by thoroughly reviewing its regulatory submissions.

And now, just over two months after the FDA ban, Juul agrees to pay $430 million to settle an investigation that was started two years ago by state officials in Connecticut, Oregon, and Texas, who were later joined by other states. While the Washington case and the settlement are separate and distinct, they are related with respect to raising doubts about the merits of vaping.

In the AFP report, Juul refers to the multi-million-dollar settlement as “a significant part of our ongoing commitment to resolve issues from the past,” as it insists its products meet US public health standards. To date, Juul continues to sell in the US Juul smoking device and cartridges in Menthol and Virginia Tobacco flavors.

Juul adds that it remains “focused on the future as we work to fulfill our mission to transition adult smokers away from cigarettes — the number one cause of preventable death — while combating underage use.”

The AFP report also quoted a September 2021 government study that noted more than two million American middle and high schoolers reported they were vapers in 2021, with eight in 10 using flavored e-cigarettes. Juul had been criticized previously for marketing fruit and candy flavored e-cigarettes, which it had stopped selling in 2019.

What matters now is how local regulators, and legislators, will appreciate the Juul settlement as well as the pending appeal of the US ban on Juul’s vaping products. As I wrote in late June, assuming that the US appeals court reverses itself and permanently allows the Juul ban, what will be the consequence and implication of this on vaping product sales in the Philippines?

In a case that ran for 11 years, the Supreme Court already upheld the authority of the Philippines’ Food and Drug Administration (FDA) to regulate cigarettes and tobacco products, noting that it has the “technical authority over matters of public health.” All future regulations regarding e-cigarettes and vaping products should recognize this.

But Senate Bill No. 2239 and House Bill No. 9007, ratified in December 2021, both transferred the regulation of vaping products from the FDA to the Department of Trade and Industry (DTI). In addition, the bills also lowered the access restriction on vaping products from 21 to 18 years old; allowed the sale of youth-appealing flavors other than plain tobacco and menthol; and, allowed online sales of e-cigarettes — all matters pertaining to the sale of vaping products to the youth — the very subject of the Juul settlement with 34 US states.

And while personally, I prefer a ban on the sale of cigarettes, tobacco products, e-cigarettes, and vaping products, the law — in all its wisdom — sees fit to allow the sale and use of such products, subject to certain regulations. Individual rights and liberties need protection as well, and this I also recognize.

But I don’t see any reason for vaping to be given more leeway than cigarettes. And in this line, I believe that legislators should consider that cigarettes and e-cigarettes, tobacco products, and vaping products, regardless of nicotine content, should all be regulated, restricted, marketed, and taxed in the same way. And final say on their use and sale should also be by the same agency — the FDA.

Marvin Tort is a former managing editor of BusinessWorld, and a former chairman of the Philippine Press Council

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